bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The primary objective of this study is to determine how daily consumption of kale changes the
      activity of human xenobiotic metabolizing enzymes. Secondary objectives are to measure
      absorption and metabolism of kale phytonutrients, and to determine how kale consumption
      affects gene expression related to metabolism and lipid measures associated with
      cardiovascular health.
    

Detailed description: 
      Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely
      associated with the incidence of several cancers, including cancers of the lung, stomach,
      liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source
      of many nutrients, but the unique characteristic of Brassicas is their rich content of
      glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to
      bioactive metabolites by a plant enzyme called myrosinase, which is released when the
      vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds
      are considered to be the active agent for cancer prevention. Their ability to reduce risk of
      cancer may derive in part from their ability to modulate foreign-substance metabolizing
      enzymes, which include enzymes called Phase I cytochrome P450s and Phase II enzymes.

      The primary aim of this study is to investigate how daily consumption of kale influences
      foreign-substance metabolizing enzymes, which in turn may reduce cancer risk. Secondary aims
      of this study include measuring metabolism of kale nutrients, effect of kale consumption on
      fecal microbiota, and how kale consumption influences risk factors for cardiovascular
      disease.
    

Intervention name(s): Base Diet; Kale Treatment
Intervention type(s): Other; Other
Intervention description(s): Base Diet; Base Diet plus Kale
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Clinical Pharmacology Study of MP-424
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To conduct the following evaluations in Korean healthy male adult volunteers receiving a
      single and multiple doses of MP-424 tablets:

        -  Pharmacokinetics of MP-424 after a single and multiple doses.

        -  Safety and tolerability of single and multiple doses of MP-424.
    


Intervention name(s): MP-424; MP-424; MP-424; MP-424
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low; Middle; High; Multiple
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Genotype 2
Brown Adipose Tissue and Body Mass Index
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study the investigators aim to investigate whether the sympathetic stimulation of
      BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed
      tomography computed tomography scan, differs between lean and obese individuals, as an
      explanation for the diminished metabolic brown adipose tissue activity in obese subjects.

      The investigators hypothesis is that sympathetic nervous system activity in the obese is
      diminished as compared to their leaner counterparts as an explanation for the diminished
      metabolic brown adipose tissue activity in the obese.
    

Detailed description: 
      The sympathetic nervous system is the primary activator of Brown Adipose Tissue.

      Obese humans are known to have less metabolically active brown adipose tissue as compared to
      their leaner counterparts.

      The reason for this diminished metabolic brown adipose tissue activity is unknown.

      However, a lower sympathetic nervous system activation to brown adipose tissue in the obese
      might explain a diminished metabolic brown adipose tissue.

      Therefore, in this study, both the sympathetic nervous system activation to brown adipose
      tissue and the metabolic activity will be measured in lean and obese subjects.

      sympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine
      single-photon emission computed tomography scans, metabolic activity will be measured using
      18F- fluorodeoxyglucose positron emission tomography CT scans.
    

Intervention name(s): 18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan
Intervention type(s): Other
Intervention MeSH terms: 3-Iodobenzylguanidine; Fluorodeoxyglucose F18
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Brown Adipose Tissue; Weight; Sympathetic Nervous System
tVNS Effects on Motivation in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Attaining goals or rewards commonly entails response costs. In light of cost and benefits,
      how do participants decide what effort should be put in to give it a shot? Figuratively, you
      may "go with your gut", but the literal contribution of the gut-brain axis in allocating
      effort is poorly understood to date. Here, the investigators propose to investigate
      non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy
      metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and
      behavioral effects of the stimulation remain largely elusive, the investigators will use
      computational modeling of instrumental behavior and determine the primary metabolic effects
      of the stimulation. The investigators hypothesize that tVNS will lead to activation of
      afferent targets in the brain. In turn, the elicited brain activation is expected to mediate
      the cognitive effects of the stimulation. This may affect both sides of the utility equation
      because anti-depressive effects may correspond to boosting the benefit of effort whereas
      anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the
      cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more
      widespread use as a treatment in mental disorders that are characterized by metabolic
      alterations such as depression.
    


Intervention name(s): transcutaneous vagus nerve stimulation; sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Non-invasive brain stimulation technique that is used to stimulate vagal afferent projections to the nucleus of the solitary tract. Invasive VNS has been approved for the treatment of treatment-resistant depression.; Sham procedure for active transcutaneous vagus nerve stimulation
Other intervention name(s): transcutaneous auricular vagus nerve stimulation; transcutaneous stimulation of the earlobe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: vagus nerve stimulation; food reward; anhedonia; vigor; reward learning; mood
Chronic Effects of Estrogen in Microcirculation
Condition: Postmenopausal Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory
      biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese
      women after three months of follow-up intervention.
    

Detailed description: 
      Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen
      receptors. Traditionally, estrogen receptors have been recognized as transcription factors
      regulating the expression of target genes, however, numerous studies have revealed rapid
      actions of estrogen in different systems, so-called 'extranuclear actions'. At this level,
      estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular
      cell growth and migration, and confers protection to cardiomyocytes. Our aims are to
      investigate estrogen´s chronic effects on microcirculation.

      The study will assess the potential benefits of estrogens on: chronic low-grade inflammation,
      metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be
      randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during
      three months in a double-blind fashion. At baseline and after intervention, nailfold
      videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography,
      inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and
      anthropometrical measures will be assessed in all subjects.
    

Intervention name(s): Estrogen
Intervention type(s): Drug
Intervention description(s): transdermal 17-β-estradiol 1mg/day during three months
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: menopause; obesity; capillary; microcirculation; estrogen; Microvascular Function
The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy
Condition: Voice Hoarseness; Sore Throat; Thyroidectomy
MeSH terms: Pharyngitis; Hoarseness; Dysphonia
Study type: Interventional

Summary: 
      The purpose of this study is an evaluation of the effect of the reinforced endotracheal tube
      on post-operative hoarseness and sore throat undergoing thyroidectomy
    


Intervention name(s): Oral/Nasal Endotracheal Tube, Reinforced (Covidien); TaperGuard oral tracheal tube (Covidien)
Intervention type(s): Device; Device
Intervention description(s): Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation; Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hoarseness; Sore Throat; Thyroidectomy
Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
Condition: G6PD; G6PD Deficiency
MeSH terms: Glucosephosphate Dehydrogenase Deficiency
Study type: Observational

Summary: 
      A prospective clinical study to compare the clinical performance of the FINDER™ Instrument
      and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate
      populations.
    

Detailed description: 
      A prospective clinical study to compare the clinical performance of the FINDER™ Instrument
      and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate
      populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate
      samples will be collected as heel prick unless an in dwelling line is already in place at
      which point a venous or arterial/umbilical sample will be collected. Adult samples will be
      collected as venous/arterial samples and finger stick samples. Samples will be tested at the
      point of care/near patient and in the clinical laboratory using the FINDER Instrument and
      G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party
      CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.
    

Intervention name(s): G6PD assay
Intervention type(s): Diagnostic Test
Intervention description(s): A test for G6PD deficiency.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational
        weeks old, recruited from the well baby nursery or the NICU.
      
Keywords: G6PD; Neonate
Metformin in Women With Type 2 Diabetes in Pregnancy Trial
Condition: Type 2 Diabetes
MeSH terms: Pregnancy in Diabetics; Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Insulin is the standard treatment for the management of type 2 diabetes in pregnancy, however
      despite treatment with insulin, these women continue to face increased rates of adverse
      maternal and fetal outcomes. The investigators hypothesize that metformin use, in addition to
      treatment with insulin, will help with blood sugar control, lower the dose of insulin needed,
      lower weight gain, and improve baby outcomes.
    

Detailed description: 
      Type 2 diabetes in pregnancy is increasing in prevalence and these women continue to face
      increased rates of adverse maternal and fetal outcomes. The investigators hypothesize that
      metformin use, as an adjunct to insulin, will decrease these adverse outcomes by reducing
      maternal hyperglycemia, high maternal insulin doses, excessive maternal weight gain and
      gestational hypertension/pre-eclampsia, all of which should reduce perinatal and neonatal
      mortality and morbidity. In addition, since metformin crosses the placenta, metformin
      treatment of the fetus may have a direct beneficial effect on neonatal outcomes. This study
      is an randomized controlled trial (RCT) that adds metformin to insulin, and is a
      double-blind, placebo-controlled RCT. The investigators believe that neither metformin alone
      nor insulin alone will effectively treat this population, and therefore our design, which
      includes the addition of metformin to insulin, will be the most relevant to our patients.
    

Intervention name(s): Metformin; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy; 500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; MiTy; Metformin in Women; Type 2 Diabetes Pregnancy
The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
Condition: Premature Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This clinical pilot trial is being conducted to learn more about the infant's feeding
      behavior while being fed by indwelling nasogastric tube placement or by intermittent oral
      tube placement.

      Healthy preterm infants who are transitioning from gavage to oral feedings via oral
      intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier
      gestational age than infants feeding with indwelling tubes and may be ready for earlier
      discharge.
    

Detailed description: 
      Independent feeding is often one of the last competencies that the premature infant must
      accomplish prior to discharge from hospital. Feeding is a complex task for the premature
      infant to accomplish and it often takes many weeks for the infant to learn how to feed.
      Therefore, tube feeding is required for the infant to ingest adequate nutrition during the
      transition from gavage feeding to oral feeding. Both intermittent oral gavage tube placement
      and indwelling nasogastric tube placement are acceptable methods for feeding preterm infants.
      However, it is not known which tube feeding method will support an expedited transition to
      oral feeding. The choice of using one method over the other is currently based on the
      individual health care provider's opinion or historical institutional practices and
      insufficient evidence is available to guide tube feeding practices.
    

Intervention name(s): Indwelling nasogastric tube placement; Intermittent orogastric tube placement; Nasogastric tube; Oral gastric tube
Intervention type(s): Procedure; Procedure; Device; Device
Intervention description(s): The premature infant is fed with an indwelling nasogastric tube during feeding transition.; The premature infant is fed with an intermittently placed orogastric tube during feeding transition.; Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.; Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.
Other intervention name(s): Nasogastric tube; Oral gastric tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: tube feeding; premature infant
The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A randomized controlled study to evaluate the effect of 3 months use with interactive
      computer game- "My Diabetic Friend"- comparing to conventional diabetes education on
      metabolic control, quality of life and diabetes knowledge.Patients will be randomized into
      two groups- one group will be supplied with interactive computer game, "My Diabetic friend",
      installed on a computer designed for children's educational needs for a period of three
      months and the other group will be supplied with the same computer without the interactive
      computer game for three months. Metabolic control, quality of life and diabetes knowledge
      will be evaluated before and after the use of the computer.

      The trial is consisting of two main periods: 3 months of the main study period and an
      optional extension period consisting of the following 3 months :

      The study will include two main periods;

        1. Period 1 which will last 3 months, in a randomized controlled manner, this period will
           serve as the main study period to assess the primary and secondary endpoints of the
           study.

        2. Period 2: this extension period will not be an integral part of the study, and only
           patients who are willing will take part at this period, will continue to participate at
           the optional extension period. During the extension period, patients in the intervention
           group will be offered to continue the use of the Computer game -"My diabetic friend) for
           the following 3 months, and patients who participated at the control group during period
           1, will be offered to start to use the Computer Game - "My Diabetic Friend" for the
           following 3 months.
    


Intervention name(s): Interactive computer game; Convertible PC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will use the interactive computer game installed on a convertible PC; Participants will be using the convertible PC without the interactive computer game
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 diabetes; "My Diabetic friend"; interactive computer game
Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
Condition: Refractory Schizophrenia
MeSH terms: Hallucinations; Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional

Summary: 
      Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for
      refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of
      studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz)
      to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation
      (hereby simply referred to as priming) has been shown to enhance the neurophysiological
      effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore,
      this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to
      the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).
    


Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Other intervention name(s): Magstim Rapid (Magstim Company Ltd., Wales, UK)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hallucinations; Schizophrenia
Turkish Version of the "Children's Assessment of Participation With Hands Scale
Condition: Participation, Patient; Child, Only
Study type: Observational [Patient Registry]

Summary: 
      To the best of our knowledge, there is no Turkish validity and reliability scale that can
      reveal children's hand involvement. In the study in which the CAP-H was developed, it was
      stated that this scale could be used in population-level research studies to examine the
      similarities and differences in children's manual life participation among different
      diagnosis groups. It is very important to adapt translated assessment tools to different
      cultures and languages and to verify their reliability and validity. Moreover, self-report
      questionnaires are advantageous in that they can be used for large-scale testing. The aim of
      this study was to examine the convergent validity and reliability of a Turkish version of the
      "Children's Assessment of Participation with Hands (CAP-H)" scale in order to evaluate the
      hand participation of physically disabled children.
    

Detailed description: 
      The CAP-H scale was used to evaluate children's hand participation and to examine the
      validity and reliability of the Turkish version. The original scale was developed by Chien et
      al. in Australia in 2015 to evaluate the difficulties experienced by children aged 2-12 years
      in using the hands in daily living activities that require hand participation. In the
      adaptation of the CAP-H to Turkish, the standard protocol of the WHO for the adaptation of
      the scales to different languages was applied:

        1. Translation of the scale into the target language (forward translation)

        2. Review of the scale translated into the target language by an expert panel of 2
           pediatric rehabilitation physiotherapists, who can speak both languages.

        3. Translation of the scale from the target language to the original language (back
           translation)

        4. Testing the translated scale and discussing its conceptual integrity

        5. Final version of the adapted scale (final version)

      For validity of CAP-H, Gross Motor Function Classification System and Manual Assesment
      Classification System scales used.
    

Intervention name(s): Survey evaluation
Intervention type(s): Other
Intervention description(s): examine the convergent validity and reliability of a Turkish version
Observational model: Case-Only
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children with physical disability
      
Keywords: validity; reliability; children; participation; hand