bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Different Birthing Balls Used at the First Stage of Childbirth
Condition: Labor Pain; Satisfaction, Patient; Labor Fast
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The study aimed to determine the effects of different birthing balls used at the first stage
      of childbirth on birth outcomes and maternal satisfaction. Randomized controlled,
      single-blind clinical study included a total of 180 pregnant women. The study included 3
      groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially
      spherical birthing ball, were effective in reducing labor pain and facilitating faster rate
      of descent of the fetal head, and they increased maternal satisfaction.
    

Detailed description: 
      The study aimed to determine the effects of different birthing balls used at the first stage
      of childbirth on birth outcomes and maternal satisfaction. Randomized controlled,
      single-blind clinical study included a total of 180 pregnant women. The study included 3
      groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially
      spherical birthing ball, were effective in reducing labor pain and facilitating faster rate
      of descent of the fetal head, and they increased maternal satisfaction.

      IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring
      during labor are known and expected situation. Some non-pharmacological methods are applied
      to ensure that birth is easy and maternal satisfaction is high.

      What the results of this study add? There is no studies using the peanut ball and the
      spherical birth ball together. In our study, it was found that both balls are effective, but
      the spherical birth ball is more significant.

      What the implications are of these findings for clinical practice and/or further research?
      Our study suggested that the spherical birth ball had effective on birth outcomes. Future
      studies should be performed to investigate the effects of birth balls in the postpartum
      period, breastfeeding or prenatal period.
    

Intervention name(s): balls
Intervention type(s): Device
Intervention description(s): Birth balls to exercise
Other intervention name(s): Birth ball; Peanut Ball
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: birth ball; labor pain; satisfaction; maternal; fetal
CES1 Crossover Trial of Clopidogrel and Ticagrelor
Condition: Myocardial Infarction; Thrombosis; Platelet Dysfunction
MeSH terms: Myocardial Infarction; Thrombosis; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this investigation is to evaluate when genetic variation in the
      carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex
      vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor.
      We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel
      platelet aggregation while having a minimal effect in ticagrelor-treated subjects.

      Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and
      ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited
      by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and
      ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet
      aggregometry performed pre- and post-drug administration in order to assess the interaction
      of genotype and drug choice on on-treatment platelet function.
    


Intervention name(s): Clopidogrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel (75 mg/d for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.; Ticagrelor (90 mg twice daily for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.
Other intervention name(s): Plavix; Brilinta
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Ninety healthy Amish subjects (30 CES1 G143E allele carriers, 30 carriers of a risk variant to be determined, and 30 age/sex-matched controls) will be enrolled. We will prospectively evaluate the effect of CES1 genotype on clopidogrel and ticagrelor response, as assessed by agonist-stimulated platelet aggregation, through the completion of a randomized crossover study of clopidogrel (75 mg per day for 7 d) and ticagrelor (90 mg twice daily for 7 d) in 90 healthy Amish individuals stratified by CES1 genotype as described above, with at least a 14-day washout period between drug interventions.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacogenetics; Carboxylesterase 1 (CES1); Antiplatelet therapy
Uncontrolled Donation After Circulatory Determination of Death (uDCDD)
Condition: Uncontrolled Donation After Circulatory Determination of Death
MeSH terms: Death
Study type: Observational

Summary: 
      World-wide, patients waiting for organ transplantation exceed the number of organs available.
      Many European countries have a uDCDD program which contribute to 10-15% of the donor pool. In
      Canada, this type of program does not exist. The purpose of this study is to report how many
      deceased person fulfill the criteria for uncontrolled DCDD in a Canadian medical center.
    

Detailed description: 
      While transplantation has become the definitive treatment for many people suffering end-stage
      organ failure, demand exceeds supply. For many years, donation after neurological death
      represented the principal source of organs for transplantation. In the last decade,
      prevention measures, improvements in neurocritical care, and decompressive craniectomy have
      led to a significant decrease in the number of non-directed donors (NDDs). In such
      situations, alternative sources for organ donation must be identified. Cardiac-arrest
      patients could provide a solution to this organ shortage. Patients who have experienced
      unexpected in or out of hospital cardiopulmonary arrest could become organ donors. Organ
      donation following uncontrolled cardiocirculatory death is currently practiced in many
      European countries. However, in Canada, it's not yet authorized. Yet, each deceased could
      save up to four lives. The purpose of this study is to determine the organ potential for a
      cohort of patient who had died from a cardiopulmonary arrest at the CHUS in 2015 and assess
      the effect of the implementation of a uDCD program on the number of additional donors.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be conducted in one organ-donation center in Quebec that is a teaching
        hospital and referral center for interventional cardiology. It serves a mixed urban and
        rural population of 350,000.
      
Keywords: unexpected cardiopulmonary arrest; potential organ donors
Development of Children With DCD Before the Age of Six
Condition: Developmental Coordination Disorder
MeSH terms: Motor Skills Disorders
Study type: Observational

Summary: 
      The aim of this study is to map the early development of children with DCD and compare it to
      typically developing (TD) children.

      At first we will investigate to what extent motor delay, reduced force, higher BMI,
      behavioral, ADL and participation problems occur in toddlerhood in DCD children and how this
      relates to TD children. We will also look into the evolution of these parameters in time
      (stability of development).

      Secondly we will explore if the diagnosis of DCD can be predicted using a standardized test
      before the age of five.
    

Detailed description: 
      A longitudinal study design enables us to assess children at three different ages (3y, 4y and
      5y).

      Assessment scores (AIMS or/and BSID) before the age of three will be retrieved
      retrospectively in the clinical group.
    

Intervention name(s): Test Battery
Intervention type(s): Other
Intervention description(s): All toddlers (DCD children + TD children) included in the study will be tested at three points in time, that is at the age of 3y, 4y and 5y with an extensive test battery. Questionnaires will be filled in by parents and teachers. Children will be tested using different instruments.
Other intervention name(s): Movement Assessment Battery for Children 2; Beery-VMI-6; Functional Strength Measurement; Child Behaviour Checklist; Little-DCD-Questionnaire; Teacher Report Form; DCD-Daily-Questionnaire; Vragenlijst motorische vaardigheden kleuters; Body mass Index; YC-PEM; Social Communication Questionnaire
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children attending the Center of Developmental Disabilities Ghent.
      
Keywords: motor development; toddler; prediction
The Impact of Food Advertisements on Brain Response and Eating Behavior in Children
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of this project is to examine the impact that television food advertisements have
      on brain responses and eating behavior in children. Food advertisements enhance children's
      liking and intake of foods that tend to be high in energy content and low in nutritional
      value. Although several studies have measured the differences in children's food intake after
      watching advertisements, none have shown the brain mechanisms associated with this change in
      behavior. In order to clarify the relationship between food advertising and eating behavior,
      the investigators have assembled a team with expertise in functional imaging, eating
      behaviors, and clinical pediatric research. First, the investigators will observe the
      differences in children's eating behaviors after being exposed to food commercials or
      non-food commercials. Second, the investigators will measure the difference in child brain
      response to high and low energy foods after being exposed to food commercials or non-food
      commercials. These data will allow us to identify which areas of the brain are specifically
      affected by exposure to food commercials and correlate activity in these areas with
      children's measured food intake in the laboratory. Children ages 7-9 will participate in this
      5-visit study which will be completed over the course of 12 months. Understanding how food
      advertisements impact children's brain responses and subsequent eating behaviors will have
      implications for understanding why some children respond differently to these cues than
      others. These outcomes may also inform the development of more effective programs and
      policies to prevent childhood obesity.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children ages 7-9 years old
      
Keywords: Magnetic Resonance Imaging; Energy Intake; Commercials; Children
QLB and Radical Cystectomy, Postoperative Pain
Condition: Postoperative Pain; Chronic Pain Post-Proceduraal; Nausea and Vomiting, Postoperative
MeSH terms: Chronic Pain; Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high
      risk bladder cancer is radical cystectomy. The golden standard is still an open surgery
      despite development of laparoscopic techniques. Epidural analgesia is considered as most
      effective for the treatment of postoperative pain. However, there is a need for other
      effective options, because epidural analgesia has some contraindications and risks for
      serious complications. Recently quadratus lumborum block has gained popularity in the
      treatment of postoperative pain after various surgeries in the area from hip to mamilla. It
      is more beneficial than other peripheral blocks, since it covers also the visceral nerves.
      Contrary to the need of epidural catether a single shot QLB has reported to last up to 48
      hours.

      Inadequately treated acute postoperative pain is considered as one of the main risk factors
      for persistent postoperative pain.

      44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome
      measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute
      pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of
      life and persistent pain.
    

Detailed description: 
      44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power
      calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a
      quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the
      current standard care of our hospital -an epidural.

      The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary
      outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes
      such as quality of life and persistent pain.
    

Intervention name(s): QLB
Intervention type(s): Procedure
Intervention description(s): bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Other intervention name(s): quadratus lumborum block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bladder cancer; radical cystectomy; epidural analgesia; quadratus lumborum block; postoperative pain
Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
Condition: Bloodstream Infections; Short Bowel Syndrome; Development; Nutrition; Biological Markers
MeSH terms: Infections; Communicable Diseases; Sepsis; Short Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the effects (good and bad) of
      supplementation with Glutamine to that of a placebo (L-alanine), on your child and their
      Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to
      oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections,
      improving growth, and/or changing the make-up of bacteria in your child's intestine.
      Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study,
      the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in
      children.
    

Detailed description: 
      This is a double-blind, randomized placebo-controlled pilot study to investigate the efficacy
      of enteral glutamine (GLN) supplementation in 36 infants, ≤ 12 months of age with parenteral
      nutrition (PN)-dependent short bowel syndrome (SBS) due to massive small bowel resection for
      NEC and/or atresia on improving weaning of PN and preventing infections. The investigators
      intend to evaluate the effect of enteral feeding and GLN supplementation on the gut bacteria.
      The investigators will also recruit 12 age-matched controls to evaluate the normal gut
      bacteria.
    

Intervention name(s): Glutamine; L-alanine
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months); 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
Other intervention name(s): NutreStore
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Short Bowel Syndrome; Necrotizing Entercolitis (NEC); Atresia; Parenteral Nutrition; Biological Markers; Growth
DIT After RYGB - A Prospective Study
Condition: Obesity; Morbid Obesity; Bariatric Surgery
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese
      patients. This loss is a result of several factors that go beyond the simple anatomical
      abnormality of the gastrointestinal tract and may be the product of post-op energy
      expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are
      important components of energy expenditure and possible changes in them can perform an
      important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted
      a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients,
      which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The
      objective of this study is to perform a prospective analysis of these same variables (RQ and
      DIT), evaluating them in the same patients, when pre and postoperatively.
    


Intervention name(s): A standard mixed Meal
Intervention type(s): Other
Intervention description(s): All patients underwent an indirect calorimetry test, after a 12-h period of fasting from food and water, avoiding intake of alcohol or coffee, and avoiding physical exercise and cigarettes the day before the examination. To examine possible changes in the thermogenic effect of food, patients received a standard mixed meal (200 ml coconut water and a chicken salad sandwich using whole wheat bread). They then repeated the test 20 min and 60 min after eating to obtain a reading of the metabolic rate by considering DIT and the RQ in the postprandial period.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diet-induced Thermogenesis;; Respiratory Quotient;; Roux-en-Y Gastric Bypass;; Energy Expenditure.
Optic Nerve Sheath Diameter in Preeclampsia
Condition: Pre-Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Interventional

Summary: 
      Severe preeclampsia is associated with an elevation in intracranial pressure (ICP). Optic
      nerve sheath diameter is a non-invasive surrogate of invasive ICP measurement. This study
      targets to evaluate the ICP in patients with or without preeclampsia.
    

Detailed description: 
      MRI studies have shown that brain edema due to an elevation in ICP develops in up to 70% of
      women with preeclampsia. Optic nerve sheath diameter is used to estimate the ICP and has been
      shown to correlate well with invasive ICP measurement. The present study aims to compare ICP
      using optic nerve sheath diameter in women with or without preeclampsia.
    

Intervention name(s): Optic nerve sheath diameter measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine wether coenzyme Q10 is effective in reducing
      markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and
      aslo to investigate its effect on glycemic control and lipid profile of those patients and
      its effect on patient's quality of life.
    


Intervention name(s): Coenzyme Q10; Insulin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Coenzyme Q10 soft gelatin capsule 100mg; multiple dose insulin injection therapy
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes mellitus; Coenzyme Q10; endothelial dysfunction; pediatric patients
Intramuscular Lipid and Insulin Action:Ethnic Aspects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      High levels of the hormone insulin are associated with risk for heart disease and diabetes,
      and may make it hard to lose weight. The types of food eaten may affect insulin levels. The
      purpose of this study is to determine if manipulation of dietary carbohydrate content
      improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance
      in healthy adults.
    


Intervention name(s): Low carbohydrate
Intervention type(s): Dietary Supplement
Intervention description(s): 43% CHO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Obesity; diet; carbohydrate; insulin
Use of Multiphoton Microscopy in the Diagnosis of Cancer
Condition: Bladder Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level.
      Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder
      urothelium from atypical and malignant urothelium in the ex vivo setting. After development
      of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a
      non-invasive means to image the interior of the bladder at the cellular level, which would
      provide direct evidence of the presence of tumor without a biopsy. After exhibiting
      usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the
      colon.
    

Detailed description: 
      Same as above
    

Intervention name(s): Multiphoton microscopy
Intervention type(s): Other
Intervention description(s): Use of multiphoton microscopy to diagnose cancer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Bladder cancer; prostate cancer; multiphoton microscopy