bioihbjkbjnl/mcl2 huggingface dataset:
Hypoxia Inducible Factor 1 Alpha as a Novel Biomarker in Septic Shock
Condition: Sepsis
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The purpose of this research study is to determine if a chemical marker in the blood,
      hypoxia-inducible factor (HIF-1 alpha), can be used to predict subject's hospital outcomes
      when the subject is diagnosed with sepsis. Sepsis is defined as either the presence of
      pathogenic organisms or their toxins in the blood and tissues. Sepsis is one of the most
      significant challenges in critical care medicine. The investigators propose that
      hypoxia-induced expression of HIF-1 alpha will correlate with the clinical features of Sepsis
      and in the future, HIF-1 alpha may be used as a biomarker in Sepsis.
    

Detailed description: 
      Sepsis is one of the most significant challenges in critical care. Septic shock (SS) is the
      most severe form of sepsis and is associated with higher mortality, significant financial
      expenses and longer lengths of stay. Pathophysiological mechanisms of SS include 3 key
      components: 1) bacterial overgrowth, 2) spill of bacterial product into the blood causing
      hemodynamic insufficiency, and 3) both lead to tissue hypoxia (TH). To date the biomarkers of
      sepsis/SS are limited to hemodynamic parameters. However, aggressive fluid resuscitation does
      not fully prevent development of tissue hypoxia (TH). To date the investigators are limited
      in appreciating TH by measurement of lactic acid (LA), which is neither an early nor an
      accurate marker. Unfortunately, LA has limited predictive value in SS due to its complex
      metabolism. Thus, there is an acute need for biomarkers that would aid diagnosis and
      prognosis of sepsis/septic shock.

      Cellular responses/adaptations to hypoxia rely on the transcription hypoxia-inducible factor
      HIF, a heterodimeric protein composed of a constitutively expressed subunit and an inducible
      (types 1, 2, and 3) subunit. More recently HIF was identified in diverse tissues including
      blood; it has been also shown that HIF expression in blood cells is representative of
      systemic tissues in hypoxic conditions.
    

Intervention name(s): Septic patients; Healthy Control
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators will draw two sets of blood samples. One at baseline, 10 mL, and another, 24 hours later, 10 mL, for a total of 20 mL.; The investigators will draw 10 mL, once, during baseline for a total of 10 mL among the healthy control group.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy controls recruited from the community. Subjects with sepsis admitted to the
        University of Florida Hospital.
      
Biospecimen description: 
      whole blood, serum
Adolescents' Use of Complementary and Alternative Medicine
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to help improve our understanding of when and why adolescents
      decide to use alternative and complimentary medicines, and to understand factors that lead to
      better communication between youth and their clinicians.
    

Detailed description: 
      Alternative therapies and herbal remedies are increasingly recognized as having therapeutic
      value, and as many as 42% adults use some form of complementary and alternative medicine
      (CAM). The prevalence of CAM use among adolescents is not known. Questions remain about the
      safety and efficacy of some CAM therapies, and how to best facilitate communication about
      alternative medicine between patients and clinicians. Research with adults shows that most do
      not reveal their use of alternative therapies to their providers. Adolescence is a time of
      experimentation and the beginning of a shift from depending upon parents to taking
      responsibility for one's own care. Thus, the health practices begun in adolescence have an
      impact into adulthood. However, none of the current guidelines for the provision of care to
      adolescents advise asking about complementary or alternative medicine use. Finally,
      adolescents are exposed to increasing coverage of CAM in the media, and on the internet. The
      specific aims of this study are to: 1) determine the prevalence of complementary and
      alternative medicine use among a representative sample of adolescents, 2) describe the range
      of therapies adolescents use, and where they are procured, 3) describe adolescent and
      clinician factors that are associated with communication between adolescents and their
      providers about complementary and alternative medicine, and 4) describe adolescents' exposure
      to information about CAM from sources such as parents, providers, and the media, and how this
      impacts CAM use. We propose a cross sectional random digit dial telephone survey of 1200
      adolescents in Monroe County, NY. Our findings will allow us to understand how adolescents
      use alternative medicine. Additionally, since alternative therapies can have potentially
      serious side-effects or drug interactions, insight into how and when alternative medicine use
      is disclosed may help clinicians provide better care to adolescents.
    

Observational model: Natural History
Time perspective: Other
Keywords: Adolescents; Alternative and complimentary medication use; Health services utilization; Communication; Quality of care
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
Condition: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary
MeSH terms: Angina, Unstable
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of abciximab (an
      anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the
      efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk
      coronary angioplasty. The primary outcomes of the study include any of the following: the
      number of deaths from any cause, or myocardial infarctions and recurrent ischemic events
      requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery,
      intracoronary stent placement, or intra-aortic balloon pump).

      Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.
    

