bioihbjkbjnl/mcl2 huggingface dataset:
Carotid Artery Corrected Flow Time as a Predictor of Hypotension After Induction of General Anesthesia in Elderly Patients
Condition: General Anesthesia Induction for Elective Surgery
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The number of elderly patients undergoing elective surgery has been growing in recent years.
      Elderly patients often have a variety of underlying diseases, including hypertension,
      coronary heart disease, diabetes, arteriosclerosis, etc., which increase the risk. When the
      elderly receive general anesthesia, hypotension often occurs after anesthesia induction. Once
      hypotension occurs, it may lead to myocardial ischemia, myocardial infarction, stroke and
      other serious complications. Therefore, in clinical anesthesia, a simple, quick and accurate
      prediction method is needed to evaluate and predict the risk of hypotension in elderly
      patients after induction, so that appropriate intervention measures can be taken in advance
      to reduce the incidence of hypotension in elderly patients after induction, thus reducing the
      occurrence of related complications and ensuring the safety of anesthesia and surgery.Carotid
      Artery Corrected Flow Time（FTc） is a recently developed volumetric predictor, which refers to
      the time between the the onset of systolic flow until the closure of the aortic valve. It is
      related to cardiac preload and can reflect cardiac output to a certain extent. It is
      considered as a reliable indicator for evaluating volume status and volumetric reactivity.
      Therefore, this study assessed the effect of FTc combined with perioperative fluid therapy on
      preventing hypotension after general anesthesia induction in elderly patients.
    


Intervention name(s): ultrasonographic measurement of carotid artery corrected flow time (FTc)
Intervention type(s): Procedure
Intervention description(s): Ultrasonic measurement of carotid corrected blood flow time: 1. Patient's head turned to the left 30°. Firstly, the 6.0 ~ 13.0MHz linear probe was placed longitudinally on the maternal neck, and the probe marker was oriented towards the maternal head. Real-time B-ultrasound images of the long axis of the right common carotid artery were obtained from the lower margin of the thyroid cartilage. Then, the probe was placed in the center of the carotid lumen, about 2cm from the bifurcation of the carotid artery, to obtain the arterial pulse Doppler flow spectrum and store the carotid flow waveform. 2. Using the caliper function of the ultrasonic instrument, carotid flow time (FT) was obtained by measuring the interval between the systolic ascending stage and the restroke notch. Wodey (W) formula to calculate FTc. FTc= FT+[1.29× (HR-60)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were scheduled to undergo elective surgery under general anesthesia
Influence of Bosentan on the Pharmacokinetics of Nintedanib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial was designed to investigate whether, and to which extent, multiple doses of
      bosentan may influence the plasma levels of nintedanib administered as a single dose.
    


Intervention name(s): Bosentan; Nintedanib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nintedanib; Bosentan
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Appearance and Disappearance of ASP3652 in Blood and Spinal Fluid in Healthy Male Subjects
Condition: Pharmacokinetics of ASP3652; Pharmacodynamics of ASP3652; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF)
      pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects.
      Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in
      healthy young Caucasian male subjects and to assess the safety and tolerability of multiple
      doses of ASP3652 in healthy young Caucasian male subjects.
    

Detailed description: 
      Screening takes place between Day -22 to Day -2. Subjects are admitted to the clinical on Day
      -1 and remain until Day 12.

      On Days 5 to 9, subjects receive twice-daily doses of ASP3652, and a single dose on the
      morning of Day 10. Subjects fast for 10h before the morning dose on Days 5 to 9 and they are
      served the first standard meal 1h after the morning dose.

      A spinal tap is used to collect cerebrospinal fluid (CSF) on Day 1 and Day 10. A plasma
      sample for PK sample is obtained before first dosing on Day 5. To confirm steady-state
      concentrations of ASP3652 in plasma, blood samples are obtained before the morning dose on
      Days 7, 9 and 10, and before the evening dose on Days 5, 7 and 9. On Day 10, a PK profile of
      ASP3652 in plasma is obtained for up to 48h after the morning dose and for up to 24h in CSF.

      Profiles of several enzyme substrates in plasma and seminal fluid (exploratory) are obtained
      on Day 1 and Day 10 up to 24h in CSF and up to 48h in plasma, before the morning and evening
      dose on Days 5, 7 and 9 in plasma.

      Vital signs, 12-lead electrocardiograms (ECGs), safety laboratory assessments, adverse events
      (AEs) and concomitant medication are monitored throughout the investigational period until
      the ESV.
    

Intervention name(s): ASP3652
Intervention type(s): Drug
Intervention description(s): oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; ASP3652; Cerebrospinal fluid (CSF); Multiple doses
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics
      (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or
      Tenofovir Disoproxil Fumarate in healthy subjects
    

Detailed description: 
      This is a 2-part study with each part is an open-label, crossover study in healthy adult
      subjects.

      Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part
      B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and
      ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the
      subject will be split into two groups and receive study drug per the defined treatment
      periods of Day 1, Day 11-20 and Day 21.
    

Intervention name(s): GLS4; RTV; ETV; TDF
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered GLS4 120 mg orally three times daily in fed state; Administered RTV 100 mg orally three times daily in fed state; Administered orally ETV 0.5 mg once daily in fasted state; Administered TDF 300 mg orally once daily in fasted state
Other intervention name(s): Morphothiadine Mesilate Capsules; Ritonavir tablet; Entecavir table; Tenofovir Disoproxil Fumarate table
Intervention MeSH terms: Ritonavir; Tenofovir; Entecavir
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects
Condition: Malaria Prophylaxis
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg)
      and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate
      release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in
      healthy adult subjects.
    

Detailed description: 
      Evaluate the relative bioavailability, assessment of the safety and tolerability of
      azithromycin microsphere and the chloroquine test formulation compared to immediate release
      individual tablets.
    

Intervention name(s): azithromycin (AZ) microsphere; test chloroquine (CQ) formulation; azithromycin (AZ); chloroquine (CQ)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AZ microsphere (2000 mg) single dose on Day 1.; Test CQ formulation, 620 mg CQ base, single dose on Day 1.; AZ IR 4 x 500 mg tablets, single dose on Day 1.; CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
Other intervention name(s): Zmax; Zithromax; Aralen
Intervention MeSH terms: Azithromycin; Chloroquine; Chloroquine diphosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Azithromycin; chloroquine; microsphere; pharmacokinetics; bioavailability
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intra-articular injection of Monovisc®
      hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
    

Detailed description: 
      This randomized, double-blind, placebo controlled prospective study will assess the safety
      and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic
      relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo
      comparator injection of sterile saline.
    

Intervention name(s): Monovisc®; Saline
Intervention type(s): Device; Other
Intervention description(s): Intra-articular injection; 0.9% Sterile Saline
Other intervention name(s): Sodium Hyaluronate; Hyaluronic Acid Gel
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Monovisc®; Hyaluronic Acid Gel; Injection; Knee
Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over
      a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).
      Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of
      maintenance treatment with inhaled corticosteroid controller medication in patients with
      moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung
      function, effects on asthma exacerbations, effects on quality of life, effects on asthma
      control, effects on health care resource utilisation, and number of adverse events.
    


Intervention name(s): placebo; placebo; placebo; tiotropium Respimat® low dose; placebo; tiotropium Respimat® high dose; 50 mcg salmeterol HFA MDI; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo that represents BI drug; Placebo that represents comparator; Placebo that represents comparator; IMP; Placebo that represents BI drug; IMP; Active comparator; Placebo that represents comparator
Intervention MeSH terms: Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy,
      safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and
      adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have
      been of short duration - up to 8 weeks.

      A number of long-term studies have been undertaken (up to 1 year) and these have confirmed
      the safety and ongoing efficacy in this patient population.

      In order to run a study with investigational medication within Poland the study changed to a
      Phase 3 rather than a Phase 4 study in that country. Please note that the study number
      remains as SPD489-404.

      Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in
      children and adolescents over a 2-year treatment period.
    


Intervention name(s): Lisdexamfetamine dimesylate
Intervention type(s): Drug
Intervention description(s): Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
Other intervention name(s): Vyvanse, SPD489, LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ADHD
Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the
      vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in
      children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2
      years) as controls. In the long-term follow-up phase of the study, the long-term protection
      offered by the vaccines will be assessed up to 5 years after vaccination.

      Subjects will be randomized in the primary vaccination phase of the study; no new subjects
      will be enrolled during the long-term follow-up phase of the study.
    

Detailed description: 
      Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will
      receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below
      two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or
      Meningitec™. All subjects will have 7 blood samples taken: prior and one month after
      vaccination and one, two, three, four and five years after vaccination.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      September 2007.
    

Intervention name(s): GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix); Mencevax™ ACWY; Meningitec™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One intramuscular dose.; One subcutaneous dose.; One intramuscular dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal serogroups A, C, W-135 and/or Y diseases; Conjugate vaccine; Immunogenicity; Meningococcal vaccine; Persistence; Non-inferiority
Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the postprandial glycemic and insulinemic response of subjects with type 2
      diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance
      test (MTT).
    


Intervention name(s): No breakfast/beverage only; Breakfast; 10004RF
Intervention type(s): Other; Other; Other
Intervention description(s): 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener; 1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener; 1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
Condition: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal
      white blood cells.

      PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin
      in treating patients who have hematologic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and toxicity of phenylbutyrate and tretinoin in patients with
           myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.

        -  Determine the pharmacokinetic interaction of this regimen in these patients.

        -  Determine any potential therapeutic activity of this regimen in these patients.

      OUTLINE: This is a dose escalation study of tretinoin.

      Patients receive phenylbutyrate IV continuously on days 1-7 of weeks 1, 5, 7, 9, 11, 13, 15,
      17, and 19. Patients also receive oral tretinoin three times daily on days 1-7 of weeks 3, 5,
      7, 9, 11, 13, 15, 17, and 19. Treatment continues in the absence of disease progression or
      unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of tretinoin until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6
      patients experience dose limiting toxicities.

      An additional cohort of 6 patients is accrued at the MTD. These patients receive
      phenylbutyrate IV continuously on days 1-3 of weeks 1 and 3-18. These patients also receive
      oral tretinoin three times daily on days 1-3 of weeks 2-18. Treatment continues in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 18 months.
    

Intervention name(s): sodium phenylbutyrate; tretinoin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tretinoin; 4-phenylbutyric acid
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; untreated adult acute myeloid leukemia; refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; previously treated myelodysplastic syndromes; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)
Carb Quality and CHD in US Adults
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      This is an analysis conducted in the Nurses Health Study and the Health Professional
      Follow-Up Study, both prospective cohort studies, where the investigators systematically
      investigated the association between carbohydrate quality using a variety of metrics in
      relation to coronary heart disease. This was a secondary data analysis of previously
      collected data in both cohorts.
    

Detailed description: 
      In this study, the investigators studied the association between carbohydrate quality and
      coronary heart disease using prospective cohort studies among US adults. Carbohydrate quality
      was evaluated using a variety of metrics including carbohydrate, starch, total fiber, cereal
      fiber, fruit fiber, and vegetable fiber intake, as well as the ratios of carbohydrate to
      total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber.
      The Nurses' Health Study (NHS) and the Health Professionals Follow Up Study (HPFS) started in
      1984 and 1986, respectively, and were followed-up every 2-4 years thereafter until 2012.
      Participants include in this study had up to 28y of follow-up. All participants were free of
      known diabetes mellitus, cancer or cardiovascular disease at baseline. Cox proportional
      hazards regression models were used to assess the relationship between dietary measures of
      carbohydrate quality and incident CHD (nonfatal myocardial infarction and fatal CHD).
    

Intervention name(s): Carbohydrate quality
Intervention type(s): Other
Intervention description(s): This is an observational study examining the association between carbohydrate quality and coronary heart disease. The investigators used a variety of carbohydrate quality metrics to evaluate carbohydrate quality including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intakes, and the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber intakes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Nurses' Health Study (NHS) was initiated in 1976 as a prospective cohort study, where
        121,701 female registered nurses between the ages of 30 and 55 years were recruited from 11
        US states. The Health Professionals Follow-up Study (HPFS) was initiated in 1986 and
        recruited 51,529 US men between the ages of 40-75. Every two years, participants updated
        their information on medical history, lifestyle, and incidence of chronic diseases using
        validated questionnaires. Follow-up rates are at least 90% of potential person-years of
        follow-up and mortality follow-up is more than 98%.