bioihbjkbjnl/mcl2 huggingface dataset:
Epidemiology of Coronary Calcification in the Elderly
Condition: Cardiovascular Diseases; Heart Diseases; Coronary Arteriosclerosis; Coronary Disease; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Arteriosclerosis; Myocardial Ischemia
Study type: Observational

Summary: 
      To investigate the prevalence and prognostic value of subclinical atherosclerosis in the
      Pittsburgh SHEP cohort and a cohort of normal controls.
    

Detailed description: 
      BACKGROUND:

      This is an ancillary study to the Systolic Hypertension in the Elderly Program (SHEP)

      DESIGN NARRATIVE:

      Continued annual telephone follow-up of the remaining 178 Pittsburgh SHEP participants and
      168 controls will be conducted . A final clinic visit will include measures of coronary and
      aortic calcification using electron beam computed tomography (CT), pulse wave velocity as a
      measure of aortic stiffening and cognitive function testing. For the Pittsburgh SHEP cohort,
      the antihypertensive treatment effect has been striking with event rates for the active and
      placebo groups continuing to diverge beyong the end of SHEP. Successful demonstration of a
      treatment effect on coronary calcium scores would be the first randomized data showing an
      antihypertensive effect directly in the coronary arteries. Risk factors for coronary
      calcification will be evaluated, producing data of a type not yet available in the literature
      for older adults and not being collected in any other ongoing studies of the elderly. The
      added measures of vascular stiffness will supplement the extensive data on subclinical
      atherosclerosis already available for this cohort. The extent to which these measures predict
      cardiovascular events will be evaluated. The study has been renewed through July 2006.

      Since hypertension and aging are associated with cognitive impairment and vascular dementia,
      SHEP participants assigned to the placebo group are expected to have lower cognitive function
      compared to those assigned to active treatment. Among both hypertensive and normotensive
      groups, lower cognitive function among those with evidence of subclinical atherosclerosis is
      expected.

      Finally, members of the cohort who were originally normotensive at study entry are now
      developing systolic hypertension. These subjects will allow a prospective evaluation of risk
      factors for systolic hypertension. Continued study of this cohort into their 80s will provide
      unique data on the risks and etiology of systolic hypertension, the efficacy of its treatment
      and the prognostic value of a number of measures of subclinical atherosclerosis. It is
      predicted that the results will be directly applicable to the largest growing segment of the
      U.S. population.
    

Sampling method: Non-Probability Sample
Study population: 
        614 older adults aged, on average, 80 years (range, 67 to 99 years); 367 (60%) were women,
        and 143 (23%) were black.
Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, phase II study of BI 695501 to assess handling experience of patients
      with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients
      with additional exposure to BI 695501 and to enhance the safety database for this compound.
    


Intervention name(s): BI 695501 Autoinjector; BI 695501 Prefilled syringe
Intervention type(s): Drug; Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test if the investigational medication ABT-089 is a safe and
      effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.
    


Intervention name(s): ABT-089; atomoxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.; Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.; Subject will take a tablet once daily for 8 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in
      liver.
    

Detailed description: 
      Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)
      activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1
      (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the
      development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some
      research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in
      SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of
      lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.
      Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c
      pathway in liver.
    

Intervention name(s): Oltipraz; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Total 90mg, By mouth, TID; Total 90mg, By mouth, TID
Other intervention name(s): Placebo
Intervention MeSH terms: Oltipraz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Influence of Intragastric Fructose Infusion on Behavioural and Neural Responses to Negative Emotion Induction
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The investigators will test whether a subliminal, intragastric dose of fructose is able to
      influence the emotional state at the behavioural and neural level, as has been previously
      shown for fatty acids. They will also examine the potential involvement of gut peptide
      release. Based on previous research using fatty acids, an attenuating effect of fructose
      compared to placebo on the induced negative emotional state is hypothesized at the
      self-report as well as the brain level.
    


Intervention name(s): Fructose; Control
Intervention type(s): Other; Other
Intervention description(s): Intragastric administration of fructose (25g dissolved in 250ml distilled water); Intragastric administration of distilled water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian
      women with endometriosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premenopausal participants with endometriosis
      
Keywords: Endometriosis; Elagolix; Real-World; Effectiveness
The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Condition: Prevention of Obesity
MeSH terms: Body Weight Changes
Study type: Interventional

Summary: 
      The primary aim is to examine the effect of a high protein intake (from soy or whey protein)
      on weightmaintenance after weight loss in a group of predisposed (severe) obese persons.
      Furthermore, to examine short-term and long-term effect of a high protein intake on appetite
      regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on
      weightmaintence, bloodlipid profilen, appetite regulation and DIT.

      The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet)
      and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese
      subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy
      protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0),
      after the WL period (week 8) and after WM period (week 24) body weight and composition will
      be measured and blood samples will be collected. Meal test will be performed at week 0 and 24
      (examining both appetite regulation and DIT). Urine and feces will be collected three times
      during the study. Subjects will receive dietary counseling (in groups) regularly during the
      study and body weight will be measured at each visit.
    


Intervention name(s): Whey protein; Whey protein enriched with calcium; Soy protein; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 45g protein/d; Dosage 3x15g protein daily; 45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily; 45g soy protein/d; dosage 15g soy protein x 3 daily; 48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Protein intake; Calcium intake; Weight loss; Weight maintenance; Blood lipid profile; Diet induced thermogenesis
Bioavailability and Dosing of a Monosaccharide Supplement in Adults
Condition: Healthy Males
Study type: Observational

Summary: 
      We are developing an oral supplement of carbohydrates to be added to infant formulas in order
      to improve brain development, immune function, and overall health of infants and children.
      After a careful review of what is known about these sugars, there is very little information
      regarding their use in infants and children, although there is some information in adults and
      animals.

      Many of these sugars have been used in a glyco-nutritional supplement in adults and children,
      with minimal or no reported side effects.

      We are developing a custom blend of important individual sugars, and need information
      regarding their dosing and blood concentrations following oral intake of the carbohydrate
      supplement. Timed blood samples following the carbohydrate supplement will provide us with a
      better understanding of the most effective dose and the metabolism of these sugars in adults.
      This will give us the preliminary information we need for developing an oral supplement of
      special sugars that can be added to infant formulas to help improve brain development and
      immune function in infants and children.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy Caucasian Males
      
Biospecimen description: 
      Plasma
    
Keywords: Nutrition; Infant Formula
Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Investigate GIP effects on biomarkers involved in bone homeostasis
    


Intervention name(s): GIP; GLP-1; Saline
Intervention type(s): Other; Other; Other
Intervention description(s): On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.; On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.; On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
Other intervention name(s): Glucose-Dependent Insulinotropic Polypeptide; glucagon-like-peptide-1; placebo
Intervention MeSH terms: Glucagon; Gastric Inhibitory Polypeptide; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Bioequivalence Study of Capecitabine Tablets
Condition: Metastatic Breast Cancer or Metastatic Colorectal Cancer
MeSH terms: Breast Neoplasms; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg
           (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets
           (Manufactured by Roche Pharma AG)

        2. Experimental Design： Two-period crossover design

        3. Test drug: Capecitabine tablets Reference drug: XELODA

        4. Sample size：24
    


Intervention name(s): Capecitabine tablets; XELODA
Intervention type(s): Drug; Drug
Intervention description(s): Single oral Capecitabine tablets 2000mg qd; Single oral XELODA 2000mg qd
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Factors Influencing of Pulse Pressure Variation (PPV)
Condition: Haemodynamics; Fluid Responsiveness; Pulse Pressure Variation
Study type: Observational

Summary: 
      The investigators studied the predictive value of PPV in the patients with different
      influencing factors;and the method to improve the predictive value,which can improve the
      application of PPV in ICU.
    

Detailed description: 
      PPV can be used to predict fluid responsiveness in patients with circulatory shock.However,
      it is affected by many factors, which leads to the decrease of the applicability of PPV in
      ICU.Therefore, the investigators studied the predictive value of PPV in the patients with
      different influencing factors;and the method to improve the predictive value,which can
      improve the application of PPV in ICU.
    

Intervention name(s): Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume; spontaneous breathing and no spontaneous breathing
Intervention type(s): Device; Behavioral
Intervention description(s): Ventilation mode was set to assist-control volume ventilation with different tidal volume, respiratory frequency 15 times/min, PEEP 5 centimeter water column.; Data were recorded when patients had and did not have spontaneous breathing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with circulatory failure selected to enter the Department of Critical Care
        Medicine
      
Keywords: haemodynamics;; Pulse pressure variation;; fluid responsiveness;; Mechanical ventilation;
Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery
Condition: Epiretinal Membrane
MeSH terms: Epiretinal Membrane
Study type: Interventional

Summary: 
      The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM)
      surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.
    

Detailed description: 
      Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana
      vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane.
      However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite
      successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a
      non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips
      (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators
      examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM
      surgery, taking COST line into account as a new parameter
    

Intervention name(s): optical coherence tomography
Intervention type(s): Device
Intervention description(s): spectral-domain optical coherence tomography
Other intervention name(s): vitreous surgery
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cone outer segment tips line; inner segment/outer segment junction line; optical coherence tomography; epiretinal membrane
Study of APD421 With and Without Ondansetron
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      Collection of pharmacokinetic and electrocardiograph data from healthy volunteers given
      APD421 +/- ondansetron
    


Intervention name(s): APD421; Placebo; Ondansetron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg IV; IV; 4 mg IV
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Condition: Meningococcal Meningitis; Human Papillomavirus Infection; Pertussis; Tetanus
MeSH terms: Whooping Cough; Tetanus; Papillomavirus Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY
      conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
    


Intervention name(s): Novartis Meningococcal ACWY Conjugate Vaccine; Tdap Vaccine; Novartis Meningococcal ACWY Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose of vaccine administered intramuscularly; One dose of vaccine administered intramuscularly; One dose of vaccine administered intramuscularly
Intervention MeSH terms: Lactitol; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; meningitis; vaccine; adolescents
Proellex Pharmacokinetics Bridging Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy female subjects received a single dose of four different types of Proellex, the
      original 25 mg dose and three new formulations
    

Detailed description: 
      Healthy female subjects received a single dose of four different types of Proellex, the
      original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected
      pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least
      one week interval from the previous dose.
    

Intervention name(s): 25 mg Proellex; 25 mg Proellex; 25 mg Proellex; 50 mg Proellex
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose; 25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose; 25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) [Blended], single dose; 50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose
Other intervention name(s): CDB-4124; Telapristone acetate; CDB-4124; CDB-4124; CDB-4124
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
Condition: Pain; Postoperative Pain; Bleeding; Nose Bleed
MeSH terms: Epistaxis
Study type: Interventional

Summary: 
      Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology
      surgeries due to the use of throat packs during the procedure. In order to optimize quality
      of care and patient satisfaction, the aim of this study to evaluate the incidence of
      post-operative, throat pain, nausea and vomiting in patients that have been packed with
      either conventional gauze throat packs or pharyngeal tampons.
    

Detailed description: 
      The nose and para nasal sinuses are anatomically known to be highly vascular and a
      substantial amount of bleeding is expected from rhinology surgeries, ingested blood is known
      to be a power full emetic, and the risk aspiration of blood is present due to the fact that
      an endotracheal tube is not 100% effective in protecting the airway. Post-operative nausea
      and vomiting is a frequent problem that is encountered in surgical patients with a 4th to 6th
      fold increase in nasal and endoscopic sinus operations.

      Posterior throat pack is an often-used in rhinology surgery, it is said to help in protecting
      the air way against aspiration and also helps in the reduction of post-operative nausea and
      vomiting, however many studies concluded that posterior throat pack is associated with higher
      amount of post-operative pain, nausea,, vomiting and in some rare cases even forgotten in the
      patient leading to mortality. However, despite poor evidence the placement of posterior
      throat packs is commonly practiced by surgeons and anesthetists because the possible risk of
      aspiration is worrisome to the latter and the former.

      A conventional throat pack consists of gauze, but an alternative practice involves the
      pharyngeal placement of tampons. In Marais and Prescott posterior pharyngeal placement of
      tampons is associated with a decrease amount of post-operative throat pain, when compared to
      conventional gauze throat packs, however they did not compare the incidence of post-operative
      nausea and vomiting in both groups.
    

Intervention name(s): Throat Pack; Pharyngeal Tampons
Intervention type(s): Other; Other
Intervention description(s): Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons); Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)
Other intervention name(s): Control; Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment