bioihbjkbjnl/mcl2 huggingface dataset:
Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans
Condition: Endothelial Dysfunction
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is
      directly connected to IRB 08-008161 as a specific aim of the National Institute of Health
      (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB
      08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac
      Catheterization Laboratory at Mayo Clinic in Rochester, Minnesota to be considered for this
      study.
    

Detailed description: 
      The main goal of AIM III is to assess and quantify the effect of long-term administration of
      darapladib 160 mg once a day, a selective, reversible, orally active inhibitor of plasma and
      vascular Lp-PLA2, on coronary endothelial function, progression of coronary atherosclerosis
      as determined by intravascular ultrasound (IVUS), and atherosclerosis in patients with early
      atherosclerosis. Patients with evidence of coronary endothelial dysfunction, as determined by
      intracoronary administration of acetylcholine during angiography and IVUS, will be followed
      for 6 months during once daily dosing of darapladib. Coronary endothelial function is
      determined by the changes in coronary artery diameter and coronary blood flow response to the
      intracoronary administration of acetylcholine and adenosine. The patients will be followed in
      clinic 6 months. They will have follow-up angiography, assessment of endothelial function,
      and IVUS during the six month visit.
    

Intervention name(s): darapladib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): darapladib, tablet, 160 mg, by mouth, one time daily, 6 month duration; placebo, by mouth, once daily for six months
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: coronary endothelial dysfunction; coronary vasospasm
Designing a Programming Language for Patient-Oriented Prescriptions
Condition: Patients; Programming Languages
Study type: Observational

Summary: 
      The purpose of this study is to create a human-readable and executable computer language to
      implement medical prescriptions and to evaluate and refine this language, with the goal of
      improving safety and efficacy of patient care.
    

Detailed description: 
      Preventable errors in healthcare are a leading cause of patient injury and death. Despite
      extensive effort and the expenditure of billions of dollars, computerization has failed to
      solve this problem. Research has shown that software design and debugging of a paper
      prescription markedly decreases the rate of injury and death associated with use of opioids
      in hospitalized patients. To further the application of insights from software engineering to
      the practice of medicine, the PIs will design and build a Patient-Oriented Prescription
      Programming Language (POP-PL) and evaluate if this new platform can be used to improve
      medical management of patients. The design of POP-PL will be based on building an
      understanding of the process of medical treatment of patients. This project is a
      collaboration between computer scientists and clinicians at Northwestern Medicine. The
      collaborating clinicians are co-investigators on this research project and also are providing
      healthcare to the patients that are being observed. The computer scientists and other
      research staff have undergone human subjects research training and are co-investigators on
      this research project as well. The clinician-investigators will oversee research project
      staff during all observations of patients, clinical encounters between healthcare providers
      and patients, and interactions between healthcare providers and healthcare information
      systems. Researchers involved in this study will observe interactions between health care
      providers and patients and will collate these observations with data from electronic data
      sources. Since this research is based mainly upon observation and chart review and will not
      involve any interventions or changes to patient care, the risk to study participants is
      minimal, involving inadvertent disclosure of healthcare information. This risk will be
      mitigated by anonymizing collected data.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen at Northwestern Memorial Hospital and Northwestern Medicine Clinics
      
Keywords: Designing; Patient-Oriented; Prescriptions
Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
Condition: Large Bowel Cancer
Study type: Interventional

Summary: 
      Aim of the study is to ascertain whether a different strategy of fluids administration can be
      responsible of differences in terms of acid/base disorders (Stewart approach),
      pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated
      either with not-balanced solutions (Normal Saline) or balanced solutions
    


Intervention name(s): balanced solutions; not balanced
Intervention type(s): Behavioral; Behavioral
Intervention description(s): during the general anaesthesia until 8 o'clock of the day after the operation the subject will receive only balanced fluids that means balanced crystalloid and colloids dissolved in balanced solution. 12 ml /Kg/h during operation time. ratio 3:1 between crystalloid and colloid.; during the operation time until the 8 o'clock of the day after the operation, the subjects will receive only normal saline and colloid dissolved in normal saline.
Other intervention name(s): sterofundin, tetraspan; Normal saline, Amidolite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: general anaesthesia for major abdominal surgery
High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women
Condition: Healthy Volunteers
MeSH terms: Overweight
Study type: Interventional

Summary: 
      High-intensity interval training (HIIT) is currently considered one of the most effective
      strategies to improved cardiorespiratory fitness, which is recognized as a protective factor
      for cardiovascular diseases and metabolic diseases such as overweight and obesity. However,
      current evidence is still limited and requires clarity (frequency, time per session and
      intensity) regarding to greater increases attributed to HIIT.

      The aim of this study is to compare the effect of a low-volume high-intensity interval
      training versus a moderate-intensity continuous exercise on maximal oxygen consumption in
      overweight women 18 to 44 years old.
    

Detailed description: 
      Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life
      setting supervised for a physical activity instructor. The interventions will performed three
      times a week for ten-weeks (on alternate days).

      The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of
      maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of
      continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will
      complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with
      recoveries between 50-55% of HRmax.

      All Participants will be evaluated to measure their maximal oxygen consumption, total body
      fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure,
      prior to start the interventions and at the end of the program (week 11).
    

Intervention name(s): High-intensity interval training; Comparator: Moderate-intensity continuous exercise
Intervention type(s): Other; Other
Intervention description(s): 21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.; 30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Muscle Strength in Shoulder and Neck Muscles in Tension Type Headache Patients. Effect of Specific Strength Training
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      Background:

      Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance.
      Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with
      trapezius myalgia. It is shown that specific strength training leads to prolonged pain
      relief.

      Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients
      with TTH compared to healthy controls.

      Intervention: To investigate the effect of specific strength training on patients with TTH
      compared with control group, receiving training in ergonomics.

      Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and
      shoulder. Testing conducted by blinded research assistant.

      Intervention group: 60 patients with tension headache randomly assigned to the intervention
      group or control group. Intervention with specific strength training program runs for 10
      weeks. The control group will be trained in ergonomics. 3 months follow up.
    


Intervention name(s): Strength training; Ergonomic and posture
Intervention type(s): Other; Other
Intervention description(s): The specific ST group trained and fulfilled a 10 week training diary. The ST consisted of 4 shoulder exercises. During the training the relative loading was progressively increased from 12 repetitions maximum (RM) (70% of maximal intensity) at the beginning to 8 RM (80 % of the maximal intensity). ST was performed with slow concentric and eccentric muscle contractions with resistance from the elastic bands.; The control group was instructed in ergonomics and posture correction (EP). They were instructed to pay attention to their sitting posture, and how they used a computer or other working tools. Further they were asked to do a posture correction exercise 3 times a day with 10 repetitions. The EP were seen twice during the 10 week period, and had a phone call every 2 weeks. After 10 weeks they were instructed that they should stop the exercise but continue to be conscious of their ergonomics and sitting position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Condition: Pre-Term; Neonatal Infection
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold
      standard still remains conventional echocardiography. It is accurate, but needs a long
      training for new users to assess cardiac function. Continuous-wave Doppler ultrasound monitor
      USCOM is a relatively new monitor which can perform faster and less complex cardiac function
      measurement, also it is easier for the operator to get trained. The aim of the study is to
      assess the level of agreement between cardiac output measured with conventional
      echocardiography and with USCOM, to present normal ranges for neonates of different
      gestational age and to look for early signs of hemodynamic changes during sepsis.
    


Intervention name(s): Ultrasound Cardiac Output Monitor (USCOM 1A)
Intervention type(s): Device
Intervention description(s): doplerometry with USCOM and echocardiograph is made for assessing central blood flow and spectroscopy with NONIN- for the blood flow in individual peripheral organs (brain and kidney)
Other intervention name(s): GE LOGIQ S8 XDclear 2.0 ultrasound system with S4-10-D (3-9MHz) probe; NONIN Equanox near-infrared spectroscope
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study enrolled both preterm and full-term newborns of any gestational age, without
        congenital heart defects and/or hemodynamically significant fetal circulation, any
        respiratory therapy, nor need of supplemental oxygen. Subjects had no clinically and
        laboratory-identified infections in control group.
      
Keywords: cardiac output; echocardiography; USCOM; neonates
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in
      chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.
    

Detailed description: 
      Six different dosages of tamoxifen will be given for 14 days with safety and viral loads
      being measured.
    

Intervention name(s): tamoxifen
Intervention type(s): Drug
Intervention description(s): giving drug tamoxifen
Other intervention name(s): Nolvadex
Intervention MeSH terms: Tamoxifen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C, tamoxifen
MiniMed™ 670G System China Study for Type I Diabetic
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to obtain clinical data in Chinese patients to support product
      registration of the MiniMed™ 670G system with the National Medical Product Administration
      (NMPA) in China. The results from the study will be submitted to the NMPA for product
      registration.
    

Detailed description: 
      This study is a multi-center, single arm study in insulin-requiring subjects with type 1
      diabetes who are 14 years of age and older. The run-in period will be approximately up to 35
      days long, followed by a study period that will be approximately up to 33 days in duration.

      The study is anticipated to last no longer than 13 months from investigational center
      initiation to completion of all data entry and monitoring procedures. The study will target
      approximately 5 months to complete subject enrollment. Subjects can expect to participate for
      approximately 2-3 months including the run-in and study periods.

      A total of up to 75 subjects (aged 14-75) will be enrolled at a minimum 2 investigational
      centers and up to 6 investigational centers (hospitals) in China to have at least 50 subjects
      who complete the study.

      The MiniMed™ HCL system that was employed in this study was the MiniMed™ 670G Bluetooth
      version (MMT-1883). The MiniMed™ 670G system with Bluetooth™ technology is the MiniMed™ 770G
      system.
    

Intervention name(s): MiniMed™ 670G system
Intervention type(s): Device
Intervention description(s): Hybrid closed loop insulin pump with associated CGM and blood glucose meter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Type 1
Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)
Condition: ARDS
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute
      respiratory failure
    

Detailed description: 
      Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid
      endotracheal intubation and mechanical ventilation
    

Intervention name(s): ECMO; ECMO in non-intubated patients
Intervention type(s): Device; Procedure
Intervention description(s): Use of veno-venous ECMO in non-intubated patients with ARDS; Use of veno-venous ECMO in non-intubated patients with ARDS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ARDS
Colloid Osmotic Pressure in Patients With Fontan Circulation
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      Children born with univentricular heart will go through step surgery and end up with a Fontan
      circulation. A circulation with cause problems with body fluid balance.This project will
      evaluate changes in interstitial colloid osmotic pressure in patients 10 year after
      completion of a three step Fontan surgery. This project will evaluate whether increased micro
      vascular leakage and change in interstitial colloid osmotic pressure are present in patients
      after ten years with a Fontan circulation.
    


Intervention name(s): Catheterization
Intervention type(s): Other
Intervention description(s): Routine catheterization during follow up.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children who will have a cathererization during their routine check up 10 years after
        completion of Fontan surgery.
      
Biospecimen description: 
      Interstitial fluid. Serum
Education and Fitness: EDUFIT Study
Condition: Physical Fitness; Body Composition; Lipid Metabolism
Study type: Interventional

Summary: 
      EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical
      fitness and other health-related factors in a school setting in adolescents.
    

Detailed description: 
      Physical fitness is a powerful marker of cardiovascular health already at early stages in
      life. To promote physical fitness enhancement from the school is therefore needed and this is
      the main aim of the EDUFIT study (EDUcation for FITness).

      The participants were randomly allocated to control group (CG), experimental group 1 (EG1)
      and experimental group 2 (EG2). The CG received 2 physical education sessions/week, the EG1
      received 4 physical education sessions/week (volume increased) and the EG2 received 4
      physical education sessions/week of high intensity (volume+intensity increased). Several
      health-related parameters were assessed before and after a 16-weeks intervention: physical
      fitness (primary outcome), body composition (secondary), and lipid-metabolic profile,
      ventilatory parameters, blood pressure, and cognitive and academic performance (tertiary
      outcomes).

      The hypothesis of the EDUFIT project was that to double the number of physical education
      classes will improve physical fitness in adolescents. The confirmation of the hypothesis
      could have important public health implications.
    

Intervention name(s): Physical activity program
Intervention type(s): Behavioral
Intervention description(s): School intervention program specifically designed to increase health-related physical fitness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered
      every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from
      baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
    


Intervention name(s): Evolocumab; Placebo to Evolocumab
Intervention type(s): Biological; Other
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9)
A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess what drug does to body when healthy Chinese
      participants receive single oral dose of JNJ-77242113.
    


Intervention name(s): JNJ-77242113
Intervention type(s): Drug
Intervention description(s): JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.
Other intervention name(s): PN-21235; PN-235
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment