bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
Condition: Healthy; Incretin Effect; Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      An open-labeled intervention study testing healthy, lean, and male volunteers on two separate
      occasions:

        1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.

        2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the
           concentrations seen during oral consumption.

      The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes
      after 3-OHB consumed orally vs. intravenously.

      Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates
      (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg
      Paracetamol consumption before each intervention day. Urine will be analyzed for ketone
      concentrations/excretion rates.
    

Detailed description: 
      An open-labeled intervention study testing healthy, lean, and male volunteers on two separate
      occasions with at least 48 hours apart.

        1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.

        2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the
           concentrations seen during oral consumption.

      The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes
      after 3-OHB consumed orally vs. intravenously.

      Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates
      (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg
      Paracetamol consumption before each intervention day. Urine will be analyzed for ketone
      concentrations/excretion rates.
    

Intervention name(s): 3-OHB salt (NaCl)
Intervention type(s): Dietary Supplement
Intervention description(s): 36 gram 3-OHB salt diluted in 500 ml sterile water
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged
      survival of beta cell allografts in type 1 diabetic patients with early chronic complications
      of diabetes.
    


Intervention name(s): islet cell grafts
Intervention type(s): Procedure
Intervention description(s): Intraportal injection of an islet cell graft into the liver.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, type 1; pancreatic beta cell; transplantation
Flavonoid Effect on Activation and Stimulation of Thrombocytes, hsCRP and Lipid Profile
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of dark chocolate with green tea in
      healthy subjects on clot formation (platelet activity) cholesterol profile and markers of
      inflammation in two groups.

      The first group will be on a regimen of dark chocolate, and the second group will be on a
      regimen of green tea. Clinical outcomes will be determined after seven days of each treatment
      and both groups will undergo both treatments subsequently and serve as their own control.

      The hypothesis is that both green tea and dark chocolate will reduce platelet activity and
      reduce LDL, hsCRP and increase HDL.
    

Detailed description: 
      Flavonoids are polyphenolic compounds ubiquitous in fruits and vegetables. They appear in
      especially high concentrations in the form of flavanols in green tea as well as in cocoa, and
      are known to have beneficial antioxidant effects in vitro. Flavonoids have been proposed as a
      key protective dietary component, reducing the risk of coronary heart disease, including the
      reduction of elevated blood pressure in persons with hypertension and capable of decreasing
      LDL.

      The aim of this prospective single cross-over study is to assess the effect of green tea and
      dark chocolate consumption on inhibiting platelet activation, Lipid levels, and hsCRP in
      healthy volunteers.

      This research will be done at Sinai Hospital of Baltimore and will include 35 subjects who
      will be randomized equally between the two groups.

      All blood work will be processed at the Sinai Center for Thrombosis Research. Clinical
      outcomes will be recorded using a standard case report form.
    

Intervention name(s): Green tea; 70% dark chocolate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The green tea group consumed first daily one liter of green tea infusate made of 4 bags left in boiling water during 3 minutes.
After a four week washout-time they were switched over to the dark chocolate treatment, which included consumption of 3.5 ounces 70% dark chocolate.
Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels; The dark chocolate group consumed 3.5 ounces 70% dark chocolate per day during a one week period.
After a four week washout-time they were given the green tea treatment, which included ingestion of one liter green tea infusate (containing 4 green tea bags).
Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Flavonoid; hsCRP; HDL; LDL; platelet reactivity
Food Reinforcement, Weight Status, and Energy Density
Condition: Reinforcing Value of Food
Study type: Observational

Summary: 
      The investigators previous studies have shown that obese and non-obese individuals respond
      differently to daily intake of snack food. The purpose of this study was to determine whether
      these differences are specific to high energy density snack foods. The investigators
      hypothesized that obese individuals would show an increase in motivation to obtain high
      energy density snack foods after two weeks of daily consumption, but that non-obese women and
      obese women consuming low energy density foods would have reduced motivation to consume snack
      foods after two weeks of daily consumption.
    


Intervention name(s): Daily snack food intake
Intervention type(s): Behavioral
Intervention description(s): participants consumed 60 gram portions of either low energy density or high energy density snack foods every day for two weeks.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women ages 18 - 50 were recruited.
      
Keywords: food reinforcement; food liking; motivation; dopamine; obesity; energy density; snacks
Effectiveness of Spirometry as a Motivational Tool to Quit Smoking
Condition: Smoking Cessation; COPD
Study type: Interventional

Summary: 
      The aim of the study is to asses the efficacy of the spirometry and a minimal smoking
      cessation counselling intervention to quit smoking after a year in patients older than 40
      years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease
      (COPD) diagnosis.
    


Intervention name(s): Spirometry and a brief advice to quit smoking; Brief advice to quit smoking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During a year, recruitment for active smoker patients was done by doctors in primary care medical offices. In the intervention group, after been randomized, one trained nurse completed the questionnaires and did the spirometry with bronchodilator test and set a date with its family doctor who did a minimal smoking cessation counselling intervention and informed the patients about the spirometry results according to established protocol.; During a year, recruitment for active smokers patients occurred through doctors in primary care medical offices. After be randomized, in de control group, a nurse complete the questionnaires. Below, patients go to the family doctor who will do a minimal smoking cessation counselling intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Spirometry; screening; smoking cessation; tobacco; COPD
Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objectives of the proposed experimental and modeling efforts are to quantify the
      influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction
      (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive
      performance and to develop a new model of sleep homeostasis that can predict the effects of
      chronic sleep restriction. This model will be based on the underlying neuroanatomy and
      neurophysiology. This new model will facilitate optimization of human performance in
      operational settings, such as are seen in military operation and other work environments.
    

Detailed description: 
      This protocol involves a baseline period consisting of 14 hours of wakefulness and 10 hour
      nocturnal sleep episodes each 24 hours. This is followed by a forced desynchrony regimen
      spanning 21 calendar days and consisting of 12 cycles ("days") of a 42.85-hour wake:bedrest
      schedule. In each 42.85 hour cycle, there are 32.85 hours of scheduled wakefulness and 10
      hour sleep opportunities. This will allow assessment of the independent contributions of
      circadian phase and homeostatic sleep pressure on sleep and neurobehavioral performance. This
      forced desynchrony regimen is followed by 10 recovery days consisting of 14 hours of
      wakefulness and 10 hour nocturnal sleep episodes each 24 hours.
    

Intervention name(s): forced desynchrony protocol with sleep restriction
Intervention type(s): Behavioral
Intervention description(s): Subjects are scheduled to live on a non-24 hour day. This separates the sleep-wake schedule from the near-24 hour circadian rhythm. This allows assessment of how circadian rhythms and the length-of-time awake contribute to sleepiness, alertness, and cognitive performance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: forced desynchrony; circadian rhythms; sleep restriction; sleep homeostasis; neurobehavioral performance
Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun
      Ring Oximeter placed on the index fingers during non-motion conditions
    

Detailed description: 
      The purpose of this study is to evaluate the SpO2 accuracy performance of Belun Ring Oximeter
      placed on the index fingers during non-motion conditions over the range of 70-100% SaO2,
      arterial blood samples, assessed by CO-Oximetry. It is expected that the Accuracy Root Mean
      Square (ARMS) performance of the oximetry system will meet the required specification of ARMS
      of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of
      70 - 100% SaO2.

      The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single
      limb blow by system used to deliver medical grade oxygen and nitrogen gas mixtures to induce
      various hypoxic levels in subjects at a slow steady rate allowing an automatic marking and
      collection of the Control or secondary Transfer reference Pulse Oximeter and other pulse
      oximetry systems at 1 second intervals.

      The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation
      levels real time throughout the study for subject safety and to target stable plateaus. This
      device is used to assess the stability of the data.

      Multi-parameter monitor used during the study to observe a subject's vital signs including
      ECG tracing, heart rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor
      for the oxygen concentration being delivered to the subject.

      A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining
      the functional SaO2 value from arterial blood samples obtained during the study.
    

Intervention name(s): Pulse Oximeter
Intervention type(s): Device
Intervention description(s): The Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adult volunteer. The skin pigmentation / tones ranged from light to dark meeting
        the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is
        larger.
Evaluation of Impulsivity on Cocaine and Crack Addicts
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders; Impulsive Behavior
Study type: Interventional

Summary: 
      This study main objective is investigating impulsivity on cocaine or crack addicts. The
      investigators main hypothesis is that different measures (such as scales or behavioral tasks,
      for example) of impulsivity may produce distinct outcomes, and they might also differ among
      cocaine (sniffed) and crack users. Thus, it would be of great value to compare such measures
      once these data are often interpreted as the same phenomenon.
    

Detailed description: 
      Drug dependence is characterized by a sum of cognitive, behavioral and physiological
      symptoms. Among these symptoms are the lack of control over ones own behavior and substance
      use even in face of significant issues related to it. Impulsivity (expressed as impulsive
      choice or fail on behavioral inhibition) is important in crucial phases of drug dependence
      development. Both behavioral and neurobiological studies have confirmed the association
      between impulsivity and addictive behaviors. Thus a high impulsivity level might have
      influence on patients' treatment. Even though, several questions on this matter remain
      unclear for humans, such as the differences on impulsivity between users of different forms
      of cocaine (either sniffed or smoked). This kind of difference could establish distinct ways
      of treatment and then enable developing better treatments for drug users. For this study it
      will be recruited 60 non-treated dependent patients, among them 30 cocaine users and 30 crack
      users. These individuals will be selected based on DSM-IV dependence criteria. The
      instruments used will be scales to measure compulsion and consumption of cocaine/crack, a
      pharmacological screening for psychotropic drugs and a cognitive evaluation. As impulsivity
      measures are Barratt Impulsivity Scale (BIS 11), a reward discounting questionnaire and a
      computer-based behavioral test on "ProgRef v3" software. For data analysis the impulsivity
      measures will be compared with the behavioral and cognitive instruments through the Pearson's
      correlation matrix. An ANOVA will be also performed to verify any differences between cocaine
      and crack dependents on the impulsivity and compulsion tests. When it is appropriate
      subsequent Newman-Keuls post-hoc test will be performed. Significance level adopted is 0.05.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention will be performed on this study
Other intervention name(s): No intervention will be performed on this study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Study
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Obesity is a serious medical, social, and economic problem and is becoming even greater
      concern, as the prevalence of overweight and obese individuals has steadily increased over
      the years. Excessive body weight can have a profound influence on lower extremities,
      including pain, degenerative disease, and compromised quality of life. However, no study
      to-date has examined the effects of weight change on foot structure and function in
      individuals over time. The purpose of this study is to determine the effects of weight
      reduction on foot structure and function in obese adults. Improved understanding of the
      relationship between body weight and foot biomechanics is needed to promote health and
      healthier lifestyles.
    


Intervention name(s): NutriSystem portion-controlled pre-packaged meals
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Foot pain
A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
Condition: Bipolar Depression
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first in human (FIH) study is to investigate the safety, tolerability,
      pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects
      the body) of PF-04455242-01 in healthy adult volunteers.
    


Intervention name(s): PF-04455242; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder-in Capsule (EP-PIC), will be used to administer doses from 0.5 mg up to and including 56 mg of a single rising dose over 3 treatment periods receiving two doses of PF-04455242 and one dose of placebo. A one-week (minimum) washout will separate each treatment period.; PIC matching in appearance to PF-04455242 will be used to administer placebo.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteer, first in human, safety and tolerability
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults
Condition: Idiopathic Pulmonary Fibrosis(IPF); Solid Tumor
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603
      and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally
      administered once daily of ZSP1603.
    

Detailed description: 
      This is a Phase 1, double-blinded, placebo-controlled, single center study aimed at
      investigating the safety, tolerability and the pharmacokinetics of ZSP1603 on fasted
      condition.Up to 4 cohorts of 32 eligible participants totally are planned to be enrolled.
      This is a two-arm clinical trial that ZSP1603 and matching placebo will be orally
      administered once daily. Two subjects in the first cohort will be assigned in a opened
      fashion to receive 7.5mg of ZSP1603 while another three cohorts of volunteers will be
      randomly assigned in a blinded fashion to receive either a single dose of ZSP1603 or matching
      placebo in an ascending dose fashion. To monitor AEs,record abnormalities (Holter, 12-lead
      ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics
      of ZSP1603.
    

Intervention name(s): ZSP1603 7.5 mg; ZSP1603 12.5 mg; Placebo 12.5mg; ZSP1603 25 mg; Placebo 25mg; ZSP1603 50 mg; Placebo 50mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ZSP1603 capsule administered orally once daily under fasted condition.; ZSP1603 capsule administered orally once daily in the fasting state.; Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.; ZSP1603 capsule administered orally once daily under fasted condition.; Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.; ZSP1603 capsule administered orally once daily under fasted state.; Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Measurement of Greenhouse Gas Emissions From Meals of a University Food Operator
Condition: Food Selection
Study type: Interventional

Summary: 
      Université Laval wishes to raise awareness among students and employees in the university
      community so that they become aware of the impacts of their consumption choices by equipping
      them to adopt consumption behaviours that are favourable to the environment and their health.
      To do this, it is necessary to assess consumers' perception of the information available when
      choosing a meal to determine, among other things, whether knowledge of greenhouse gas (GHG)
      emissions influences their selections. In addition to this evaluation criterion, consumer
      perception of the nutritional quality of food will also be assessed. The nutritional
      composition of the meals of the characterized week will make it possible to calculate, using
      a nutritional profiling tool, the nutritional quality score of each meal of the day.
    

Detailed description: 
      This study consists of an individual meeting with each participant. This meeting will last
      approximately 1 hour during which each subject will choose a meal and complete various
      questionnaires. Subjects (male or female) will be randomly assigned to one of the four
      experimental conditions ("GHG", "nutrition", "GHG+nutrition" and "no logo"). Since subjects
      could change their eating behaviours if they knew the true purpose of the study, they will be
      deliberately misled when they enter the study. Participants will be recruited to participate
      in a market research study in which they will be invited to taste and evaluate a new meal for
      the cafeteria. At the end of the session, each participant will be informed of the actual
      objective of the study.

      In this context, the general objectives of this second phase of the project are therefore:

        1. Evaluate consumer perceptions of the available information on the GHG score (in
           equivalent C02), the nutritional quality score and the eco-efficiency score (combination
           of GHG + nutrition), and;

        2. Determine if the presence of information (logo on the different scores) influences food
           choice and consumption among Université Laval students and staff.
    

Intervention name(s): Information regarding GHG and/or nutrition
Intervention type(s): Behavioral
Intervention description(s): Participants will have to select a meal from a menu.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: environmental concerns; nutrient profiling