bioihbjkbjnl/mcl2 huggingface dataset:
Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask
Condition: Tracheostomy Complication
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      In this study, our primary goal is to compare whether there is any difference in the
      complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided
      percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of
      processing time.
    

Detailed description: 
      Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee,
      61 cases over the age of 18 who were scheduled for elective percutaneous dilatation
      tracheostomy in intensive care units were included in the study.

      Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups.
      Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.

      In the endotracheal tube group, which is a conventional method, after entering the trachea
      with percutaneous technique, the intubation tube was removed before dilatation and
      percutaneous dilatation tracheostomy was performed with the Seldinger method.

      In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a
      pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation
      tracheostomy was performed using the Seldinger Method.

      Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical
      ventilation mode, positive end expiratory pressure and mean airway pressure values were
      recorded before and 30 minutes after the procedure.

      The time until the end of the procedure and complications were determined.
    

Intervention name(s): Percutaneous Dilatation Tracheostomy
Intervention type(s): Procedure
Intervention description(s): pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.
Other intervention name(s): Bronchoscopy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: percutan tracheostomy; bronchoscopy; pro-seal Laryngeal mask
Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a research study designed to compare the single-dose efficacy of
      albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose
      inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.
    


Intervention name(s): Albuterol-HFA-MDI; Albuterol-HFA-BAI
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation Aerosols, 90 mcg, 1 dose per treatment period; Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
Other intervention name(s): Albuterol; ProAir; Albuterol
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma and Poor Coordinators of Asthma Inhalers
Intra-Arterial Microdosing: Proof-of-Concept in Humans
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this protocol is to demonstrate that intra-arterial administration of a drug
      can generate information in a manner that faithfully mimics effects of systemic
      administration but with little or no systemic effects.
    

Detailed description: 
      IAM is a novel approach combining the methodologies and techniques of 'microdosing' and
      'intra-arterial drug delivery' to test new drugs in targeted organs or tissues. The main
      feature of this approach is that when a microdose (defined as 1/100th of the total body
      minimal pharmacological dose) is given into a body area 1/100th of the total body mass - a
      temporary pharmacological concentration is generated in that area that may be sufficient to
      generate and detect a biomarker relevant to the drug's safety and efficacy. The drug then
      returns systemically and is diluted to become a subpharmacological microdose. The
      significance of the approach is in the ability to obtain information on novel drugs in humans
      in a safe manner.

      Insulin will be administered into the radial artery and compared with systemic
      administration. The effects on the ipsilateral hand will be compared with systemic effects
      and effects on the contralateral hand. The outcomes will be insulin pharmacokinetics, glucose
      and potassium levels, and 18F fluorodeoxyglucose (FDG) uptake as measured with Positron
      Emission Tomography (PET) imaging.
    

Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): Insulin will be administered either into the radial artery (microdose intervention) or IV (systemic intervention).
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Microdosing; Phase 0; Exploratory Investigational New Drug (IND); Intra-Arterial; PET Imaging
Fenoldopam in Pediatric Cardiac Surgery
Condition: Kidney Failure, Acute
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary
      bypass in young children with congenital heart disease is able to reduce indicators of acute
      kidney injury (biomarkers reduction, diuresis increase) compared to a control group.
    


Intervention name(s): Placebo; Fenoldopam
Intervention type(s): Drug; Drug
Intervention description(s): Saline continuous infusion during cardiopulmonary by pass at 1 ml/h; Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.
Other intervention name(s): saline; corlopam
Intervention MeSH terms: Fenoldopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: cardiopulmonary bypass; pediatric cardiac surgery; acute renal failure; renal biomarkers; fenoldopam; Focus on optimization of perfusion during pediatric CPB
Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
Condition: Current Smokers
Study type: Interventional
Phase: Phase 2

Summary: 
      Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary
      clearance
    


Intervention name(s): administration of Sinupret; administration of Bronchipret; administration of Sinupret Placebo; administration of Bronchipret Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Thymol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of [14C]-LY3537982 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in
      the bloodstream and how the body handles and eliminates LY3537982 in healthy participants.
      This study will involve a single dose of 14C radiolabeled LY3537982. This means that a
      radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to
      investigate the study drug and its breakdown products and to find out how much of these
      passes from blood into urine, feces and expired air. The study will also evaluate the safety
      and tolerability of LY3537982. The study will be conducted in two parts. The study will last
      up to 71 days and 61 days for part 1 and 2, respectively.
    


Intervention name(s): LY3537982; [¹⁴C]-LY3537982; [¹⁴C]-LY3537982
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered IV.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique
Condition: Guided Bone Regeneration
Study type: Interventional

Summary: 
      clinical study with guided bone regeneration for deficient alveolar ridge to restore the
      defect in width and be able to place implant with two different technique
    

Detailed description: 
      This study will be conducted to compare the bone formation with double layer graft technique
      versus standard protocol in GBR for horizontal ridge augmentation with staged implant
      placement

      Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically.

      Secondary outcome: Histological analysis of remodeled bone.
    

Intervention name(s): Double layer technique
Intervention type(s): Procedure
Intervention description(s): Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sausage technique
Intubation During Spinal Immobilization
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed
      in patients with immobilized cervical spine by unexperienced physicians.
    


Intervention name(s): Standard endotracheal tube; C-MAC
Intervention type(s): Device; Device
Intervention description(s): 1) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube; C-MAC introduced with a h size 3 blade.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endotracheal intubation; trauma; paramedic
Investigating the Pathophysiological Roles of Cortical, Sub-thalamic Nuclear and Pedunculo-pontine Nuclear Oscillation in Movement Termination of Parkinson Disease Patients
Condition: Parkinson's Disease; Deep Brain Stimulation
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The ERD and ERS patterns of coordination between the STN and cortical regions in the
      termination of volitional movement in PD patients.
    

Detailed description: 
      The project will investigate the roles of cortical regions, sub-thalamic nucleus and
      pedunculo-pontine nucleus in the preparation of volitional movement termination in patients
      with Parkinson's disease (PD)receiving deep brain stimulation. Currently there are two models
      of inhibitory preparation of volitional movements. The "withdrawal mechanism" posits the
      explanation that movement termination is due to the"shutting off" of the activated
      neuralcircuitry, whereas the "inhibition mechanism" suggests that inhibitory neural
      structures are activated to terminate the voluntary movement. These hypotheses were deduced
      from the study of scalp movement-related cortical potential recordings and how the deep
      structures involved in the execution in movement termination is uncertain. Movement
      preparation prior to movement onset (Mon) has been addressed in both scalp recordings of MRCP
      and from recent studies of STN in PD patients. However,the electro-physiologic information
      concerning the role of STN in the preparation of movement offset (Moff)is less understood. In
      our pilot study, we have found that high-beta event-related de-synchronization (ERD)appeared
      earlier (3 seconds prior to Mon) than those of low-beta and alpha for the Mon phasic
      movement.There was no alpha ERD for the Mon tonic movement. Alpha, low-beta, and high-beta
      ERD all appeared about 1 second prior to the Moff tonic movement. These findings suggest that
      STN participates in the preparation of volitional movement termination but via different
      mechanism from that in movement initiation.Unlike asynchronous ERD frequency bands present in
      movement initiation, a simultaneous ERD across wide frequency bands in STN may play a pivotal
      role in terminating volitional movement. Since there is tight connection between the cortical
      regions and STN, it is intriguing to know the relationship of these oscillatory patterns
      between the deep and superficial neural structures. In the current proposal, we will examine
      the patterns of ERD and ERS prior to Mon and Moff of tonic movements in both cortical and STN
      regions and determine the temporal relationship among them.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PD undergoing deep brain stimulation of the sub-thalamic nucleus.
      
Keywords: Parkinson's disease; sub-thalamic nucleus; oscillation; local field potential
A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the single dose pharmacokinetic profile (explores what
      a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in
      chinese participants with cancer (abnormal tissue that grows and spreads in the body) who are
      not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage of
      drug over time and higher doses of a drug are needed to get desired effect).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-dose study
      in adult chinese participants with cancer. The study will consist of a screening phase
      (within 21 to 1 days before admission to the research facility on Day -1) followed by a 4-day
      open-label treatment phase (Day -1 to Day 3). Participants will remain confined to the study
      center from Day -1 until completion of the end-of-study visit or withdrawal assessments,
      which will be done upon completion of the 48-hour pharmacokinetic sampling on Day 3, or upon
      early withdrawal. The total study duration will be approximately 24 days. All participants
      will undergo a naloxone challenge test (at a subcutaneous [under the skin] dose of 0.8
      milligram [mg]) for opioid dependency during the screening phase. Only those participants who
      pass this challenge test will be allowed to continue in the study. During the treatment
      phase, upon completion of a 10-hour overnight fast, participants will receive a single oral
      (having to do with the mouth) 8 mg dose of hydromorphone in the morning of Day 1. Serial
      blood samples will be collected immediately before and through 48 hours after dosing for the
      determination of plasma hydromorphone concentrations. Participants will be administered
      naltrexone 50 mg, to block the opioid effects of hydromorphone, 14 hours before, 2 hours
      before, and 10 hours after study drug administration. After the 10-hour dose, additional
      doses of naltrexone will be administered every 12 hours up to 34 hours postdose.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): Participants will be administered a single dose of Osmotic Release Oral System (OROS) hydromorphone tablet of 8 milligram (mg) orally on Day 1 under fasting conditions.
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Hydromorphone; OROS
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether fish oil supplements may be beneficial in
      preventing the recurrence of atrial fibrillation after cardioversion.

      Atrial fibrillation is a heart condition which can sometimes be successfully treated by a
      cardioversion.

      Cardioversion involves resetting the heart back to normal with the use of electric current.

      There is a tendency for the atrial fibrillation to recur , days weeks or even months after
      the cardioversion.

      Fish oil supplements may be of benefit to patients with heart problems Recent evidence
      suggests that fish oils may be beneficial to patients with rhythm disturbances.
    


Intervention name(s): Fish oil
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients
Condition: Ascites Infection
MeSH terms: Peritonitis; Hepatorenal Syndrome; Ascites
Study type: Interventional
Phase: Phase 2

Summary: 
      Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial
      peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum
      antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's
      diarrhea and prevention of hepatic encephalopathy.
    

Detailed description: 
      Prophylaxis against spontaneous bacterial peritonitis (SBP) in cirrhotic patients recovered
      from an episode of SBP using Norfloxacin 400 mg/day is currently established standard of
      care. Recently we are facing the growing challenge of standard SBP prophylaxis lacking
      efficacy as extended spectrum beta-lactamases and fluoro-quinolone resistant bacteria in
      isolates of patients on Norfloxacin.

      Prophylaxis against Hepatorenal Syndrome in decompensated liver cirrhosis is limited to IV
      administration of Albumin in patients who develop SBP and the prevention of SBP using
      Norfloxacin.

      this study aims to investigate the effectiveness of Rifaximin in decompensated cirrhotic
      patients against SBP as a secondary prophylaxis measure and Hepatorenal Syndrome.

      our study was non inferiority prospective non randomized controlled trial The study enrolled
      patients with chronic liver disease and ascites who were monitored at outpatient clinics or
      who were admitted to Ain Shams University hospitals.104 patients with decompensated liver
      cirrhosis were enrolled in the study, The Control Group (n=52), to receive standard of care
      treatment & Norfloxacin prophylaxis for the decompensated liver disease and a second
      Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original
      management.
    

Intervention name(s): Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Intervention type(s): Drug
Intervention description(s): Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months
Other intervention name(s): xifaxan
Intervention MeSH terms: Rifaximin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Study design: non inferiority prospective non randomized controlled trial
Study population and setting:
The study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals.
Sample size: 104 patients with decompensated liver cirrhosis were enrolled in the study. The Control Group (n=52), to receive standard of care treatment & Norfloxacin prophylaxis for the decompensated liver disease and a second Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original management.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rifaximin; Norflixacin; Spontaneous bacterial peritonitis
Clozapine and Olanzapine Treatment of Aggression
Condition: Schizophrenia
MeSH terms: Schizophrenia; Aggression
Study type: Interventional

Summary: 
      This was a double-blind randomized study with three treatment arms: clozapine, olanzapine and
      haloperidol. We compared these three medications in the treatment of aggressive behavior over
      a 12 week period.
    

Detailed description: 
      Objective: The purpose of our study was the investigation of the effect of atypical
      antipsychotic agents on interpersonal violence and aggression.

      We compared the efficacy of two atypical antipsychotic agents, clozapine and olanzapine with
      one another and with haloperidol in the treatment of physical assaults and other assaultive
      behaviors in physically assaultive patients with schizophrenia and schizoaffective disorder.

      Method: The subjects were 110 physically assaultive inpatients diagnosed with schizophrenia
      or schizoaffective disorder.

      They were randomly assigned to treatment with clozapine (N=37), olanzapine (N=37) or
      haloperidol (N=36) in a 12-week, double-blind trial. Incidents of overt aggression were
      recorded and their severity was scored with the Modified Overt Aggression Scale (MOAS).
      Psychiatric symptoms were assessed through the Positive and Negative Syndrome Scale (PANSS).
      We also assessed various side effects and monitored vital signs and drew bloods.
    

Intervention name(s): Clozapine; Olanzapine; Haloperidol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 mg/day; 20 mg/day; 20 mg/day
Other intervention name(s): clozaryl; zyprexa; Haldol
Intervention MeSH terms: Haloperidol; Olanzapine; Haloperidol decanoate; Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; aggression; clozapine; olanzapine
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood
Condition: Pregnancy; Parturition
Study type: Interventional

Summary: 
      1. To study the influence of antenatal classes for first time parents and their effect ob
           pregnancy, birth and parenthood.

        2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)

        3. Data on pregnancy, birth and parenthood are collected from register and questionaire
    

Detailed description: 
      Data collected contain register data and data from questionnaire, which also contains
      psychometric tests
    

Intervention name(s): Antenatal classes
Intervention type(s): Other
Intervention description(s): 3 sessions of 3 hours each
Other intervention name(s): 1. The delivery process, pain relief and coping strategy; 2. Infant care and breastfeeding; 3. The parental role and the relationship
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnancy; Parturition; Depression; Randomized; Antenatal classes