bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Dairy and Non-dairy Breakfasts on Satiety and Post-meal Glycemia in Healthy Older Adults
Condition: Diabetes; Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt,
      cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each
      participant will receive every treatment in this crossover design study.
    

Detailed description: 
      Regular consumption of dairy is associated with better body composition and lower incidences
      of type 2 diabetes and obesity. This may be due to dairy's ability to increase satiety and
      decrease post-prandial glycemia. However, most clinical studies have only investigated
      isolated dairy proteins (whey and casein) and the effects of whole dairy products, consumed
      as part of a meal, remain unclear. Additionally, the effect of dairy type and form remain to
      be further investigated. Therefore, this study will test the effects of dairy products when
      consumed with a high glycemic index breakfast on satiety and post-prandial glycemia.

      Thirty healthy older males and females (60-70 years, BMI 18.5-30.0 kg/m2) will be recruited
      for the randomized, unblinded, crossover study. Participants will fast overnight, and at
      baseline will consume 1) 2% milk (250 mL), 2) soy beverage (250 mL), 3) plain 2% Greek yogurt
      (175 g), 4) cheddar cheese (30 g), or 5) water (250 mL - control). Treatments will be
      consumed along with 2 pieces of white toast with strawberry jam, except for the water control
      which will be consumed alone. All breakfast meals will be isocaloric and water will be given
      with the yogurt (75 mL) and cheese (220 mL) to compensate for fluid content. At 0 (baseline),
      15, 30, 45, 60, 90, 120, 150, 180, (pre-meal period) and 210 minutes (post-meal period) blood
      will be collected for glucose analysis and subjective appetite ratings completed. Insulin
      will be analyzed every 30 minutes. Between 180-200 minutes, an ad libitum lunch will be
      provided to assess food intake.
    

Intervention name(s): 2% M.F. Milk; White Bread; Strawberry Jam; 31% M.F. Cheddar Cheese; 2% M.F. Plain Greek yogurt; Soy Beverage; Water
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Other intervention name(s): 2% cow's milk; Neilsen Canada; White milk; White toast; Wonder Bread Canada; Pure strawberry jam (not seedless); Fruit jam; Smucker's; Mild cheddar cheese; Hard cheese; Armstrong Canada; Yogurt; Oikos, Danone Canada; Soy milk; Non-dairy alternative; So Good, Vanilla; Calorie-free control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dairy; Post-prandial Glycemia; Satiety; Food Intake; Insulin; Milk; Greek yogurt; Cheese; Soy beverage
A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess mass balance, biotransformation, and excretion of
      BMS-986369 following study drug administration.
    


Intervention name(s): BMS-986369
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMS-986369; Drug absorption, distribution, metabolism, and excretion (ADME)
Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction
Condition: Impaired Left Ventricular Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Measuring cardiac contractility is commonly realized with gold standard echocardiography or
      MRI. Portable devices to measure this contractility are not available as for rhythm and
      electric function assessment. The new Kinocardiography technology could provide a non
      invasive and portable tool to measure contractility.

      This device records the electric and mechanic function of the heart simultaneously. With
      electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are
      also included in the device to measure the micro accelerations of the body at the body
      surface when the device is placed on the skin. Using physics principles and adequate
      calibration, those accelerations allow the investigators to calculate parameters such as
      kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and
      portable technology.
    


Intervention name(s): Kinocardiography
Intervention type(s): Device
Intervention description(s): This device records the electric and mechanic function of the heart. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow us to calculate parameters such as kinetics energies related to cardiac contractility.
During a standard echocardiography appointment for a patient suffering from a cardiovascular condition with/without heart failure, the cardiologist will monitor the heart of the patient with the Kino device (examination lasting a few minutes with the patient lying down on a bed). Data will be matched between the control group and the experimental group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Kinocardiography; Cardiac contractility; Heart kinetic energy
Performance of Pulse Oximeter Sensors in Neonates
Condition: Cardiac Surgery
Study type: Observational

Summary: 
      Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples
      during cardiac surgery.
    

Detailed description: 
      Researchers at the University of California, San Francisco have developed methods that permit
      them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac
      surgery. During this type of surgery, the arterial oxygen saturation changes over a wide
      range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many
      levels of oxygen saturation. Several arterial blood gas samples are typically obtained during
      these procedures. Saturation of each arterial blood sample is determined by direct oximetry
      in a hemoximeter and this measurement is compared to the reading displayed on the pulse
      oximeter.
    

Intervention name(s): Pulse Oximeter
Intervention type(s): Device
Intervention description(s): Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonatal patients undergoing complex cardiac surgical procedures.
Treatment for Acute Postoperative Voiding Dysfunction
Condition: Urinary Retention
MeSH terms: Urinary Retention
Study type: Interventional

Summary: 
      If patients are unable to have their foley catheter removed because their bladder is not
      emptying well, they may be eligible for study participation. This study is designed to
      evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder
      function after surgery. Study participation is limited to one day.
    

Detailed description: 
      If patients fail a voiding trial (the test done to see if a foley catheter is ready to be
      removed after surgery), they may be offered participation in this trial. Patients are
      randomized to receive active treatment or a sham treatment. A small, accupuncture-type needle
      is inserted through the skin just above the ankle. A small, battery-powered generator will be
      attached to the needle. The generator will give a low-voltabe stimulation which is adjusted
      for comfort level and applied for 30 minutes. After treatemnt, the voiding trial will be
      repeated.
    

Intervention name(s): PTNS Active Treatment; Sham treatment
Intervention type(s): Device; Other
Intervention description(s): 34 gauge needle inserted 3cm above the medial ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period.; 34 gauge needle inserted 3cm above the medial ankle, but nonconductive cables are connected, so that no electrical stimulation is applied, over a 30-minute treatment period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Voiding dysfunction
TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation
Condition: Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19)
MeSH terms: COVID-19; Coronavirus Infections; Lung Injury; Acute Lung Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma
      pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903)
      with supplemental oxygenation.
    

Detailed description: 
      A Phase 1, open-label, fixed-sequence, 4-period study to evaluate the plasma PK, safety and
      tolerability of single inhaled doses of nezulcitinib (TD-0903) administered under different
      supplemental oxygenation scenarios in healthy participants.

      Approximately 14 healthy adult male and female participants will receive a single inhaled
      dose of nezulcitinib using a nebulizer device on Day 1 of each administration period, under
      different supplementary oxygenations conditions.

      Administration A: Dose A nezulcitinib delivered by nasal inhalation via the Aerogen Solo with
      a high-flow nasal cannula circuit delivering supplemental oxygen, Administration B: Dose A
      nezulcitinib delivered by oral inhalation via the Aerogen Solo together with the Aerogen
      Ultra handheld device with a low-flow nasal cannula delivering supplemental oxygen,
      Administration C: Dose A nezulcitinib delivered by oral inhalation via the Aerogen Solo
      together with the Aerogen Ultra handheld device with a high-flow nasal cannula delivering
      supplemental oxygen, Administration D: Nezulcitinib delivered by inhalation. Route to be
      determined based on data from administration A-C.
    

Intervention name(s): Nezulcitinib (TD-0903) Dose A; Nezulcitinib (TD-0903) Dose B
Intervention type(s): Drug; Drug
Intervention description(s): TD-0903 Dose A; TD-0903 Dose B
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute lung injury; ALI; Coronavirus Disease-2019; COVID-19; Supplemental oxygen
Postprandial VLDL-TG Metabolism
Condition: Type 2 Diabetes
Study type: Observational

Summary: 
      In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2
      diabetic and healthy subjects matched for BMI in order to elucidate the potential
      pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in
      abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of
      fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal
      muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes
      that might be involved in regulating skeletal muscle and adipose tissue FA storage.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Males with diabetes from the department´s out-patient clinic. Control group of healthy
        volunteers
      
Biospecimen description: 
      specimen of muscle specimen of adipose tissue
    
Keywords: VLDL-TG kinetics; Postprandial state; Obesity
Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles
Condition: Endometrial Preparation; Frozen Embryo Transfer
Study type: Interventional
Phase: Phase 4

Summary: 
      The target of this study was an estimate the result of sildenafil on ultrasonographic
      endometrial thickness, endometrial pattern investigation estrogen level on the day of
      progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo
      transfer cycles .
    


Intervention name(s): Sildenafil; estradiol valerat
Intervention type(s): Drug; Drug
Intervention description(s): sildenafil tablets(50 mg) daily
Intervention MeSH terms: Sildenafil Citrate; Estradiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sildenafil; Endometrial thickness; Frozen embryo transfer; ultrasonographic endometrial thickness; endometrial pattern; Implantation rate; chemical pregnancy rate
Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
Condition: Colorectal Cancer; Liver Metastases
MeSH terms: Neoplasm Metastasis; Liver Neoplasms
Study type: Observational

Summary: 
      For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving
      effective conversion therapy, disease relapse after conversion hepatectomy is common due to
      the extensive tumor load. Yet, few studies have focused on the assessment and management of
      relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact
      of surgical management for relapse after conversion hepatectomy in IU-CRLM.
    


Intervention name(s): Repeat Liver Surgery; Non-Repeat Liver Surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): repeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA); Systemic palliative chemotherapy
Intervention MeSH terms: Liver Extracts
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with initially unresectable colorectal liver metastasis (IU-CRLM) underwent
        hepatectomy after conversion therapy
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the safety and efficacy of once-weekly omarigliptin in participants
      18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The
      study hypothesis is that treatment with omarigliptin compared with placebo provides greater
      reduction in hemoglobin A1c (A1C) in participants after 24 weeks.
    


Intervention name(s): Omarigliptin; Placebo to omarigliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omarigliptin 25 mg capsule administered orally once weekly; Matching placebo to omarigliptin 25 mg capsule administered orally once weekly; Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Other intervention name(s): MK-3102; Fortamet®; Glucophage®; Glucophage® XR; Glumetza®; Riomet®; Metgluco®; Glycoran®
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Hypoglycemic Agents; Pharmacologic Actions; Therapeutic Uses
CryoValve® SG Aortic Human Heart Valve Combination Study
Condition: Aortic Valve Stenosis; Aortic Valve Insufficiency
MeSH terms: Aortic Valve Stenosis; Aortic Valve Insufficiency
Study type: Observational

Summary: 
      The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human
      Heart Valve used in pediatric patients as an aortic valve replacement.
    

Detailed description: 
      The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated
      with the SynerGraft® (SG) process,which is designed to reduce the donor cells present on the
      graft. The valve is then cryopreserved for storage until use. Removing cells from the heart
      valve has been shown to reduce a component of the immune response after implant compared to a
      standard allograft valve. However, it is not known how this affects the long-term durability
      of the valve.
    

Intervention name(s): Echocardiogram
Intervention type(s): Procedure
Intervention description(s): A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric (21 years of age or younger) patients who received a CryoValve SG Aortic Valve
        distributed during the 2000 to 2003 period as an aortic valve replacement.
      
Keywords: Aortic Valve
Effect of MK0524A on Cholesterol Levels (0524A-048)
Condition: Hypercholesterolemia; Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to assess the effects of MK0524A in reducing
      cholesterol levels in an Asian population.
    


Intervention name(s): laropiprant/niacin (MK0524A); Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks.
All patients will receive placebo for a 4 week run-in period before randomization; Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks.
All patients will receive placebo for a 4 week run-in period before randomization.
Other intervention name(s): MK0524A
Intervention MeSH terms: Niacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: High Cholesterol; Excess lipids
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Condition: Myocardial Infarction; Myocardial Infarction, Acute; Myocardial Infarction Old
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the
      consequent treatment after detected arrhythmias in patients after myocardial infarction with
      preserved cardiac function, but other risk factors, decreases the risk of major adverse
      cardiac events.
    

Detailed description: 
      Patients randomized to the BioMonitor arm will receive an implantable cardiac monitor (ICM;
      BioMonitor) with remote monitoring function (Home Monitoring®). If the device detects and
      reports an arrhythmia, patients will be appropriately examined and treated. Patients
      randomized to the control arm will receive best proven treatment, but no implantable cardiac
      monitor.
    

Intervention name(s): BioMonitor
Intervention type(s): Device
Intervention description(s): Patients will be implanted with the BioMonitor + Home Monitoring feature
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
Condition: Risk Factors Cardiovascular Disease; Inflammation; Exercise; Sedentary Life
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4
      weeks of sedentary life style, randomization decides whether they start with exercise or with
      being "couch potatoes". All participants are also randomized to also consume 150 g of
      blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a
      week during the 4 week period. The exercise period and the "couch" period are started and
      ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk
      factors are measured before and after this run, ie 8 times in total.
    


Intervention name(s): Blueberries
Intervention type(s): Biological
Intervention description(s): 150 grams of frozen blueberries on the same day as exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inflammation; lipids; CRP
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
Condition: Tuberculosis; Healthy
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential
      substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation
      in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight
      against the current world epidemics in tuberculosis and resistance to anti-TB drugs.
    

Detailed description: 
      A randomized, double-blind, controlled Phase I study conducted at CHUV, Lausanne,
      Switzerland, to compare MTBVAC to licensed BCG in healthy, PPD-negative adult male and female
      volunteers. The study involves random allocation of up to 36 subjects (4 vaccine groups of 9
      volunteers fulfilling the inclusion criteria) to MTBVAC (tested at three separate doses) or
      standard dose BCG (on a 3 verum : 1control basis) in a dose-escalation manner to one of three
      cohorts. Each cohort includes 9 subjects set to receive MTBVAC lowest dose 5x10E03, or MTBVAC
      intermediate dose 5x10E04, or high dose 5x10E05 colony forming units (CFU) in 0.1 mL and 3
      subjects set to receive standard dose BCG (5x10E05 CFU in 0.1 mL). A single intradermal
      injection is given in the non-dominant arm of each volunteer starting with the lowest MTBVAC
      dose. Each MTBVAC vaccine dose is administered staggered by cohort, starting with the cohort
      with the lowest MTBVAC dose level. After at least 35 days of follow-up within each cohort a
      safety review and evaluation by Independent Data Safety Monitoring Board provides go/no-go
      for vaccination of the subsequent cohorts if no safety issues as defined by preset stopping
      rules.
    

Intervention name(s): MTBVAC live vaccine; Commercially available BCG live vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Live-attenuated Mycobacterium tuberculosis vaccine; Live-attenuated Mycobacterium bovis vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention