bioihbjkbjnl/mcl2 huggingface dataset:
Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™
Condition: Difficult Airway
Study type: Interventional
Phase: Phase 4

Summary: 
      Supraglottic airway tools, one of the tools used in the management of the difficult airway.
      American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom
      airway management algorithms have included the LMA. In our study investigators aimed to
      determine which one will show the best performance with supraglottic airway means that LMA -
      Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created
      with attaching collar.
    


Intervention name(s): Laryngeal Mask Airway Classic
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study of AT2101 (Afegostat Tartrate) in Adult Patients With Type 1 Gaucher Disease Currently Receiving Enzyme Replacement Therapy
Condition: Gaucher Disease, Type 1; Type 1 Gaucher Disease; Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted to test the safety and tolerability of afegostat tartrate in
      participants with type 1 Gaucher disease already receiving enzyme replacement therapy.
    

Detailed description: 
      This was a Phase 2, open-label study in participants with Gaucher disease, a lysosomal
      storage disorder. Afegostat tartrate (also known as AT2101 or isofagomine tartrate) is
      designed to act as a pharmacological chaperone by selectively binding to misfolded
      β-glucocerebrosidase (GCase) and helping it fold correctly, intended to restore GCase
      activity. The study consisted of a 14-day screening period, a 28-day treatment period, and a
      7-day wash-out period. Participants received 1 of 4 dosing regimens for afegostat tartrate.
    

Intervention name(s): Afegostat tartrate
Intervention type(s): Drug
Other intervention name(s): isofagomine tartrate; AT2101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: afegostat tartrate; isofagomine tartrate; AT2101; Amicus Therapeutics
Effect of Feeding Mode on Infant Growth and Cognitive Function
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      This study is intended to compare growth, nutritional status, and brain development in
      children fed an Investigational cow's milk based formula containing a nutrient-rich whey
      protein, a standard cow's milk based formula, or fed exclusively breast milk.
    


Intervention name(s): Investigational nutrient-rich whey protein formula; Cow's milk based formula
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Assessment of the Biodistribution and Safety of [18F]MNI-1054
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-1054 as a
      LSD1 targeted radiopharmaceutical.
    

Detailed description: 
      The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-1054 as a
      LSD1 targeted radiopharmaceutical. The specific objectives are:

        -  To determine the radiation dosimetry of [18F]MNI-1054

        -  To assess the safety and tolerability of a single dose of [18F]MNI-1054
    

Intervention name(s): [18F]MNI-1054
Intervention type(s): Drug
Intervention description(s): Healthy Volunteers recruited for the study will undergo a single [18F]MNI-1054 injection and PET scan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is:

        -  To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia,
           assessed by continuous glucose monitoring data and serum fructosamine levels in patient
           volunteers with Type 2 Diabetes.

        -  To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient
           volunteers with Type 2 Diabetes
    

Detailed description: 
      This proof of concept trial has a randomized, parallel, double-blind, placebo-controlled
      design with a 4-week single-blind placebo and diet run-in period. Given a ratio of 1:1,
      patient volunteers will be randomized into one of two parallel treatment arms, Nasulin in a
      combination with insulin glargine or placebo in combination with insulin glargine. The
      randomization period will be 6 weeks in length. The total length of individual patient
      volunteer participation, including screening and follow-up will be approximately 13-14 weeks.
    

Intervention name(s): Placebo for Nasulin; Nasulin
Intervention type(s): Other; Drug
Intervention description(s): Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.; Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
Other intervention name(s): Intranasal insulin spray 1%
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Phase 2 Study for novel insulin delivery of type 2 diabetes
Brief Interventions for Drop-out Re-engagement
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      We will evaluate a series of interventions intended to help individuals who drop out of
      substance abuse treatment re-engage in order to improve treatment outcome.
    

Detailed description: 
      We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively
      evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a
      manual of single session phone-and office-based interventions to re-engage these individual
      in treatment.
    

Intervention name(s): brief (behavioral therapy); Drop out re-engagement motivational intervention; standard care follow up
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment.; Up to 3 phone or office based counseling sessions to promote reengagement in treatment; routine counselor phone calls and letters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: behavior therapy; counseling; drug abuse therapy; outpatient care; therapy compliance; clinical trial phase I; coping; outcomes research; satisfaction; social psychology; patient oriented research
A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars
Condition: Other Unsatisfactory Restoration of Tooth
Study type: Interventional
Phase: Phase 3

Summary: 
      Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly
      broken down primary teeth since 1950. They are generally considered more expedient to place
      than large multi-surface amalgam or composite restorations and have a longer life. They have
      been used successfully in clinical practice for many years and have presented little in the
      way of adverse events. The major drawback is the poor esthetics along with lingering concerns
      over potential health hazards associated with the nickel content. Several attempts have been
      made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and
      occlusal surfaces and substituting composite resin for the entire crown, but to date none of
      these approaches have been very successful.

      Acetal resin has been used in a number of applications in medicine and dentistry, and
      recently has met with early success when tested as a substitute for stainless steel crowns.
      It has a number of excellent physical and mechanical properties including a low coefficient
      of friction, good wear resistance, high fatigue resistance, good impact strength and
      resistance to creep.

      The purpose of this trial is to compare the clinical performance of preformed acetal resin
      crowns and preformed stainless steel crowns.

      2.0 OBJECTIVES

      The objective of this study is to compare the clinical performance of acetal resin crowns
      with preformed stainless steel crowns when used to restore primary molar teeth.
    

Detailed description: 
      STUDY POPULATION

      A minimum of 25 subjects contributing a minimum of 40 acetal crowns ( on primary molar teeth
      will be recruited from the patient pool of the pediatric dentistry clinic at Barzilai Medical
      Center, Ashkelon and enrolled into the study. A maximum of four crowns will be placed in any
      subject. It is estimated that it will take approximately 14 weeks to place all crowns and
      complete the baseline examination.
    

Intervention name(s): Acetal crown, LD Caulk ltd, USA
Intervention type(s): Procedure
Intervention description(s): Experimental trial of preformed acetal crowns for primary molars
Other intervention name(s): Prefabricated crowns for primary molars
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acetal crowns; Primary molars; The retention of acetal crowns in primary dentition; Color changes of acetal crowns
The Effects of Interrupting Prolonged Sitting With Intermittent Exercise on Postprandial Lipemia
Condition: Metabolic Syndrome X; Atherosclerosis; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Metabolic Syndrome; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of interrupting prolong sedentary
      behavior with interval exercise on postprandial metabolism following a high fat glucose
      tolerance test.
    

Detailed description: 
      All subjects complete two trials in a randomized crossover design, with each trial occurring
      over 4 days with a minimum of seven days between trials. The first two days of each trial
      serve as a control period allowing for familiarization and the control of physical activity
      and calorie consumption prior to the intervention. Following each control period, subjects
      then perform one of the interventions on Day 3. The interventions consist of either
      eight-hours of prolonged sitting, or eight hours of sitting interrupted every hour by five
      sprints lasting 4 seconds each using the interval exercise. On day 4, all subjects will
      undergo a high fat glucose tolerance test to determine the body's ability to clear
      triglycerides from the blood as well as insulin/glucose response and substrate oxidation.
      Blood samples will be assayed for the previously mentioned substances and postprandial gas
      collection will be analyzed via indirect calorimetry.
    

Intervention name(s): Prolonged sitting without exercise; Prolonged sitting with interval exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo the prolonged sitting trial. Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.; Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo a prolonged sit which with will be broken up every hour on the hour by a small bout of interval exercise. Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Cervical Collar on Intracranial Pressure
Condition: Optic Nerve Sheath Diameter; Ultrasonography
Study type: Interventional

Summary: 
      The routine use of cervical collar in emergency medical conditions has recently been
      questioned. The application of cervical collars, as their opponents point out, results in
      deterioration of intubation conditions, intensification of pain in the region of mastoid
      processes, and impaired venous outflow from the head.
    


Intervention name(s): Ambu Perfect ACE; Philly One-Peace Collar; Necloc Collar; NexSplit Plus; NECKLITE
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): patient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes; patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes; patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes; patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes; patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical collar; sonography; adult patients; Optic nerve sheath diameter; Ultrasonography
Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether closure of the PDA in premature neonates
      using IV ibuprofen vs continuous IV indomethacin has different side effects, eg. effects on
      renal function, on blood flow velocity in the superior mesenteric artery, the anterior
      cerebral artery, and the renal artery.
    

Detailed description: 
      Despite the fact that ibuprofen appears to minimize the renal side effects seen following
      bolus indomethacin, other concerns regarding both short and long-term safety remain.
      Indomethacin, on the other hand, has been used to treat premature neonates for many years.
      Other than transient vasoconstrictive effects, no significant toxicity has been noted. Thus,
      if we were to be able to eliminate the differential renal effects, indomethacin would remain,
      for many, the therapy of choice for the premature neonate with a persistent PDA. We
      hypothesized that continuous administration of indomethacin would provide this option.
      Ibuprofen therapy has not, to date, been compared with indomethacin administered by
      continuous infusion. Hence, in the current study we attempted to determine whether continuous
      indomethacin administration could potentially offer the same advantages as ibuprofen in
      treating PDA, specifically in terms of mitigation of renal side effects. Specifically, our
      primary objective was to show no differences in urine output and/or in serum creatinine
      between the treatment groups. As a secondary objective, we aimed to show no other potentially
      vascular-mediated clinical differences, eg. Necrotizing enterocolitis (NEC), intraventricular
      hemorrhage (IVH), retinopathy of prematurity (ROP) and on bilirubin albumin binding between
      the groups.

      B-type natriuretic peptide (BNP) is released by ventricular myocytes in response to
      ventricular volume load. It, in turn, mediates vasodilation, natriuresis and diuresis. Serum
      BNP levels have been shown to be clinically useful in differentiating between respiratory and
      cardiac disease, in monitoring heart failure therapies and in serving as early diagnostic
      biomarkers of ductal patency in premature neonates. As secondary objectives we intend to
      determine whether a decrease in BNP levels would be an equally reliable indicator of
      therapeutic efficacy in infants treated with ibuprofen as with indomethacin.In addition we
      will look at comparative effects on other vascular beds which might mediate long term side
      effects described above.
    

Intervention name(s): Continuous indomethacin; ibuprofen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ibuprofen; Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patent Ductus Arteriosus; Indomethacin; Ibuprofen; Renal effects
Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The primary aim of this study is to evaluate the extent to which an exercise intervention
      timed after diet-induced weight loss (rather than initiated at the same time) improves
      exercise adherence and long-term weight loss. An 18 month randomized trial will be used to
      compare two behavioral weight loss programs; standard behavioral therapy (Standard BT) and
      sequential behavioral therapy (Sequential BT). The Standard BT group will receive a
      traditional behavioral weight loss program where diet and exercise changes are initiated at
      the same time. The Sequential BT group will receive a program that focuses solely on dietary
      changes in the initial 6 months, and then incorporates exercise in the ensuing 6 months. Both
      groups will be followed for 18 months to assess long-term weight loss. The hypothesis is that
      delivery of diet and exercise interventions in sequence will result in improved adherence to
      exercise and weight loss at 18 months when compared to a traditional program in which
      identical diet and exercise interventions are initiated at the same time. This study could
      identify a strategy that could aid in the development of more effective obesity treatment
      programs and help more people achieve and sustain a weight loss.
    


Intervention name(s): Sequential BT; Standard BT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Both study arms (Standard BT and Sequential BT) will receive an identical 6 month group-based weight loss program, followed by an identical 6 month group-based weight maintenance program, followed by an identical 6 months of weight maintenance phone support. Both groups will also receive an identical 6 month exercise intervention. Groups will differ only in the timing of exercise initiation. Sequential BT will be asked not to begin exercise during months 0-6. They will receive a progressive exercise program and exercise behavior support during months 7-12.; Both study arms (Standard BT and Sequential BT) will receive an identical 6 month group-based weight loss program, followed by an identical 6 month group-based weight maintenance program, followed by an identical 6 months of weight maintenance phone support. Both groups will also receive an identical 6 month exercise intervention. Groups will differ only in the timing of exercise initiation. Standard BT will begin exercise immediately upon starting the 6 month dietary weight loss intervention. They will receive a progressive exercise program and exercise behavior support during months 0-6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; weight-loss; Physical activity
Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
Condition: Developmental Disability; Developmental Dyslexia; Intellectual Disability
MeSH terms: Intellectual Disability; Dyslexia; Developmental Disabilities
Study type: Observational

Summary: 
      This study investigates physical changes in children with Dyslexia and Intellectual
      Disability. Participants divided into three groups and Body Posture, Postural Control and
      Hand Grip Strengths was evaluated.
    

Detailed description: 
      Children with Intellectual Disability and Dyslexia have academic and behavioral problems but
      also they might have physical changes related to poor motor development.

      Three evaluation method was used in study. Postural Deformities were evaluated by
      PostureScreen Mobile App which is a mobile app allows to assess photographic body posture in
      four aspects (anterior, posterior, lateral) Postural Control was tested by Wii Balance Board.
      Wii balance board is a force plate that can measure person's center of gravity displacements
      Hand grip strength tested by Jamar Hand Dynamometer. It was completed according to American
      Hand Therapist's Association guidelines.

      All data collected from participants have analysed within the control group (typical
      developed children)
    

Intervention name(s): Body Posture Assessment
Intervention type(s): Other
Intervention description(s): Application of three evaluations above at a one time.
Other intervention name(s): Postural Control Assessment; Hand Grip Strength Assessment
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population consisted children diagnosed with Dyslexia and Intellecutal Disability who
        continue their regular special education. The investigators also enrolled age matched
        typical developed children to establish control group
      
Keywords: Postural Control,; Body Posture; Hand Grip