bioihbjkbjnl/mcl2 huggingface dataset:
3-D Visualization of the Anti-Obstructive Effect of Levocetirizine
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it
      is important and necessary to understand and visualize therapy effects on this disease. In
      this study we will demonstrate the effect of levocetirizine on nasal cavity dimensions by
      assessing not only standard nasal flow diagnostics such as rhinomanometry and acoustic
      rhinometry, but supplement exami¬nation procedures with long-term rhinometry and magnetic
      resonance imaging (MRI). With the aid of a virtual model and computer fluid dynamics, we are
      able to simulate nasal air flow and provide three-dimensional visualization of the computed
      flow.

      In previous trials ([Bachert], [deBlic], [Day] and [Deruaz]) it has been shown that allergic
      symptoms, especially nasal congestion, diminish significantly under treatment with
      levocetirizine. We will demonstrate this anti-obstructive effect by comparing the reaction to
      nasal allergen challenge before and after four-week treatment with levocetirizine.
    


Intervention name(s): Levocetirizine; Levocetirizine
Intervention type(s): Drug; Drug
Intervention description(s): The study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride). 28 film tablets will be dispensed. Oral intake should be performed once daily (administration in the evening).; Levocetirizine
Intervention MeSH terms: Cetirizine; Levocetirizine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the efficacy of the epicardial or endocardial
      radiofrequency ablation in the treatment of atrial fibrillation.

      It is a multicentric, prospective, randomized, parallel, comparative, double blind study. The
      study principal objective is to evaluate the absence of atrial fibrillation after 3 months.
      The secondary objectives consist in the evaluation of the maintenance of the sinusal heart
      rate at one year and of the quality of life improvement
    

Detailed description: 
      Principal objective:

      To evaluate the efficacy at 3 months of combined ablation technique in the treatment of
      chronic atrial fibrillation during cardiac surgery in order to obtain a sinusal heart rate.

      A sequential statistical analysis of the results will be performed every 10 patients.

      In case of validation of the principal objective by a sequential method i.e. proving the
      superiority of the treatment by ablation, ,the study would then be opened and pursued by
      using the ablation technique for all subsequent patients in order to validate the secondary
      study objectives

      Secondary objectives:

        -  To evaluate the quality of life of the patients at one year and the absence of atrial
           fibrillation relapse.

        -  6 and 12 months clinical follow-up

        -  To evaluate the left atrial function at 6 months by trans-oesophagus echocardiography
    

Intervention name(s): Radiofrequency ablation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cardiac surgery; Radiofrequency ablation; Atrial fibrillation
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is
      known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is
      the source of local and/or systemic infection or sepsis. The local inflammation and infection
      destroy healthy surrounding tissues and extends the original damage. In order to prevent
      these complications, and in order to minimize the risk of infection, it is imperative to
      evaluate the burn and remove all of the offending eschar at the earliest possible
      opportunity. This removal of dead tissue is termed "debridement".

      The most direct debridement method for eschar removal is surgery. Traditional, conservative
      non-surgical debridement is a lengthy process which often involves many complications.

      The objective of this study is to evaluate the safety and enzymatic debriding efficacy of
      Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full
      thickness thermal burns and to compare DGD to standard of care (SOC).
    

Detailed description: 
      Completed study.
    

Intervention name(s): DGD
Intervention type(s): Drug
Intervention description(s): Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)
Condition: Liver Diseases; Liver Cirrhosis; Sepsis; Critical Illness
MeSH terms: Sepsis; Toxemia; Liver Diseases; Liver Cirrhosis; Liver Failure; Hepatic Insufficiency; Fibrosis; Critical Illness
Study type: Observational

Summary: 
      The purpose of the study is to determine the role of new biomarkers in the diagnosis of
      sepsis in critically-ill patients with liver failure and to correlate the prognosis of these
      patients with parameters of endothelial function and lipid metabolism.
    

Detailed description: 
      Early diagnosis of sepsis may be difficult in patients with severe liver failure in the
      absence of usual warning clinical signs. Furthermore, routine laboratory tests like blood
      leucocyte count and serum c-reactive protein may be misleading in most of these patients. A
      great interest is taken in the identification of sepsis biomarkers or sepsis-induced
      alterations in the inflammation cascade, whose expression is independent of liver function.
      Determination of such a biomarker may be a useful tool for the early diagnosis of sepsis and
      may have a prognostic significance in patients with liver failure.

      Septic complications in patients with liver failure may induce a disruption of liver
      microcirculation, which is regulated by several factors acting on endothelial and liver
      stellate cells. Furthermore, generation of reactive oxygen species results in an oxidative
      stress on lipids, proteins, and DNA. Lipid peroxidation may contribute to further
      hepatocellular injury and activation of systemic inflammation cascade. Both endothelial
      dysfunction and alterations in lipid metabolism may have a role in the prognosis of liver
      disease and its complications.

      The purpose of this prospective observational study is to determine the role of new
      biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to
      correlate the prognosis of these patients with parameters of endothelial function and lipid
      metabolism. In addition, the porto-systemic gradient of these parameters will be determined
      in patients planned for a transjugular intra-hepatic porto-systemic shunt (TIPSS).

      An overall number of 120 patients will be enrolled. According to the mode of presentation,
      the planned number of patients in the different study groups will be as follow : 70 patients
      with chronic liver failure and acute on chronic liver failure; 20 patients with acute liver
      failure ; 30 patients post-liver transplantation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        intensive care unit
      
Biospecimen description: 
      plasma, urine, ascites fluid.
    
Keywords: Liver cirrhosis; acute liver failure; liver transplantation; sepsis, infection; endothelium; lipids; diagnosis; prognosis
Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate a treatment program for young children with Obsessive Compulsive
      Disorder (OCD) and their families.
    

Detailed description: 
      Childhood onset OCD is a serious condition that may be a predictor of illness in adulthood.
      To date, no OCD psychotherapy trials have specifically focused on early childhood.
      Development of interventions for childhood onset OCD that address both developmental
      considerations and familial relationships is necessary.

      Participants are randomly assigned to receive 12 sessions of either Cognitive Behavioral
      Therapy (CBT) or Relaxation Training (RT) over the course of 14 weeks. The CBT treatment is
      designed to lessen anxiety by addressing specific OCD symptoms. The relaxation intervention
      addresses generalized feelings of anxiety with the expectation that OCD symptoms may benefit
      indirectly. The clarity, completeness, acceptability, and feasibility of both interventions
      is assessed. A 3-month post-treatment follow-up is also conducted.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT); Relaxation Training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Video Diversion During Fundoscopic Exam in Children
Condition: Other Disorders of Optic Disc, Bilateral
Study type: Interventional

Summary: 
      Fundoscopy is an important aspect of the neurological examination, but can be challenging in
      uncooperative children. This study explored whether viewing a video (selected by patient or
      caregiver) during eye examination improves the success, duration and ease of pediatric
      fundoscopy.

      Hypothesis: Showing a short video clip during a fundoscopic exam will increase the
      probability of successfully visualizing the optic disk and reduce the amount of time needed
      to perform a fundoscopic exam in children between 1-8 years old.
    

Detailed description: 
      The purpose of this study is to examine whether showing a video clip with sound of the
      patient's choice can improve the ease of fundoscopic exam as defined by improved success of
      visualizing the optic disk and the reduction in time needed to perform the exam. The
      investigators will also examine the physician's and caregiver's perception on whether the
      video was effective in improving the ease of the exam. The purpose of the video is to capture
      the visual attention of the patient thereby allowing the physician to swiftly perform the
      fundoscopic exam. The literature has suggested that young patients are most uncooperative,
      therefore the investigators will focus our study on younger patients 1-8 years old.
    

Intervention name(s): Video (played on a computer monitor)
Intervention type(s): Other
Intervention description(s): The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: optic disk; fundoscopy; pediatric; clinical examination
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Condition: Obesity; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect
      its elimination from the body via metabolism. This study will therefore compare the
      pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability
      of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control
      subjects.
    


Intervention name(s): CP-945,598; CP-945,598; CP-945,598
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of CP-945,598 in subjects with mild hepatic function; Administration of CP-945,598 in subjects with moderate hepatic function; Administration of CP-945,598 in subjects with normal hepatic function
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of ProQuad® rHA in Infants (V221-037)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured
      with recombinant human albumin (rHA) when administered to children in their second year of
      life.

      Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured
      with rHA when administered to children in their second year of life.
    


Intervention name(s): ProQuad®
Intervention type(s): Biological
Intervention description(s): ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of: measles, mumps, rubella and varicella
Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
Condition: Cirrhosis; Renal Failure
MeSH terms: Liver Cirrhosis; Renal Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study was evaluate the effect of administration of midodrine and albumin
      on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.
    

Detailed description: 
      Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine
      greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of
      10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In
      all patients, liver and renal function, and vasoactive hormones (plasma renin activity,
      aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline
      conditions. At this moment, glomerular filtration rate and renal plasma flow determined by
      isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be
      performed too. All these determinations will be repeated at 4 and 12 weeks. During the study
      period, just before the albumin infusions, blood will be drawn for creatinine and
      electrolytes determinations and these will be recorded as well physical examination
      performed.
    

Intervention name(s): Midodrine plus Albumin
Intervention type(s): Drug
Intervention description(s): MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Other intervention name(s): Albumin Grifols; Gutron
Intervention MeSH terms: Midodrine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; renal failure; hepatorenal syndrome; albumine; midodrine
Therapy of Alzheimer's Disease With Neurofeedback
Condition: Alzheimer Dementia (AD); Elderly
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The project aims to investigate in patients of Alzheimer's disease in a prodromal state
      (early state of the disease) compared to healthy subjects whether neurofeedback training with
      functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary
      modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive
      ability, as well as functional and structural measures of the brain.

      Over the course of the study subjects will learn a real-world footpath. During neurofeedback
      training subjects are then asked to recall this footpath while simultaneously trying to
      modulate their own brain activation based on feedback. Feedback is given about the
      parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial
      memory, which is known to be affected early by Alzheimer's disease pathology.

      Before and after the training cognitive ability is assessed using neuropsychological tests
      mainly measuring numerous domains of memory.

      The investigators hypothesise that the training leads to an improvement of the trained
      cognitive domain, but also induces changes in brain structure and function.
    


Intervention name(s): rtfMRI neurofeedback training; 3T MRI
Intervention type(s): Other; Device
Intervention description(s): Information about the state of brain activation was given to subjects. That information was visualised as a thermometer bar. Subjects tried to modulate that activation while performing a mental imagery task.; A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The design is a pre-test/post-test study with an intervention of three parallel groups. The groups are a healthy elderly experimental group, a patient group and a healthy elderly sham-feedback group.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: neurofeedback; real-time functional MRI; parahippocampus
Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale
      (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).
    

Detailed description: 
      This study will based on a prospective, observational investigation of two different patient
      education techniques about the effect of third molar removal on patients' anxiety level. A
      total of 240 patients will be divided into two groups.

      Information about operation procedures and a recovery will be given verbally in group 1 and
      information about operation procedures and recovery will be given in group 2. Anxiety levels
      were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for
      intra-group comparison of anxiety levels.
    

Intervention name(s): Anxiety measurement method
Intervention type(s): Other
Intervention description(s): Two different techniques (video or verbal information) will be examined about impacted third molar surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Video; Anxiety
Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning,
      behavior and development in young children and whether there are associated changes on their
      MRI scan.
    

Detailed description: 
      In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type
      1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the
      head performed every three years for three years. We will compare this to a control group of
      10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control
      subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The
      children with Type 1 diabetes mellitus will not have any changes made to their current
      diabetes regimen.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        please see inclusion and exclusion criteria
      
Keywords: Type 1 diabetes mellitus
Human Milk Oligossaccharide and Acetate Production in Vivo
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between
      metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of
      polymerization and branching namely a resistant starch and a human-like milk oligosaccharide
      enhance the acetate availability in the distal colon and systemic circulation, consequently
      leading to its metabolic effects.

      To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese,
      prediabetic men with the fibre mixture the day before the clinical investigation day (CID)
      and study during the CID its effects on fasting and postprandial substrate and energy
      metabolism.
    


Intervention name(s): Human Milk Oligossaccharide; Maltodextrin; Human Milk Oligossaccharide and resistant starch
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The day before the CIDs, the participants receive the supplements 3x a day in randomized order; The day before the CIDs, the participants receive the supplements 3x a day in randomized order; The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala
Condition: Adherence to Vaccination Schedules; Timeliness of Vaccination; Acceptability of SMS Reminder Program
Study type: Interventional

Summary: 
      This project plans to learn more about whether sending text messages to parents on their
      mobile phones to remind them when their child is due for his or her next vaccination will
      improve children getting vaccinated on time.
    

Detailed description: 
      This project plans to learn more about whether sending text messages to parents on their
      mobile phones to remind them when their child is due for his or her next vaccination will
      improve children getting vaccinated on time. The vaccines that will be given are the same
      routine vaccinations registered in Guatemala and used by the Ministry of Health regardless of
      enrollment in the study.
    

Intervention name(s): SMS message; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): SMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group; Health clinic nurse provides regular appointment in the vaccination card with no active reminders
Other intervention name(s): text messages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: vaccines; reminders; immunization timeliness; vaccine coverage