bioihbjkbjnl/mcl2 huggingface dataset:
Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma,
      Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia
      in CSII- and MDI-treated people with type 1 diabetes.
    

Detailed description: 
      Near-normalization of blood glucose levels through intensive insulin therapy has shown to
      reduce the risk of diabetes late complications, but the approach is associated with two major
      side effects: hypoglycemia and weight gain. Although management of hypoglycemia through oral
      carbohydrate consumption is generally effective, the approach can lead to excessive
      carbohydrate intake and cause rebound hyperglycemia. It has previously been demonstrated that
      subcutaneous (s.c.) low-dose glucagon can be utilized to effectively treat mild hypoglycemia
      in people with type 1 diabetes. However, the instability in aqueous solution of currently
      available glucagon and the need for reconstitution with sterile water immediately prior to
      administration has limited its clinical role outside emergency settings. Due to the stability
      and ready-to-use formulation, dasiglucagon does not hold the limitations known for the
      currently available glucagon preparations.

      The aim of this randomized, partially single-blinded, three-arm cross-over study is to
      compare the efficacy of low-dose dasiglucagon (80 and 120 μg) to oral carbohydrate (15 g)
      consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated
      people with type 1 diabetes. On each study visit (separated by ≥ 3 days), an initial insulin
      bolus will be administered (at t = 0) aiming for a plasma glucose (PG) level of 3.0 mmol/l.
      When reaching 4.5 mmol/l, the intervention (s.c. dasiglucagon or oral carbohydrates) will be
      administered (t-intervention = 0), whereafter PG will me monitored for an additional 180 min.
    

Intervention name(s): Dasiglucagon; Carbohydrate (dextrose tablets)
Intervention type(s): Drug; Other
Intervention description(s): Abdominal s.c. administration; Oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-blinded, randomized (using blocks of 3/6 and stratification by treatment modality), three-arm crossover study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Hypoglycemia; Dasiglucagon
The Efficacy of Reminders to Complete HPV Series
Condition: Completion of Three Dose Series of HPV; Improvement in Vaccine Intervals Between HPV Doses
Study type: Interventional

Summary: 
      The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and
      boys starting at age 11, although it can be offered as young as 9 years of age. This is a
      3-dose series and many adolescents do not complete it after getting the first dose. This
      study will study how effective it will be to send reminders to parents to schedule an
      appointment when their child is due for the next dose of HPV. Parents can chose whether they
      would like a phone call or text message reminder. This study will determine if the reminders
      work, and if one method is better than another (phone message vs. text message).
    


Intervention name(s): Telephone reminder; Text Message reminder
Intervention type(s): Other; Other
Intervention description(s): One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.; One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Human Papillomavirus
The Effect of Digital Storytelling on Nursing Students' Compliance
Condition: Education; Isolation; Nursing Students
Study type: Interventional

Summary: 
      This study investigated the effect of digital storytelling on nursing students' compliance
      with isolation precautions and their knowledge levels.This was a pretest-posttest open-label
      randomized controlled trial. The nursing department of the faculty of health sciences of a
      university in the eastern Black Sea region of Turkey. The sample consisted of 109 fourth-year
      nursing students divided into groups of experimental (n=66) and control (n=43). Data were
      collected using a demographic characteristics questionnaire, an Isolation Knowledge Test
      (IKT), a Questionnaire of Students' Opinions on Digital storytelling (QSODS), and the Scale
      of Compliance with Isolation Precautions (SKIP). The experimental group attended a digital
      storytelling activity (intervention), while the control group received an education based on
      the curriculum. The data were analyzed using the Mann-Whitney U test, the Wilcoxon test, the
      Analysis of variance (ANOVA), and the Spearman correlation test.
    


Intervention name(s): Education, dijital storytelling
Intervention type(s): Other
Intervention description(s): Digital story
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Relationship Between Aortic Pulse Wave, Aortic Calcification and Peripheral Artery Occlusion Disease in Peritoneal Dialysis Patients
Condition: End-stage Renal Disease; Peritoneal Dialysis; Aortic Calcification; Peripheral Artery Occlusion; Cardiovascular Disease
MeSH terms: Kidney Failure, Chronic; Cardiovascular Diseases; Arterial Occlusive Diseases; Calcinosis
Study type: Observational

Summary: 
      Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage
      renal disease (ESRD), which means that it is important to find out risk factors of CVD in
      order to prevent or treat it. In recent years, there has been more and more recognition of a
      very high prevalence of CV calcification in the ESRD population. Many observational cohort
      studies have shown that CV calcification in these patients can predict mortality, CV
      mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may
      result in vessel calcification. Calcification leads to arterial stenosis and increasing
      arterial stiffness and then heart afterload, both contribute to the development of CVD.
      Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic,
      immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent
      in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis
      would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly
      associated with the presence and extent of atherosclerosis and constitutes a forceful marker
      and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery
      occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which
      would increase the condition of infection and gangrene. Thus, life safety and quality would
      be influenced severely and early detection might prevent future amputation. As compared with
      HD or pre-dialysis patients, uremic patients treated with PD have a higher risk for metabolic
      syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD,
      especially in PD patients, are needed for future management and preventions of CV related
      morbidity and mortality.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PD patients
      
Biospecimen description: 
      Plasma, 8ml/patient
    
Keywords: Calcification; aortic pulse wave velocity; peripheral artery occlusion disease; peritoneal dialysis; metabolic syndrome
One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
Condition: Concussion, Brain
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed
      to study the impact of huddles on concussion safety in youth sport, primarily regarding
      intention to report concussive symptoms.
    

Detailed description: 
      More than 1 million youth sustain a sport-related concussion (SRC) each year. The middle
      school age range is particularly concerning because it is a time when children have both a
      unique susceptibility to brain injury and high participation rates in organized sports with
      concussion risk, such as soccer and football. There are two avenues to decrease concussion
      risk: (1) minimizing the number and force of collisions to decrease concussion incidence
      (primary prevention) and (2) improving concussion identification to decrease morbidity
      (secondary prevention). The goal of this study is to utilize Pre-Game Safety Huddles to
      discuss sportsmanship (primary prevention) and concussion reporting (secondary prevention)
      with a goal of improving concussion safety.

      To assess the efficacy of Pre-Game Safety Huddles as a tool for injury prevention, we will
      conduct a Randomized controlled trial with youth sport teams. We will recruit leagues in the
      Seattle area (girls' soccer, boys' soccer and football) and randomize them to either
      intervention or control. Coaches in the intervention group will then be trained to lead
      Pre-Game Safety Huddles before each game over the course of the season (9-12 weeks). Youth
      and coaches will be surveyed at three time points and data will be analyzed to determine
      impact of the intervention on two outcomes: 1) expectations regarding reporting concussive
      symptoms (CR-E) and 2) expectations regarding engaging in potentially injurious play (IP-E).
    

Intervention name(s): Pre-game Safety Huddles
Intervention type(s): Behavioral
Intervention description(s): Coaches will be trained to lead Pre-game Safety Huddles by the RA with the study using a multi-media tool we have developed. Huddles will be brief (1-2 minutes) and will primarily focused on 1) encouraging concussion reporting and 2) encouraging good sportsmanship
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Leagues were randomized to intervention or control
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Soccer; Football; Injury; Prevention; Concussion; Education; Huddles; Primary prevention; Secondary prevention; Behavioral intervention
Midkine and ACE-Ang II Induced Endothelial Injury in Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational [Patient Registry]

Summary: 
      Plasma midkine has reported to be elevated in infection and a regulator of
      angiotensin-converting enzyme (ACE). We aimed to investigate the plasma midkine in septic
      patients and its association with 28-day mortality and organ function, and also with plasma
      ACE and angiotensin II.
    

Detailed description: 
      This study showed that Ang II induced endothelial injury in sepsis patients. Midkine has been
      shown to regulate the renin-angiotensin system and acts in the upstream signaling pathway of
      angiotensin (ANG) II. The investigators want to access the relationship between midkine level
      and ACE-Ang II induced endothelial injury in sepsis
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who diagnosed for sepsis
      
Biospecimen description: 
      Plasma
    
Keywords: midkine; endothelial injury; sepsis; angiotensin-converting enzyme; angiotensin II
Effects of Exercise During Gestation on Maternal and Foetal Health
Condition: Pregnancy
Study type: Interventional

Summary: 
      The main objective of this project is to assess the effects of a novel and supervised
      exercise intervention in overweight pregnant and their newborn.

      Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant
      interested in participate in the intervention program will be randomly assigned to either
      exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The
      primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic
      profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii)
      physical fitness; iv) objectively measured physical activity and sedentary behaviour; v)
      sleep quality; vi) mental health, quality of life and positive health; vii) haematology and
      biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone
      health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an
      intention-to-treat basis and per protocol.
    


Intervention name(s): Exercise intervention
Intervention type(s): Other
Intervention description(s): The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pregnant Women; Quality of Life; Exercise; Sleep; Fetal Research; Diet, Mediterranean; Physical Fitness; Oxidative stress; Inflammation
A Drug-drug Interaction Study Between Daclatasvir and Metformin
Condition: Hepatitis C; Diabetes Mellitus; Insulin Resistance
MeSH terms: Hepatitis C; Hepatitis; Diabetes Mellitus; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to provide clinical information on a potential drug-drug interaction between
      daclatasvir and metformin.
    

Detailed description: 
      Daclatasvir is a recently approved anti-HCV agent that is a cytochrome P450 3a (CYP3A)
      substrate but does not affect CYP3A itself. It is also a moderate inhibitor of various
      membrane transporters such as organic anion-transporting polypeptide 1B1 (OATP1B1) ,
      p-glycoprotein (P-gP), and organic cation transporter (OCT) 1 and 2.

      Metformin is used to treat diabetes mellitus. It is an OCT-2 and OCT-1 substrate and when
      combined with daclatasvir increased levels of metformin may occur, with risk on hypoglycaemic
      episodes. The Summary of Product Characteristics (SmPC) of daclatasvir currently does not
      mention this potential drug-drug interaction.

      HCV is associated with insulin resistance (IR) which may develop to diabetes mellitus (DM).
      The prevalence of IR in HCV infected patients is estimated varying from 30% to 70%. Several
      studies showed that IR has a negative impact on the achievement of an undetectable HCV viral
      load after completing 12 weeks of treatment (Sustained Virologic Response (SVR)).

      This study aims to provide clinical information on a potential drug-drug interaction between
      daclatasvir and metformin.
    

Intervention name(s): Daclatasvir; Metformin
Intervention type(s): Drug; Drug
Other intervention name(s): Daklinza
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HCV; Diabetes Mellitus; Daclatasvir; Metformin; drug-drug interaction; pharmacokinetics
Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Study type: Interventional
Phase: Phase 4

Summary: 
      This within-person, crossover, 2-condition, placebo-controlled study compares the impact of
      two perimenstrual conditions on severity of suicidal symptoms in females with past-month
      suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) natural
      perimenstrual withdrawal from estradiol and progesterone (during placebo), (2) perimenstrual
      stabilization of estradiol and progesterone using transdermal estradiol and oral micronized
      progesterone.
    

Detailed description: 
      A large number of observational studies have documented increased risk of suicide attempt,
      suicide death, and more lethal attempts during the perimenstrual (around menses) window of
      the female reproductive cycle; however, no experiments have investigated the causal role of
      ovarian steroid changes across the natural perimenstrual period in risk factors for acute
      suicidality. In response, the proposed experimental work investigates a causal role of
      perimenstrual withdrawal from the hormones estradiol (E2) and progesterone (P4) in
      previously-documented acute perimenstrual increases in suicidality.

      Participants are 30 women between the ages of 18 and 45 with current suicidal ideation but
      minimal risk for suicide attempt. Using a placebo-controlled, crossover within-person design,
      the experiment tests the hypothesis that suicidality will be heightened during natural
      perimenstrual E2/P4 withdrawal (under placebo), but that experimental prevention of this
      perimenstrual E2/P4 withdrawal (with exogenous administration of E2/P4 hormones) will prevent
      these perimenstrual increases in suicidality and associated risk factors.
    

Intervention name(s): Estradiol Transdermal Patch 0.1 mg/24 hrs; Oral Micronized Progesterone; Inactive Clear Patch; Placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation; 100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation; Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation; Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
Other intervention name(s): Climara; Prometrium; Placebo transdermal patch; Sugar pill
Intervention MeSH terms: Estradiol; Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover 2-Condition Placebo-Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Steroid hormones; Estradiol; Progesterone; Depression; Suicide
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other
      Allergic Symptoms in Children
    


Intervention name(s): levocetirizine dihydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Levocetirizine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levocetirizine dihydrochloride Xyzal tablets
Effect of POCO on Gastric Function in HV
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to investigate changes in gastric motility (including gastric accommodation),
      nutrient volume tolerance, gastric emptying and gastrointestinal hormones in healthy
      volunteers after an acute intake of a combination of peppermint oil and caraway oil, compared
      to placebo. In addition, the effect of a combination of peppermint oil and caraway oil on
      appetite-related sensations and upper gastrointestinal symptoms will be assessed.

      Gastric emptying rate will be assessed using a 13C breath test. Intragastric pressure (IGP)
      will be measured using high-resolution manometry in fasted state and during intragastric
      infusion of a nutrient drink (350 mL or until full satiation). Appetite-related sensations
      and gastrointestinal symptoms were rated during IGP measurements. Blood samples were
      collected to assess peptide hormone levels.
    

Detailed description: 
      This study aims to investigate changes in gastric motility (including gastric accommodation),
      nutrient volume tolerance, gastric emptying and gastrointestinal hormones in healthy
      volunteers after an acute intake of a combination of peppermint oil and caraway oil, compared
      to placebo. In addition, the effect of a combination of peppermint oil and caraway oil on
      appetite-related sensations and upper gastrointestinal symptoms will be assessed. These
      outcomes will be studied on 2 study days. On study day 1, gastric emptying rate will be
      assessed using a 13C breath test 30 minutes after intake of study medication. This test is
      followed by an intragastric pressure (IGP) measurement during which 350 mL of a nutrient
      drink will be intragastrically infused 30 minutes after intake of study medication. On the
      second study day, IGP will be measured in fasted state for 4 hours after intake of study
      medication. Hereafter, a second dose of study medication will be administered. Thirty minutes
      later, a nutrient drink will be infused until the participant is fully satiated.
      Appetite-related sensations and gastrointestinal symptoms will be rated during IGP
      measurements on a 100mm VAS. Blood samples will be collected to assess peptide hormone
      levels.
    

Intervention name(s): FDGard; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): capsule containing peppermint oil and caraway oil; Placebo capsule containing cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, parallel, single-blind, placebo-controlled
Masking: Single (Participant)
Primary purpose: Other
Keywords: gastric motility; gastric emptying; nutrient volume tolerance; peppermint oil; caraway oil