bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal
      Medicine unit will be included after informing the parents. Abdominal skin and peripheral
      (arm or leg) and incubator air temperatures and relative humidity will be obtained from data
      recorded by the incubator without using any additional transducer compared to standard care.
      Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization
      will also be recorded from routine monitoring. A case report form and a wide-angle video
      recording of the infant's room will allow description of the type of care, determine the
      duration of care and the impact on incubator function. Data will be recorded for the first 7
      days of life of the preterm neonate.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal
        Medicine unit
      
Keywords: hypothermia; routine care; preterm neonates
Mobile Sensing of Smoking Behavior
Condition: Smoking; Health
Study type: Interventional

Summary: 
      Smokers will use a smartphone app on a smartphone provided for the study that will passively
      sense and record information about their activities. Information collected from the
      smartphone app will be used to develop future smartphone apps that will predict when an
      individual is at risk of smoking.
    

Detailed description: 
      Smokers will carry an Android-based smartphone, which they are to use as their own for one
      month. After using the smartphone for two weeks, they will abstain from smoking for 48 hours.
      The phone will passively sense and record information from onboard sensors and send that
      information to a central server. When server based algorithms detect a pattern of signals
      likely associated with smoking behavior, the smoker will be queried regarding their current
      state (smoking?, not smoking but likely to in the next 10 minutes?, etc.). Likewise, when
      smokers are about to smoke but were not queried, they can indicate they are about to smoke.
      This information will be used to update algorithms using machine learning techniques. As
      such, in this study investigators will gain knowledge that will increase understanding of
      antecedents of smoking behavior and improve the accuracy with which smoking risk can be
      detected.
    

Intervention name(s): 48 hour smoking abstinence; Smartphone
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will maintain smoking abstinence for 48 hours; Participants will use an Android-based smartphone as their own for one month
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: smoking; healthy; smartphone
Safety and Efficacy of MEM 3454 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine in an 8-week treatment study if MEM 3454 is a safe
      and effective treatment for patients with mild to moderate Alzheimer's disease.
    

Detailed description: 
      Alzheimer's disease is the leading cause of dementia and one of the most common diseases of
      the aging population. It is a chronic brain disease that involves gradual memory loss,
      decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss
      of language skills, impairment of judgment, and personality changes in affected individuals.
      The neurodegenerative nature of the disease eventually leads to the failure of other organ
      systems and death.

      A consistent and marked change in the brains of patients with AD is degeneration of the
      cholinergic innervation in the hippocampus and cerebral cortex areas. The activity of choline
      acetyl transferase (ChAT) is significantly reduced in these brain regions, and a linear
      correlation is seen between the reduction in cortical ChAT activity and the progress of
      dementia, indicating a progressive loss of cholinergic function.

      Receptor selective nicotinic alpha-7 receptor agonists can modulate acetylcholine in
      selective brain regions and contribute to symptomatic treatment of AD. MEM 3454 is a novel
      nicotinic alpha-7 receptor selective partial agonist having serotonin type 3 (5-HT3) receptor
      antagonist properties.
    

Intervention name(s): MEM 3454
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Cognition; Cognitive impairment
An Open Positron Emission Tomography Study to Assess the Effects of Varying Mass of AZD4694 on Radioligand Binding Parameters in Healthy Volunteers and Patients With Alzheimer's Disease
Condition: Maximum Diagnostic Mass of [18Fluor]AZD4694
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study different mass of the radioligand AZD4694 will be given to patients with
      Alzheimer's Disease and healthy volunteers to evaluate wich Mass of AZD4694 that gives the
      best opportunities for following disease progress and treatment effects.
    