Intervention name(s): Abciximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.25 mg/kg of body weight of abciximab either bolus or infusion.; Matching Placebo soulution either bolus or infusion.
Other intervention name(s): c7E3 Fab
Intervention MeSH terms: Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abciximab; Angina, unstable; Angioplasty, transluminal, Percutaneous coronary
Non-surgical Treatment of Carpal Tunnel Syndrome by Means of Mechanical Traction
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the effectiveness of mechanical traction in
      patients with Carpal Tunnel Syndrome compared to care as usual.
    

Detailed description: 
      This randomized controlled trial will examine the effectiveness of mechanical traction
      compared to care as usual as a non-surgical treatment for Carpal Tunnel Syndrome (CTS).

      Patients diagnosed with CTS are recruited from the outpatient neurology clinic of VieCuri
      Medical Center in Venlo, The Netherlands. They will be randomly assigned to the intervention
      or control group. Patients in the intervention group will receive 12 treatments with
      mechanical traction during six consecutive weeks. Patients in the control group will receive
      care as usual, which can include splinting, a corticosteroid injection, carpal tunnel release
      surgery or an expectant strategy. Outcomes will be assessed at baseline and at 3, 6, and 12
      months after inclusion.
    

Intervention name(s): mechanical traction; Care as usual
Intervention type(s): Device; Other
Intervention description(s): Twelve treatments with mechanical traction using the Phystrac traction apparatus. The Phystrac provides traction to the wrist using weights between 1 and 18 kg. The weights provide a pulling force in line with the forearm. After 8 seconds the weight is lifted, and there is a rest period of 4 seconds. This cycle will be repeated 10 times. Another two sets of 10 traction movements will be applied with the wrist positioned in 30 degrees supination and 30 degrees pronation. In total, 30 traction movements will be applied during each treatment.; Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
Other intervention name(s): Phystrac mechanical traction device (type GR 10)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; traction; mechanical traction; Phystrac
Validity Reliability of The Dubousset Functional Test in Stroke Patients
Condition: Stroke Syndrome; Balance; Distorted; Walking, Difficulty
MeSH terms: Stroke; Mobility Limitation
Study type: Observational

Summary: 
      Increased muscle tone, decreased normal range of motion, and functional impairments may
      result in decreased load on the affected limb, deviations in gait patterns, balance and
      coordination disorders in individuals with stroke.

      In the literature, there are many scales that evaluate balance and functional performance in
      stroke. However there is no validity and reliability study of Dubousset Function Test
      developed to evaluate balance and functional performance of stroke. For this reason, the aim
      of study is to examine the validity and reliability of Dubousset Function Test in stroke
      patients.
    

Detailed description: 
      While the ambulation ability is completely lost in some patients after stroke, impaired
      balance reactions and increased postural oscillations cause an increase in the fear of
      falling and the risk of falling in stroke patients. These disturbances cause stroke patients
      to make more effort to balance while standing. Balance assessment performed in individuals
      with stroke determines the risk of falling and is important in preventing complications that
      may develop due to loss of balance.

      Dubousset Functional Test (DFT); A conceptually practical four-component assessment test has
      been proposed by Dr. Jean Dubousset to assess the functional capacity of adult individuals.
      The validity of the test was made in individuals with spinal deformity. DFT; It consists of
      four components: getting up from a chair without arms and walking 5 meters forward and
      backward, descending and climbing steps, transition from standing to sitting on the ground,
      and the dual task test in which the individual walks while counting down from 50 at the same
      time. In the literature, there are many scales that evaluate balance and functional
      performance in stroke. However there is no validity and reliability study of Dubousset
      Function Test developed to evaluate balance and functional performance of stroke. For this
      reason, the aim of study is to examine the validity and reliability of Dubousset Function
      Test in stroke patients
    

Intervention name(s): stroke patients, balance assessment
Intervention type(s): Other
Intervention description(s): validity relability dubousset functional test
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stroke patients
Effects of a Peripheral Nerve Block on Biomarkers of Pain and Inflammation
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a local anesthetic nerve block on
      markers of inflammation and pain after a sunburn. This is important because it may provide
      information regarding the way that nerve blocks help with the treatment of pain and in
      particular provide preemptive analgesia.
    


Intervention name(s): femoral nerve block
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
High Water Intake to Slow Progression of Polycystic Kidney Disease
Condition: Kidney, Polycystic, Autosomal Dominant
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional

Summary: 
      Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and
      leads to kidney failure in half of all affected. Currently, no treatments exist for PKD.
      PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs
      called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue,
      leading to kidney failure. Based on evidence from basic science research it is believed that
      drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at
      changes in urine composition with high water intake in PKD-affected persons compared to
      healthy individuals.
    


Intervention name(s): Water
Intervention type(s): Other
Intervention description(s): Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Autosomal Dominant Polycystic Kidney Disease; Polycystic Kidney Disease; Water Loading; Biomarkers
A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the time for patients to relapse when switched from an
      oral antipsychotic to one of two doses of long-acting risperidone injection (shots).
      Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.
    

Detailed description: 
      Results from studies of older long-acting injectable antipsychotics (not risperidone) show
      that patients tend to relapse (which means start having symptoms again) when they are given
      low doses. However, increasing the dose may cause more side effects. This study will measure
      the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective
      disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses
      of long-acting risperidone injections (shots). The patients will be assigned to a dose of
      either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual
      oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week
      period, they will receive the injectable risperidone only. Patients will be asked questions
      at each visit to help determine the effectiveness of the drug as assessed by the Clinical
      Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug
      will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom
      Rating Scale and self-reported treatment-emergent adverse events. Long-acting risperidone
      injection, 25 or 50 milligrams per injection, every 2 weeks for 52 weeks. Patients will
      continue to take their current oral antipsychotics for up to 3 weeks following the first
      injection of risperidone.
    

Intervention name(s): Risperidone, long-acting injectable
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; long-acting risperidone; intramuscular injection risperidone; risperidone
Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery
Condition: Cognition
Study type: Interventional

Summary: 
      In this randomized controlled trial, we aim to investigate whether the avoidance of
      mechanical ventilation by application of nonintubated thoracoscopic surgery improves
      intraoperative cerebral oxygenation and postoperative cognition recovery for patients
      undergoing thoracic surgery.
    

Detailed description: 
      Postoperative neurocognitive impairment is not uncommon for patients undergoing thoracic
      surgery. Based on the literature, this is associated with reduced cerebral oxygenation during
      one-lung ventilation which may be because of reduced cardiac output, impeded cerebral venous
      return due to mechanical ventilation. In our hospital, nonintubated thoracoscopic surgery is
      commonly conducted and achieves noninferior outcomes than intubated thoracoscopic surgery.
      Particularly, the application of nasal high flow oxygen may maintain intraoperative
      oxygenation despite the absence of controlled ventilation. Therefore, the nonintubated
      technique may be beneficial to maintain an improved intraoperative cerebral oxygenation and
      hopefully improves postoperative cognition recovery. In this randomized controlled study, we
      aim to investigate the differences in intraoperative cerebral oxygenation and postoperative
      cognitive recovery bewteen nonintubated and intubated thoracoscopic surgery. Patient will be
      randomly assigned to receive nonintubated or intubated thoracoscopic surgery. During surgery,
      bifrontal cerebral oxygenation will be monitored. Cognitive test will be arranged before and
      after surgery.
    

Intervention name(s): Nonintubated; Intubated
Intervention type(s): Procedure; Procedure
Intervention description(s): During surgery, patient is deeply sedated and respiration is maintained by spontaneous breath under the nasal high flow oxygen support.; During surgery, patient received standard general anesthesia and respiration is maintained by using mechanical ventilation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative cognition; nonintubated thoracic surgery
A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to evaluate the sensory attributes and estimate the relative
      bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses
      by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout
      period of at least 14 days (Cohort 2).
    


Intervention name(s): Crizotinib prototype microsphere 0.529 mg/mg; crizotinib prototype microsphere 0.470 mg/mg; crizotinib prototype microsphere 0.420 mg/mg; crizotinib oral solution; crizotinib prototype microsphere 0.529 mg/mg; crizotinib prototype microsphere 0.470 mg/mg; crizotinib prototype microsphere 0.420 mg/mg; crizotinib capsule; crizotinib oral solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.; Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.; Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.; Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.; Subjects will receive a single 250-mg oral dose of crizotinib.; Subjects will receive a single 250-mg oral dose of crizotinib.; Subjects will receive a single 250-mg oral dose of crizotinib.; Subjects will receive a single 250-mg oral dose of crizotinib.; Subjects will receive a single 250-mg oral dose of crizotinib.
Intervention MeSH terms: Crizotinib; Pharmaceutical Solutions
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; taste; bioavailability
Shared Decision Making in Hospitalized AECOPD
Condition: COPD Exacerbation
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality
      worldwide. Patients require good communication with the physician to improve control illness.
      Shared decision making is a promising opportunity for chronic disease management due to the
      relative cost, medicine optimization and decreases hospital admissions/re-admissions
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is the leading one on hospital care cost,
      physician services, and prescription drugs. Additionally to the disease progression with the
      reduction in lung function, COPD patients experiment a progressive decline in functional
      capacity and health-related quality of life (HRQoL) with a significant burden in terms of
      disability. Shared Decision Making is defined as an approach where clinicians and patients
      share the available information to making clinical decisions, and where patients are
      counseled. SDM is a way to empower patients when decisions are made about treatment as a
      determinant factor in patient-centered care. Decision aids have been proven effective in
      improving disease knowledge, decision making, and self-care.
    

Intervention name(s): Shared decision making
Intervention type(s): Other
Intervention description(s): Decision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize how PF-05212384 is metabolized in the body
      following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).
    


Intervention name(s): PF-05212384
Intervention type(s): Drug
Intervention description(s): Single 89 mg Dose via 30 minute IV infusion
Intervention MeSH terms: Gedatolisib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers