bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood
      glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type
      1 diabetes.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days; 0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to extend the intended use of two BGMSs to include testing of
      neonatal blood by Health Care Professionals in a clinical setting for the quantitative
      measurement of glucose levels in neonates.
    

Detailed description: 
      This trial will evaluate the performance of both the CONTOUR NEXT BGMS and CONTOUR PLUS ELITE
      BGMS using blood from neonates within a hospital ward, e.g. routine/newborn nurseries,
      Special Care Nurseries, Neonatal Intensive Care Unit (NICU). The investigational BGMSs will
      be tested by a Point-of-Care operator using residual heel-stick capillary blood samples from
      neonates who underwent routine prescribed testing.
    

Intervention name(s): Contour Next and Contour Plus Elite BGMS testing of neonatal blood
Intervention type(s): Device
Intervention description(s): The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The subject population will consist of neonates from hospital wards (e.g. routine/newborn
        nurseries, SCN, NICU) of the clinical investigational site.
High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
Condition: Body Composition; Physical Performance; Intermittent Fasting
Study type: Interventional

Summary: 
      The objective of this study is to compare the body composition and physical performance
      effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen
      active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks
      without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in
      weekly energy intake) on body composition and performance (Hand-grip strength, Counter
      movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in
      between both phases when they did not perform the scheduled activity, so as not to alter the
      experimental phase.
    


Intervention name(s): Intensity interval training (HIIT); Intensity interval training (HIIT) + intermittent fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2x8 weeks of high-intensity interval training (HIIT); 2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Soda and Milk Study
Condition: Obesity; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Much attention has been directed at the unhealthy effects of sugar-sweetened beverages
      (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults,
      SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared
      to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda
      with milk had the added benefit of also reducing systolic blood pressure. While several
      studies have investigated the effects of SSBs on weight gain in children, no published
      studies have investigated their effects on lipid and lipoprotein risk factors under
      isocaloric conditions in metabolically at-risk adolescents, who are among the greatest
      consumers of SSBs. The main objective of this study is to test whether isocaloric replacement
      of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood
      pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are
      habitual soda consumers. The investigators will test this in a 8 week randomized two period
      crossover trial in 30 overweight and obese adolescent males who are self-reported habitual
      consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda
      containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks
      each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and
      blood samples will be collected at screen and at the end of each intervention period. Plasma
      measurements will include LDL peak particle diameter; lipoprotein subclass concentrations;
      triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and
      insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.
    


Intervention name(s): Reduced Fat Milk; Sugar Sweetened Soda
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks; Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks
Other intervention name(s): 2% milk; High fructose corn syrup sweetened soda
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical pharmacology research study will assess the safety and pharmacokinetics of the
      drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.
    


Intervention name(s): Everolimus
Intervention type(s): Drug
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic insufficiency; liver disease; cirrhosis; pharmacokinetics
Head Position for Endotracheal Intubation
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether degree of neck flexion affect on
      laryngeal view and discomfort during endotracheal intubation in adult patients.
    

Detailed description: 
      The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal,
      pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There
      have been scarce clinical studies about the appropriate degree of neck flexion for
      endotracheal intubation. In the present study, the laryngeal view and physician's discomfort
      during endotracheal intubation were evaluated according to the two degrees of neck flexion(4
      cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.
    

Intervention name(s): Neck flexion
Intervention type(s): Other
Intervention description(s): Patient's neck was flexed using a 4 cm or 8 cm height of pillow
Intervention model: Single Group Assignment
Masking: Single (Participant)
Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may
      kill more tumor cells.

      PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when
      given together with paclitaxel and carboplatin to compare how well they work in treating
      patients with stage III, stage IV, or recurrent non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the major objective response (complete and partial response) rates in patients
           with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus
           low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin.

        -  Compare the duration of response, time to progression, and survival of patients treated
           with these regimens.

        -  Characterize and compare the toxicities of these regimens.

        -  Determine the recommended phase III dose of erlotinib hydrochloride.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to gender. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2. Patients
           also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on
           day 3.

        -  Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and
           carboplatin as in arm I.

      In both arms, treatment repeats every 21 days for 6 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
    

Intervention name(s): Carboplatin; erlotinib hydrochloride; Paclitaxel; erlotinib hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 150mg; 200mg/m2; 1500mg
Other intervention name(s): Carboplatin AUC6; Erlotinib; Erlotinib
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
The Role of Emotional Arousal in Food Preference and Taste
Condition: Obesity; Food Craving; Food Consumption
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the role of stress in food craving and food
      consumption in obesity. Using experimentally validated guided imagery procedure, the
      investigators propose to examine the stress response using subjective, physiological and
      neurobiological measurements.
    

Detailed description: 
      One hundred and fifty men and women will participate in three laboratory sessions to assess
      stress responses to personal stress imagery, food cue imagery, and to neutral-relaxing
      imagery. Subjects will be distributed into 3 groups stratified by BMI category. Subject
      recruitment, eligibility determination, baseline assessments and script development will be
      conducted at the Yale Stress Center. Subjects will complete a variety of diagnostic,
      cognitive and psychological assessments, a comprehensive physical examination and blood work
      and will be involved in development of imagery scripts from personal stress, food cue and
      neutral-relaxing situations. Subjects will then be scheduled for three laboratory sessions at
      the Yale Stress Center. Subjects will also participate in an imagery and relaxation training
      session followed by three laboratory sessions. The three laboratory sessions will be
      conducted within a brief interval of days, when subjects will be exposed to a personal
      stress, a food cue and a neutral-relaxing imagery condition, one condition per day. The order
      of imagery conditions will be randomly assigned and counterbalanced across subjects in order
      to balance any influences due to order of imagery conditions.
    

Intervention name(s): Stress Imagery; Food Cue Imagery; Neutral-Relaxing
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The stress imagery script will be based on subjects' description of a recent personal stressful event that they had experienced as "most stressful". "Most stressful" is determined by having the subjects rate the perceived stress experienced by them on a 10-point Likert scale where "1=not at all stressful" and "10=the most stress they felt recently in their life". Only situations rated as 8 or above on this scale are accepted as appropriate for script development. Examples of acceptable stressful situations include breakup with significant other, a verbal argument with a significant other or family member or unemployment-related stress, such as being fired or laid off from work.; A food cue script will be developed from the subjects' experience of eating their most favorite foods. Examples include ordering pizza, cooking a favorite meal, or going out to a restaurant.; A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: stress; food cues; obesity
Physical Activity and Gastrointestinal Investigations
Condition: Gastro-oesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      This is an observational study, which aims to compare the outcomes of ambulatory
      gastrointestinal investigations with physical activity using accelerometry. An ambulatory
      study refers to one in which the patient is monitored freely, often outside of the hospital
      environment. For this the investigators will use a lightweight (7.4g) tri-axial accelerometer
      worn behind the ear.

      Hypothesis 1 There is no change in the amount or nature of physical activity taken by
      patients during ambulatory oesophageal pH monitoring or capsule endoscopy.

      Hypothesis 2 There is no correlation between physical activity levels and speed of
      gastrointestinal transit.
    

Detailed description: 
      For capsule endoscopy, the investigators are interested in how physical activity affects the
      speed of capsule transit through the GI tract. Capsule endoscopy involves a patient
      swallowing a pill which contains a camera, in order to image the parts of the bowel that a
      conventional endoscope cannot reach. A rapid transit may result in insufficient mucosal
      visualisation, which would reduce the sensitivity of the investigation.

      For oesophageal pH monitoring, it is essential that the patient behaves as they would
      normally to produce measurements that represent a standard day. Using accelerometry, the
      investigators can compare the amount, and nature, of physical activity taken throughout the
      investigation to that of the preceding day, or week. In addition, further analysis of motion
      data captured will allow us to correlate specific activities and body orientation with pH
      readings to get a better insight into the pathophysiology of a patient's condition.

      The studies will be conducted over 6-9 months in Imperial College Trust's medical outpatient
      service. All patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will
      be asked to consider participating. Patients will receive the eAR sensor up to 2 days before
      their investigation, and will be asked to wear it until the end of their investigation (not
      whilst sleeping). Capsule endoscopy normally takes less than 12 hours, and pH monitoring
      takes between 24 and 48 hours. Participation makes no difference to the standard or type of
      care that they will receive, the sensor data is additional.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those who have been advised to undergo 24 hour oesophageal pH monitoring, or capsule
        endoscopy (from GI outpatients clinic)
      
Keywords: Physical activity; Accelerometry; Oesophageal pH; Capsule endoscopy
Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Condition: Delirium; Cognitive Impairment
MeSH terms: Delirium; Confusion
Study type: Observational

Summary: 
      The investigators hypothesize that critical care trained registered nurses and physicians can
      perform measurements of cognitive impairment in critically ill pediatric patients in a
      reliable and valid manner. To test this hypothesis, the investigators will incorporate an
      instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in
      critically ill pediatric patients at least 6 months to children 5 years of age, both on and
      off mechanical ventilation, and compare these assessments to those of the reference standard.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill pediatric patients at least 6 months to children 5 years of age, both on and
        off mechanical ventilation
Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot trial is to determine whether an intensive treatment with insulin
      glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients
      with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.
    

Detailed description: 
      This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4
      months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.
    

Intervention name(s): insulin glargine; metformin; acarbose; lifestyle therapy; insulin glargine; metformin; acarbose; lifestyle therapy; Standard glycemic care
Intervention type(s): Drug; Drug; Drug; Behavioral; Drug; Drug; Drug; Behavioral; Other
Intervention description(s): sc injection; oral administration; oral administration; diet and exercise; sc injection; oral administration; oral administration; diet and exercise; as informed by the current clinical practice guidelines
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Insulin; Glargine; Metformin; Acarbose; Diet; Exercise; Lifestyle
Effect of Itraconazole on the Pharmacokinetics of Apatinib
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      he primary purpose of this study is to investigate potential pharmacokinetic interaction in
      healthy volunteers when apatinib is administered in combination with itraconazole. Secondary
      objective is evaluating the safety and tolerability of apatinib alone and when
      co-administered with itraconazole.
    


Intervention name(s): Apatinib Mesylate Tablets; Itraconazole Capsules
Intervention type(s): Drug; Drug
Intervention description(s): apatinib was administered in the morning after an overnight fast of at least 10 h; rifampicin was administered in the morning 0.5 hours after breakfast
Other intervention name(s): apatinib; itraconazole
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iron and Vaccine Response
Condition: Iron Deficiency Anemia; Vaccine Preventable Disease; Vaccine Response Impaired; Iron Deficiency Anemia Treatment
MeSH terms: Vaccine-Preventable Diseases; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not
      work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study
      objective is to assess whether iron deficiency anaemia in young women impairs their immune
      response to viral vaccines, and whether iron treatment improves their response.
    

Detailed description: 
      Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in
      both groups will receive two intramuscular vaccines (influenza and yellow fever). Vaccine
      response will be measured 28 and 56 days after vaccine administration in both groups. Group 2
      (delayed iron treatment) will receive iron treatment at study end.
    

Intervention name(s): Ferinject
Intervention type(s): Dietary Supplement
Intervention description(s): intravenous iron carboxymaltose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate pharmacokinetic drug interaction between teneligliptin and
      empagliflozin in healthy adults.
    


Intervention name(s): Teneligliptin; Empagliflozin; Teneligliptin and Empagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Teneligliptin alone; Empagliflozin alone; Teneligliptin and empagliflozin
Other intervention name(s): Tenelia®; Jardiance®; Tenelia® and Jardiance®
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment