bioihbjkbjnl/mcl2 huggingface dataset:
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
Condition: Preterm Infant; Morbidity;Infant; Outcome, Fatal
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      From November 2014 to October 2015, a multi-centers retrospective study was conducted to
      collect compliance, and 8 three-level hospitals from China were included. The infants
      survived to a postmenstrual age of 36 week with birth weight less than 1500g and without
      congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death,
      cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to
      observe the relationship between morbidities and poor outcomes. And the predictive effect on
      the number of the top three morbidities were analyzed by Logistic regression analysis.
    


Intervention name(s): Mental Development Index;Auditory Brainstem Response;okineticnystagmus
Intervention type(s): Diagnostic Test
Intervention description(s): mental development index(MDI）<70:cognitive delay do not pass auditory brainstem response(ABR）：hearing impairment do not pass okineticnystagmus:visual impairment Patent Ductus Arteriosus
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From November 2014 to October 2015, a multi-centers retrospective study was conducted to
        collect compliance, and 8 three-level hospitals from China were included. The infants
        survived to a postmenstrual age of 36 week with birth weight less than 1500g and without
        congenital disease.
Effect of Bile Acids on the Secretion of Satiation Peptides in Humans
Condition: Echolocation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is do determine the functional significance of the G
      protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile
      acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.
    

Detailed description: 
      TGR5 is expressed in GLP-1-secreting cell lines and L cells from mice; gain- and
      loss-of-function models suggest a physiological role for TGR5 activation on GLP-1 secretion
      in rodents. TGR5 signaling showed improved postprandial glucose tolerance in obese mice,
      associated with marked postprandial GLP-1 release and insulin secretion. In contrast, TGR5-/-
      mice exhibited reduced glucose tolerance. In animals, TGR5 activation has been shown for
      natural bile acids (BAs) and triterpenoid compounds of plant origin, such as oleanolic acid
      (OA), suggesting a role for postprandial BAs in modulating nutrient-induced GLP-1 secretion.
      We therefore hypothesized that intraduodenal (ID) perfusions of TGR5 agonists (BAs and OA)
      stimulate the secretion of GLP-1 with respective changes in the glucose metabolism of healthy
      humans.
    

Intervention name(s): saline; bile acid (CDCA, chenodeoxycholic acid); oleanolic acid; oleic acid
Intervention type(s): Other; Other; Other; Dietary Supplement
Intervention description(s): intraduodenal perfusion; intraduodenal perfusion; intraduodenal perfusion; intraduodenal perfusion
Other intervention name(s): primary bile acid; triterpenoid compound of plant origin; fatty acid
Intervention MeSH terms: Chenodeoxycholic Acid; Bile Acids and Salts
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GI-physiology; CDCA; bile acids; TGR5; satiation peptides
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults
Condition: Body Weight
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body
      weight/ body fat in the overweight and obese adult population.
    

Detailed description: 
      Polyphenols are phytochemicals widely available in plants, and may have several favourable
      effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods.
      Animal and in vitro studies have demonstrated that cocoa and dark chocolate may exert
      anti-obesity effects mainly due to the polyphenol effect on glucose and fatty acid
      metabolism. Human studies have showed that regular chocolate eaters have a lower body weight
      compared to non regular eaters, and that DC promotes satiety and reduces cravings. The aim of
      this pilot study is to investigate the effect of polyphenol-rich DC on body weight in the
      overweight and obese adult population, when incorporated into a non-restricted diet.
      Twenty-eight apparently healthy volunteers will be recruited. Participants will randomly
      receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or
      DC rich in polyphenols (500mg) for a period of twelve weeks. Participants will be asked to
      make three appointments and one follow-up appointment to the university clinical lab.
      Anthropometric measurements (height, weight, waist circumference, body fat percentage) will
      be taken during each visit. Compliance will be defined by the intake of 85 % or more of the
      chocolate weekly, and will be tested by the measure of total polyphenols in a 24-hour urine
      sample before, during and at the end of the intervention. To monitor any fluctuations in the
      participants' diet or physical activity during the study period, a three-day diet diary, a
      Food Frequency questionnaire assessment for polyphenol intake and a physical activity
      questionnaire will be collected before the start of the study and every four weeks. A
      follow-up appointment (four weeks after the end of intervention) will check if any
      differences in anthropometric measures have been maintained. Data will be analysed with an
      ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor.
      This study will have novel findings and will be the basis for a future larger trial.
    

Intervention name(s): Polyphenol-rich Dark chocolate; Placebo Dark chocolate
Intervention type(s): Other; Other
Intervention description(s): Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks; Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes
Condition: Parkinson's Disease; Amyotrophic Lateral Sclerosis; Oxidative Stress; Iron Overload
MeSH terms: Parkinson Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Iron Overload; Sclerosis
Study type: Interventional

Summary: 
      Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models
      to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC
      can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative
      stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron
      metabolism and programmed cell death ...). The platelets are pivotal in the healing system
      with large range of growth factors. A new therapeutic concept of conservative iron chelation
      with deferiprone for neuroprotection is under development.

      The action of deferiprone on the different mechanisms and notably the oxidative stress are to
      obtain from a collection of PBMC and platelets from patient having Parkinson's disease and
      Amyotrophic lateral sclerosis and healthy controls to study ex vivo.

      PBMC and platelets will be stored for future analyses.
    

Detailed description: 
      The study collection of PBMC and platelets from 30 patient having Parkinson's disease 30
      patients having Amyotrophic lateral sclerosis and 30 healthy controls.

      The collection will be performed either by cytapheresis for half of the patient and by
      collecting the whole blood for the other half.

      PBMC and platelets will be stored at minus 80°C. PBMC of patients and controls are exposed ex
      vivo to different pathological condition (mainly Hydrogen peroxide, menadione, hypoxia...)
      with and without deferiprone to analyse whether the level of oxidative stress (Reactive
      Oxygen Species and notably hydroxyl radical with hydroxypethidine probe with flow cytometry)
      is reduced under deferiprone (primary criterion. Secondary analyses will concern the level of
      iron, the energy metabolism (aerobic versus anaerobic and the level of Adenosine triphosphate
      production), the type of cell death (apoptosis, autophagy and new programmed cell death:
      Ferroptosis) and inflammation. Finally, the level of growth factors and their effectiveness
      will be studied from platelets.
    

Intervention name(s): deferiprone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): to test the action of deferiprone on lymphocytes from patients and controls ex vivo; to control the action of placebo on lymphocytes from patients and controls ex vivo
Other intervention name(s): FERRIPROX
Intervention MeSH terms: Deferiprone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinson's disease; Amyotrophic lateral sclerosis; Peripheral blood mononuclear cells; ex vivo model for oxidative stress; iron metabolism and chelation
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Interventional

Summary: 
      The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E.
      Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were
      evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for
      which changes were made to dose and excipient.
    

Detailed description: 
      The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate,
      Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse
      blue 106, and Bronopol was the original objective of the study. The protocol was amended to
      include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate,
      ethylenediamne dihydrochloride and fragrance mix.
    

Intervention name(s): Panels 1.3, 2.2 and 3.2 experimental allergens
Intervention type(s): Diagnostic Test
Intervention description(s): Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
Intervention model: Single Group Assignment
Intervention model description: 3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Contact dermatitis; Eczema
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Obese; Overweight
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity,
      postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum
      FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on
      therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in
      combination with metformin.
    

Detailed description: 
      This is a single-center, placebo-controlled, parallel-group, single dose, randomized,
      controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the
      effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin
      sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight
      loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy
      with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected
      at defined times to measure glycemia, FGF-19 and incretins (GLP-1 [glucagon-like peptide-1],
      OXM [oxyntomodulin], PYY 3-36 [peptide YY]) fasting levels and responses to the meal.
    

Intervention name(s): Gastric Emptying test; Mixed Oral Glucose Tolerance test; Conjugated bile acids sodium; Placebo
Intervention type(s): Radiation; Other; Drug; Other
Intervention description(s): participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.; Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.; 500 mg tablets taken orally twice daily for 28 (+/- 4) days; Placebo tablets taken orally twice daily for 28 (+/- 4) days
Other intervention name(s): Ox Bile extract
Intervention MeSH terms: Bile Acids and Salts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)
Condition: Radiculopathy Lumbar; MRI; Diffusion Tensor Imaging
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach
      that provides morphological information about the microstructures of the nerve roots. DTI is
      a widely used neuroimaging technique and is a current topic of research in the field of
      peripheral nerve imaging. The aim of this work is therefore to improve DTI sequences by
      specifically evaluating the contribution of the multiband technique in healthy volunteers.
    

Detailed description: 
      For every healthy volunteer will be acquired:

        -  a morphological sequence

        -  a reference diffusion tensor sequence covering three lumbar stages (reference DTI),

        -  a diffusion tensor sequence acquired in multiband technique, covering three lumbar
           stages (optimized DTI),

        -  a diffusion tensor sequence acquired in a multiband technique, covering a lumbar stage,
           of higher spatial resolution (centred DTI)
    

Intervention name(s): Optimisation of DTI sequences
Intervention type(s): Diagnostic Test
Intervention description(s): Optimisation of DTI sequences in the study of lumbar roots by MRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radiculopathy Lumbar; MRI; Diffusion tensor imaging; Multiband technique
Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects and tolerability of rice bran extract on depressive symptoms and related
      biomarkers in mildly to moderately depressed patients for 8 weeks.
    

Detailed description: 
      A previous animal study has indicated that rice bran extract provided inhibition of MAO-B
      enzyme activity and ROS formation in a corticosterone-induced depression-like animal model.
      Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to
      investigate the effects of rice bran extract on depressive symptoms and related biomarkers in
      mildly to moderately depressed patients for 8 weeks; the safety of the compound is also
      evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating
      Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the
      Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck
      Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred
      adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8
      weeks.
    

Intervention name(s): Rice bran extract group; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Rice bran extract 1,000 mg/day for 8 weeks; Placebo 1,000 mg/day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Affect Management for Early Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Adolescents are at risk for HIV because of sexual and drug use behavior initiated during
      early adolescence, and those with mental health problems appear to be particularly
      susceptible. Problems with managing emotions may make it difficult for early adolescents to
      make good decisions about sexual and substance use behaviors. This project will develop and
      evaluate interventions for early adolescents with mental health issues. An intervention
      focused on teaching affect management skills will be compared to an intervention addressing a
      variety of health topics to determine which intervention best reduces risk behavior among
      this at-risk population.
    


Intervention name(s): Affect Management; General Health Promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-session group intervention including affect management training as well as sexual health skills training.; 12-session group intervention including health information on a variety of developmentally relevant health topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus
      Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains
      Preservative.
    

Detailed description: 
      Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA
      contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

      Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents
      7.5μg/0.5ml per dose include H1N1、H3N2 and B.

      This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to
      36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion,
      Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each
      group will be vaccinated with two doses of either Influenza Virus Vaccine (Split Virion,
      Inactivated) or Sanof IVV respectively,21 days apart.
    

Intervention name(s): Influenza Virus Vaccine(no Preservative ); Influenza Virus Vaccine(contains Preservative)
Intervention type(s): Biological; Biological
Intervention description(s): Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections; Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
Other intervention name(s): Vaxigrip
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Virus Vaccine (Split Virion, Inactivated); Influenza
The Use of Ligasure (r) for Hydrocelectomy Surgery
Condition: Hydrocele
MeSH terms: Testicular Hydrocele
Study type: Interventional

Summary: 
      Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain,
      with interfering with the normal testes function. however, during activity, this can
      interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I
      surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for
      cutting and coagulating tissues during hydrocelectomy.
    

Detailed description: 
      Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain,
      with interfering with the normal testes function. however, during activity, this can
      interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I
      surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for
      cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who
      suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.
    

Intervention name(s): Ligasure
Intervention type(s): Device
Intervention description(s): Using ligasure to treat hydrocele
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To confirm that the combination therapy of rufinamide has superior efficacy compared to
      placebo in patients with Lennox-Gastaut syndrome.
    


Intervention name(s): Rufinamide (E2080); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.
Target maintenance dose:
15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening); Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Other intervention name(s): E2080
Intervention MeSH terms: Rufinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Seizures