bioihbjkbjnl/mcl2 huggingface dataset:
Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
Condition: Diabetes; Impaired Glucose Tolerance; Obesity
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      This study hypothesizes that milk protein consumed together or shortly before a white rice or
      white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic
      responses.
    

Detailed description: 
      Consumption of milk proteins increase satiety and reduce glucose response when consumed alone
      or with carbohydrate. Milk proteins are of interest because proteins are more satiating than
      either carbohydrate or fat, and they regulate food intake and metabolic functions by the
      intact protein, encrypted peptides and amino acids on gastrointestinal and central pathways.
      White rice and white bread are two common carbohydrates types mostly consumed in Asia. Both
      of them are known to result in high glycaemic and insulinaemic responses. However, in most
      meals, they are accompanied by other foods such as soy milk, cow milk products. The glyceamic
      and insulinaemic responses are determined by the type of protein and the type of
      carbohydrates. And also the consumption time of protein and carbohydrate. Recent research
      points to an intrinsic value of small amounts of milk protein or dairy consumed shortly
      before a meal can reduce the glycemic response to carbohydrate and that this is not at the
      cost of increased demand for insulin. The objective of the present study is to investigate
      how glycaemic, insulinaemic and satiety responses to a white rice or white bread meal changed
      when a soy milk or cow milk consumed together or shortly before the meal. Whole soy milk and
      whole cow milk will be added to the meal. Healthy subjects (n 15) will ingest the test meals
      once. The meals will be provided as breakfasts, on 10 different occasions, in random order
      with ≥ 7 days between each. Blood samples (from the cannula and finger pricks) will be then
      drawn for 3 h, and glucose and serum insulin, plasma glucagon, satiety markers, inflammation
      markers, amino acids et.al will be analysed. The objective of the study is determining if
      different liquid protein consumed shortly before or with carbohydrate has different effects
      on metabolism. And also we will compare the difference of white rice and white bread.
      Determining the consuming time effect, milk protein type and carbohydrate type on glycaemic
      and insulinaemic are critical for the provision of dietary advice and formulation of public
      health guidelines.
    

Intervention name(s): Bread, Soy milk and cow milk; real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)
Intervention type(s): Dietary Supplement; Device
Intervention description(s): The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Etomidate to Improve Outcome in Elderly Patients
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Elderly patients have high mortality and postoperative complications rate after surgery,
      especially postoperative cardiac complications. A meta-analysis revealed haemodynamic
      intraoperative events significantly increased the risk of postoperative cardiac
      complications.To limit the risk, optimize the intraoperative management of circulation is
      essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of
      postoperative complications should aimed at choosing the optimal anesthetic drug with minimal
      effect on haemodynamic.So this study is to explore the comparative efficacy and safety of
      anesthetic drug (etomidate or propofol) in elderly patients
    


Intervention name(s): Etomidate; propofol; Sufentanil; Cisatracurium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): etomidate is given intravenously; propofol is given intravenously; sufentanil is given intravenously; Cisatracurium is given intravenously
Intervention MeSH terms: Sufentanil; Propofol; Etomidate; Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: etomidate; propofol
Bioequivalence Study Comparing Two Formulations of Escitalopram
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study, which is a regulatory requirement to ensure comparable in
      vivo performance, i.e. similarities in terms of safety and efficacy, after administration of
      two different dosage forms of escitalopram.

      All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg
      of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being
      tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test
      treatments B and C will each be compared to Treatment A, which is the active comparator
      (reference formulation).
    


Intervention name(s): Escitalopram; Escitalopram; Escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 x 10 mg, single dose; 2 x 10 mg, single dose; 1 x 20 mg, single dose
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Assessing the bioequivalence of escitalopram dosage forms
Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder
Condition: PTSD, Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This is a research study that will look at how well a treatment called Cranial Electrotherapy
      Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress
      Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®.
      This is a safe, non-invasive treatment that applies a low-level pulsed electric current
      through the brain using clip-on electrodes attached to the earlobes. Cranial Electrotherapy
      Stimulation treats conditions such as physical pain, anxiety, and depression.
    


Intervention name(s): Alpha Stim
Intervention type(s): Device
Intervention description(s): Use of Alpha Stim Device
Intervention model: Single Group Assignment
Intervention model description: Using Alpha Stim
Masking: None (Open Label)
Primary purpose: Device Feasibility
Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement
Condition: High Caries Risk Patients
Study type: Interventional

Summary: 
      Introduction:

      Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous
      properties. However, they present inferior physical and mechanical properties compared to
      resin composites.

      Aim:

      Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode
      radiant heat enhancement. .

      Methodology:

      Eighteen healthy patients with 36-second molar teeth will be selected where each patient
      should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be
      prepared for all the selected teeth, for each patient the first tooth will be restored with
      chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second
      tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat
      (LED) (M2 group). functional and biological criteria of each restoration will be clinically
      evaluated at 4 time points
    

Detailed description: 
      Introduction:

      Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous
      properties. However, they present inferior physical and mechanical properties compared to
      resin composites. Various techniques have been suggested to improve properties of
      conventional GICs such as radiant heat transfer by Light Emitting Diode (LED) or lasers,
      ultrasonic energy transfer also using of (CaCl2) solution.

      Aim:

      Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode
      radiant heat enhancement. .

      Methodology:

      Eighteen healthy patients with 36-second molar teeth will be selected where each patient
      should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be
      prepared for all the selected teeth, for each patient the first tooth will be restored with
      chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second
      tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat
      (LED) (M2 group). functional and biological criteria of each restoration will be clinically
      evaluated immediately after restoration (T0), six months later (T1), and after 12 months (T2)
      using Federation Dentaire International (FDI) criteria for assessment of dental restorations.
    

Intervention name(s): KetacTM Universal AplicapTM; KetacTM Universal AplicapTM with light cure
Intervention type(s): Other; Other
Intervention description(s): chemically cured conventional GICs; chemically cured conventional GICs with light curing enhancement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this multicentre, randomised, double-blind, placebo-controlled study is to
      evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3)
      in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.)
      interferon beta-1a 44 microgram (mcg) [Rebif] 3 times weekly. The subjects will be divided
      into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif
      treatment and the other group will be on placebo along with Rebif treatment. A total of 200
      subjects will be recruited in 20-30 centres in France.
    


Intervention name(s): Cholecalciferol (Vitamin D3); Placebo; Rebif
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.; Subjects receive matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.; Subjects receive subcutaneous injection of Rebif 44 mcg 3 times weekly.
Other intervention name(s): Vitamin D3; Interferon beta-1a
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Multiple Sclerosis Relapsing-Remitting; Relapsing Multiple Sclerosis (RMS); Rebif; Vitamin D3; Cholecalciferol
Does Dual Therapy Hasten Antidepressant Response?
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will utilize a randomized double-blind design to evaluate whether initial
      treatment with two anti-depressant medications (escitalopram and bupropion) results in more
      rapid remission and greater over-all remission rates than either monotherapy in 240 depressed
      subjects.
    

Detailed description: 
      Depression is a major public health problem due to its prevalence and accompanying
      dysfunction and costs. Depression is undertreated, but even when treatment is adequate and
      effective, sources of delay in current pharmacologic strategies include: mechanistic delays,
      those related to the physiologic and behavioral effects of antidepressants; dosing delays in
      identifying the effective dose; and programmatic delays in identifying an effective agent
      using sequential monotherapy. This study will randomize 240 patients with Diagnostic and
      Statistical Manual, 4th Edition (DSM-IV) Major Depressive Disorder (MDD) to 12 week double
      blind treatment with combined escitalopram and bupropion or each antidepressant administered
      alone to evaluate whether combined escitalopram and bupropion result in more rapid remission
      and greater over-all remission than monotherapy. Preclinical and clinical studies suggest
      that bupropion might prevent one mechanistic delay inherent in escitalopram monotherapy.
      Rapid dose escalation may counter dosing delays. The simultaneous use of two known
      antidepressant medications may alleviate programmatic delays inherent in usual sequential
      monotherapy. Six months follow up and careful assessment of adverse events will address
      tolerability, acceptability, sustainability, and pharmacoeconomic concerns. If successful,
      this study might have a significant impact on clinical practice, public health, and
      depression's cost consequences.
    

Intervention name(s): escitalopram; bupropion extra long (XL); escitalopram + bupropion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted; 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted; same dosing schedule as for monotherapy
Other intervention name(s): Lexapro; Wellbutrin extra long (XL); Lexapro; Wellbutrin
Intervention MeSH terms: Dexetimide; Citalopram; Bupropion; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; Major Depressive Disorder
Rehabilitation Boot Camp: Intensive Balance and Mobility Therapy for People With Acquired Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine

        1. if it is practical to treat moderately to severely brain injured patients who have
           problems with their balance and mobility in a group "boot camp" (3 days a week, 6
           hours/day for 4 weeks) exercise class.

        2. If they show improvements compared to 4 weeks of not receiving this treatment

        3. If electronic daily monitoring of their center of foot pressure during a standardized
           balance task will allow us to see small changes in ability.

      A baseline assessment of all outcome measures will be performed. This will be repeated 4
      weeks later. The intervention will be delivered (4 weeks) and a follow up assessment of all
      outcome measures will be performed one week later. A follow up of the Primary outcome
      measure, the PART-O participation questionnaire will be done 12 weeks later.

      Participants will attend group therapy consisting of a variety of exercises designed
      specifically to target balance and mobility deficits and based on the concept that through
      Repetitive Functional Task Practice (RFTP), recovery of function can occur as the result of
      neural adaptation. Exercises will be both individualized (delivered in a circuit) and group
      activities. Supervision and guidance will be provided by a registered Physical Therapist and
      a Rehabilitation Assistant. During the intervention, the amount and type of RFTP, any adverse
      events, and any need for extra staff will be recorded on a daily basis. As well, a
      standardized individualized task will be performed with center of foot pressure recording on
      a daily basis.

      Analysis: changes in outcome measures immediately after the non-intervention compared to the
      after the intervention period will be statistically determined to estimate efficacy of this
      treatment model. Descriptive measures of RFTP time/day, staffing levels/day and adverse
      events will be used to support feasibility and safety of this model.
    

Detailed description: 
      See below for details about outcome measures and eligibility criteria.
    

Intervention name(s): Boot Camp Balance Training
Intervention type(s): Behavioral
Intervention description(s): Intense physical rehabilitation directed at improving balance and mobility will be provided to individuals in a group setting (6 participants in a group) for 4 weeks, 3 days a week for 6 hours per day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise therapy; brain injury; postural balance
A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
Condition: Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial will be studying how well Apatinib working in patients with
      Hepatocellular carcinoma.
    


Intervention name(s): Apatinib
Intervention type(s): Drug
Intervention description(s): apatinib p.o. once daily for 4 weeks
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCC, Apatinib, phase II, Cancer
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like Peptide 2
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study
           A)

        2. To assess whether GLP-2 affects the release of preformed chylomicrons (study B)
    

Detailed description: 
      Study A: Using constant feeding with a nasoduodenal tube and stable isotope infusion,
      mathematical modelling will be utilised to measure lipoprotein production and clearance. The
      lipoproteins assessed will be apoB-100 from the liver and apoB-48 from the intestine.

      StudyB: Volunteers will be given a liquid meal with retinyl palmitate (vitamin A) to label
      chylomicrons made from the meal. 7 hours later they will be given GLP-2 or placebo.
      Measurements of plasma and TRL(triglyceride rich lipoprotein) triglyceride and TRL retinyl
      palmitate will be carried out to see whether GLP-2 increases these parameters.
    

Intervention name(s): GLP-2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single subcutaneous dose of 1500mcg
Other intervention name(s): glucagon like peptide 2
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Lipoproteins, apoB, GLP-2
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study attempts to differentiate the clinical responses of Choline Acetyltransferase and
      Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
    


Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): 2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease
Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted
      in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each
      condition) to assess the bioequivalence between two formulations of Sitagliptin
      Phosphate/metformin Hydrochloride Tablets.
    

Detailed description: 
      The single-dose randomized, open-label, two-period crossover study was executed in the Phase
      I Clinical Research Center of the Affiliated Hospital of Qingdao University. This study was
      conducted to assess the bioequivalence of Sitagliptin Phosphate/metformin Hydrochloride
      Tablets in healthy Chinese subjects and estimate the pharmacokinetics profiles of Sitagliptin
      Phosphate/metformin Hydrochloride Tablets. An open-label, randomized, single-dose,
      two-period, crossover study was conducted in 48 healthy Chinese volunteers under fasted or
      fed conditions (24 subjects for each condition) to assess the bioequivalence between two
      formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets. Blood samples were
      collected at specified time intervals, and the plasma concentrations of sitagliptin and
      metformin were determined by a validated liquid chromatography mass spectrum/ mass spectrum
      method. Pharmacokinetic and bioavailability parameters were estimated via non-compartmental
      methods. Adverse events were also recorded. If the 90% confidence intervals of the ratios of
      geometrical mean of test and reference formulations for Cmax, AUC0-t and AUC0-∞ are all
      within the predefined bioequivalence criteria range of 80%-125% for sitagliptin and
      metformin, the two formulations can be considered bioequivalent.
    

Intervention name(s): Sitagliptin Phosphate/metformin Hydrochloride Tablets(JANUMET®,50mg/850mg); Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)
Intervention type(s): Drug; Drug
Intervention description(s): The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®, 50mg/850mg); The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment