bioihbjkbjnl/mcl2 huggingface dataset:
Compare the Efficacy of Different Laryngeal Mask Size Selection Methods in General Anesthesia in Children
Condition: Airway Management
Study type: Interventional

Summary: 
      The laryngeal mask is widely used in general anesthesia in children. Selection of an
      appropriately sized laryngeal mask airway (LMA) is critical to ensure safe and effective use
      of the device. In children, the appropriate size of the LMA to be used is usually determined
      by the patient's weight. Up to now, this is the gold standard method, but the weight-related
      technique is not always possible. The patient's weight is sometimes unknown or medical staff
      do not remember the relationship between weight and size. Moreover, there are no constant
      correlations between laryngeal airways and body indices such as height and weight, so that
      the standard method could cause an inappropriate size of laryngeal mask airway to be chosen.
      Researchers from Spain introduced a new technique to determine the size of the LMA in
      children by choosing the LMA that best matched the combined widths of the patient's index,
      middle and ring fingers, but needs to be formally evaluated in clinical application. In order
      to compare the application effects of two methods (weight-related and three-fingers), we
      designed a research plan.
    

Detailed description: 
      The allocation sequence is generated by computer random number generation, and the allocation
      is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment
      and data collection are performed by trained research staff who are not involved in the care
      of the patients. The treating clinicians are not blinded to the assignment group, but all
      other staff involved in both the collection and collation of data are blinded to group
      allocation. The primary measurement is the oropharyngeal leak pressure (OLP) at the
      recommended intracuff pressure. The secondary measurements included insertion time,
      fibreoptic view grade, insufficient ventilation, and the occurrence of complications such as
      postoperative sore throat. The sample size was calculated to be 390 by a statistical software
      based on previous research results. The continuous variables were expressed as means ±
      standard deviation (SD) whereas categorical variables were expressed as frequency and
      percentage for data description. P <0.05 was considered statistically significant.
    

Intervention name(s): use the three-finger method; use the weight-related method
Intervention type(s): Procedure; Procedure
Intervention description(s): The size of the laryngeal mask airway was determined by choosing the laryngeal mask that best matched the combined widths of the patient's index, middle and ring fingers.; The size of the laryngeal mask airway was determined by the patient's weight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: airway; anaesthesia; laryngeal mask airway; paediatric
Neural Mechanisms of Cost and Benefit Integration During Decision-Making, Aim 2: Acute & Lifetime Stress
Condition: Healthy
Study type: Observational

Summary: 
      The central aim of this study is to characterize how the costs of acute and lifetime stress
      affect the neural architecture for decision-making in healthy humans. Investigators will use
      behavioral choice paradigms to measure how the costs of stress influence decisions about
      rewards (e.g., foods, money) as well as decisions about the use of self-control strategies.
      They will further examine associations between these stress measures and other decision
      variables commonly studied in our lab which have well-understood mechanisms, such as risk
      preferences. This behavioral work lays the foundation for an fMRI experiment that combines
      our measures of the behavioral costs of stress with neural measures of brain changes. Acute
      stress will be measured using a physiological stressor (cold-pressor task) coupled with
      saliva sample collection for cortisol analysis. Lifetime stress will be measured using a
      computerized life stress survey. We will study three cohorts: One purely behavioral cohort
      will be examined on-site (n=60). In a smaller subset of participants (n=40), investigators
      will measure neural activity changes in relevant brain areas as measured with MRI during
      decisions to use self-control in the presence of rewards. In a larger sample (n=500) the
      correlation between participants' risk preferences and lifetime stress exposure at scale
      using Amazon Mechanical Turk subjects will be measured.
    


Intervention name(s): Cold-Pressor Task (CPT); Control CPT; fMRI
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes.; The control CPT involves participants submerging their dominant forearm in warm water (~30°C) for 3 minutes.; Participants in the neuroimaging cohort will complete up to two fMRI experimental sessions on different days, with at least a day between sessions, each lasting approximately 2 hours. Imaging data will be collected with a Prisma 3T head- only scanner equipped with a head coil from Nova Medical.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be healthy males and females between ages of 18-64 reflecting the
        demographics of NYU Washington Square and New York area.
Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
Condition: Facelift
Study type: Interventional

Summary: 
      Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among
      female and male patients of all ages. Different technologies are presently available to
      rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL),
      however radiofrequency has emerged as the most effective and versatile modality for the
      broadest range of body and facial treatments, including non-invasive wrinkle treatment.

      The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is
      based on three or more electrodes designed to deliver RF current focused into the skin, thus
      generating heat in the dermal layer. Selective and focused electro-heating of the skin is
      intended to stimulate collagen remodeling in the dermal layer resulting in non invasive
      wrinkle treatment.

      The apollo™ system is intended for use in dermatologic and general surgical procedures for
      non invasive treatment of facial wrinkles and rhytides. This study was designed in order to
      evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides
      treatments.
    


Intervention name(s): apollo device
Intervention type(s): Device
Intervention description(s): RF treatments for wrinkles and rhytides reduction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wrinkles reduction; rhytides reduction; RF treatment
Neurogenic Inflammation in Peri-implant and Periodontal Diseases
Condition: Neurogenic Inflammation; Periimplant Diseases; Periodontal Diseases; Gingival Crevicular Fluid; Periimplant Sulcular Fluid
MeSH terms: Periodontal Diseases; Neurogenic Inflammation; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Regulatory effects of some neuropeptides substance-P (SP), neurokinin-A (NKA), calcitonin
      gene-linked peptide (CGRP) and neuropeptide-Y (NPY) )on inflammatory responses in periodontal
      disease has been described; however, the impact of neuropeptide levels are not clearly
      defined in healthy and diseased peri-implant tissues.ın order to evaluate the situation,
      thirty-nine implants that have been loaded over the past 12 months and their symmetrically
      matching teeth were evaluated using a split-mouth study design. Clinical periodontal
      examinations included the Silness-Löe plaque index, Löe-Silness gingival index, bleeding on
      probing, probing pocket depth and clinical attachment level parameters were determined.
      Gingival crevicular fluid (GCF)/Periimplant sulcular fluid (PISF) samples were collected, and
      the levels of the neuropeptides were determined by enzyme-linked immunosorbent assay.
      Correlations between GCF/PISF neuropeptide levels and the clinical examination parameters
      were evaluated in the peri-implant/periodontal soft tissues.
    


Intervention name(s): gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection
Intervention type(s): Diagnostic Test
Intervention description(s): GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thirty-nine male, systemically healthy adult individuals (35-55 years old) and 39 dental
        implants were recruited for the present study. The same implant system was utilized for the
        treatments and the clinical treatment procedures were completed by the same two clinicians
        at the Ondokuz Mayis University Dental Faculty between 2011 and 2013.
      
Biospecimen description: 
      gingival crevicular fluid
Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.
Condition: Anesthesia; Local Anesthesia
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To
      offer an satisfied surgery process for patients, a proper sedation is necessary. So in this
      study, we want to investigate the influence of two different sedative drugs on outcomes of
      patients received hip replacement surgery .
    


Intervention name(s): propofol; dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): For patients in Group P, the sedation was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.; For patients in Group D, the sedation was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. The depth of sedation was considered enough when patient was unresponsive to voice.
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Sprayshield as Adhesion Barrier System for Obese Patients
Condition: Severe Obesity
MeSH terms: Obesity, Morbid; Tissue Adhesions
Study type: Observational

Summary: 
      The application of SprayShield during a laparoscopic band removal (first surgical step) will
      be evaluated to see if the postoperative adhesions between the stomach, the left liver and
      the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or
      a sleeve gastrectomy.
    

Detailed description: 
      Monocenter and observational study on 20 obese patients, requiring removal of the gastric
      band for poor results (weight regain or insufficient weight-loss) or mechanical complications
      of the band ( slippage, esophageal dilation) and schedule for a second step surgery of
      gastric bypass or sleeve gastrectomy 2 months later.
    

Intervention name(s): ablation of gastric
Intervention type(s): Procedure
Intervention description(s): Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie in wing
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obese male or female who would benefit from a gastric band removal and for whom a second
        surgical step with conversion to sleeve gastrectomy or bypass is scheduled
      
Keywords: Adhesion barrier system; Bariatric surgery
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
Condition: Lung Injury, Acute
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an early phase (phase IIa), randomized, multi-center study in subjects with acute
      lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is
      to investigate the safety of GSK2586881 and to determine what effects it has on people with
      Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).

      The study has two parts: Part A will be an open-label investigation in five subjects. Part B
      will be a double-blind, placebo controlled investigation and will involve approximately 60
      subjects.
    

Detailed description: 
      The acute respiratory distress syndrome (ARDS) is a form of severe acute lung injury (ALI)
      characterized by hypoxemic respiratory failure (the lungs are unable to absorb oxygen to the
      arterial blood) and non-cardiogenic pulmonary edema (accumulation of fluid in the lungs). The
      syndrome may be caused by direct or indirect injury to the lungs. It is associated with a
      mortality rate of up to 40-50%. There are no marketed pharmacologic therapies for this
      devastating syndrome.

      This study aims to assess the safety, tolerability and pharmacodynamics of GSK2586881, a
      recombinant human angiotensin converting enzyme type 2 (rhACE2).

      ACE2 is involved in the Renin-Angiotensin System (RAS), which controls blood pressure,
      electrolytes and intravascular fluid volume. A key function of rhACE2 is believed to be the
      cleavage of Angiotensin II (Ang II) to Ang (1-7), which have opposing physiological roles.
      Elevated levels of Ang II are associated with vasoconstriction, inflammation, fibrosis,
      vascular leak, and sodium absorption. Ang (1-7) appears to be a counterregulatory protein in
      the RAS; associated with vasodilation, anti-proliferation, antiinflammation, and reduced
      vascular leak. It has been observed that levels of Ang II are increased in humans with ALI/
      ARDS. It is expected that the reduction of Ang II should have a positive impact on ALI and
      ARDS.
    

Intervention name(s): Dose 1 GSK2586881; Dose 2 GSK2586881; Dose 3 GSK2586881; Dose 4 GSK2586881; Placebo (saline)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Low dose GSK2586881 administered intravenously; Medium dose GSK2586881 administered intravenously; Medium-High dose GSK2586881 administered intravenously; High dose GSK2586881 administered intravenously; Administered intravenously to match intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rhACE2; Acute Respiratory Distress Syndrome (ARDS); Acute Lung Injury; GSK2586881; critical care
MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME IN ELDERLY
Condition: Healthy
Study type: Interventional

Summary: 
      Question: Does manual diaphragm release change kinematics and respiratory function of elderly
      subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.

      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control
      Group (CG) and 08 in the Intervention Group (IG).

      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten
      deep breaths, with a one minute interval between them. The CG underwent a sham protocol
      (light touch), with same sets and time of interval.

      Outcome measures: The groups were evaluated using spirometry, manovacuometry and
      optoelectronic plethysmography (OEP), in that order, before and immediately after the
      intervention.
    


Intervention name(s): Sham manual diaphragm release technique; The manual diaphragm release technique
Intervention type(s): Other; Other
Intervention description(s): For this group, light touch at the same anatomical points was done without exerting pressure or traction. Positioning and duration were identical to the IG to perform the sham protocol (Licciardone & Russo, 2006).; To perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: elderly; subjects
Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral
      activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to
      patients who either failed to have at least a 100-fold HCV reduction at Week 12 of standard
      therapy or still have detectable HCV at Week 24.
    

Detailed description: 
      Previously untreated chronic hepatitis C patients undergoing therapy with peginterferon alfa
      and ribavirin have a very poor probability of achieving a sustained virologic response if
      they either do not have a 100-fold or greater reduction in their plasma HCV RNA levels at the
      12th week of treatment or have detectable plasma HCV RNA at the 24th week of treatment. ISIS
      14803 is an experimental antiviral medication for the treatment of chronic hepatitis C that
      has been given to chronic hepatitis C patients in two previous single-agent clinical trials
      (approximately 70 patients).

      In this clinical research study, 12 weeks of ISIS 14803 treatment will be added to the
      peginterferon alfa and ribavirin treatment regimen of previously untreated chronic hepatitis
      C patients who have a very poor probability of achieving a sustained virologic response based
      upon either of the above two criteria. Enrolled patients must continue to be treated with
      peginterferon alfa and ribavirin and must begin ISIS 14803 treatment within four weeks of
      their HCV RNA result report date. ISIS 14803 will be given as a two-hour intravenous
      infusion, two times each week, for 12 weeks. Depending on their HCV response to the
      three-drug combination, patients may continue treatment with peginterferon alfa and ribavirin
      after the end of ISIS 14803 treatment. Patients will be monitored for at least eight weeks
      (for safety) after the end of ISIS 14803 treatment and possibly for longer (for sustained
      virologic response). Two dose levels of ISIS 14803 will be studied in this trial, 3 and 6
      mg/kg ideal body weight.
    

Intervention name(s): ISIS 14803, peginterferon alfa, ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Ribavirin
Primary purpose: Treatment
Keywords: Hepatitis; Chronic
Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The aim of our study was to compare the daily living activities with a performance-based
      protocol in lung cancer patients and healthy controls.
    

Detailed description: 
      Lung cancer is the abnormal proliferation of cells in the lung tissue and a mass in the lung.
      The primary symptoms of this health problem include cough, dyspnea, chest pain, hemoptysis
      and sputum. In addition to these symptoms, muscle strength, respiratory function and effort
      level are decreased.

      Inadequate daily living activities in cancer patients are expressed.But studies evaluating
      the activities of daily living in patients with lung cancer are inadequate and patients are
      evaluated only using scales. For the measurement of functional status in daily living
      activities, these scales provide important information about the detection of symptoms and
      the progression of the disease. However, it is very difficult to determine the limitation of
      perceived difficulty in daily living activities with these scales. In addition, since these
      scales are a method of measurement, the objectivity is open to discussion. It is thought that
      a performance-based protocol will facilitate the detection of limitations and provide more
      objective findings. We think that the Londrina protocol fully reflects the activities of
      daily living and thus will give us an objective measurement.

      This study will show us the problem and its cause in daily life activities in patients with
      lung cancer.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals who are diagnosed with Lung Cancer at Hacettepe University and who reffered to
        the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to
        participate in the study will be included in the study.
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder
Condition: General Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the long-term safety and tolerability of tiagabine treatment in patients with
      generalized anxiety disorder (GAD).
    


Intervention name(s): GABITRIL (tiagabine hydrochloride; CEP-6671)
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg
      tablets of linagliptin
    


Intervention name(s): Linagliptin, low dose; Linagliptin, medium dose; Linagliptin, high dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment