bioihbjkbjnl/mcl2 huggingface dataset:
Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites
Condition: Keratinized Mucosa
Study type: Interventional

Summary: 
      For the management of peridontal and peri-implant conditions, free epithelial grafts have
      been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing
      confort during brushing and reducing the level of inflammation. Nevertheless, these are
      subjected to dimensional changes that may jeopardise the final outcome of providing
      sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim
      at shedding light on the dimensional changes and the variables affecting these changes.
    


Intervention name(s): Free epithelial (gingival) graft
Intervention type(s): Procedure
Intervention description(s): 1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa
Intervention model: Single Group Assignment
Intervention model description: Teeth and implants receiving free epithelial grafts harvested from the palate
Masking: None (Open Label)
Primary purpose: Treatment
Palatability of Oral Rehydration Solutions
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the mean taste scores for three fruit
      flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective
      is to compare the proportions of children who indicate a taste preference for one of the
      solutions.
    

Detailed description: 
      In Canada, acute gastroenteritis remains a major cause of morbidity and hospitalizations.
      This, in large part, is due to an inability to realize the full benefits of oral rehydration
      therapy. Because oral rehydration solutions have a salty taste, many mild to moderate
      dehydrated children refuse to drink them. This has resulted in pediatricians recommending
      inappropriate solutions and the unnecessary administration of intravenous fluids. Although
      two meta-analyses have concluded that rice-based ORS (Enfalyte) is as or more effective than
      traditional ORS in reducing stool output, the palatability of different oral rehydration
      solutions have never been evaluated.

      This will be the first prospective trial comparing the palatability of the most commonly
      recommended oral rehydration solutions, Pedialyte and Enfalyte with a newer solution,
      Pediatric Electrolyte. Both Pedialyte and Pediatric Electrolyte contain sucralose, dextrose,
      and fructose while Enfalyte contains rice syrup solids. Although the latter is as, or more
      effective than Pedialyte in reducing stool output, palatability may limit its use. Taste is
      important as children with gastroenteritis are frequently nauseated and may refuse to drink
      or vomit when consuming less palatable solutions.

      We hypothesize that, compared to children who receive a rice-based ORS (Enfalyte), those who
      receive a sucralose ORS (Pediatric Electrolyte or Pedialyte) will report a higher mean taste
      score, will prefer to drink the sucralose sweetened ORS if they had to consume a larger
      volume, and are more likely to drink the entire volume they are provided.
    

Intervention name(s): Enfalyte; Pediatric Electrolyte; Pedialyte
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each patient will receive one 250 ml dose.; Each patient will receive one 250 ml dose.; Each patient will receive one 250 ml dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Gastroenteritis; Pediatrics; Rehydration therapy
Subjective Evaluation of a Sound Processing Method for Hearing Aids on Auditory Distance Perception
Condition: Hearing Disorders; Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural; Hearing Disorders
Study type: Interventional

Summary: 
      Within the course of this study, a signal processing feature has been developed at Ecole
      Polytechnique Fédérale de Lausanne (EPFL), in collaboration with Sonova AG, in order to
      enhance the listening experience with remote microphone systems. In particular, the developed
      feature is supposed to improve the so-called audio-visual fusion, i.e. the fact to perceive
      the sound as coming from the physical location of the source. One of the main goals of the
      present study is to evaluate the extent to which this feature reaches that objective.
    


Intervention name(s): Digital signal processing algorithms
Intervention type(s): Other
Intervention description(s): The intervention consists in applying five processing on some recorded speech signals. In particular, the processing performed by one specific algorithm is compared against the four other. The applied processing is supposed to restore sound externalization (expected audio-visual fusion).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hearing aids; Remote microphone systems; Roger technology; Sound externalization; Auditory distance estimation
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
Condition: Shift-Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and
      staff during night shift.
    

Detailed description: 
      Night shift increases physical and psychological pressure, and even affects their sleep
      quality. This study aims to evaluate the effects of aroma massage to sleep quality of the
      nurses during night shift after life-style modification and/or aroma massage. The
      investigators adopt a Randomized Controlled Trial (RCT) in this study. The investigators
      expect aroma massage would improve the sleep quality during night shift.
    

Intervention name(s): massage
Intervention type(s): Behavioral
Intervention description(s): massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy
Condition: Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Observational

Summary: 
      OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma
      glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic
      receptor in 6 patients with regional lipoatrophy and in 6 controls.

      II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic
      DNA from peripheral blood leukocytes.
    

Detailed description: 
      PROTOCOL OUTLINE: Antihypertensives are held, beginning 3 days before the first study day.

      An oral challenge is administered as follows: clonidine on day 1, yohimbine on day 2. The
      order of administration is reversed in alternate subjects.

      Timed measurements of norepinephrine, glycerol, and free fatty acids follow each challenge.
      Structural gene sequencing is evaluated for each participant.
    

Keywords: endocrine disorders; rare disease
Dexmedetomidine Versus Midazolam Added to Ketamine in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
Condition: Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
Study type: Interventional

Summary: 
      Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg
      diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).

      Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of
      2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).

      The objective of this study to evaluate the clinical effects, adverse effects and recovery
      time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine
      during conscious sedation for child patient with haematological cancer undergoing BMA
      &biopsy.
    


Intervention name(s): midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine; Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine
Intervention type(s): Drug; Drug
Intervention description(s): midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine; Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Androgenetic Alopecia in Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease; Alopecia; Alopecia Areata
Study type: Observational

Summary: 
      The purpose of this study is to assess whether patients with the classic form of Fabry
      disease have significantly less androgenic alopecia (male pattern baldness).
    

Detailed description: 
      Objectives: To test the hypothesis that adult males with classic form of Fabry disease have a
      significantly lower incidence of androgenic alopecia than matched controls.

      Study Population: 120 patients aged 20-64 with Fabry disease that have GLA mutations or
      alpha-galactosidase A activity associated with no residual enzyme activity and non-Fabry male
      controls of the same age range and the same number of non-Fabry controls.

      Design: This is a cross-sectional study comparing the prevalence of androgenic alopecia in
      two groups of subjects.

      Outcome Measures: The levels of the outcome will be no androgenic alopecia and frontal only
      androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Selected from specialy clinic
      
Keywords: Fabry disease; Male pattern baldness; Alopecia; GLA gene mutation; Alpha-galactosidase A
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in
      a prospective randomized study.
    

Detailed description: 
      The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success.
      Previous studies have reported good safety and tissue adequacy with both the needles, but the
      head-on comparison between these two needles is lacking.

      This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge
      versus 22Gauge core needles for EUS-LB.
    

Intervention name(s): 19G FNB; 22G FNB
Intervention type(s): Procedure; Procedure
Intervention description(s): Biopsy specimen adequacy using the 19G FNB; Biopsy specimen adequacy using the 22G FNB.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
Masking: None (Open Label)
Primary purpose: Diagnostic
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Condition: Healthy Term Infants Solely Formula Fed
Study type: Interventional

Summary: 
      To compare the number of infants who discontinue from study formula due to formula
      intolerance as documented by the investigator.

      Hypothesize there will be no difference between formula groups.
    


Intervention name(s): Enfamil LIPIL with iron; Good Start Supreme with DHA and ARA
Intervention type(s): Other; Other
Intervention description(s): cow's milk based infant formula; partially hydrolzed cow's milk protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
Condition: Laser Stimulation
MeSH terms: Retinopathy of Prematurity
Study type: Interventional

Summary: 
      Pain management in premature infants is essential because they are exposed to repeated minor
      painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown
      its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast,
      side-effect-free method, but no study exists on the contribution of acupuncture in the
      management of pain caused by the examination of the fundus in addition to conventional
      therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently
      effective.

      Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort
      of premature newborns when examining the fundus with a digital camera.
    

Detailed description: 
      Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in
      two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy
      (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main
      objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the
      G30% glucose solution 2 minutes before the examination associated with the instillation of a
      drop of oxybuprocaine administered 1 minute before the start of the examination on pain
      assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP)
      measured before the start of the examination (baseline) and on 30 seconds after the
      examination of both eyes.
    

Intervention name(s): Laser stimulation
Intervention type(s): Device
Intervention description(s): an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Vitamin B12 Supplementation to Improve B12 Status and Child Development
Condition: Early Pregnancy
Study type: Interventional

Summary: 
      Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth
      defects and common complications (e.g. intrauterine growth restriction, neural tube defects),
      and possibly immune function impairment. The newborns and infants of B12-deficient mothers
      have low B12 stores at birth, further exacerbated by a very low concentration of B12 in
      breast milk that may hinder their growth and development. In regions such as Bangladesh, many
      women of reproductive age have inadequate B12 status, probably due to low intake of animal
      source food. Vitamin B12 intake and status in pregnancy and lactation is potentially
      insufficient to prevent impaired child development and immune function related to inadequate
      B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through
      fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1)
      biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive
      immunity in infants; (3) neurological and cognitive function in infants.
    

Detailed description: 
      The investigators aim to conduct a double-blind, randomized trial, to investigate the effects
      of B12-fortified milk on maternal and infant B12 status, immune function and child
      development. Pregnant women (n=148) will be randomized to receive B12-fortified milk (100
      μg/day) or milk without fortification. The daily supplementation beginning at the baseline
      visit (GW 11-14) will continue until 6 mo-postpartum. Biomarkers of B12 status will be
      measured in mothers (GW 11-14 and 6-mo postpartum) and infants (3 and 6-mo). Infant
      development (6 and 12-mo) will be evaluated by Bayley Scales of Infant and Toddler
      Development. Immune responses will be measured in infant at 3 and 6-mo. Data on socioeconomic
      status, dietary diversity, and anthropometric indices will be recorded at baseline.
      Additional tests in mothers include screening for H. pylori and plasma gastrin.
    

Intervention name(s): Vitamin B12 fortified UHT milk; Plain UHT milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12; Daily intake of 200 mL of plain UHT milk
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Vitamin B12, Fortified milk, Immunity, Child development
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061
      administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with
      active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.

      To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics
      (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,
      based on safety and efficacy, for further clinical development.
    

Detailed description: 
      Subjects who completed the 24-week assessment period and achieved at least 20% improvement in
      swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201
      were invited to participate in an open-label extension (OLE) study ALX0061-C203
      (NCT02518620), if the study was approved in their country and selection criteria were met.
    

Intervention name(s): ALX-0061; Placebo; Methotrexate
Intervention type(s): Biological; Other; Drug
Intervention description(s): Stable background dose of commercially available methotrexate (not provided by the Sponsor).
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
Condition: Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The primary objective of this trial is to demonstrate the effectiveness of the powered
      vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during
      Video-Assisted Thoracoscopic Lobectomy.
    


Intervention name(s): Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Intervention type(s): Device
Intervention description(s): Powered Vascular Stapler used on vessels
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Prospective Randomised Study for Use of CHG Dressing at Entry Site of EVD's to Reduce EVD-associated Infections
Condition: Wound Contamination
MeSH terms: Infections
Study type: Interventional

Summary: 
      The objective of this study is to assess the efficacy of 3M™ Tegaderm™ CHG I.V. Securement
      Dressing at the entry-site of a EVD in reducing quantity of microorganisms (CFU/cm2) after a
      time period of 5 days as a surrogate marker for EVD-associated infections [1, 2], compared to
      a nonantimicrobial polyurethane 3M Tegaderm™ Transparent Film Dressing. We aim to
      investigate, if the adjunct of an additional CHG-impregnated device on a routinely basis for
      the daily care is as a valuable and effective option to reduce contamination of the EVD
      entry-site and consecutive colonization of the catheter.
    

Detailed description: 
      Randomised, parallel group, single-centre Phase IV trial comparing the change in the quantity
      of microorganisms (CFU/cm2) after a time period of 5 days (primary endpoint) as surrogate
      marker for EVD-associated infections [1, 2], in patients undergoing EVD with dressing at the
      entry site with 3M™ Tegaderm™ CHG I.V. Securement Dressing (study arm) versus 3M™ Tegaderm™
      I.V. Advanced Dressing (standard arm). Secondary objectives are the comparison of regrowth
      (CFU/cm2) every 5th day before routine change of the device, cerebrospinal fluid (CSF)
      cultures every 2nd day and sonication of the catheter tip after explantation (secondary
      endpoints).

      We hypothesize that bacterial contamination (CFU/cm2) of the EVD entry-site after 5 days
      compared to baseline (bacterial regrowth since baseline) in subjects treated with the 3M™
      Tegaderm™ CHG I.V. Securement Dressing is significantly lower compared to subjects treated
      with 3M™ Tegaderm™ I.V. Advanced Dressing. Quantitative microbiology of the catheter tip
      (sonication) might be reduced by this external intervention, as well as CSF cultures.

      We will use an internal pilot study design [3]. The three step procedure includes:

        -  initial sample size calculation

        -  sample size review

        -  final analysis.
    

Intervention name(s): 3M™ Tegaderm™ CHG I.V. Securement Dressing; Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing
Intervention type(s): Device; Device
Intervention description(s): Chlorhexidine gluconate (CHG) has been dissolved into a soft gel pad (3x4 cm) to provide a reservoir for consistent and continuous antimicrobial action over time. The gel pad is active on contact without requiring additional moisture. CHG migrates under the catheter to provide continuous circumferential antimicrobial protection at the insertion site. Soft and conformable, the gel pad moulds around the catheter and hub.; Placebo Dressing with the same shape like the CHG-Dressing without CHG.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Wound Contamination
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
Condition: Smallpox Vaccine Adverse Reaction
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for
      collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous
      (VIGIV).
    


Intervention name(s): ACAM2000
Intervention type(s): Biological
Intervention description(s): Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other