Detailed description: 
      Open-Label Positron Emission Tomography Study with Selective Beta Amyloid Radioligand
      (18Fluor)AZD4694 to Assess the Effects of Varying Mass of AZD4694 on Radioligand Binding
      Parameters in Healthy Volunteers and Patients with Alzheimer's Disease
    

Intervention name(s): [18Fluor]AZD4694; [18Fluor]AZD4694; [18Fluor]AZD4694
Intervention type(s): Other; Other; Other
Intervention description(s): Low mass dose below 5ug. High mass dose around 40 and 50 ug.; Low mass dose below 5ug. High mass dose around 20 ug.; Low mass dose below 5ug. High mass dose will be the Maximum Detective Mass established in the previous panels.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radioligand; Alzheimers disease; Maximum Diagnostic Mass; Beta amyloid
Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery
Condition: Cataract
MeSH terms: Cataract; Mydriasis
Study type: Interventional

Summary: 
      The purpose of this study is to study the safety and efficacy of intracameral adrenaline for
      pupil dilation without topical mydriatics in refractive cataract surgery.
    


Intervention name(s): adrenalin
Intervention type(s): Drug
Intervention description(s): adrenalin 0.01%
Other intervention name(s): adrenaline hydrochloride
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: cataract
A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study
Condition: Dysentery, Bacillary
MeSH terms: Dysentery, Bacillary; Dysentery
Study type: Interventional
Phase: Phase 1

Summary: 
      GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella
      sonnei.

      A post-hoc analysis of subjects who participated in the parent study showed significantly
      different responses in subjects with detectable versus undetectable antibody titres at
      baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic
      in completely naïve adults.

      This study was then designed to further characterize the immunogenicity profile of the
      vaccine and to evaluate whether it was able to induce an immunological memory response.
    


Intervention name(s): GVGH Shigella sonnei 1790GAHB vaccine
Intervention type(s): Biological
Intervention description(s): Single dose administered at Day 1, by intramuscular injection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity, Vaccine; Immunologic Memory; GMMA; Shigella Vaccines; Shigellosis; Dysentery, Bacillary; Healthy Volunteers; Safety; Bacteria; Clinical Trials, Phase 1; Shigella sonnei
Spatial Hearing Perception in Bilateral Cochlear Implant Children
Condition: Cochlear Impant Children
Study type: Interventional

Summary: 
      Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no
      studies have explored yet spatial auditory perception in three-dimensional space (3D).
      Moreover auditory rehabilitation after cochlear implantation is totally devoted to speech
      rehabilitation to date.

      A novel methodology based on virtual reality and 3D motion capture protocol in an immersive
      reality system has recently been developed to evaluate and record spatial hearing abilities
      of norm-hearing (NH) listeners and CI adults in 3D. The results revealed worse sound
      localization in 3D for CI users compared to NH participants, and interestingly noted that
      head movements could improve sound localization performances, leading to a possible track for
      auditory rehabilitation.

      The aim of this study is to explore spatial hearing in CI children with the protocol already
      tested in CI adults. This protocol will be adapted to children over eight years old. Children
      will have to perform a sound localization task in 3D without any feedback of performances.
      The knowledge improvement in pediatric sound localization will lead to develop a specific
      spatial rehabilitation in cochlear implant children.
    


Intervention name(s): behavioral exploration of spatial hearing performances; The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents); The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)
Intervention type(s): Other; Other; Other
Intervention description(s): Normal hearing children and cochlear implant children will have to localize a sound source in three dimensional space by using a virtual reality system (Neuro immersion platform). The experiment will last thirty minutes.
For normal hearing children, this experience will be performed at the inclusion visit.
For cochlear implant children, this experience will be performed 28 days (+/- 2 days) after inclusion.; For cochlear implant children and their parents, a SSQ questionnaire will be given and completed during the first visit (at the inclusion).
This questionnaire offers a version for parents of children with hearing loss ("SSQ Parents CI") and a version for the children themselves ("SSQ Children CI").; The SSQ questionnaire for Parents of CI children is composed of three distinct sections (A, B and C).
Each section will be filled separately by parents of CI children with one of the study collaborators during 3 telephone calls spaced 1 week apart. Thus, section A will be completed 7 days (+/- 2 days) after inclusion , section B 14 days (+/- 2 days) after inclusion, and section C 21 days (+/- 2 days) after inclusion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: spatial hearing perception; cochlear implant; child; virtual reality
An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      A retrospective study was done on the medical records for 24 rectal cancer patients underwent
      robotic proctectomy from September 2017 to July 2018 at the First Afﬁliated Hospital of Xi'an
      Jiaotong University.In the same department,a total of 25 patients who treated with
      laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as
      controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related
      costs of the three groups.
    


Intervention name(s): open, laparoscopic, and robotic
Intervention type(s): Procedure
Intervention description(s): Radical resection of rectal cancer in robotic, laparoscopic, and open approach
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Diagnosis of rectal cancer
Sub Occipital Inhibition Technique on Postural Balance
Condition: Movement Disorders
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      In the present study the investigators want to verify if the inhibition of the suboccipital
      muscles improves the postural balance in subjects with cervical pain objectified by
      stabilometry.
    


Intervention name(s): Suboccipital inhibition; Placebo technique
Intervention type(s): Procedure; Procedure
Intervention description(s): With the patient in the supine position and the therapist sitting at the head of the bed with the elbows resting on its surface. The therapist palpates the cervical spinous processes and slides the fingers upwards until contacting the posterior projection of the posterior arch of the atlas. Then, flexing the metacarpophalangeal at 90 degrees slowly raises the skull. The therapist's hands should remain together and the base of the skull should rest on his palms pressing with the index, middle and ring fingers of each hand in a sustained manner, but without causing pain. This pressure must be maintained during 4 minutes.; A superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Quantification of Hyperpronation
Condition: Foot Pain Chronic
Study type: Observational

Summary: 
      Hyperpronation is af frequent cause of excessive load in foot and crus. Pain and limited
      functional ability cause problems with work-related activities, sport activities and leisure
      activities.

      There are only few studies of the frequency of pain related to hyperpronation in foot and the
      effect of exercises. Medics and physiotherapists need sufficient evidence-based knowledge to
      treat these patients correctly.

      Therefore, the investigators want to study the effect of exercises and inner soles for
      treatment of patients with chronic pain and hyperpronation of foot.
    


Sampling method: Non-Probability Sample
Study population: 
        Hyperpronation of foot
      
Keywords: Pain; Foot
Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.
Condition: Myopia; Esophoria; Fixation Disparity
MeSH terms: Esotropia; Myopia; Disease Progression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether bifocal soft contact lenses are effective
      in controlling the progression of myopia in children and adolescents that exhibit a tendency
      to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several
      studies have demonstrated that bifocal or progressive multifocal spectacles are effective in
      slowing the progression of myopia in children either with near point esophoria and/or with
      inadequate focusing at near. A prominent theory for one cause of myopia progression is that
      poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an
      increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the
      stimulus to eye elongation, and thus may reduce myopia progression.
    

Detailed description: 
      Myopia has become the focus of growing attention and concern because the prevalence of myopia
      appears to increasing in some populations (reaching 90% for some university student
      populations in Asia). There are serious risks to higher levels of myopia, including
      cataracts, glaucoma, retinal detachment and myopic retinal degeneration. Several studies have
      shown mild to moderate control of myopia progressionwith bifocal or multifocal spectacles in
      children with esophoria at near and/or with accommodative deficiencies. Pilot studies by the
      P.I. have suggested that bifocal contact lenses may control myopia progression in children
      with near point eso fixation disparity.

      CONTROL is a controlled, randomized, prospective, double-blind, one year study of the changes
      in myopia in 80-90 subjects from age 8-18 with low to moderate levels of myopia, low levels
      of astigmatism, and eso fixation disparity at near, when fitted with either bifocal soft
      contact lenses or single vision soft contact lenses. The primary outcome measures will be
      cycloplegic refraction and axial length measures.
    

Intervention name(s): Bifocal Contact Lenses; Placebo Control
Intervention type(s): Device; Device
Intervention description(s): Use of bifocal contact lenses of varying add powers to control the progression of myopia; Single vision soft contact lenses
Other intervention name(s): Bifocal Soft Contact Lenses; Hydrophilic Bifocal Contact Lenses; Simultaneous Vision Bifocal Contact Lenses; Soft Contact Lenses; Hydrophilic Contact Lenses; Single Vision Soft Contact Lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Myopia Progression; Myopia Control; Bifocal Contact Lenses; Esophoria; Fixation Disparity
Stair Descending vs. Stair Ascending Exercise
Condition: Aging; Heart Failure; Sarcopenia
MeSH terms: Sarcopenia; Heart Failure
Study type: Interventional

Summary: 
      The aim of the present project is to compare the acute and chronic effect of stair descending
      versus stair ascending exercise on muscle damage and performance in elderly males with
      chronic heart failure.
    

Detailed description: 
      Study design:

      Twelve elderly males with chronic heart failure, New York Heart Association class I-II, will
      participate in this study. Participants will be allocated into two equally-sized groups: a
      stair descending group (n = 6) and a stair ascending group (n = 6). At the beginning of the
      study, the volunteers will perform an acute bout of stair descending or stair ascending
      exercise on an automatic escalator (4 sets of 3 min each, speed will be set at 45
      steps∙min-1). Step height will be 20.5 mm. Before and at day 2 post exercise, physiologic
      measurements will be performed and blood samples will be collected. Then, participants will
      carry out six weeks of stair descending or ascending training consisting of three exercise
      sessions per week (the first two weeks the speed will be set at 45 steps∙min-1, the next two
      weeks at 50 steps∙min-1 and the last two weeks at 55 steps∙min-1 for both groups). Afterward,
      they will repeat the acute stair descending or ascending protocol, as carried out at the
      beginning of the study, and the same physiologic measurements will be performed and blood
      samples will be collected.

      Measurements:

      Isometric (at 90 knee flexion), concentric and eccentric peak torque at 60o∙s-1of quadriceps
      femoris, pain-free range of motion, delayed onset muscle soreness and creatine kinase will be
      measured.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Comparison between stair descending and stair ascending training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Eccentric exercise; Aging; Heart failure; Muscle strength loss; Sarcopenia
The Effect of Creatine on Muscle Loss
Condition: Muscle Loss
Study type: Interventional

Summary: 
      The primary aim of this study is to determine the effect of creatine supplementation on
      muscle mass loss during short-term immobilisation in healthy, young people.
    

Detailed description: 
      Seven days of one-legged knee immobilisation in young subjects with creatine or Placebo
      supplementation. A randomly selected leg is immobilized for seven days. Muscle mass and
      strength will be determined and muscle biopsies will be collected before and immediately
      after immobilisation. A week after the cast is removed we will assess any differences in
      recovery between intervention groups.
    

Intervention name(s): Placebo supplementation; Creatine supplementation
Intervention type(s): Other; Other
Intervention description(s): Seven days of one-legged knee immobilisation with placebo supplementation; Seven days of one-legged knee immobilisation with creatine supplementation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of
      ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and
      intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male
      participants.
    


Intervention name(s): Unlabeled ertugliflozin for oral use; 14^C-labeled ertugliflozin for IV use; 14^C-labeled ertugliflozin for oral use
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg oral (3 x 5 mg tablets); 100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin); 100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin)
Intervention MeSH terms: Ertugliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™
      (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit
      Hyperactivity Disorder (ADHD)
    


Intervention name(s): clonidine hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, 0.3 mg, or 0.4 mg from Weeks 11-36; KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, or 0.3 mg at Week 11; KAPVAY™ 0.1 mg, KAPVAY™ 0.2 mg, or placebo at Week 12; KAPVAY™ 0.1 mg or placebo at Week 13; placebo from Weeks 14-36
Other intervention name(s): KAPVAY™
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder