bioihbjkbjnl/mcl2 huggingface dataset:
Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty
Condition: Injury Throat
Study type: Interventional

Summary: 
      General anaesthesia demands securing patient's airway either with endotracheal tube or
      laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat.
      Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar
      throat.6 The primary end point of our study is to assess the incidence of soar throat with
      the use of NPA compared to LMA in patients receiving general anaesthesia during
      blepharoplasty.
    

Detailed description: 
      After approval of medical ethical committee at Ain-Shams University and obtaining written
      informed consent, 148 adult ASA II-III patients aged between 40 and 60 years old admitted to
      Ain-Shams university hospitals for blepharoplasty will be enrolled in this study.

      Patients will then be randomly and evenly divided into two equal groups (74 patients each)
      using computer-generated list:

      Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be
      applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be
      advanced into the dominant nostril along the septum horizontally.

      Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size.
      The LMA will be introduced along the hard palate towards the hypopharynx until resistance is
      felt.

      Anaesthesia will be maintained by sevoflurane 3-4% and propofol infusion 0.5-1
      mg.kg-1.hr-1.All patients will receive local infiltration anaesthesia given by the surgeon.

      At the conclusion of surgery, sevoflurane and propofol infusion will be discontinued and
      patients will inhale 100% O2 till spontaneous recovery.

      Recovery time will be recorded (defined as the time from discontinuation of anaesthetic drugs
      till response to verbal command).

      Incidence of postoperative soar throat, unsteadiness, nausea and vomiting will be recorded as
      well as patient and surgeon satisfaction.
    

Intervention name(s): Nasopharyngeal airway or laryngeal mask airway
Intervention type(s): Device
Intervention description(s): Comparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. The NPA will then be advanced into the dominant nostril along the septum horizontally.
Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Bronchoscopic Findings
Condition: Pneumonia
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Study type: Observational

Summary: 
      This study aims to determine whether interpretations of bronchoscopic results enable
      physicians to successfully predict the presence of pneumonia in traumatically injured
      patients.
    

Detailed description: 
      This study aims to determine whether interpretations of bronchoscopic results enable
      physicians to successfully predict the presence of pneumonia in traumatically injured
      patients. Bronchoscopies will be videotaped. The clinician doing the procedure will make
      prediction as to whether the patient, in fact, has pneumonia. In addition, at least one other
      physician will view the videotape and predict whether the patient has pneumonia.

      Once laboratory results are available, the physician predictions will be compared against the
      definitive laboratory determination
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Physicians working in the Surgical Intensive Care Unit
      
Biospecimen description: 
      Standard lavage specimens collected as part of standard of care and submitted for laboratory
      evaluation
    
Keywords: Pneumonia
Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes
Condition: Breastfeeding Duration; Exclusive Breastfeeding; Donor Milk Supplementation
Study type: Interventional

Summary: 
      This study is a randomized controlled trial seeking to determine whether supplementing
      infants at risk for excessive neonatal weight loss with a small volume of human donor milk
      prophylactically in the first 1-3 days of life, before maternal mature milk production
      (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2,
      and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk
      population.

      We hypothesize that supplementation of term infants who have lost greater than or equal to 5%
      birth weight by 36 hours of age with a small volume of donor breast milk following feeds,
      until mature milk production, will result in decreased supplemental formula use at 1 week and
      increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This
      study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive
      breastfeeding with offering early small-volume donor milk supplementation in a population of
      infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence
      of formula supplementation at 1 week of life and 2) improving breastfeeding duration.
    


Intervention name(s): Donor Milk
Intervention type(s): Other
Intervention description(s): breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
Other intervention name(s): donor breast milk; human donor milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breastfeeding; donor milk; formula; exclusive breastfeeding; newborn
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
Condition: Cerebral Palsy; Acquired Brain Injury; Neuromuscular Diseases in Children
MeSH terms: Brain Injuries; Cerebral Palsy; Neuromuscular Diseases
Study type: Interventional

Summary: 
      The goal of this clinical trial is to analyze the usability and safety of the prototype gait
      exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.

      Participants will use the exoskeletons in their home and the community and variables
      regarding safety and usability will be measured and recorded.
    

Detailed description: 
      Neurological and neuromuscular diseases are the main cause of motor disability in children,
      leading to the inability to stand and walk in many cases. Exoskeletons are a useful tool in
      the rehabilitation of these children, but most of them are designed to be used in the
      clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton designed to assist
      gait in children with motor disability in their homes and the community. The aim of this
      study is to analyze the safety and usability of the EXPLORER V2 as a proof of concept.

      A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the
      aim of evaluating safety and usability in healthy participants prior to the use of the device
      in children with neurological and neuromuscular disease (phases 1 and 2). After this,
      participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait
      analysis and 3 in their homes and the community.
    

Intervention name(s): EXPLORER V2
Intervention type(s): Device
Intervention description(s): 4 sessions of use of the exoskeleton, 1 in a laboratory of gait analysis and 3 in the home and the community of the participants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exoskeleton; cerebral palsy; acquired brain injury; neuromuscular disease; gait; rehabilitation
Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the Racecadotril pharmacokinetic linearity after single oral administration of
      10, 30 and 60 mg as a suspension.

      To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension)
      versus the reference sachet formulation (granules)
    

Detailed description: 
      This is a single center, open-label, single oral dose, 4-period cross-over study to assess
      the bioequivalence of a new formulation (suspension) in healthy male volunteers.
    

Intervention name(s): Racecadotril suspension; Racecadotril granules
Intervention type(s): Drug; Drug
Intervention description(s): Racecadotril suspension at 10, 30 and 60mg. Single oral dose.; Racecadotril granules at 60mg. Single oral dose.
Intervention MeSH terms: Racecadotril; Thiorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Acute Kidney Injury in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease; Kidney Injury; Kidney Diseases; Kidney Disease, Chronic
MeSH terms: Kidney Diseases; Acute Kidney Injury; Renal Insufficiency, Chronic; Anemia, Sickle Cell; Wounds and Injuries
Study type: Observational

Summary: 
      Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle
      cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis
      during SCD crisis on the development of AKI and the role for monitoring urine biomarkers
      during an admission for crisis and during well clinic follow-up.
    

Detailed description: 
      Patients admitted to the hospital for acute chest syndrome or vaso-occlusive pain events may
      consent to participate in this study. Patients will consent to daily blood and urine
      collection during their hospitalization and during well clinic visits.

      Each AM, participants will have blood and urine collected, processed, and strored for future
      analysis of hemolytic markers and biomarkers of kidney injury. Patients will also have strict
      urine output recorded. Acute kidney injury (AKI) will be defined by the current KDIGO
      definition based on either a rise in serum creatinine or decline in urine output. Patient
      medical course will be reviewed to determine interventions and outcomes of their admission
      based on the development of AKI.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with HbSS or SB0 thalassemia admitted to Children's of Alabama for a
        vaso-occlusive pain crisis or acute chest syndrome.
      
Biospecimen description: 
      Urine and blood will be stored in biorepository.
Impact of Human Embryo Culture System on Live Birth
Condition: Embryo Culture
Study type: Interventional

Summary: 
      Previous studies in human and different mammals have proved that the embryo group culture (in
      the same culture medium drop) using a reduced volume is associated with a better embryo
      development. This is due to the effect of different autocrine and paracrine factors secreted
      by the embryos. Besides, previous studies with embryos from human and other mammals have
      shown that a high oxygen concentration may have a negative effect on embryo quality due to
      the generation of reactive oxygen species, which cause oxidative stress. The embryo culture
      at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.

      The purpose of this study is to evaluate the combined effect of the embryo group culture and
      the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments.
      The specific goal is to compare the embryo group culture in a reduced volume of medium at a
      low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension
      (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®),
      whereas the second condition will be applied using a Heracell incubator (Heraeus®).
    


Intervention name(s): New Culture Condition; Standard Culture Condition
Intervention type(s): Procedure; Procedure
Intervention description(s): Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.; Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: grouped embryo culture; embryo density; low oxygen; benchtop incubator; culture condition
Bronchial Hyperreactivity in Children With Crohn Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Bronchial Hyperreactivity
Study type: Observational

Summary: 
      Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial
      hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two
      studies involving mainly adults.Our aim was to determine the frequency of bronchial
      hyperreactivity in pediatric patients followed and treated for Crohn disease.

      Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by
      spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO
      (FENO). The control group included patients evaluated for functional cough who had negative
      Methacholine Challenge Test (MCT).
    


Intervention name(s): Methacholine Challenge Test; Fractional Exhaled NO (FENO); Blood Test; PCDAI
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Methacholine challenge test to evaluate airway hyperreactivity; Fractional Exhaled NO to evaluate eosinophilic inflammation; Blood Tests (Eosinophil Count); Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)
Intervention MeSH terms: Methacholine Chloride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty-three children with Crohn disease in the age of 11 to 22 yr
      
Keywords: Crohn's Disease; Bronchial hyper reactivity; Fractional exhaled NO; Methacholine Challenge Test; Pediatric Crohn's Disease Activity Index; To determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease
Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and
      safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals'
      HPV vaccine GSK580299 in healthy female subjects.
    


Intervention name(s): Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™); Engerix™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular administration, 3 doses.; Intramuscular administration, 4 doses.
Other intervention name(s): GSK Biologicals' HPV vaccine 580299; GSK Biologicals' vaccine 103860
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human papillomavirus (HPV) vaccine; Hepatitis B; Cervical cancer; HPV; Papillomavirus
Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to
      assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared
      to cumulative doses of Proventil as an active control in subjects with mild to moderate
      asthma
    

Detailed description: 
      This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to
      assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses
      of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI)
      compared to cumulative doses of Proventil® hydrofluoroalkane (HFA; hereafter referred to as
      Proventil) as an active control in subjects with mild to moderate asthma.
    

Intervention name(s): AS MDI; Proventil
Intervention type(s): Drug; Drug
Intervention description(s): AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation; Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Facilitating Adolescent Self-Change for Alcohol Problems
Condition: Underage Drinking
MeSH terms: Alcohol-Related Disorders; Underage Drinking
Study type: Interventional

Summary: 
      This present multi-site investigation compares a voluntary brief intervention for adolescent
      alcohol problems to an educational comparison condition. Measures are taken at intake and at
      4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal
      change efforts and arrest progression of alcohol problems. This study tests cognitive
      mechanisms of change and treatment characteristics and processes associated with youth
      self-regulation to reduce or stop hazardous drinking.
    


Intervention name(s): Motivation interviewing based brief intervention; Standard Intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational [Patient Registry]

Summary: 
      The primary objective is to create a multicenter registry which captures information relating
      to the perioperative anesthesia course and management of children undergoing anterior
      cruciate ligament reconstruction and to examine practice patterns and incidence of
      complications. Data from any single institution involved in this registry will be used for
      local safety and quality improvement efforts. In addition data from each institution can be
      compared to the information from the entire group of institutions participating in the
      project, thus providing a measure for comparison with national practice. The aggregate
      multi-institutional data set will be used to develop quality benchmarks for national safety
      and quality improvement efforts and best practice recommendation. We believe that this
      registry can also demonstrate how web based data collection can be used to evaluate clinical
      anesthesia outcomes for surgeries with a low incidence of critical events but with
      significant variability in medical management.
    

Detailed description: 
      This multi institutional registry will capture data relating to perioperative practices and
      complications, some of which may be relatively infrequent. The goal of this group is to
      create this registry to be used for local safety and quality improvement and multi-center
      benchmarking in this population. Reports generated from the registry will provide individual
      institutions with comparative data showing how their site performs compared to composite
      averages from all participating sites. Queries of the composite data set may allow for
      identification of factors associated with improved outcomes in this population. Future
      queries of the data-base for research purposes will require approval of the participating
      members of SPAIN.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children undergoing scheduled surgical procedures on the anterior cruciate ligament in
        a hospital setting or surgical day center, aged 12-18 years old.
The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple
      Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in
      Healthy Adult Subjects
    


Intervention name(s): HEC110114 tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): administered orally once daily; Placebo will be administered orally at a dose and frequency matched to HEC110114
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment