bioihbjkbjnl/mcl2 huggingface dataset:
Enteral Feeding and Early Gut Colonization of Preterm Infants
Condition: Premature Birth of Newborn
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The aim of this study is to evaluate the potential role of the enteral feeding systems on the
      bacterial colonization of premature infants during their NICU admittance and its evolution
      after 2 years, which is the age when the infant's gut starts to contain an adult-like
      microbiota.
    

Detailed description: 
      First spontaneously evacuated meconium and fecal samples were collected by the medical staff
      of the Hospital weekly from the diapers of the infants during their stay at the Neonatal
      Intensive Care Unit.

      To evaluate the potential role of the enteral feeding systems as a site for colonization by
      nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's
      own milk, donor milk and preterm formula samples were obtained after passing through the
      external part of the enteral feeding tubes and cultured.

      Later, when the infants reached 2 years of age, parents were contacted by phone to provide an
      additional fecal sample if their infants had not taken antibiotics within the previous 2
      months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants born from October 2009 to June 2010 at the Hospital 12 de Octubre with a
        gestational age of less than 32 weeks or with birth weight of less than 1,200 g
      
Biospecimen description: 
      meconium, fecal samples mother's milk donor's milk
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects who completed ZA-003 were eligible to receive an additional year of treatment in
      this extension study.
    

Detailed description: 
      The objectives of this study were to evaluate the safety and efficacy of Androxal®
      administered orally once daily for one year in men with secondary hypogonadism and who had
      completed ZA-003.
    

Intervention name(s): Androxal; Androxal
Intervention type(s): Drug; Drug
Intervention description(s): 12.5 mg once daily; 25 mg once daily
Other intervention name(s): Enclomiphene citrate; Enclomiphene citrate
Intervention MeSH terms: Citric Acid; Sodium Citrate; Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Hypogonadism
Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial.
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test whether early pre-reperfusion metoprolol administration
      in patients suffering and acute myocardial infarction might reduce the size of myocardial
      necrosis.
    

Detailed description: 
      Acute myocardial infarction (AMI) is a chief cause of death worldwide. The best strategy to
      limit myocardial damage is to perform an early coronary reperfusion. However, despite
      reperfusion, the size of infarctions is many times large. Infarct size has been recently
      shown to be a strong predictor of future cardiovascular events and mortality. Therefore
      interventions aimed at reducing infarct size are the matter of intense research; but despite
      great efforts, no therapy has been shown to consistently limit infarct size.

      ß-blockers are a class of drugs that have been used to treat cardiovascular conditions for
      several decades. β-blockers reduce mortality when administered after an AMI, and are a class
      IA indication in this context. What remains unclear is what timing and route of β-blocker
      administration gives the maximum cardioprotective effect. In particular, whether early
      β-blocker administration is able to reduce infarct size is a subject of debate. Recent
      experimental data suggest that the β1 selective blocker metoprolol is able to limit the area
      of necrosis only when administered before reperfusion.

      The objective of this trial is to determine whether the administration of intravenous
      pre-reperfusion metoprolol might reduce infarct size.
    

Intervention name(s): Injectable (i.v.) metoprolol tartrate (up to 15 mg).
Intervention type(s): Drug
Intervention description(s): Patients are randomized to active intervention (early metoprolol initiation strategy) or no treatment (delayed metoprolol initiation strategy).
Patients randomized to early metoprolol initiation strategy receive up to three 5mg i.v. dosages (2 minutes apart) before reperfusion.
Patients randomized to delayed metoprolol initiation strategy receive no active treatment before reperfusion.
Patients in both groups receive oral metoprolol tartrate treatment (25-100mg/12h), starting 12-24 hr post-reperfusion.
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemia; Reperfusion; Myocardial infarction; Beta blockers; Metoprolol; Acute myocardial infarction; Necrosis; Salvaged Myocardium
Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)
Condition: Diverticulitis, Colonic; Colonic Neoplasms
MeSH terms: Colonic Neoplasms; Diverticulitis; Diverticulitis, Colonic
Study type: Interventional

Summary: 
      This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute
      diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be
      made in order to determinate whether there are differences of advanced colonic neoplasia
      (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.
    

Detailed description: 
      This is a prospective study that eliminates biases in the selection, design and variability
      of retrospective studies to reliably assess the global prevalence of advanced colon neoplasia
      (ACN) and the difference in prevalence among populations with complicated and uncomplicated
      acute diverticulitis diagnosed by computed tomography. Another objective is to assess the
      diagnostic prediction of computed tomography to detect ACN in acute diverticulitis. It also
      aims to assess the safety and quality of colonoscopy in a patient recently diagnosed with
      acute diverticulitis. Finally, it aims to study whether other diagnostic tools such as the
      presence of clinical risk symptoms or the performance of fecal biological tests could help in
      narrowing the indication of colonoscopy in this clinical scenario.
    

Intervention name(s): Colonoscopy; Fecal immunochemical and occult blood test; Fecal calprotectin test
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities; A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.; Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.
Other intervention name(s): FIT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Diagnostic clinical trial
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diverticulitis; Advanced colonic neoplasm; Colonoscopy
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number-SR15-63-Z13-084).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high
      luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated
      low-frequency EA restore these alterations and induce ovulation.
    

Detailed description: 
      Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude
      as well as sex steroid secretion as compared to a control group receiving same amount of
      attention.

      Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a
      control group receiving same amount of attention.

      Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as
      compared to a control group receiving same amount of attention.in women with PCOS.
    

Intervention name(s): Low-frequency electro-acupuncture (EA); Meeting a therapist - attention control
Intervention type(s): Device; Other
Intervention description(s): 2 Hz EA during 30 minutes, twice a week, 14 weeks.; Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Luteinizing hormone; Cortisol; HPA axis; HPO axis; Ovulation; Heart rate variability; Psychological distress and quality of life
Benefits of Eggs in Combination With a Plant-based Diet
Condition: Coronary Artery Disease; Diabetes; Metabolic Syndrome
MeSH terms: Coronary Artery Disease; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based
      diet will not increase the risk for heart disease but will increase the concentration of
      lutein and zeaxanthin, two important antioxidants and will also increase choline, an
      important component of membrane phospholipids.
    

Detailed description: 
      Results from studies involving cells, animal models and clinical trials have demonstrated
      that lutein and zeaxanthin potentially protect against chronic diseases, including
      age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma
      concentrations of lutein and zeaxanthin are closely associated with their antioxidant
      properties and with their protection against reactive oxygen species (ROS).

      Choline is recognized as an essential nutrient for health because of its many functions in
      growth and development, as well as neurological function and formation of membrane
      phospholipids, including phosphatidylcholine (PC) and sphingomyelin.

      Therefore the objective of this study is to demonstrate that inclusion of eggs in a
      plant-based diet will potentiate the benefits of this healthy diet by increasing plasma
      concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically
      increase the antioxidant and anti-inflammatory actions of these components. This would be
      potentially more important in those individuals with metabolic syndrome, which is the target
      population of this intervention.
    

Intervention name(s): Consume 2 eggs with spinach per day; Egg Subsitute with spinach per day
Intervention type(s): Other; Other
Intervention description(s): Participants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment; Egg Subsitute with spinach per day
Other intervention name(s): Egg substitute
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Crossover design
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: eggs; lutein; zeaxanthin; choline; metabolic syndrome; plant-based diet
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Condition: Inflammation; Malnutrition; Protein Energy Wasting Syndrome; Oxidative Stress; Diet Therapy
MeSH terms: Malnutrition; Wasting Syndrome; Inflammation; Cachexia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of especial diet therapy
      "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the
      context of protein-energy wasting syndrome(PEW) in hemodialysis patients.
    


Intervention name(s): Diet Therapy; Control Group
Intervention type(s): Other; Other
Intervention description(s): The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks.; The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Diet; Inflammation; Malnutrition
Imaging of Pilosebaceous Units and Acne Lesions by RCM and OCT Confocal Microscopy and Optical Coherence Tomography
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and
      optical coherence tomography (OCT) could be used in combination to investigate the morphology
      of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore,
      to investigate contrast effects, biodistribution and selective photothermolysis provided by
      gold microparticles and diode laser pulses, using RCM, OCT and histology.
    


Intervention name(s): SEB-250
Intervention type(s): Device
Intervention description(s): Gold microparticles (SEB-250) are massaged into 2 or 3 2x2 cm facial areas and exposed to 2 pulses from a diode laser
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Selective Photothermolysis; Reflectance Confocal Microscopy; Optical Coherence Tomography; Pilosebaceous Unit; Gold Microparticles
Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, fixed-sequence study in healthy Chinese subjects, performed at
      a single study centre. Cohort A will assess the Pharmacokinetic (PK) profile of rongliflozin
      when administered alone and the combination with rifampicin; Cohort B will assess the PK
      profile of rongliflozin when administered alone and combination with probenecid.
    


Intervention name(s): Rongliflozin; Rifampin; Rongliflozin; Probenecid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral administration, single dose on Day 1 and Day 11; QD for 10 days; oral administration, single dose on Day 1 and Day 6; twice a day, for 5 days
Intervention MeSH terms: Rifampin; Probenecid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Lateral Neck Flexor Endurance and Hyperlaxity
Condition: Physical Endurance; Hypermobility, Joint; Muscular Weakness
MeSH terms: Muscle Weakness; Joint Instability
Study type: Observational

Summary: 
      The lateral neck flexor endurance test has been proposed to assess for unilateral muscular
      deficits. It is not known if individuals with hyperlaxity have different muscular endurance
      than individuals without hyperlaxity.
    

Detailed description: 
      Thirty individuals with systemic hyperlaxity as determined with the Beighton scale will be
      assessed for lateral neck flexor endurance and compared to age and gender matched controls.
      Basic demographic information will be collected, and all individuals will report Neck
      Disability Index (NDI) and Numeric Pain Rating Scales (NPRS) for their neck, as well duration
      of any neck pain. All participants will then undergo testing of lateral neck flexor muscle
      endurance, repeated twice on each side. Average hold times will be compared for individuals
      with hyperlaxity (5 or greater on Beighton scale) and the healthy age and gender matched
      controls. Analysis will also include covariates of NDI scores, pain scores, and chronicity of
      symptoms.
    

Intervention name(s): lateral neck flexor endurance test
Intervention type(s): Other
Intervention description(s): Individuals will maintain the head in a neutral position off the ground in sidelying for as long as possible.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals between the ages of 18-60 with and without systemic hyperlaxity
      
Keywords: neck musculature; endurance; tests and measures
Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
Condition: Cognitive Function and Mood
Study type: Interventional

Summary: 
      The primary objectives of this study are to assess the effects of three investigational
      drinks containing three botanicals in differing combinations versus a placebo control, on
      mood, psychological state, physical response, and cognitive performance during and after
      exposure to an observed multi-tasking stressor.
    


Intervention name(s): Herbal Beverage
Intervention type(s): Other
Intervention description(s): Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Development of Fall Prediction Model for Older Adults Based on Multi-faceted Data
Condition: Gait
Study type: Observational

Summary: 
      This study aimed to develop a fall prediction model for older adults by measuring the
      multi-faceted biosignal data to classify the walking patterns and by identifying causal
      relationships with the variables that affect the fall.
    

Detailed description: 
      This study aimed to develop a fall prediction model by measuring the multi-paceted biosignal
      data for the elderly's physical function and walking to classify the walking patterns of the
      elderly, and by identifying causal relationships and influences with the variables that
      affect the fall.
    

Intervention name(s): Older adults
Intervention type(s): Other
Intervention description(s): The data for motor function and gait pattern analysis was obtained.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community seniors aged 65 to 84 years
      
Keywords: Fall prediction model; Gait Pattern; Muscle activity; Brain activity; Cardiopulmonary metabolic cost
Maturation of Auditory Processing in Children With Dyslexia Compared to Average-reading Children
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Observational

Summary: 
      The hypothesis of central auditory processing disorders has been advanced to explain the
      anomalies of the grapheme/phoneme combination in some dyslexia. These phonological disorders
      may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and
      of cortical asymmetry. Indeed, the efferent system has an asymmetry in relation to
      handedness. Thus, in right-handed subject, it is predominant on the right side. In contrast,
      in the subject-handed dyslexic, the efferent system tends to be right-lateralized or
      non-lateralized. However, after an audio-visual training, normal lateralization can appear.
      This maturation of the efferent system lateralization during reading acquisition seems to
      have a particular profile in dyslexics with phonological disorder, especially if it is
      persistent. This finding allows to consider new prognostic evaluation and speech therapy
      rehabilitation in the dyslexic child.
    


Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For the dyslexic children: primary care clinic and speech therapists For the normal reading
        children : elementary schools of Lyon and Clermond-Ferrand and their suburbs
      
Keywords: Dyslexia, Medial olivocochlear system, Maturation, Auditory Processing
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women
Condition: Attention; Memory; Alertness
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of the dietary supplement oréVida™
      (active ingredient on the basis of a culinary herb)administered twice daily in an acute study
      on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men
      and pre-menopausal women, aged 35-50 years, inclusive.

      oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the
      Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
      Administration does not strictly regulate herbs and dietary supplements. We do not claim that
      this supplement is meant to treat any ailment.
    


Intervention name(s): oréVida™; oréVida™; oréVida™; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day); 1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day); 1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day); 1 capsule of placebo twice a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Attention; Vigilance; Concentration; Memory; Healthy Volunteer