bioihbjkbjnl/mcl2 huggingface dataset:
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
Condition: Diabetes Type 2; Dementia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on
      brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism
      using positron emission tomography before and after short-term administration of transdermal
      17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal
      women.
    

Detailed description: 
      Epidemiological studies suggest there may be an interaction between type 2 diabetes and
      estrogen in postmenopausal women, such that diabetes may interact with estrogen levels over
      time to increase risk for dementia. The mechanism for this effect is now known. However,
      animal research suggests that it may occur through estrogen's effects on cellular metabolism
      of glucose and ketone bodies. The primary aim of this study is to test whether type 2
      diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be
      accomplished by imaging brain metabolism using positron emission tomography before and after
      short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with
      diabetes and 10 non-diabetic postmenopausal women.
    

Intervention name(s): Estradiol patch
Intervention type(s): Drug
Intervention description(s): transdermal 17β-estradiol patch
Other intervention name(s): Climara patch
Intervention MeSH terms: Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Primary Objective: The primary objective is to determine whether the effects of glucose and ketone body uptake to the brain in response to 8-week administration of transdermal 17β-estradiol differ in postmenopausal women with and without type 2 diabetes.
Masking: None (Open Label)
Primary purpose: Other
Keywords: women's health; estradiol; postmenopausal
Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      Postoperative complication rates in patients undergoing pancreaticoduodenectomy remain high
      although the operation techniques have developed a lot in recent years. There is evidence
      that restrictive intraoperative fluid therapy could decrease postoperative complication rates
      but the results of the former studies have been somewhat controversial. The aim of this study
      is to examine whether the intraoperative and postoperative fluid therapy affect to the
      postoperative complication rates in patients undergoing pancreaticoduodenectomy.
    

Detailed description: 
      The study is a retrospective cohort study. The first cohort consists of patients who
      underwent pancreaticoduodenectomy in year 2015 when intraoperative fluid therapy were managed
      using goal directed fluid therapy technique. The second cohort consists of patients who
      underwent pancreaticoduodenectomy in year 2017 when intraoperative fluid therapy were based
      on the consideration of the anaesthesiologist. In 2015 most of the patients spent the first
      postoperative night in the ICU where the fluid management and monitoring of the urine output
      and vital functions were more controlled than in the normal ward. In 2017 most of the
      patients got in the regular ward right after the surgery. The aim of the study is to examine
      whether there are differences in the amounts of the intraoperative and postoperative fluids
      between the cohorts and does the perioperative fluid therapy affect to the complication
      rates.
    

Intervention name(s): Goal directed fluid therapy; Liberal fluid therapy
Intervention type(s): Other; Other
Intervention description(s): Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.; Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients who have underwent pancreaticoduodenectomy in years 2015 and 2017 are counted
        in the study.
      
Keywords: pancreaticoduodenectomy; Clavien-Dindo classification; pancreatic fistulas
Inofolic NRT and the Metabolic Syndrome
Condition: Metabolic Syndrome; Postmenopausal Disorder
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      A prospective, randomized, controlled, open-label study will be carried out on 80
      post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP
      III). After a written informed consent, women will be randomly treated for 6 months with
      hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg
      plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty
      post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40
      treated with myo-inositol 2 g twice per day and forty treated with placebo for six months.
      The investigators hypothesize that the administration of myo-inositol would improve the
      insulin-receptor activity in these women, reducing insulin resistance.
    

Detailed description: 
      Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by
      metabolic syndrome according to ATP III, 2001.

      At least 3 of following 5 criteria must be present:

        1. waist circumference > 88 cm

        2. Triglycerides > 150 mg/dl

        3. HDL-cholesterol < 50 mg/dl

        4. Fast glycemia > 110 mg/dl

        5. Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -

      Exclusion Criteria:1) post-menopausal women with less than 12 months from the last
      menstruation 2) less than 3 criteria according with ATP III 3) TSH > 3.5 4) in treatment with
      drugs lowering glycemia or cholesterol 5) allergy to cocoa
    

Intervention name(s): Inofolic NRT
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: menopause; metabolic syndrome; myo-inositol; insulin resistance; cocoa polyphenols; isoflavones
A Phase 1/2 Study to Determine Safety and Immunogenicity of Two COVID 19 Vaccines VB10.2129 (RBD Candidate) and VB10.2210 (T Cell Candidate) Previously Vaccinated in Healthy Adult Volunteers
Condition: COVID-19; Infection Viral; Infections
MeSH terms: Infections; Communicable Diseases; COVID-19; Virus Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open label, dose escalation, and dose expansion study to evaluate the safety,
      reactogenicity and immunogenicity of two SARS-CoV-2 DNA plasmid vaccine candidates, VB10.2129
      (C1) and VB10.2210 (C2). tThree dose levels will be tested. IM administrations 21 days apart.
      Part 1 is a dose escalation phase and Part 2 is a dose expansion phase. In Part 2 a selected
      dose will be tested further in additional healty volunteers.
    

Detailed description: 
      This is an open label, dose escalation, and dose expansion study designed to evaluate the
      safety, reactogenicity and immunogenicity of two SARS-CoV-2 or COVID-19 DNA plasmid vaccine
      candidates, VB10.2129 (C1) and VB10.2210 (C2).

      Part 1 is a dose escalation phase and Part 2 is a dose expansion phase and both vaccine
      candidates, ie, VB10.2129 (C1) and VB10.2210 (C2) will be tested.

      Part 1 consist of two arms: one arm with each vaccine candidate and each arm investigating
      three escalating dose levels.

      10 subjects previously vaccinated with an mRNA vaccine will be enrolled at each dose level.
      Each subject will receive two vaccinations 21 days apart (Day 0 and Day 21).

      In Part 2 is a dose expansion phase with one arm for each candidate; VB10.2129 and VB10.2210,
      in previously vaccinated healthy subjects only. The dose to be investigated will be selected
      based on safety and inital immune response data from Part 1. All subjects will be folowed for
      up to 1 year after the first vaccination.
    

Intervention name(s): VB10.2129; VB10.2210
Intervention type(s): Biological; Biological
Intervention description(s): 0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0; 3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two vaccine candidates are investigated in parallell.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19; Coronavirus; DNA vaccine; Vaccine
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Cervical Carcinoma
Condition: Cervical Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional
      therapy using digital subtraction angiography（DSA） for cervical carcinoma.
    

Detailed description: 
      By enrolling patients with cervical carcinoma adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of HepaSphere
      interventional therapy using digital subtraction angiography（DSA） for cervical carcinoma.
    

Intervention name(s): interventional therapy
Intervention type(s): Procedure
Intervention description(s): cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Carcinoma; HepaSphere
The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients
Condition: Children
Study type: Observational

Summary: 
      The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway
      maintenance during routine anesthesia and as a conduit for tracheal intubation for patients
      with a difficult airway. The investigators goal for this study is to compare the performance
      of the ILA with the current standard of care the standard LMA during routine anesthesia.
    

Detailed description: 
      The goal for this randomized, crossover investigation is to compare a disposable version of
      the standard LMA, LMA Unique TM,with the air-Q ILA in pediatric patients. Oropharyngeal leak
      pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible
      fiberoptic bronchoscope examination is often employed to assess proper placement of airway
      devices. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these
      regards:

        1. We hypothesize that airway leak pressures will be higher with the ILA. Airway leak
           pressures will be measured by recording the circuit pressure at which an equilibrium is
           reached.

        2. We hypothesize that flexible fiberoptic view of the airway will be superior with the
           ILA. The airway view will be assessed using a previously used and published grading
           scale.
    

Intervention name(s): each child will receive both the LMA and ILA
Intervention type(s): Device
Intervention description(s): each child will receive both the size 2 LMA and size 1.5 ILA
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy children undergoing general anesthesia for their scheduled elective outpatient
        surgeries using a supraglottic airway device for airway maintenance.
      
Keywords: airway sealing pressure; fiberoptic assessment; ease and time for successful insertion; incidence of gastric insufflation; complications were also evaluated
Improving Outcomes and Quality of Life After CABG
Condition: Coronary Artery Bypass Graft Surgery Patients
Study type: Interventional

Summary: 
      The principal objective to this randomized trial is to compare the efficacy of two strategies
      of intra-operative hemodynamic management during cardiopulmonary bypass among patients
      undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing
      peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative
      deterioration in the patient's quality of life as measured by the seven domains of SF-36
      Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role
      function).
    

Detailed description: 
      In one group, mean arterial pressure (MAP) was 65 mmHg. In the other, the MAP target was
      determined by the patients usual preoperative MAP. Thus, the trial will evaluate whether
      tailoring the MAP target for the period of cardiopulmonary bypass to within 10 mmHg of the
      patients usual MAP, but < 90 mmHg (and thus achieving pressures during bypass within the
      patients usual autoregulatory range) reduces major neurologic and cardiac morbidity and
      mortality, as well as cognitive complications, thereby improving post-operative quality of
      life.
    

Intervention name(s): Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Cardiopulmonary bypass; Coronary artery disease; Cardiac morbidity; Neurologic morbidity; Neurocognitive function; Autoregulation
ViVEXX Carotid Revascularization Trial (VIVA)
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire
      Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery
      stenosis in patients at high risk for carotid endarterectomy.
    

Detailed description: 
      Patients with clinically significant stenosis within the common and/or internal carotid
      artery who are at high risk for carotid endarterectomy and are amenable to percutaneous
      treatment including embolic protection, balloon angioplasty and the carotid stent placement.
    

Intervention name(s): Carotid Artery Stenting
Intervention type(s): Device
Intervention description(s): placement of a bare metal stent at sites of stenosis in the carotid artery
Other intervention name(s): CAS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carotid; Artery; Stenosis
Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
Condition: Investigating Spinal Atrophy in Patients With Spinal Injury
MeSH terms: Spinal Injuries
Study type: Observational

Summary: 
      We aim to investigate the effect of motor skill training of the upper and lower limbs on the
      function and structure of the CNS as measured by neuroimaging parameters sensitive to changes
      in tissue volume and density and the properties of myelin.
    

Detailed description: 
      Functional recovery following human spinal cord injury (SCI) remains frustratingly limited
      and the majority of patients are left with severe impairments. While rehabilitative training
      has been shown to improve clinical outcome following SCI and has a major effect on patients'
      quality of life, the neuronal mechanisms underpinning neurological and functional recovery
      are not well understood.

      Until recently, degenerative changes in components of the CNS remote to a SCI were thought to
      occur slowly (over years) and correlate with the degree of disability. Using longitudinal MRI
      protocols we have shown that these structural changes in fact occur early and progress both
      at the cord and brain level according to a specific spatial and temporal pattern (Freund et
      al 2013). It is thought that these trauma-induced structural changes progress retrogradely
      along central motor nerve fibres of the myelinated corticospinal tract (CST) and this is
      accompanied over time by shrinkage of corticospinal projecting neuronal bodies. Crucially,
      patients with less atrophy throughout the CST were those with better clinical recovery at
      twelve months. Despite this significant recovery advantage in some patients, all participants
      showed irreversible tissue loss, potentially hindering further recovery. Using the
      neuroimaging biomarkers established in the previous study cited above, we now aim to assess
      whether specific and intensive motor learning through tasks for the upper and lower limb
      might slow or reverse the atrophy seen in the sensorimotor system.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with spinal injury
Neurofeedback-EEG-VR System for Non-opioid Pain Therapy
Condition: Pain Management
Study type: Interventional

Summary: 
      This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system
      for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR
      and Neurofeedback training and their pain will be assessed.
    

Detailed description: 
      QUASAR and UCSD are conducting a clinical trial on 25 subjects to evaluate the feasibility of
      a novel Neurofeedback electroencephalography (EEG) Virtual Reality (VR) system aimed at
      reducing chronic pain. The NEVR device consists of a dry electrode EEG headset combined with
      a VR Head-Mounted Display (VR-HMD) device and neurofeedback software. This approach relies on
      retraining the brain's networks to reduce the perception of pain and does not involve
      pharmaceutical drugs. Patients with chronic lower back pain will be recruited by UCSD at its
      Altman Clinical & Translational Research Institute. Patients that meet the recruitment
      criteria will be asked to conduct 20 1-hour long sessions of EEG-based Neurofeedback in VR
      over the course of a couple of months. Pain assessment and device usability questionnaires
      will be conducted prior to and after the first and last sessions, and at intermediate time
      points. This will be a single arm clinical trial aimed at demonstrating the safety and
      viability of the NEVR device, with the primary outcome measure being the ability of patients
      to conduct all 20 sessions safely and comfortably. Secondary outcome measures include
      assessment of changes in pain perception, and of changes in EEG activity patterns.
    

Intervention name(s): NEVR
Intervention type(s): Device
Intervention description(s): a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if we can safely regenerate cartilage without invasive
      surgery using a biologic product called TissueGene-C.
    

Detailed description: 
      Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A
      total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of
      the knee joint (as determined by radiographic examination) will be enrolled into the study.
      TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C
      will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will
      receive a single normal saline injection.

      The objectives of this study are to:

        1. Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of
           knee osteoarthritis including pain.

        2. Evaluate the safety of administration of a single intra-articular dose of TissueGene-C
           as evidenced by observation of the injection site for irritation or other abnormalities,
           the incidence and severity of adverse events, and the changes in physical examination
           findings and laboratory tests, including immune analyses.

        3. Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication.

        4. Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance
           imaging (MRI).

        5. Evaluate distribution of hChonJb#7 cells out of the injection site.

        6. Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty
           after treatment
    

Intervention name(s): TissueGene-C; Normal Saline
Intervention type(s): Biological; Drug
Intervention description(s): Single intraarticular injection at 3 x 10e7 cells; Single intraarticular injection of normal saline as a placebo control
Other intervention name(s): TG-C; 0.9% Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cartilage; Knee; Osteoarthritis
Disturbed Sleep Model Study.
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG
      nights, study drug administration and noise model is conducted on second night.
    


Intervention name(s): SB-649868; Zolpidem; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SB-649868 tablets will be available with dose strength of 5 and 25 mg.; Zolpidem capsules will be available with dose strength of 10 mg.; Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Other intervention name(s): SB-649868
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Noise induced Situational insomnia,; healthy volunteers; SB-649868,; Zolpidem,