bioihbjkbjnl/mcl2 huggingface dataset:
Hypocholesterolemic Effect of Fibracep
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      FIBRACEP is an onion based fiber that has demonstrated in vitro and in animal models the
      capacity to increase HDL cholesterol levels as well to improve other lipid profile species.
      This intervention aims to demonstrate FIBRACEP's blood lipid profile improvement effect. For
      that purpose, hypercholesterolemic subjects will be recruited and given a daily dose of 7 g
      of FIBRACEP for two months. Changes in blood lipid profile will be the end-point of the
      study.
    


Intervention name(s): FIBRACEP; INSOLUBLE; SOLUBLE
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months; A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months; A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months
Other intervention name(s): Onion fiber; Insoluble fibre from wheat bran; Soluble fibre from Psyllium plantago
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fiber; Cholesterol
Oxytocin Trial in Prader-Willi Syndrome
Condition: Prader Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of
      oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of
      this study is to determine if oxytocin (OT) administration will improve some of the aspects
      of Prader-Willi syndrome that are particularly troublesome for children and their families
      (the insatiable appetite and social behaviors).

      The research questions are:

        1. Does intranasal oxytocin cause any side effects in children with PWS?

        2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?
    

Detailed description: 
      This study is to investigate if intranasal oxytocin will improve hyperphagia, social skills,
      and behaviors in subjects with Prader-Willi syndrome. This will be a randomized placebo
      controlled pilot study. The primary outcome measure is to determine if intranasal
      administration of oxytocin will cause any adverse events in subjects with Prader-Willi
      syndrome. Secondarily, the investigators will also perform evaluations to determine if
      intranasal oxytocin has any effect on social skills, behaviors, or appetite in children with
      Prader-Willi syndrome.
    

Intervention name(s): Intranasal oxytocin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): This is a double-blind placebo controlled 2x2 study. Subjects will receive OT for 5 consecutive days during their 7 day stay. This will be followed by a wash out period of 4-6 weeks.; This is a double-blind placebo controlled 2x2 study. Placebo will be given via intranasal spray, one spray in each nostril daily x 5 days. One month interval between arms of treatment.
Other intervention name(s): Pitocin; Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prader Willi syndrome; Oxytocin
Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are:

      To demonstrate the immunogenicity in terms of antibody response following primary vaccination
      of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™
      when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during
      the first 6 months of life.

      To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and
      serious adverse events following primary vaccination of Korean infants with the pneumococcal
      conjugate vaccine GSK 1024850A.
    

Detailed description: 
      Vaccination course at 2, 4, 6 months of age.
    

Intervention name(s): Pneumococcal vaccine GSK1024850A (Synflorix); Prevenar; GSK Biologicals' Hiberix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 doses administered intramuscularly.; 3 doses administered intramuscularly.; 3 doses administered intramuscularly.
Other intervention name(s): Hib
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Streptococcus pneumoniae; pneumococcal conjugate vaccine
Virtual Reality and Congenital Diaphragmatic Hernia
Condition: Virtual Reality; Congenital Diaphragmatic Hernia; Children
MeSH terms: Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Study type: Interventional

Summary: 
      The study has been designed to investigate the effect of 12 weeks of using virtual reality
      based exercises on pulmonary functions, exercise capacity, functional performance, and
      quality of life in children with surgically-repaired congenital diaphragmatic hernia.
    

Detailed description: 
      Children with CDH have significant disruptions in their quality of life (QoL) due to their
      poor health, in this randomized controlled clinical trial, one important aspect of virtual
      reality is the interactivity of children and their interests in choosing the exercised game.
      Each child in two groups perform a specific virtual reality based respiratory exercises for 3
      months.
    

Intervention name(s): Traditional physical therapy program; Virtual reality-based exercises
Intervention type(s): Other; Other
Intervention description(s): resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.; Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Epigenetics and the Origin of Muscle Insulin Resistance in Humans
Condition: Diabetes Mellitus Type 2 in Obese; Obesity
MeSH terms: Diabetes Mellitus; Insulin Resistance; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The investigators are trying to understand the role of DNA (deoxyribonucleic acid)
      methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a
      normal chemical process in the body that modifies DNA. By studying this, the investigators
      hope to better understand the causes of insulin resistance.
    

Detailed description: 
      Insulin resistance is defined as the decreased ability of insulin to perform its biological
      function in the muscle, liver and fat. Genetic and environmental factors are known to
      influence insulin sensitivity. It is not known how this is mediated. This study looks at the
      role of epigenetics (modifications of proteins associated with DNA and methylation of DNA) in
      alterations in insulin resistance. We will study lean healthy people, obese non-diabetic
      people and people with type 2 diabetes to characterize the DNA methylation patterns in muscle
      in each group. The second aim of the study is to see how a single bout of exercise affects
      the DNA methylation in the muscle. The third aim looks at the effect of 8 weeks of supervised
      exercise on the DNA methylation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three groups of volunteers will be studied: 1) lean, healthy volunteers, 2)obese volunteers
        without type 2 diabetes, and 3) volunteers with type 2 diabetes.
      
Biospecimen description: 
      thigh muscle biopsies bloodsamples
    
Keywords: Insulin resistance; Exercise; Type 2 diabetes mellitus; Obesity; Epigenetic studies
A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in
      the body. Researchers will compare the new tablet formulation to the capsule formulation that
      is currently being tested in other clinical trials. They will measure the levels of the drug
      in the bloodstream for up to 3 days after participants take either the tablet or the capsule
      formulation. They will also look at whether the tablet formulation behaves differently when
      it is taken with and without food.
    

Detailed description: 
      This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The
      first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by
      a washout period of at least 72 hours.
    

Intervention name(s): Lu AG06466 Capsule; Lu AG06466 Tablet; Antacid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hard capsule; Film-coated tablet; Oral suspension
Other intervention name(s): Maalox; Aluminum hydroxide and magnesium hydroxide
Intervention MeSH terms: Aluminum Hydroxide; Antacids; Magnesium Hydroxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The first 3 periods will be randomized.
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Epstein-Barr Virus Infections; Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel
      disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD,
      whereas their absence would preclude such association.
    

Detailed description: 
      The protocol is designed to evaluate the following objectives:

        1. The prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6 virus DNA in
           inflamed intestinal mucosa of patients with Crohn's colitis and ulcerative colitis
           compared to their prevalence in healthy intestinal mucosa of patients not affected by
           these conditions;

        2. To evaluate the prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6
           virus DNA in the intestinal mucosa of patients with Crohn's colitis and ulcerative
           colitis compared to that in inflamed mucosa caused by other conditions (non specific
           colitis);

        3. To compare the prevalence of cytomegalovirus, Epstein Barr virus and human herpes 6
           virus DNA in inflamed and healthy tissue in the same patients with Crohn's colitis and
           ulcerative colitis;

        4. To determine whether the presence of cytomegalovirus, Epstein Barr virus and human
           herpes 6 virus DNA detected by nPCR correlates with immunohistochemical detection of
           viral protein in colonic tissue.

        5. To determine whether the relative viral quantity of CMV, EBV or HHV-6 is related to
           severity of disease activity.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with inflammatory bowel disease (ulcerative colitis and Crohn's Colitis), Other
        inflammatory conditions of the colon
      
Biospecimen description: 
      Specimens will be discarded upon study completion
    
Keywords: Crohn's disease; ulcerative colitis; cytomegalovirus; Epstein Bar Virus; Human Herpes virus 6
Brain Stimulation During Arm Immobilisation
Condition: Muscle Loss
Study type: Interventional

Summary: 
      The research project explores how non-invasive brain stimulation can be used to detect and
      ameliorate loss of muscle strength after inactivity. At present, there is a limited
      understanding of how to maintain muscle strength during inactivity. Increasing evidence
      indicates that reduction in muscle strength following immobilisation is associated with
      reduced cortical motor output. Therefore, the aim of the study is to test if brain
      stimulation, can maintain cortical motor output and ameliorate the loss of muscle strength
      following immobilisation.
    


Intervention name(s): Transcranial Magnetic Stimulation (TMS)
Intervention type(s): Other
Intervention description(s): TMS is a safe and non-invasive technique, which involves the generation of brief magnetic pulses applied to the head through a coil. The magnetic pulses pass through the scalp and skull and induce weak electric currents in the neural tissue directly underneath the coil. When TMS is applied in repetitive, patterned trains of pulses (rTMS), it can induce cortical plasticity specifically in the targeted brain region.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
Condition: Obesity
Study type: Interventional

Summary: 
      In this study the investigators aim to quantitate the extent of cervical and upper thoracic
      brown adipose tissue (BAT) activation in lean and obese humans via positron emission
      tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic
      receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological
      adrenergic stimulus will result in activation of BAT in these participants, and that this
      activation will be reduced in obese patients. This study will provide important preliminary
      information with respect to allowing the investigators to progress with longer trials with
      specific beta 3 AR agonists.
    


Intervention name(s): ephedrine hydrochloride; ephedrine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose, 1mg/kg body weight; single dose of 1 mg/kg body weight
Intervention MeSH terms: Ephedrine; Pseudoephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Treating PCOS With Digital Intervention vs. Metformin
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      With the change in environment and lifestyle, and the improvement of people's understanding
      of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the
      prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are
      the main treatment option for patients with PCOS. In addition, research has shown that
      digital therapy can effectively improve behavior changes in diet, exercise, and medication
      adherence, predict disease progression, reduce the frequency of disease-related symptoms, and
      promote effective disease management. This study aimed to investigate the efficacy of digital
      intervention versus traditional metformin monotherapy in patients with PCOS.
    

Detailed description: 
      This study developed a mini-program that combined diet, exercise, sleep, and mood
      interventions for PCOS women.
    

Intervention name(s): Digital Intervention; Metformin
Intervention type(s): Behavioral; Drug
Intervention description(s): This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.; Traditional metformin monotherapy.
Other intervention name(s): Metformin treatment
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mindful Awareness Practices for ADHD Pilot Open Trial
Condition: ADHD
Study type: Interventional

Summary: 
      It is estimated that 25-40% of youth with ADHD have co-occurring cognitive disengagement
      syndrome (CDS; previously sluggish cognitive tempo), a set of behavioral symptoms
      characterized by excessive daydreaming, slowed thinking, and mental confusion and fogginess.
      A growing body of research demonstrates CDS to be associated with functional impairment above
      and beyond that which can be accounted for by ADHD severity. However, no treatment currently
      exists that directly targets CDS symptoms. This is a critical clinical and scientific gap,
      leaving youth with ADHD and co-occurring CDS at risk for experiencing negative immediate and
      long-term outcomes. In considering intervention approaches, mindfulness meditation involves
      regular practice to catch oneself when the mind wanders, and may thus an ideal intervention
      for youth with CDS. However, mindfulness interventions, including the Mindful Awareness
      Practices (MAPs) for ADHD, have never been tested in adolescents with ADHD and co-occurring
      CDS specifically. This study will recruit up to 15 adolescents with ADHD and co-occurring CDS
      symptoms to enroll in an open trial of MAPs to evaluate its feasibility, acceptability, and
      preliminary efficacy. Findings will provide key pilot data regarding treatment of CDS in
      adolescents with ADHD.
    


Intervention name(s): Mindful Awareness Practices (MAPs)
Intervention type(s): Behavioral
Intervention description(s): MAPs is an 8-session, group-based approach for individuals with ADHD to improve attentional difficulties and related impairments by enhancing attending to and accepting experiences in the present moment. Sessions typically last between 60 and 90 minutes, though may last up to 120 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Basic Life Support Performance With Serious Game Based Module and Simulation Based Hands on Training
Condition: Cardiopulmonary Resuscitation; Simulation Training
Study type: Observational

Summary: 
      The aim of this study is creating this platform and investigating whether performance
      evaluation of BLS trainings would be more objective compared to conventional OSCE (Objective
      Structured Clinical Examination) exams, if these evaluations were carried out with the
      platform which is combining OSCE scoring criteria with sensor data retrieved from the
      simulator's sensors.
    

Detailed description: 
      The participants of this study consisted of 25 volunteers among Acibadem Mehmet Ali Aydinlar
      University students without prior knowledge of basic life support protocol. 11 Participants
      (44.0%) were male, 14 (56.0%) were female. The participants were informed about the study and
      signed consent forms before participating the study. After a brief introduction of the
      serious gaming module, the participants were asked to choose the self-test mode of the
      serious game module. The participants' number of attempts was not limited. Following serious
      game based training, the hands-on training module combining OSCE scoring criteria with sensor
      data retrieved from the simulator's sensors was used for hands-on performance evaluation.
      After familiarization with the system using self-training mode, the participants were asked
      to proceed the BLS Hands-on training app with the simulator under the supervision of the
      educator. The simulation sessions were also recorded in order to use these recordings for
      conventional OSCE (Objective Structured Clinical Examination) performance evaluation.
      Conventional OSCE score of each participant was obtained by watching the recorded sessions of
      BLS trainings.Spearman's rho correlation test was used for calculating the correlation
      between serious gaming, hands on training module with including sensor data from the
      simulator and OSCE scores.
    

Intervention name(s): Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores
Intervention type(s): Other
Intervention description(s): Hands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.
Other intervention name(s): Basic Life Support Serious Game Module
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The participants of this study consisted of 25 volunteers among Acıbadem Mehmet Ali
        Aydinlar University students without prior knowledge of basic life support protocol. 11
        Participants (44.0%) were male, 14 (56.0%) were female. The mean age of the participants
        was 24,2 years.
Safety Study of Anti-IgE Immunotherapy in Allergic Patients
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate safety and efficacy of three doses and two dosing
      regimens of RP01 as an anti-IgE immunotherapy in allergic patients.
    

Detailed description: 
      Immunotherapy is based on the principle of eliciting an immune reaction in order to block the
      negative effect of a specific disease-causing protein. The potential to treat diseases by
      means of immunotherapy instead of using conventional drugs represents an attractive
      opportunity in a number of chronic disease areas, including asthma and allergy. Resistentia's
      model to treat allergic diseases, and ultimately asthma, is to use the immune system to
      produce antibodies against the IgE molecules themselves. The resulting anti-IgE antibodies
      intercept and form complexes with the IgE molecules before they can bind to the mast cells
      and basophils and are thus able to block any allergen-triggered inflammatory reaction. The
      approach works in all types of IgE-mediated allergies independently of allergen, and also in
      patients sensitive to multiple allergens.

      Comparisons: Three doses and two dosing regimes of RP01 will be compared as regards safety
      and effect.
    

Intervention name(s): RP 01
Intervention type(s): Biological
Intervention description(s): Active immunotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: immunotherapy; allergy