bioihbjkbjnl/mcl2 huggingface dataset:
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators are conducting this study to find out whether a new device can control
      blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have
      high blood sugar levels because they do not make enough insulin. The standard treatment is to
      give insulin either by shots or using an insulin pump. A new device, called closed-loop
      insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a
      computer. The CGM will send the sugar levels to a computer which automatically figures out
      how much insulin to give and then gives that amount of insulin through the insulin pump. It
      will give the child insulin to bring sugar levels down if they are high, and will give less
      insulin if the child's blood sugar is getting lower. Earlier research using closed-loop
      insulin therapy has shown the ability for it to improve diabetes care in adults and older
      children, but there has been no research of closed-loop insulin therapy in young children.
      This study will compare children's current insulin therapy with the closed-loop system. The
      knowledge that the investigators gain from this research will help us to figure out whether
      closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes
      care.
    

Detailed description: 
      We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children
      less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient
      clinical research center for 48 hours. They will receive their standard home insulin therapy
      for one day and semi-closed-loop insulin therapy for the other day.
    

Intervention name(s): Closed-loop Insulin Pump therapy; Standard Insulin Pump Therapy
Intervention type(s): Device; Device
Intervention description(s): Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.; Subjects insulin doses followed their usual home routine.
Other intervention name(s): Continuous glucose monitor and computer-linked insulin pump; Open-Loop Therapy
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closed Loop Insulin Delivery; Diabetes; Type 1 Diabetes; Artificial pancreas
A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants
Condition: Rheumatoid Arthritis; Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to assess the safety and tolerability of multiple ascending doses of
      LB-P6 or LB-P8 in healthy participants.
    

Detailed description: 
      This is randomised, double-blind, placebo-controlled, single centre study to assess the
      safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy
      participants.

      A total of up to 30 healthy participants will be enrolled in 2 cohorts.
    

Intervention name(s): LB-P6; LB-P8; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Healthy subjects will be randomized to receive LB-P6 once daily orally; Healthy subjects will be randomized to receive LB-P8 once daily orally; Healthy subjects will be randomized to receive placebo once daily orally
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the safety and efficacy of 3 different doses of
      CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on
      stable dopaminergic antipsychotic medication.
    


Intervention name(s): CTP-692; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as powder for oral solution.; Administered as powder for oral solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-invasive Assessment of Pulmonary Artery Pressure
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular
      function stand in the focus of the diagnosis and clinical management of pulmonary
      hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure
      PAP and to provide hemodynamic information on right ventricular function. However, due to its
      invasive nature, RHC is not optimal for screening and for close monitoring of the disease.
      Therefore, the development of non-invasive methods providing reliable PAP measurements and
      right ventricular functional parameters would be of major benefit.

      Today, the most often used comprehensive non-invasive method for these purposes is
      echocardiography. However, the method has limitations; in many cases PAP is significantly
      under- or overestimated - especially in subjects with co-existing pulmonary diseases.
      Regarding right ventricular function, although novel echocardiography parameters appear to be
      promising, they have not yet been evaluated in all forms of PH.

      Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is
      considered to be as gold standard for the non-invasive assessment of right ventricular
      function. In addition, our group showed that with a special approach ("vortex method"), MRI
      enables the determination of PAP with physiologic accuracy, but the method has not yet been
      validated systematically in different forms of PH.

      All patients undergoing right heart catheterization in our clinic are candidates for the
      study. Excluded will be patients not eligible for MRI or declining to take part in the study.
      MRI and Echocardiography will be performed within two weeks of the RHC.

      Hypothesis:

        1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad
           collective of patients with PH of diverse ethology.

        2. MRI derived right ventricular functional parameters correlate better to invasive
           measurements and to established prognostic parameters than echocardiography derived
           right ventricular functional parameters.

        3. Novel right ventricular tissue Doppler parameters add substantially to "classical"
           echocardiography parameters to describe right ventricular function.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing right heart catheterization due to clinical reasons
      
Biospecimen description: 
      Serum and plasma samples will be retrained
Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study is planned to evaluate the effect of the aclidinium bromide/formoterol
      fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in
      patients with moderate to severe COPD. Additionally, the effect of the behavioural
      intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both
      on the exercise endurance and the physical activity.
    


Intervention name(s): Aclidinium/Formoterol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler; Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD
Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour
Condition: Healthy
Study type: Interventional

Summary: 
      In integrative medicine wraps are applied for different indications. In this study the
      effects of thorax with ginger and mustard flour are investigated under standardized
      conditions. Heart rate variability, well being, warmth distribution and respiratory activity
      of healthy subjects will be measured.
    

Detailed description: 
      The purpose of this study is to investigate the effects of different thorax wraps in healthy
      subjects. Subjects undergo three different interventions (wraps with ginger flour, mustard
      flour or warm water (placebo)) on three different days. Heart rate variability and
      respiratory activity is measured for ten minutes before, during (up to 20 minutes) and for
      ten minutes after each thorax wrap. To investigate the effects on heat development and
      regulation, photos are taken with a thermographic infrared camera at various moments in time.
      Participants are asked to fill in questionnaires referring to their subjective perceptions of
      warmth, bodily warmth distribution and wellbeing. The order of the thorax wrap interventions
      is randomized.
    

Intervention name(s): Zingiberis Rhizoma plv.; Sinapis nigrea semen; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: physiologcal phenomena; .HRV Parameters; respiratory activity; thorax wraps
Parent Interventions to Prevent Student Drinking
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Examine the efficacy of parent interventions to prevent college student drinking in first
      year students.
    

Detailed description: 
      The aims of the study are to:

        1. efficacy of parent interventions to prevent college student drinking in first year
           students;

        2. examine mediators of efficacy; and

        3. examine moderators of efficacy.
    

Intervention name(s): parent handbook
Intervention type(s): Behavioral
Intervention description(s): parent handbook
Other intervention name(s): Parent Communication Materials
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: drinking; alcohol consequences
Intervention With Black Currant Seed Press Residues in Healthy Subjects
Condition: Smoking
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of the consumption of black currant seed
      press residues, which were baked into bread.
    

Detailed description: 
      Berry seeds are a by-product of berry fabrication (e. g. to juices or jam). In order to
      maintain their functionality and long life span, berry seeds need to contain cell stabilizing
      ingredients such as vitamins and polyphenols. Since it seems to be a valuable source of
      health beneficial substances in human nutrition, commercial use should be found. Therefore,
      seeds were pressed (seed press residue), ground and baked into bread for consumption.

      Black currant seed press residues are rich in tocopherols and also contain anthocyanins; both
      act as antioxidants. Additionally there is 50% fibre in the residue, soluble and insoluble
      fibre in equal shares.
    

Intervention name(s): black currant seed press residue; Bread without black currant seed press residues; Baseline data
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Black currant seed press residue, baked into bread; Same bread but without seeds; No supplement was administered.
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Black currant; Berry seed; Press residue; Tocopherol; Fatty acids; Fiber; Total phenols; TEAC; Comet assay; Dihydroxybenzoic acid
PRevention Using EPA Against coloREctal Cancer
Condition: Colorectal Adenoma; Colorectal Cancer; Endoscopic Surgery; Eicosapentaenoic Acid; Gastrointestinal Microbiome
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to
      reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.

      - The name of the study drug involved in this study is:

      -- AMR101 (VASCEPA).
    

Detailed description: 
      This prospective, single-arm, research study evaluating the effect of AMR101, as a
      chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of
      colorectal adenoma.

        -  AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances
           found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid
           cannot be produced in sufficient amount by the human body and has to be obtained through
           diet or supplemented to maintain normal function in the body.

        -  The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for
           any disease.

        -  AMR101 is commercially available in the US as VASCEPA (icosapent ethyl)

        -  The research study procedures include screening for eligibility and study treatment
           including evaluations and follow up visits, including:

             -  Lifestyle questionnaire,

             -  Nutritional survey

             -  Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)

             -  Blood samples,

        -  AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will
           take part.
    

Intervention name(s): AMR101
Intervention type(s): Drug
Intervention description(s): AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
Other intervention name(s): VASCEPA
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colorectal Adenoma; Colorectal Cancer; colonoscopic Surgery; Endoscopic Surgery; Eicosapentaenoic acid; Gastrointestinal Microbiome; Mucosal Tissue
An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and
      effectiveness of the drug amongst different conditions and populations.
    


Intervention name(s): BMS-986259; Placebo; P-Aminohippurate; Iohexol
Intervention type(s): Drug; Other; Diagnostic Test; Diagnostic Test
Intervention description(s): Single and Multiple ascending dose from Dose 1 to Dose 5; Placebo matching BMS-986259; Diagnostic Agent; Diagnostic Agent
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
Condition: Asthma, Aspirin-Induced
MeSH terms: Asthma; Respiratory Tract Diseases; Respiration Disorders; Asthma, Aspirin-Induced
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of aspirin desensitization on symptoms
      and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).
    


Intervention name(s): aspirin
Intervention type(s): Drug
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aspirin; asthma; Aspirin desensitization; Aspirin induced asthma; Immune System Diseases; Respiratory Hypersensitivity
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ustekinumab is effective in the treatment
      of moderate to severe hidradenitis suppurativa.
    

Detailed description: 
      An open label prospective study is performed to investigate the effectiveness and safety of
      ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive
      ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.
    

Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
Other intervention name(s): Stelara
Intervention MeSH terms: Ustekinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hidradenitis suppurativa; Acne ectopica; Inverse acne; Ustekinumab; Stelara
Improving Asthma Communication in Minority Families
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if teaching children with asthma how to talk to
      their doctor about controlling their asthma including symptom frequency in an asthma diary
      and medication use techniques, will result in less symptom and missed school days, fewer
      emergency room visits and reduce the cost of asthma health care.
    

Detailed description: 
      Children with persistent asthma are often not receiving regular preventive asthma care
      despite experiencing frequent asthma symptoms. When linked to timely and appropriate asthma
      medication use, good physician-parent-child communication is associated with a decrease in
      asthma morbidity and mortality. Removing obstacles to preventive asthma care and improving
      communication between the parent-children and PCP are two necessary prerequisites to
      improving asthma outcomes in low-income minority children.

      We, the researchers at Johns Hopkins University, hypothesize that a culturally-tailored
      parent and child asthma communication intervention (ACI) designed to teach parent and child
      communication skills for use with their health care provider regarding asthma symptom
      severity, medication use, personal goal of treatment and quality of life issues will
      significantly reduce emergency room utilization for asthma care. We propose to compare this
      parent/child asthma communication intervention (ACI) to a developed standard asthma education
      intervention (SAE) designed to increase basic asthma self-management.

      This study will advance nursing science by improving asthma self-management for school age
      children, who may be self-administering their asthma medications, yet not participate in
      receiving information or making their own medical decisions regarding their asthma. The
      proposed study is targeted at low-income minority school-aged children with evidence of
      poorly controlled, high-risk asthma. If successful, this intervention could have significant
      practical applications as a component of asthma nurse-case management, to practice currently
      being employed by many managed care groups across the country as an intervention for their
      high-risk/high ED use asthma patients. Because of the high prevalence and enormous health
      impact of asthma and the disproportionate asthma burden experienced by minority children, the
      outcome of the proposed study will have significant pediatric nursing applicability.
    

Intervention name(s): Asthma Communication Education; Standard Asthma Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Nutrient Mixtures and Neurodevelopment
Condition: Neurodevelopment
Study type: Observational

Summary: 
      Background: Adequate levels of beneficial nutrients are important for neurodevelopment.
      Although, nutrients are ingested in combination, considering nutrients as a mixture has not
      been studied with respect to health, such as neurodevelopment.

      Objective: To examine the impact of prenatal and childhood nutrition mixtures on
      neurodevelopment.

      Design: Participants included mother-child pairs in the Programming Research in Obesity,
      Growth Environment and Social Stress (PROGRESS) prospective birth cohort in Mexico City.
      Prenatal and child nutrition profiles were assessed among 65 and 329 children respectively by
      analyzing components of a food frequency questionnaire. Child neurodevelopmental outcomes at
      4-6 years of age were measured using the McCarthy Scales of Children's Abilities (MSCA).
    


Intervention name(s): Nutrient mixtures
Intervention type(s): Other
Intervention description(s): consumption of a mixture of beneficial nutrients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy pregnant women living in Mexico city from 2006-2009 seeking health care in clinics
        (Parent-child pairs) and their children at 4 - 6 years of age.
      
Keywords: Nutrition; Nutrients; Mixtures; Neurodevelopment; Prenatal; Children
Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter (VERO Study)
Condition: Cardiac Output, Low; Liver Transplant; Complications
MeSH terms: Cardiac Output, Low
Study type: Observational

Summary: 
      The Swan-Ganz catheter is the gold standard to measure cardiac output during liver
      transplantation surgery. This is an invasive hemodynamic monitoring system.

      The VenArt Cardiac Output (Mespere LifeSciences, Waterloo, Canada) is a new, innovative and
      non-invasive device that permits hemodynamic monitoring.

      With a software based on Fick's principle it is able to calculate cardiac output, cardiac
      index and continuous cardiac output.

      The hypothesis of this study is to investigate the precision and accuracy of this method
      versus the standard of care during liver transplantation.
    


Intervention name(s): VEnaRt Cardiac Output
Intervention type(s): Device
Intervention description(s): Every patient is monitored during liver transplantation with VEnaRt Cardiac Output versus Swan-Ganz Catheter
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All the patients undergoing liver transplant at our institution