bioihbjkbjnl/mcl2 huggingface dataset:
Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control
Condition: Septic Shock; Sepsis
MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock
Study type: Interventional

Summary: 
      Study of the lipid metabolism under glycemic control in septic patients who got an university
      14 bed ICU.

      Hypothesis: establish a relationship between lipid metabolism alterations and glycemic
      control or infusion of exogenous insulin
    

Detailed description: 
      The investigators enrolled 69 consecutive patients with severe sepsis or septic shock and
      divided them in two different groups after randomization with sealed envelopes.

      One group called intensive glycemic control with glycemic levels been between 80 to 110 mg/dl
      with exogenous insulin.

      The other group called conventional glycemic control with glycemic levels been between 180
      and 220 mg/dl.

      Blood samples were collected at 0, 12, 24, 48 and 72 hours to measure HDL, LDL, Total
      cholesterol, free fatty acids and oxidized LDL.

      Clinical data as creatinine, P/F ratio, bilirubins, platelets, lactate, arterial blood
      gasometry were either monitored.
    

Intervention name(s): glycemic control
Intervention type(s): Procedure
Intervention description(s): exogenous insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: septic shock; glycemic control; icu; lipid metabolism; septic patients
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
Condition: Atherosclerosis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending
      doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus
    

Detailed description: 
      A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and
      Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects with Type 2
      Diabetes Mellitus
    

Intervention name(s): MEDI6570; Placebo; Part B Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): MEDI6570; Placebo; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atherosclerosis; Cardiovascular Disease; CAD; Atherosclerotic Cardiovascular Disease
Safety & Efficacy Evaluation of a Radiofrequency & Laser/Light System for Improvement of Skin Texture
Condition: Skin Texture Irregularities; Facial Skin Wrinkles
Study type: Observational

Summary: 
      Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light
      based device for the treatment of facial wrinkles.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Male of Female between ages 35 and 60 with presence of mild to moderate facial
        photodamage (sun damage) and presence of mild to moderate facial wrinkling
      
Biospecimen description: 
      Optional biopsy, for consenting subjects, of facial skin tissue from areas directly in front
      of ear (Pre-Auricular)
    
Keywords: Wrinkle Reduction; Skin Resurfacing; Skin Texture Improvement
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions
Condition: Prophylaxis of Organ Rejection
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg
      Capsules under fasted conditions.
    


Intervention name(s): Mycophenolate Mofetil
Intervention type(s): Drug
Intervention description(s): mycophenolate mofetil 250 mg capsule
Other intervention name(s): CellCept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric
      pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients
    


Intervention name(s): Calcium (13C)Carbonate; Gastric acid inhibitors; Gastric pH monitoring
Intervention type(s): Drug; Drug; Other
Intervention description(s): C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.; Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.; Gastric pH monitoring was performed once under fasting condition.
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Social Media and Breastfeeding Self Efficacy
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This study aimed to determine the effect of breastfeeding support on women's breastfeeding
      self-efficacy via social media. This study was conducted maternity unit at a state hospital
      in Turkey. Education and consulting about breastfeeding were given via WhatsApp application
      to women in the intervention group. Women in the control group receive only routine
      breastfeeding training.
    

Detailed description: 
      The research was conducted as a randomized controlled trial. The stratified and permutation
      block randomization methods were used in the study. The personal information form and BSES-SF
      were administered to women in the hospital before the intervention. Breastfeeding education
      and counseling were provided via social media (WhatsApp) to support women for breastfeeding
      and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding
      education was given to women in the first four weeks after discharge from the hospital. The
      control group received the routine breastfeeding postpartum educational training given to all
      women by healthcare personnel as part of the hospital procedures. Except for routine
      breastfeeding training, no intervention was applied to the control group.
    

Intervention name(s): Breastfeeding education and counseling; Routine postpartum breastfeeding training included in the hospital procedure
Intervention type(s): Other; Other
Intervention description(s): Breastfeeding education was applied for four weeks.; The routine breastfeeding postpartum educational training given to all women by healthcare personnel as part of the hospital procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: breastfeeding self-efficacy; breastfeeding support; social media; WhatsApp
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately
      Controlled With Either Metformin Or Insulin
    

Detailed description: 
      Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately
      Controlled With Either Metformin Or Insulin
    

Intervention name(s): Farxiga; Placebo; Metformin; Insulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Farxiga 10mg/day; Placebo; Metformin background therapy >/= 1500mg/day; Insulin >/= 30 units
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
Condition: Spondylarthritis
MeSH terms: Spondylitis; Spondylarthritis
Study type: Interventional

Summary: 
      Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition
      at a temperature of approximately -110 degrees.

      A considerable increase in the popularity of WBC has occurred in rheumatologic patients,
      despite a lack of evidences of its efficiency.

      Because of its interesting anti-inflammatory properties, the investigators think that WBC
      could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs)
      and corticosteroids, in patients suffering from axial spondyloarthritis.

      This is a proof of concept study.
    


Intervention name(s): cryotherapy
Intervention type(s): Other
Intervention description(s): The treatment arm :Whole body cryotherpy (WBC) (20 sessions of 3 minutes at a temperature of -110 degrees Celsius, on the basis of two sessions a day, spread over two weeks).
The control arm : Whole body cryotherpy (WBC) (20 sessions of 1 minute at a temperature of -60 degrees Celsius, on the basis of two sessions a day, spread over two weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Using Artificial Intelligence (AI)-Assisted Pulse Diagnosis Analysis on Precision Critical Medicine.
Condition: ICU Patients; Shock
MeSH terms: Disease
Study type: Observational

Summary: 
      Precision/personalized medicine becomes an important part of modern medical system in the
      recent years. In the past, the treatments for patients have been decided by doctors according
      patients' symptoms and/or regular biochemical profiles. However, it is not uncommon that
      patients' condition varies tremendously even they have same diagnosis, and under such
      condition, treatment efficacy may be limited due to the heterogeneity among patients.
      Therefore, lack of therapeutic efficacy may be not really ineffective, and the main reason
      may be inadequate patient classification. For this reason, the "omics"-based
      personal/precision medicine emerges recently and becomes more and more important. However, in
      contrast to feasible and common "personalized" medicine, the approach of precision medicine
      to the molecular medicine level is still difficult, especially among patients in intensive
      critical units (ICUs). In contrast to cancer, which has remarkable advances in the past
      decades, the precision/personal medicine is more difficult in critical and emergent medicine.
      One reason is the amount of omics data is quite huge and thus dealing with omics data is time
      consuming. Therefore, it is not effective in daily clinical practice in ICUs care. For this
      condition, the investigators propose that the combination of clinical data, including pulse
      diagnosis by traditional Chinese medicine (TCM) doctor or ANSwatch wrist sphygmomanometer,
      fluid responsiveness by "Masimo" Radical-7 Pulse CO-Oximeter, and the specific database from
      monitors in ICUs may be a feasible way to predict outcome among ICU patients. There are two
      main goals for this study: (1) After establishing clinical traditional Chinese medicine (TCM)
      pulse diagnosis and ICU clinical parameters databases, acquiring and features of pulse
      diagnosis by applying AI and (2) analyzing the correlations between the features of pulse
      diagnosis and important clinical parameters.
    


Intervention name(s): ANSwatch
Intervention type(s): Device
Intervention description(s): ANSwatch wrist sphygmomanometer and the specific database from monitors in ICUs may be a feasible way to predict outcome among ICU patients. Two measurements will be obtained:
Pulse diagnosis: Pulse diagnosis done on radial artery is recorded by traditional Chinese medicine physician and ANSwatch wrist sphygmomanometer at the same time.
Heart rate variability: Heart Rate Variability represents significant information on autonomic nervous system (ANS)'s regulating function and balance status.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The ICU patient under acute circulatory failure
      
Keywords: traditional Chinese medicine; pulse diagnosis; artificial intelligence; precision critical medicine
Evaluation of a Biomarker Related to the GI Tract for the Diagnosis of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic
      factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed
      throughout the entire nervous system including the central, peripheral, and enteric nervous
      system. There is evidence that inflammation plays a major role in neurodegeneration in PD. In
      both the striatum and substantia nigra of PD patients activated microglia were found and
      proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An
      inflammation-driven animal model has emerged and has been widely accepted as a model of the
      disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found on
      the outer membrane of gram negative bacteria and humans are exposed to LPS through the
      intestinal tract. The intestinal tract and thus the enteric nervous system serve as a conduit
      to the central nervous system. It has been posited that the inflammatory process could gain
      access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and
      forebrain until it reaches the cerebral cortex, producing various pre-motor and motor
      symptoms of PD along the way. LPS may be one of the inflammatory triggers involved in this
      process. Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS
      binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr stage 2)
      and age matched controls found that the PD subjects had a significantly lower mean level of
      plasma LBP compared to control subjects. The aim of the research plan is to establish LBP as
      a potential biomarker for PD across a spectrum of disease severity.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Rush University Movement Disorders Clinic
      
Keywords: Parkinson's disease; GI tract; Lipopolysaccharide binding protein
Safety, Blood Levels and Effects of AUT00201
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The study medicine is a potential future treatment for schizophrenia, an illness that affects
      the way that people think, feel or behave. It is not clear what causes schizophrenia, but
      it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will
      activate specific sites in the brain to help correct that imbalance. Current treatments for
      schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that
      the study medicine will work better, and have fewer side effects than existing medicines.

      In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female
      subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the
      study medicine is in healthy men and women.

      This study will be in 2 parts, as follows:

      Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A
      will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men,
      Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the
      effect of food on the PK of AUT00201 in healthy men.

      A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will
      take place at 1 centre in London.
    


Intervention name(s): AUT00201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose of AUT00201; Oral dose of placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteer; Schizophrenia
Large-scale Brain Organization During Cognitive Control in ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test whether children with attention-deficit/hyperactivity
      disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in
      response to shifting cognitive demands during the exertion of cognitive control, by assessing
      changes in network dynamics resulting from stimulant administration in children with ADHD,
      and how those changes relate to behavioral and symptom improvements. Subjects will be
      children with ADHD aged 8-12. Subjects will participate in multiple testing sessions that
      include: diagnosis and eligibility screening, neuropsychological and behavioral testing, and,
      if eligible, MRI scans and a medication challenge. Children with ADHD who are enrolled in the
      medication challenge will undergo one MRI scan on placebo and one MRI scan on stimulant
      medication, counterbalanced and double-blind. Functional connectivity will be measured using
      functional MRI and innovative graph theoretical analytic tools will be implemented. Network
      metrics will be related to symptomatology and behavioral testing measures. It is hypothesized
      that stimulant administration in children with ADHD will increase flexibility in network
      reconfiguration in response to changing cognitive control demands as compared to when they
      are on placebo. It is further hypothesized that the degree to which brain network
      organization is changed will be related to the degree of improvement in cognitive control
      performance.
    


Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A single, low dose of methylphenidate (0.3 mg/kg) will be administered on the drug day.; A matching placebo pill will be administered on the placebo day.
Other intervention name(s): Ritalin; Sugar pill
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, crossover design. Each subject with ADHD participates in two sessions, one on drug and one on placebo (order randomized ). Both subjects and experimenters are blind to the order.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: methylphenidate; functional connectivity; graph theory; cognitive control
A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy
      and safety of PRAX-114 in participants with moderate to severe major depressive disorder
      (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo
      in a 1:1 ratio.
    


Intervention name(s): PRAX-114; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg once daily; Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Unipolar; Depressive Symptoms; Agents, GABA; Receptors, GABA-A; Allosteric Regulation
Comparing Driving Performance Among Trained and Untrained Drivers Using a Driving Simulator
Condition: Prevention Harmful Effects; Accidents, Traffic; Accident Prevention
Study type: Interventional

Summary: 
      The purpose of this study is to examine differences in driving performance on a simulated
      driving assessment between novice teen drivers who receive the Risk Anticipation-Perception
      Training (RAPT) program and novice teen drivers who do not receive the training program.
    

Detailed description: 
      Motor vehicle crashes remain the number one cause of death among teens in the United States.
      Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than
      adult drivers (ages 25 to 69). Driving simulators are a safer alternative to on-road
      assessments that are often affordable and can provide experimental control for research.
      Though driving simulators have advantages for evaluating driving performance in teens, there
      are gaps in the literature on the validity of a multidimensional outcome of driving
      performance in a simulator. To further examine the validity of a multidimensional measure of
      driving performance in a simulator, we compare simulated driving performance among teens who
      are trained hazard anticipation-perception training and those who are not.
    

Intervention name(s): Risk Anticipation -Perception Training
Intervention type(s): Behavioral
Intervention description(s): Web-based computer training program designed to teach novice teen drivers how to properly scan for hazards
Other intervention name(s): RAPT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: accident prevention; Adolescent; examination, automobile driver; Driving simulator; Young drivers; Driving education