bioihbjkbjnl/mcl2 huggingface dataset:
Vascular Function in Adolescent, Diabetic Children
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The objectives of this investigator initiated study are to:

        1. Determine if and when vascular abnormalities occur during early adolescence

        2. Determine if poor diabetic control is related to vascular abnormalities.

      The development of vascular plaques and vascular contractility will be assessed through the
      use of the SyphmgnoCor equipment.
    

Detailed description: 
      Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the
      study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm
      and the pressure tonometer will be used on various vessels. Cardiovascular data will be
      recorded. The procedure is non-invasive, will last approximately 10 minutes and will be
      performed during a routine clinic visit. Onset of diabetes and level of diabetic control as
      measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the
      medical record. Microalbumin levels covering the prior 12 months will be collected from the
      medical record of diabetic subjects.
    

Intervention name(s): Measurement of vascular function per SphymgnoCor equipment
Intervention type(s): Procedure
Intervention description(s): Pressure tonometer will be used on various vessels, non-invasive.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Vascular abnormalities; Type 1 diabetes; Healthy control subjects
Study of Serum Hepcidin Rate Variations During Menstrual Cycle
Condition: Healthy Women
Study type: Observational

Summary: 
      Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron
      stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.

      The interpretation of hepcidin dosage results requires to know the physiological variations
      of this hormone.

      This study investigate whether there are significant variations in the values of serum
      hepcidin rates during the menstrual cycle in order to make recommendations on the practical
      dosage determination of hepcidin in premenopausal women.
    

Detailed description: 
      Hepcidin is the major hormone regulating Iron Metabolism. Synthesized primarily by
      hepatocytes, it interacts with the cellular iron exporter ferroportin, causing its
      internalization and preventing the release of iron from enterocytes and macrophages.

      In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus
      promoting intestinal absorption of iron.

      Since valid methods for the determination of hepcidin serum rate are available, this dosage
      is increasingly used to diagnosis iron metabolism pathologies, in particular iron overload.
      The interpretation of hepcidin dosage results requires to know physiological variations of
      this hormone.

      Several works have shown that hepcidin varies according to a circadian cycle, that its values
      differ by sex and, in women, by age. As far as the investigators know, no study has focused
      on possible variations in serum hepcidin rates values during menstrual cycle in women. Yet
      this question seems relevant since it has been shown that during the menstrual cycle blood
      loss can cause significant iron and hemoglobin variations, which can significantly modulate
      the synthesis of hepcidin.

      This study investigate whether there are significant variations in the values of serum
      hepcidin rates during the menstrual cycle in order to make recommendations on the practical
      dosage determination of hepcidin in premenopausal women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women
      
Biospecimen description: 
      Hepcidin Serum iron Transfferin saturation Serum transfferin Serum ferritin
    
Keywords: Healthy women; Menstrual cycle; Hepcidin; Seric iron
Incubation of Alcohol Craving During Abstinence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      In order to determine whether the 'incubation of craving' phenomenon also occurred in
      alcoholics, investigators employed an experimental approach to investigate the time course of
      cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four
      groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced
      alcohol craving . Another group including 19 patients was repeatedly tested for the
      cue-induced alcohol craving at the above abstinence days. Other psychological and
      physiological measures were administered at the four abstinence time points.
    

Detailed description: 
      All subjects provided written informed consent after a full explanation of the protocol
      design.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        alcohol dependence
      
Biospecimen description: 
      The blood samples of all participants were collected at each point of withdrawal.
    
Keywords: incubation; Craving; alcohol dependence
A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of the study is to assess the safety profile of candidate vaccines
      ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVcnsv4 administered sequentially in healthy
      HIV-1/2 negative adult volunteers.

      In addition, the study will assess the immune responses generated of the candidate vaccines
      ChAdOx1.tHIVconsv1, MV.tHIVconsv3 and MVA.tHIVconsv4 administered sequentially in healthy
      HIV-1/2 negative adult volunteers.

      3 healthy, HIV-1 negative adult volunteers will receive one vaccination of low dose
      ChAdOx1.tHIVconsv1. A further 10 healthy, HIV-1 negative adult volunteers will receive a
      higher dose of ChAdOx1.tHIVconsv1, followed by one vaccination each of MVA.tHIVconsv3 and
      MVA.tHIVconsv4 4 weeks later.
    


Intervention name(s): ChAdOx1.tHIVconsv1 (C1); ChAdOx1.tHIVconsv1 (C1); MVA.tHIVconsv3 (M3); MVA.tHIVconsv4 (M4)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): ChAdOx1.tHIVconsv1 5 x 10^9 vp; ChAdOx1.tHIVconsv1 5 x 10^10 vp; MVA.tHIVconsv3 1 x 10^8 pfu; MVA.tHIVconsv4 09. x 10^8 pfu
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The first three participants will receive a low dose of ChAdOx1.tHIVconsv1 only. A further ten participants will receive a higher dose of ChAdOx1.tHIVconsv1 and a subsequent vaccination of MVA.tHIVconsv3 and MVA.tHIVconsv4
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators
Condition: Airway
Study type: Interventional

Summary: 
      Patients presenting for elective surgery requiring tracheal intubation will be randomized to
      one of two different endotracheal tube (ETT) stylets. The intubation will be done with a
      GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.
    


Intervention name(s): GlideScope rigid stylet
Intervention type(s): Device
Intervention description(s): Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Exercise Challenge in a Cold Chamber
Condition: Exercise-induced Asthma
MeSH terms: Asthma, Exercise-Induced
Study type: Interventional

Summary: 
      The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to
      the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced
      bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.
    

Detailed description: 
      Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung
      function testing at rest. To provoke asthma symptoms a provocation test is necessary, e.g.,
      by bronchial methacholine testing or by a standardised exercise test on a treadmill. The
      correlation between methacholine and exercise test is fair, possibly because both methods
      measure different kinds of bronchial hyperresponsiveness. Moreover, the sensitivity and the
      repeatability of the exercise test is fair.

      The value of the methacholine test to predict a positive exercise test will be measured. We
      hypothesize that the exercise test in a cold chamber, a combination of two provocation
      methods cold air and exercise, is more sensitive to detect EIB and that the test has a better
      repeatability.
    

Intervention name(s): Exercise challenge in a cold chamber; Methacholine challenge; Exercise challenge in room temperature
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.; nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg; Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in room temperature.
Intervention MeSH terms: Methacholine Chloride
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: exercise-induced bronchoconstriction; exercise-induced asthma; cold chamber; exercise challenge; cold air challenge; combined exercise- and cold-air challenge; methacholine challenge
Effects of Recruitment Maneuver on Functional Residual Capacity
Condition: Anesthesia; Surgery; Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia
      and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries
      affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at
      bedside in intensive care units.

      The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers
      affect it, attract attention.
    

Detailed description: 
      An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in
      patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved
      with TIVA.

      FRC will be measured in different steps of the operation. In the study group, a recruitment
      manover will be applied to evaluate its effects on FRC.
    

Intervention name(s): recruitment maneuver
Intervention type(s): Procedure
Intervention description(s): 30 cmH2O pressure 15 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims mainly to investigate the effects of two approaches to control blood pressure
      in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume
      control (by strict dietary salt restriction and persistent ultrafiltration) without using
      antihypertensive drugs on cardiac structure and inflammation.
    

Detailed description: 
      This randomised, controlled and prospective study aims mainly to investigate the effects of
      two approaches to control blood pressure in hypertensive hemodialysis patients; using
      antihypertensive drugs versus persistent strict volume control without using antihypertensive
      drugs on cardiac structure (mainly left ventricular hypertrophy)and inflammation.

      We hypothesize that better blood pressure control and regression of left ventricular mass may
      be reached by a policy of strict volume control consisting of strict dietary salt restriction
      and persistent ultrafiltration.

      258 Hypertensive hemodialysis patients (BP>130/80 mmHg and/or being on antihypertensive
      medication) will be randomized to two arms:

      Group 1: Antihypertensive medicine will be stopped and strict volume control policy will be
      applied.

      Group 2: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both
      groups.

      The patients will be evaluated at 12 months for primary outcomes. Primary end-points are
      significant changes in left ventricular hypertrophy and left ventricular mass and significant
      change in left ventricular end-diastolic volume.

      Secondary end-points are changes in post-dialysis weight, changes in hematocrit, albumin, BNP
      and hsCRP levels.
    

Intervention name(s): strict volume control policy; antihypertensive drugs administration
Intervention type(s): Procedure; Procedure
Intervention description(s): strict volume control by UF and dietary salt restriction; continue antihypertensive medications
Intervention MeSH terms: Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end-stage renal disease; hemodialysis; volume control; ultrafiltration; inflammation; cardiovascular disease; left ventricular hypertrophy; dietary salt restriction
Short bouTs of Exercise for Preschool-age Children
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to examine if short bouts of structured physical activity
      implemented within the classroom setting as part of designated gross-motor playtime will
      increase preschool-age children during-school physical activity level.
    

Detailed description: 
      Most preschool centers provide two 30-minute sessions of gross-motor/outdoor playtime per
      preschool day. Within this time frame, children accumulate most of their activity within the
      first 10 minutes. This study is a cluster randomized controlled study designed to examine the
      effects of short bouts of structured physical activity implemented within the classroom
      setting as part of designated gross-motor playtime on during-school physical activity in
      preschoolers. Results from this intervention could provide evidence that a physical activity
      policy that exposes preschoolers to shorter bouts of structured physical activity throughout
      the preschool day could potentially increase preschooler's physical activity levels.
    

Intervention name(s): Short bouts of structured physical activity; Unstructured physical activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Short bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities. Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months.; Unstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice. intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months.
Other intervention name(s): Instant Recess for preschoolers; Free playtime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical activity; preschoolers
Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia
Condition: Lung Ultrasound; Pneumonia; Covid19
MeSH terms: COVID-19; Pneumonia
Study type: Interventional

Summary: 
      Lung ultrasonography (LUS) is also used in COVID 19 pneumonia for diagnostic and follow-up
      purposes.It has been demonstrated in different studies that it can be used for pathologies in
      pleural and lung tissue. LUS was applied by different researchers by dividing the lungs into
      12 and 14 regions and the results were shared.
    

Detailed description: 
      In our study, we aimed to determine the correlation between lung findings of COVID 19
      pneumonia and thoracic tomography with the results of LUS applied to different numbers (12
      versus 14) of areas.
    

Intervention name(s): LUS Twelve area; LUS Fourteen area
Intervention type(s): Device; Device
Intervention description(s): Application of 12 areas (2 posterior, 2 lateral, and 2 anterior)lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz); Application of 14 areas (3 posterior, 2 lateral, and 2 anterior) lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Changes of Right and Left Cerebral Oxygen Saturation and Blood Flow During Nephrectomy in Lateral Decubitus Position
Condition: Nephrectomy
Study type: Observational

Summary: 
      The purpose of this study is to determine changes of right and left cerebral oxygen
      saturation and blood flow during nephrectomy in lateral decubitus position.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the patients who visit Severance hospital for nephrectomy
      
Keywords: To compare the change of cerebral oxygen saturation and blood flow between right and left side in lateral decubitus position during nephrectomy
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each
      of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.
    

Detailed description: 
      The study aims to assess safety, tolerability and PK of once weekly administration of Elpida
      in different doses.
    

Intervention name(s): Elpida
Intervention type(s): Drug
Intervention description(s): elsulfavirine, capsules
Other intervention name(s): elsulfavirine; VM-1500; VM1500
Intervention MeSH terms: Elsulfavirine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol
      Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate
      to severe COPD
    


Intervention name(s): PT003; PT001; PT005; Tiotropium inhalation powder
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PT003 MDI administered as two puffs BID for 7 days; PT001 MDI administered as two puffs BID for 7 days; PT005 MDI administered as two puffs BID for 7 days; Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
Condition: Hypohydrated; Euhydrated
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      Acute Kidney Injury (AKI) is common in prolonged endurance events. Risk factors for
      exercise-associated AKI include: the exercise itself, heat, hypohydration, muscle breakdown
      and non-steroidal anti-inflammatory drug (NSAID) use. Prior research from our laboratory
      showed the hypohydration during high-intensity running increased a biomarker of AKI (urine
      osmolality-corrected kidney injury molecule 1). Therefore, the current study will now
      investigate the effect of manipulating hydration status during cycling on biomarkers of AKI.
    


Intervention name(s): Water intake
Intervention type(s): Other
Intervention description(s): Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities
      of an allergen extract to an allergic patient, is a curative approach which directly treats
      the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal
      specific immunotherapy for patients with an allergy to tree pollen (hay fever).

      The purpose of this double-blind Phase IIb study is to assess the tolerability and
      immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and
      alder pollen.
    

Detailed description: 
      Tree MATAMPL (tyrosine adsorbed tree pollen allergoid with monophosphoryl lipid A (MPL®)) has
      been developed to provide pre-seasonal specific immunotherapy for patients with proven type I
      hypersensitivity to cross-reacting tree pollens that cause rhinitis and/or conjunctivitis
      with or without mild to moderate asthma.

      This was a phase IIb, double-blind, placebo-controlled study to assess the tolerability and
      immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and
      alder pollen.

      Sixty eight (68) volunteers were randomly assigned to one of three active treatments or
      placebo to receive up to 4 subcutaneous injections of either increasing doses of Tree MATAMPL
      or Placebo over 7 day (+1 day) interval.

      The duration of the study from screening (Visit 1) to end of study (Visit 6, Post-Treatment
      Visit) was approximately 50 days.
    

Intervention name(s): Tree MATA MPL - Therapeutic Regimen; Tree MATA MPL - Intermediate dose; Tree MATA MPL - Low dose; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 600, 1600, 4000, 4000 SU/0.5 mL; 300, 600, 1600, 1600 SU/0.5 mL; 300, 300, 300, 300 SU/0.5 mL; L-tyrosine 2% w/v , 4 injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergy; Specific Immunotherapy; Allergy Vaccination; Allergenicity