bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      The research study is designed to examine the impact of low blood sugar on brain function in
      individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar)
      compared to those who do not.
    

Detailed description: 
      During the course of treating diabetes (for example, after an insulin injection), blood sugar
      levels will sometimes drop too low. This condition is known as hypoglycemia. Normally, a
      healthy body responds to hypoglycemia by producing a number of "anti-insulin" hormones which
      raise blood sugar levels. In addition, these hormones provide the individual with warning
      signals of hypoglycemia, including hunger, sweating, shaking and heart palpitations. These
      warning signals allow diabetics to correct low blood sugar levels by eating sugar tablets or
      by having a snack.

      Unfortunately, and for unclear reasons, many people with longstanding diabetes lose their
      ability to recognize low blood sugar levels-a condition called "hypoglycemia unawareness."
      The brain, in particular, is extremely sensitive to hypoglycemia. Unable to sense and respond
      to low blood sugar levels, these individuals may experience a sudden onset of blurred vision,
      confusion, seizures, coma, or even death.

      In recent years, a new technique called "islet cell transplantation" has been developed as an
      alternate means of treating insulin-dependent diabetes. Pancreatic islet cells (the cells
      that produce insulin), from human donors, are injected into the diabetic patient's liver
      where the cells are capable of making insulin and can regulate blood sugar levels without the
      need for insulin injections. Currently, this technique is used primarily in patients with
      severe hypoglycemia unawareness.

      While it is known that islet cell transplantation can reduce the risk of severe hypoglycemia,
      the effects of transplantation on hypoglycemia unawareness are unknown. This study is
      designed to investigate why hypoglycemia unawareness happens and the impact it has on brain
      function in individuals with type 1 diabetes.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Group 1A) T1DM subjects with severe hypoglycemia unawareness and awaiting islet cell
        transplantation will be referred by participating islet transplantation centers.

        Group 1B) T1DM subjects with severe hypoglycemia unawareness but not awaiting islet cell
        transplantation will be from the greater New Haven, CT area.

        Group 2)T1DM, not optimally controlled and without hypoglycemia unawareness will be from
        the greater New Haven, CT area.

        Group 3) Non-Diabetics from the greater New Haven CT area.
      
Keywords: type 1 diabetes; hypoglycemia; magnetic resonance imaging
Spermidine Intake and All-cause Mortality
Condition: Healthy Diet; Mortality
Study type: Observational

Summary: 
      This study seeks to test the potential association between spermidine content in diet and
      mortality in humans.
    

Detailed description: 
      This prospective community-based cohort study includes 829 participants aged 45-84 years,
      49.9% of which are male. Diet is assessed by repeated dietician-administered validated
      food-frequency questionnaires (2540 assessments) in 1995, 2000, 2005, and 2010. Nutrient
      intakes including spermidine are calculated using USDA standard databases. Clinical events
      (all-cause mortality and cause-specific mortality) are recorded from 1995 to 2015.

      The primary endpoint of all-cause mortality is related to the exposure of long-term average
      spermidine intake by Cox proportional hazards models with time-varying covariates. Additional
      analyses employ the Fine and Gray proportional subdistribution hazards model and flexible
      Royston-Parmar spline-based models. Comprehensive sensitivity analyses are performed to guard
      against potential biases associated with nutritional epidemiology.
    

Intervention name(s): Spermidine content of natural diet
Intervention type(s): Other
Intervention description(s): The exposure consists in the long-term average dietary intake of the polyamine spermidine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A random sample intended to represent the general population, recruited in 1990.
      
Keywords: Polyamine, cardiovascular disease, cancer
Patient-Centered Smartphone-Based Diabetes Care
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS).
      This study was aimed to test the feasibility of the PSDCS.
    


Intervention name(s): patient-centered smartphone-based diabetes care system
Intervention type(s): Device
Intervention description(s): patient-centered smartphone-based diabetes care system (PSDCS) is composed of 4 modules such as glucose module, diet module, physical activity module, and SNS module. Participants were instructed to use the PSDCS and to measure blood glucose levels with a Bluetooth glucometer, input daily food intake, and wear an activity tracker.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Health care systems; Mobile applications; Self-care; Diabetes mellitus; Smartphone
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if isotonic solutions reduce the risk of hospital
      acquired hyponatremia compared with hypotonic solutions.
    

Detailed description: 
      Multicenter, Randomized, Controlled clinical trial.

      The purpose of this study is to determine if isotonic solutions reduce the risk of hospital
      acquired hyponatremia compared with hypotonic solutions

      This study will include 150 patients in 2 groups according to these type of pathology: group
      1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute
      asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and
      group 2: surgical conditions (pre, peri or postoperative patients will be included). Each
      group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic
      solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In
      non-dehydrated patients the daily total volume of liquid infused will be determined by the
      volumetric Holliday- Segar* formula and the daily total volume will be calculated by adding
      the maintenance requirements (using the Holliday Segar formula) to the fluid deficit
      (according to percent of estimated weight**) in dehydrated patients.

      The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%.
      The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected
      before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of
      sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24
      hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the
      incidence of hyponatremia and the adverse clinical outcomes will be compared.

      *0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; >20 kg:
      1500 ml + 20ml/ kg over 20kg

      ** In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10%
      in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60
      mL/kg) in moderate dehydration.
    

Intervention name(s): 0.3% Saline in 3.3% dextrose; 0.45% Saline in 5% dextrose; 0.9% Saline in 5% dextrose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hypotonic Solutions: 0.3% Saline in 3.3% dextrose; Hypotonic Solutions: 0.45% Saline in 5% dextrose; Isotonic Solutions 0.9% Saline in 5% dextrose
Other intervention name(s): Hypotonic Solutions: 0.3% Saline + 3.3% dextrose; Hypotonic Solutions: 0.45% Saline in 5% dextrose; Isotonic Solutions 0.9% Saline in 5% dextrose
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Behavioral Weight Loss Treatment for Individuals With Food Addiction
Condition: Food Addiction; Overweight and Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss; Behavior, Addictive; Food Addiction
Study type: Interventional

Summary: 
      The purpose of this research study is to examine how well an existing weight loss treatment
      works for individuals with food addiction. Treatment will consist of a preliminary 12-week
      RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a
      waitlist control.
    


Intervention name(s): Behavioral Weight Loss (BWL) counseling
Intervention type(s): Behavioral
Intervention description(s): This therapy is a weekly treatment which focuses on making gradual and modest lifestyle changes with goals of establishing regular patterns of eating, setting weekly goals, decreasing caloric intake, developing coping skills, and increasing physical activity.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
Condition: Shigellosis; Bacillary Dysentery
MeSH terms: Dysentery, Bacillary; Dysentery
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a
      InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a
      InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).
    

Detailed description: 
      The vaccine will be administered on Days 0,14, and 28. Volunteers (10 per group [8 minimum])
      will receive the same dose at each vaccination dependent upon group assignment. Groups will
      be divided according to the table below. An interval no less than 1 week will separate the
      third dose of a group from the first dose of the next group (receiving an increased
      InvaplexAR dose). Blood, stool, and saliva specimens will be collected at pre-specified
      intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Ocular
      tear samples will be collected in groups C and D. Vaccine safety will be actively monitored
      during vaccination and for 28 days following the third vaccine dose. The decision to advance
      to the next dose level is based on the safety assessment (not immunogenicity). A dose level
      with no occurrence of stopping criteria in the 7 days following the last vaccine dose will
      prompt moving to the next higher level. All safety data will be summarized and reviewed with
      the research monitor prior to dose escalation. In addition, a report of all safety data will
      be provided to the sponsor's safety office for informational purposes.
    

Intervention name(s): Shigella flexneri 2a InvaplexAR
Intervention type(s): Biological
Intervention description(s): The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 Hemagglutinin (HA) Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GlaxoSmithKline (GSK) Biologicals' Pandemic Influenza Vaccines
Condition: Immunologic Tests
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The purpose of this exploratory, retrospective laboratory study is to assess the humoral
      immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes
      following administration, in adults and children, of GSK Biologicals' adjuvanted and
      unadjuvanted pandemic influenza vaccines, using archived serum samples from previously
      completed clinical trials.
    


Intervention name(s): Serum samples
Intervention type(s): Other
Intervention description(s): The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Archived serum samples to be evaluated in this study were collected from adults 18-64 years
        of age and children 6-35 months of age.
      
Biospecimen description: 
      Serum samples
    
Keywords: Supra-seasonal influenza vaccine; Pandemic; Exploratory; Protein epitopes; Laboratory evaluation; Retrospective
Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)
Condition: Adolescent Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goals of this R21 exploratory pilot and feasibility study were to: 1) design an
      Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test
      that intervention in a small randomized trial to establish technical feasibility,
      intervention acceptability, and competence in completing the necessary recruitment and
      research procedures. Although not powered to detect statistically significant changes,
      possible outcomes of this study include improvements in problem-solving, coping, and
      self-management behaviors.
    


Intervention name(s): YourWay Internet Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention is an 11 week program that teaches problem solving of barriers to self-management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: type 1 diabetes, adolescent, self-management
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
Condition: Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal
      guardian had provided signed informed consent and satisfied the inclusion and exclusion
      criteria.
    


Intervention name(s): Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Intervention type(s): Drug
Intervention MeSH terms: Ferric gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iron Deficiency; Anemia in Pediatric Hemodialysis
Study to Evaluate Darapladib in Moderately Hepatically Impaired Subjects
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine any differences in pharmacokinetic parameters of
      darapladib when dosed to people with moderate liver disease as compared to when dosed in
      normal healthy volunteers.
    

Detailed description: 
      This study is an open-label, non-randomised study to assess the pharmacokinetics and
      safety/tolerability of repeat oral 40 mg doses of darapladib in subjects with moderate
      hepatic impairment (as defined by a Child-Pugh score of 7-9) in comparison to matched healthy
      volunteers.

      The hepatically impaired and healthy volunteer groups will receive repeat oral doses of
      darapladib for 10 consecutive days. The pharmacokinetics of darapladib and its metabolites
      will be evaluated. The effect of liver impairment on the plasma protein binding of darapladib
      and metabolites will also be determined as data permit. Safety will be assessed by clinical
      laboratory tests (hematology, chemistry and urinalysis), vital signs (blood pressure and
      heart rate measurements), 12-lead electrocardiograms (ECGs) and monitoring for adverse events
      (AEs).

      Subjects will be housed in the clinical unit from the evening before first dose until 24
      hours after the final dose of 10 days of repeat dosing. A follow-up period will include 2
      visits, one of which will be conducted approximately 10-14 days from the last dose of study
      drug and the second visit will be 35 days +/- one week after the last dose of study drug
    

Intervention name(s): darapladib
Intervention type(s): Drug
Intervention description(s): darapladib 40 mg oral dose
Intervention MeSH terms: Darapladib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteer; hepatic impairment; darapladib; atherosclerosis
Mylan Insulin Glargine Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D
      products produced from two manufacturing processes (Process V and Process VI) in combination
      with insulin lispro in patients with type 1 diabetes mellitus (T1DM).
    

Detailed description: 
      This is a multicenter, double-blind, randomized, parallel-group Phase 3 study in subjects
      with type 1 diabetes mellitus (T1DM) comparing the efficacy, immunogenicity, and safety of
      MYL-1501D products from 2 manufacturing processes (Process V and Process VI). After a 2-week
      screening period, all subjects will be titrated on Lantus® during a 4-week run-in period and
      shifted from their current mealtime insulin to insulin lispro (Humalog®). Subjects will then
      be randomized (stratified by time of administration of glargine [morning and evening]) to 1
      of 2 groups:

        -  MYL-1501D product from Process V

        -  MYL-1501D product from Process VI Treatment with MYL-1501D is for 18 weeks. A follow-up
           visit is scheduled 2 weeks after last dose of MYL 1501D.
    

Intervention name(s): MYL-1501D product using manufacture process V; MYL-1501D product using manufacture process VI
Intervention type(s): Drug; Drug
Intervention description(s): MYL-1501D product using manufacture process V; MYL-1501D product using manufacture process VI
Intervention MeSH terms: MYL-1501D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of
      lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
    


Intervention name(s): lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
Intervention type(s): Drug
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics, hepatic impairment
A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at a new study medicine for weight control in people with overweight or
      obesity. The aim of this study is to see if the study medicine is safe for people to take.
      The study also looks at how fast the body removes the study medicine. The participants will
      either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the
      medicine but does not have active ingredients). Which treatment the participants get is
      decided by chance. The participants will get 1 or more injections into the skin of stomach
      area once each week for 12 weeks. The study will last for about 4 to 5 months. The
      participants will have 18 visits to the clinic.
    


Intervention name(s): NNC0194-0499; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level.
Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.; Participants will receive once weekly injections of NNC0194-0499 matched placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show the non-inferiority of insulin glulisine administered
      with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c
      (HbA1c), from baseline to study week 24.
    


Intervention name(s): insulin glulisine
Intervention type(s): Drug
Intervention description(s): Once Daily Insulin: Subjects will receive insulin glulisine administered once daily 0-15 minutes before the greatest glycemic impact meal of the day starting at one-tenth the total dose of insulin glargine with maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
Twice Daily: Subjects will receive insulin glulisine administered twice daily 0-15 minutes before the 2 greatest glycemic impact meals of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
Three Times Daily: Subjects will receive insulin glulisine administered 3 times daily 0-15 minutes before each meal of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units for each meal and additional monitoring as shown in the table below.
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment