bioihbjkbjnl/mcl2 huggingface dataset:
Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory
Condition: Lack of Satiety; Dietary Modification; Memory Deficits; Obesity
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      One important factor determining school performance is the consumption of breakfast. While
      research has shown that older children perform better in school after consuming breakfast,
      there are little data for preschool-age children. Consuming breakfasts with different macro-
      and micronutrient contents may have different effects on performance, which may be associated
      with variations in satiation and satiety during and after the different breakfasts. In
      addition, children who consume breakfast have better diet quality than children who skip
      breakfast.

      The investigators will conduct a community based, randomized, crossover trial in 4-5 year old
      children over 7 weeks to examine the short-term effect of feeding preschoolers three
      different intervention breakfast types: high protein, high-fiber, or high protein and high
      fiber compared to a usual breakfast served at the preschool. The investigators expect that
      the children consuming any of the three experimental breakfasts will consume less overall
      calories and have better diet quality and memory performance compared to children who have
      the usual breakfast. The investigators hypothesis is that preschoolers will experience the
      highest level of satiety as well as highest level of overall diet quality when they consume
      the combined high-protein and high-fiber based breakfast foods.

      This study will be conducted at Bauer Family Resources in Lafayette as these are the sites of
      Head Start programs, which are preschools for children from low-income families. Children
      from families of low income are more likely to have poor diet quality and poor school
      performance compared to children from families with higher incomes. Therefore, this
      population is most in need of this type of intervention.
    


Intervention name(s): High fiber breakfast; High Protein Breakfast; High Protein/High Fiber Breakfast
Intervention type(s): Other; Other; Other
Intervention description(s): Breakfast will contain 10-11g fiber.; Breakfast will contain 19-20g of protein.; Breakfast will include 19-22g of protein and 10-12g of fiber.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: satiety; satiation; diet quality; memory; obesity; protein; fiber
Oxytocin, Emotions and Mirror Neurons
Condition: Social Cognition; Expressed Emotion
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this project is to investigate the possible effect of intranasally
      administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron
      system (MNS) is thought to be involved in action perception and understanding, and may also
      underlie more complex cognitive processes such as imitation. We will use
      electroencephalographic (EEG) investigations to examine brain activity while participants
      complete two different tasks, consisting of the observation and imitation of emotional facial
      expressions (video presented) and the observation and execution of simple grasping actions
      (live presented), respectively. In addition, before the beginning of the EEG recording
      session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo
      group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is
      a polypeptide hormone that plays a critical role in social behavior. We will identify mu and
      beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal
      directed action perception and imitation/execution.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session; The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
Other intervention name(s): Syntocinon nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mirror neurons; Imitation; Oxytocin
Serial Usage of Combitube in Anesthesiology
Condition: Surgery
Study type: Observational

Summary: 
      Retrospective evaluation of a database of ETC routine uses during general anaesthesia.
    

Detailed description: 
      Background: The oesophageal-tracheal Combitube (ETC) was designed for the use in the
      pre-hospital setting and has proven its value both there and in difficult airway management.
      The ETC is a double-lumen tube and as such it enables ventilation independent of its position
      in either the trachea or the oesophagus. Since laryngoscopy is not necessary for positioning
      the ETC, it is especially favoured in pre-hospital setting, but is also used in clinical
      setting.

      Objectives: Retrospective evaluation of a database of ETC routine uses during general
      anaesthesia.
    

Intervention name(s): Combitube
Intervention type(s): Device
Intervention description(s): Intubation with Combitube
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing general anesthesia physical status ASA class I and II
Study of the Fecal Microbiome in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the intestinal microbiome in subjects with
      Parkinson's disease and to determine safety and trends in improvements in diversity of
      colonic microbiome following administration of lyophilized PRIM-DJ2727
    


Intervention name(s): PRIM-DJ2727; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks; Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Neurological Outcome of VLBW Infants With Early Hypotension
Condition: 1. VLBW Infants; 2. Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Comparison of short and long term neurological outcome of VLBW infants with and without early
      onset hypotension required intervention. The cohort includes all VLBW infants born in our
      institution between January 1997 and December 2000.
A Study to Investigate the Effect of Itraconazole on the Way the Body Absorbs, Distributes, and Gets Rid of ACT-1004-1239 Given as a Single Dose of 10 mg to Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the effect of itraconazole on the way the body absorbs, distributes,
      and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects
    


Intervention name(s): ACT-1004-1239 (10 mg); Itraconazole (200 mg, o.d.)
Intervention type(s): Drug; Drug
Intervention description(s): ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.; Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Intervention model description: Open-label, fixed-sequence, drug-drug interaction (DDI) study
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Dentists Burnout in Turkey
Condition: Burnout, Psychological
MeSH terms: Burnout, Psychological
Study type: Observational

Summary: 
      The aim of this study is to determine the level of burnout in Turkish dentists. The
      Copenhagen Burnout Inventory of 19 questions will be used to assess burnout; and 4 more
      about; gender, occupational age, institution and title. All surveys will be conducted online
      and we plan to reach approximately 400 participants. After the burnout levels are determined,
      it will be statistically investigated whether there is a difference between the groups
      according to gender, occupational age, institution and title.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Dentist who is still working as a dentist in a health institute.
LT Vaccine Patch Self-Administration Study
Condition: Prevention of Travelers' Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the immune responses achieved following self-administered heat-labile enterotoxin
      of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses
      achieved by clinician-administered vaccination.
    


Intervention name(s): heat-labile enterotoxin of E. coli (LT)
Intervention type(s): Biological
Intervention description(s): 37.5ug patch applied on either the deltoid or the thigh
Other intervention name(s): TD Vaccine System
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Condition: Labor Pain; Early Labor
MeSH terms: Obstetric Labor, Premature; Labor Pain
Study type: Observational

Summary: 
      This will be a prospective study on labor characteristics, and obstetric and neonatal
      outcomes in women who accept and women who decline morphine as a form of pain management in
      labor. The study will also investigate patient satisfaction with this form of analgesia. The
      participants will be those who accept morphine and promethazine and those who decline
      morphine and promethazine for pain control.
    

Detailed description: 
      Objective: Therapeutic rest in labor involves administration of parenteral analgesics in
      early or prodromal labor to relieve the patient's discomfort and allow for progression of
      labor while the patient rests. No prospective studies exist which examine the safety and
      clinical utility of therapeutic rest in early labor, and no published studies examine the
      potential benefits of therapeutic rest from the perspective of either patient satisfaction or
      cost-effectiveness. The investigators aim to determine whether therapeutic rest using
      morphine and promethazine is associated with variations in labor characteristics, or
      obstetric or neonatal outcomes as well as patient satisfaction with this form of pain
      management.

      Methods: This will be a prospective cohort study. Women who are eligible for therapeutic rest
      (reactive non-stress test, normal amniotic fluid, in prodromal or early labor as defined by
      obstetric provider, and plan to discharge home after evaluation) will be recruited for the
      study. Participants will receive routine obstetric care by providers who are unaware of
      patient enrollment. A research assistant will then approach all participants in the
      postpartum period, prior to discharge from the hospital or with a phone call if permitted by
      the patient, to complete a questionnaire including patient satisfaction items. Chart review
      will be performed to determine differences in hospital stay and common obstetric and neonatal
      outcomes to compare these data among women who do and do not choose to receive therapeutic
      rest. These results will provide insight into a common clinical practice, helping to not only
      guide management at institutions where therapeutic rest is commonly utilized but also
      potentially encourage its initiation at hospitals were therapeutic rest is not available.
    

Intervention name(s): Morphine Sulfate and Promethazine
Intervention type(s): Drug
Intervention description(s): Morphine sulfate and promethazine
Other intervention name(s): Morphine Sleep
Intervention MeSH terms: Promethazine; Diphenhydramine; Morphine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women presenting to Labor & Delivery Triage who meet inclusion criteria and are offered
        morphine sulfate and promethazine by labor provider for therapeutic rest.
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, reactogenicity and immunogenicity of two formulations of
      GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course
      during the first 6 months of life followed by a booster dose at 12-15 months of age and
      co-administered with DTPa-HBV-IPV/Hib vaccine.
    

Detailed description: 
      This study will assess the safety, reactogenicity, immunogenicity and persistence of two
      formulations of GSK Biologicals' pneumococcal vaccine 2189242A [high dose (HD) or low dose
      (LD)] given as a 3-dose primary vaccination course during the first 6 months of life followed
      by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and
      compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered
      with the Infanrix hexa™ vaccine.
    

Intervention name(s): Pneumococcal vaccine GSK 2189242A (LD formulation 1); Pneumococcal vaccine GSK 2189242A (HD formulation 2); Synflorix; Prevenar 13; Infanrix Hexa (DTPa-HBV-IPV/Hib)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection
Other intervention name(s): GSK 2189242A; 10PP-LD; GSK 2189242A; 10PP-HD
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Haemophilus influenzae; Streptococcus pneumoniae; immunogenicity; Pneumococcal vaccine; infants; safety
Validity and Reliability in Measuring the Subacromial Space by Using Ultrasound
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Observational

Summary: 
      To investigate validity and reliability in measuring the subacrominal space by using
      ultrasound
    


Observational model: Defined Population
Time perspective: Other
Keywords: subacrominal space
Children With HIV and Asthma (CHIVAS)
Condition: T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To explore allergen-specific effector and regulatory T cell response in HIV-infected children
      before and after HAART initiation
    

Detailed description: 
      Recently, US investigators have observed that HIV-infected (HIV+) children on highly active
      antiretroviral therapy (HAART) have a much greater cumulative incidence of asthma.Regulatory
      T cells may mitigate the pathogenicity of asthma through the suppression of Th2 responses.
      Since asthma is predominantly a TH2 mediated condition, we propose that new onset of asthma
      after HAART in HIV- infected children may be secondary to dysregulated immune reconstitution.
      The restoration of CD4+ T cell-mediated immunity in HIV+ patients treated with HAART may lead
      to airway inflammation, narrowing, hyperresponsiveness, and possibly remodeling.

      The increased incidence of asthma in HIV-infected children treated with HAART is likely
      secondary to multiple factors that may include hypersensitivity to certain aeroallergens,
      dysregulation of effector and regulatory T cell response, as well as the imbalance of TH1 vs.
      TH2 cytokines. Therefore this study will identify the immunopathogenesis of increased airway
      hyperresponsiveness in HIV-positive patients.
    

Intervention name(s): HAART
Intervention type(s): Drug
Intervention description(s): as per Thai HIV Treatment guidelines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV-infected children; T cell response; asthma
Minimally Invasive Knee Replacement Outcomes (MIKRO) Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and
      cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally
      invasive knee joint replacement surgical techniques. The primary study hypothesis is that in
      comparing total knee replacement performed with the two different surgical techniques that
      respect four minimally invasive surgery principles (low-profile instrumentation, "minimally
      invasive" incision, overall minimal knee surgical intervention), a faster return to function
      will result when the technique does not incise the tendon.
    

Detailed description: 
      This study does not include financial compensation for treatments involved.
    

Intervention name(s): MPPA; SV
Intervention type(s): Procedure; Procedure
Intervention description(s): - Medial Parapatellar Arthrotomy; - Subvastus Technique
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Minimally Invasive Knee Replacement; Knee Osteoarthritis; Cost effectiveness minimally invasive knee surgery
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Thoracic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is comparison of the effectiveness of ultrasound guided serratus
      anterior plane block and thoracic paravertebral block as a preventive analgesia method after
      VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block
      application, postoperative complications and hospital lenght of stay.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        who underwent elective video-assisted thoracoscopic surgery
      
Keywords: thoracoscopic surgery video assisted; serratus anterior; paravertebral block
5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential
      therapy for eradication of H. pylori infection.
    

Detailed description: 
      The investigators studied 180 consecutive patients with H. pylori infection who were
      randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90
      patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H.
      pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were
      evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was
      performed and antimicrobial resistance was determined
    

Intervention name(s): Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
Intervention type(s): Drug
Intervention description(s): amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Other intervention name(s): proton pump inhibitors
Intervention MeSH terms: Amoxicillin; Levofloxacin; Tinidazole; Esomeprazole; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Concomitant therapy; Sequential therapy; levofloxacin
A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, parallel group study will investigate the
      safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal
      function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers
      will be randomized to receive daily doses of aleglitazar or placebo in combination with
      aspirin. The anticipated time on study drug is 5 weeks.
    


Intervention name(s): aleglitazar; aspirin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): repeated daily doses; repeated daily doses; repeated daily doses
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment