bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Protein and Fiber at Breakfast on Appetite, Blood Sugar, and Cholesterol
Condition: Brain Activity; Appetite; Ingestive Behavior; Glucose Control; Cholesterol
Study type: Interventional

Summary: 
      The objectives of the research are to assess the effects of increased protein and fiber
      intake at breakfast on neural activation in brain regions associated with appetitive drive
      and reward-driven eating, measures of subjective appetite, and ingestive behavior in
      overweight adults. Additional outcomes of interest include the effects of the breakfast
      intervention on blood sugar and cholesterol profiles.
    

Detailed description: 
      The objectives of the research are to assess the effects of increased protein and fiber
      intake at breakfast on neural activation in brain regions associated with appetitive drive
      and reward-driven eating, measures of subjective appetite, and ingestive behavior in
      overweight adults. Additional outcomes of interest include the effects of the breakfast
      intervention on 24-hour glucose profile as well as fasting and postprandial glycemic and
      lipemic regulation. The investigators will test the effects of consuming breakfasts with
      normal protein/normal fiber (NPNF), normal protein/high fiber (NPHF), high protein/normal
      fiber (HPNF), and high protein/high fiber (HPHF) for two weeks in a randomized cross-over
      study.
    

Intervention name(s): Dietary control of protein and fiber intake at breakfast
Intervention type(s): Other
Intervention description(s): Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Conservation of Red Cell Mass , Oxygen Supply and Demand in Cardiac Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Fifty patients will be enrolled into the study. The purpose of the study is to investigate
      the relevance of Hct levels in determining need for transfusion during operations employing
      bypass as well as to test the hypothesis that, while HCt levels may decrease during surgery ,
      red blood cell mass and tissue oxygenation remain fairly constant.
    

Detailed description: 
      Fifty adults( male or female-nonpregnant) whose weight is between 55-85 kg and are scheduled
      to undergo elective cardiac surgery with cardiopulmonary bypass for CABG or primary valve
      repair or replacement will be eligible. Patients with any history of abnormal bleeding
      disorders, urgent or emergent need for surgery, and combination surgeries will be excluded.
      Blood volume analysis will be performed with the DAXOR Blood Volume Analyzer BVA-100 System
      and the Volumex HSA I-131 radiopharmaceutical for use for determining circulating volume.
      Multiple timed sample points will be obtained. The DAXOR blood volume analyzer will batch
      samples and with input of patients height, weight, gender, time of draw, and corresponding
      Hct, calculate circulating total blood volume. We hypothesize that Total red cell mass is
      relatively well conserved( <20% decrease) during and immediately after surgery as long as
      major bleeding does not occur. We hypothesize that decrease in Hct during surgery are related
      to changes in circulating plasma volume. Total red cell O2 carrying capacity and O2 economics
      will be measured and it is also hypothesized that lowered Hct values, even as low as 15%, do
      not independently signal a tissue or whole body O2 deficit.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pre-OP, surgery clinics, inpatients
      
Keywords: Transfusion regulation
A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety
      of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.
    


Intervention name(s): SK-PC-B70M
Intervention type(s): Drug
Intervention description(s): dosage, frequency
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and
      rosuvastatin when coadministered or administered alone as a single dose or as multiple doses
      to healthy male subjects.
    

Detailed description: 
      This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each
      period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or
      rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd)
      from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic
      sampling for 48 hours or 72 hours.
    

Intervention name(s): Fimasartan; Rosuvastatin; Fimasartan + Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fimasartan
Oral Immunotherapy (OIT) for Peanut Allergy
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is
      to produce a new treatment that would benefit subjects who have peanut allergy by lowering
      the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune
      response in subjects who have peanut allergy (tolerance).
    

Detailed description: 
      Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food
      allergies it tends to be more persistent and also its prevalence seems to be rising.
      Currently there is no proven treatment other than strict avoidance. We are attempting to
      decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut
      using peanut oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the
      peanut specific immune response to determine if tolerance to peanut protein will develop.
      Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or
      placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects
      will not receive any peanut or placebo but only have skin prick testing and lab work in
      addition to a history and physical exam. Active subjects will undergo a modified rush
      immunotherapy on the first day and then increase the doses at least every two weeks up to a
      maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at
      home except for dose increases which will be done on the research unit. Outcome variables of
      interest include response to double-blind placebo controlled food challenge, skin prick
      testing, peanut specific IgE, and adverse events. These results will be compared between the
      start and end of peanut OIT using appropriate statistical analysis.
    

Intervention name(s): Peanut OIT; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Peanut flour that is orally ingested in a graded fashion.; Oat flour used as a placebo that is orally ingested a graded fashion
Other intervention name(s): Peanut flour; Oat flour
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Peanut Allergy
A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Condition: Myeloid Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered
      for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid
      leukemia (CML) once daily (QD) or twice daily. (BID)
    


Intervention name(s): Dasatinib; dasatinib
Intervention type(s): Drug; Drug
Intervention description(s): tablets, Oral, 100 mg, once daily; tablets, Oral, 50 mg, twice daily
Other intervention name(s): Sprycel; BMS-354825; Sprycel; BMS-354825
Intervention MeSH terms: Dasatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Imatinib resistant or intolerant chronic phase CML
Oral GW766944 (Oral CCR3 Antagonist)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      GW766994 is a selective, competitive antagonist of the human CC chemokine receptor-3 (CCR3).
      It is proposed that the inhibition of the CCR3 receptor may provide a treatment for airway
      inflammation such as in asthma. This will be a double-blind, placebo controlled, parallel
      group study being conducted to evaluate the effects of GW766994 in subjects with
      mild-moderate asthma who have high sputum eosinophilia. The primary objective is to compare
      the effects of GW766994 to placebo on sputum eosinophils.
    

Detailed description: 
      This will be a multi-centre study. This is a randomized, double-blind, placebo-controlled,
      parallel-group study, in patients with asthma and eosinophilic bronchitis. Subjects with
      asthma will be atopic and not on oral prednisone. Inhaled corticosteroids are allowed if on
      stable dose. All subjects will receive a 5 day course of 30mg daily of oral prednisone after
      one week stopping study drug.

      All subjects will attend screening (Visit 1) at which their eligibility for inclusion will be
      assessed. Eligible subjects will be randomized to receive either 300 mg of GW766994 twice
      daily or matching placebo at Day 1 (Visit 2) and will be stratified according to the
      subject's sputum eosinophil count at Visit 1. Treatment will be 10 days of oral dosing, and
      subjects will participate in a Day 7 or 8 visit (Visit 3), Day 10 visit (Visit 4 - End of
      Treatment), followed by a 1 week wash out period (Visit 5 -Follow Up Visit). At Visit 5, all
      subjects will be given 30 mg oral daily prednisone for 5 days and subjects to return to
      clinic at a Post Oral Prednisone Visit (Visit 6) at Day 22.

      Pharmacodynamic assessments will include both sputum and blood biomarkers and spirometry.

      Safety will be assessed by vital sign measurement, electrocardiogram, clinical laboratory
      tests (hematology, chemistry & urinalysis), clinical monitoring and adverse event reporting.
      Pharmacokinetic samples will be collected from each subject according to the sample schedule
      in the timing and events table.

      Study will involved sputum biology (progenitors, cell counts). Study will be conducted in
      Canada only.
    

Intervention name(s): GW766944; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Drug: GW766944 (Active Drug Treatment); This is placebo to match.
Other intervention name(s): Placebo Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Asthma; CCR3 receptor antagonists; GW766944
Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose
      co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose
      co-transporter 2 inhibitors is associated with moderate weight (fat) loss, in addition to
      other health benefits, including decreased blood pressure, decreased inflammation, and
      decreased oxidative stress. It is unclear as to whether these health benefits are due to
      SGLT2 inhibition per se, or as a secondary effect of weight loss. We wish to compare the
      health benefits of dietary counseling for weight loss with and without concomitant use of an
      SGLT2 inhibitor.
    

Detailed description: 
      This is a randomized, prospective, placebo-controlled, double blind, repeated measures study.
      50 overweight/obese adults (body mas index > 27.5 kg/m2) will be recruited for participation
      and randomly assigned to one of two 12 week treatments: (1) daily oral administration of
      Dapagliflozin with dietary counseling to promote weight loss; or, (2) daily oral
      administration of a placebo with dietary counseling to promote weight loss.
    

Intervention name(s): Dapagliflozin Tablet; Placebo Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.; Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Other intervention name(s): Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Caffein Consumption and Response Inhibition
Condition: Eating Behavior; Obesity
Study type: Interventional

Summary: 
      With the abundance of energy-dense foods that are designed for ease of consumption in the
      current environment, it is of importance to better understand the factors that may undermine
      the control of energy intake at healthy levels.

      One of the factors that is potentially important in response inhibition is caffeine.

      The aim is to assess the direct effects of caffeine on response inhibition, using a No
      Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as
      pictures, modulate response inhibition different in restrained vs. non-restrained eaters.
    

Detailed description: 
      In a blinded, randomized cross-over design, participants will receive either a capsule with
      caffeine or placebo at two separate occasions whereupon study tasks will be performed.
    

Intervention name(s): Caffeine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test.; Administration of placebo with subsequent cognitive tasks and food test.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Caffeine effects; Inhibitory control
Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to evaluate the efficacy of quetiapine fumarate
      (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute
      schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day
      56 using the last observation carried forward (LOCF) method.
    


Intervention name(s): Quetiapine Fumarate (Seroquel)
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Raspberry Intake on Metabolic Control and Cognitive Function
Condition: Aging; Age-related Cognitive Decline; Obesity
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this project is to determine whether restoring the post-prandial
      metabolic/inflammatory balance via supplementation with raspberries results in improved
      cognitive performance, and if these enhancements are mediated through improvements in
      vascular function.
    

Detailed description: 
      This study will investigate the effects of red raspberry in a relevant human model of
      metabolic disturbance to understand the relationship between red raspberry intake, metabolic
      and immune- balance and cognitive and psychomotor performance in older/over weight adults. A
      secondary goal of the project is to provide data on central vascular function in relation to
      metabolic-, inflammatory- and cognitive outcomes. Our primary working hypothesis is that red
      raspberries will improve metabolic- / inflammatory- balance in older overweight and obese
      adults resulting in improved cognitive and psychomotor performance mediated in part through
      improvements in vascular function. Two main objectives have been devised to meet the goals of
      the project and test our hypotheses: 1) Evaluate the effects of acute dietary raspberry
      intake on metabolic-associated impairments in cognitive and psychomotor function in
      overweight/obese adults (55-70y) following a meal challenge. 2) Evaluate the effects of acute
      dietary raspberry on measures of vascular function
    

Intervention name(s): Active breakfast; Control breakfast
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich; Control drink + buttermilk biscuit sandwich
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Raspberry; Cognition; Vascular function
Effect of holoBLG on Cat Allergic Patients
Condition: Allergy to Cats; Allergic Rhinoconjunctivitis
Study type: Interventional

Summary: 
      The aim of the study is to investigate the antigen-unspecific effect of a 3 months
      supplementation with a food for special medical purposes (FSMP) in form of a lozenge
      containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in
      patients with allergic rhinoconjunctivitis caused by cat (hair/dander) and the associated
      symptoms (symptom type and severity) during exposure to cat allergen in an Allergen Exposure
      Chamber (AEC).
    


Intervention name(s): holoBLG
Intervention type(s): Dietary Supplement
Intervention description(s): holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Different Tools to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use
Condition: Nasotracheal Intubation
Study type: Interventional

Summary: 
      to investigate the effectiveness of techniques of either using Magill forceps or cuff
      inflation in facilitation of nasotracheal tube advancement into trachea
    

Detailed description: 
      Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good
      surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from
      nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill
      forceps or cuff inflation is advantageous is not determined.
    

Intervention name(s): Magill forceps; cuff inflation
Intervention type(s): Procedure; Procedure
Intervention description(s): Magill forceps techniques to facilitate nasotracheal tube advancement into trachea; cuff inflation techniques to facilitate nasotracheal tube advancement into trachea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magill forceps; cuff inflation; Nasotracheal Intubation
Laryngomalacia Exposed
Condition: Complications
MeSH terms: Laryngomalacia
Study type: Observational

Summary: 
      Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of
      stridor in infants and children. Symptoms usually appear within the first 2 weeks of life.
      Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous
      airway anomalies.
    

Detailed description: 
      The most common health complications associated with laryngomalacia were: 1. Gastroesophageal
      reflux which was presented by arching, choking, gagging, feeding aversion and continuous
      crying 2. Frequent unilateral eye infections 3. Repeated choking, frequent vomiting and poor
      weight gain 4. Repeated upper respiratory tract infections (viral and bacterial), coughing
      and cyanosis 5. Repeated secretory otitis media 6. Aspiration pneumonia
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinics
      
Keywords: Factors Predisposing or Causing