bioihbjkbjnl/mcl2 huggingface dataset:
hCT-MSC in Children With Autism Spectrum Disorder
Condition: Autism; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II study is to determine the efficacy of human umbilical cord
      tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication
      abilities in children with autism spectrum disorder (ASD).
    

Detailed description: 
      The purpose of this double blinded Phase II study is to determine the efficacy of human
      umbilical cord tissue-derived mesencymal stromal cells (hCT-MSC), administered in two
      different dosing strategies, in children with autism spectrum disorder (ASD).

      This study will be enrolling children with ASD, aging 4-11 years of age. Qualifying subjects
      will undergo neuropsychological evaluation, EEG testing, eye tracking, CVA assessments, and
      infusion of study product. Subjects will be randomized to one of two study arms; 1) a single
      infusion of 6.0x106 cells/Kg at baseline, followed by a blinded placebo infusion at six
      months or, 2) Placebo infusion at baseline, followed by an intravenous dose of 6x106 cells/Kg
      at six months.

      The primary endpoint of this study is the change in social communication skill from baseline
      to six months. The potential risks associated with infusion of MSCs include a reaction to the
      product (rash, shortness of breath, wheezing, difficulty breathing, hypotension, swelling
      around the mouth, throat or eyes, tachycardia, diaphoresis), transmission of infection, and
      HLA sensitization.
    

Intervention name(s): Cord Tissue Mesenchymal Stromal Cells; Placebo Infusion
Intervention type(s): Biological; Other
Intervention description(s): Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC), isolated and expanded from umbilical cord tissue from allogeneic unrelated donors. One dose of 6x10e6 cells/kg administered intravenously.; Placebo comparative infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a phase II, prospective, randomized, blinded, cross over, clinical trial designed to assess the efficacy of intravenous dosing of hCT-MSC for improving social communication abilities in young children with ASD. All participants will ultimately be treated with hCT-MSC. Participants randomized to arm A will each receive a single intravenous dose of 6x106 hCT-MSC per kilogram at baseline, followed by a placebo infusion at six months. Participants randomized to arm B will each receive a placebo infusion at baseline, followed by an intravenous dose of 6x106 hCT-MSC per kilogram at six months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorder; Stem cell; Mesenchymal Stromal Cells
Compliance With Treatment For Patients With Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      It is a prospective observational study.

      Patients will be high risk patients (for developing cardiovascular events) that are treated
      with a statin. Patients will be enrolled at a normal clinic visit and provided with a small
      box containing info about the disease, a LDL self-test and two questionnaires. They will test
      themselves for LDL at home between normal clinic visits (normally 12 months interval) and
      note their value. In the end of the study all patients will fill out a questionnaire with
      questions if the tests and info have raised their awareness of the disease as well if their
      motivation to be compliant has increased.

      We want to look at the possibility to put more responsibility for treatment and for reaching
      treatment goals on the patients since there's a big problem with compliance in this group of
      patients.
    

Detailed description: 
      Consecutive patient sampling
    

Intervention name(s): Lipid Self Test
Intervention type(s): Device
Intervention description(s): Self test for lipid levels, twice during study period
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Aged 18 years or older and able to understand and sign the informed consent form.

        • Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular
        disease prescribed statin treatment according to clinical praxis and the recommendations
        set forth in the MPA national guideline for treatment of hyperlipidemia.
A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge
      diagnosis. Medication management practices for schizophrenia often are not
      guideline-concordant and place patients at risk for adverse outcomes. This project tests a
      new strategy to standard implementation for VHA Schizophrenia Guidelines.
    

Detailed description: 
      Background:

      Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge
      diagnosis. Medication management practices for schizophrenia often are not
      guideline-concordant and place patients at risk for adverse outcomes. This project tests a
      new strategy to standard implementation for VHA Schizophrenia Guidelines.

      Objectives:

      Research objectives are: (1) to compare the effectiveness of a conceptually-based, enhanced
      intervention to that of a basic educational strategy with regard to improving guideline
      adherence and patient compliance; (2) to compare the effectiveness of the two strategies with
      regard to improving symptom and side effect outcomes; (3) to determine the effect of the
      enhanced intervention on service utilization for acute exacerbations of schizophrenia; (4) to
      determine the extent to which guideline-concordant medication management improves patient
      outcomes; and (5) to examine providers' knowledge of and attitudes toward guidelines.

      Methods:

      Thirteen VA sites were considered for the study, and VistA data were extracted to assess
      baseline guideline performance. Seven sites were selected and received basic education about
      schizophrenia guidelines. Three of these sites were randomly selected to receive the enhanced
      intervention, employing a nurse coordinator to promote providers' guideline adherence and
      patients' treatment adherence. Subjects with an acute exacerbation of schizophrenia were
      enrolled and were interviewed at baseline and six months using the Positive and Negative
      Syndrome Scale, the Schizophrenia Outcomes Module, and the Barnes Akathisia Scale. Data on
      guideline adherence were collected from medical records and VistA files. When data collection
      is completed, analyses will be conducted to determine the effectiveness of the enhanced
      intervention with regard to improving guideline adherence and patient outcomes.

      Status:

      The project is ongoing. To date, 401 subjects have been enrolled in the intervention study.
      The rate of completed follow-up assessments to date is 86 percent.
    

Intervention name(s): Test strategy for implementation guideline
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA
Condition: Anesthesia; Pain; Nerve Pain; Knee Arthroplasty; Nerve Block
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The purpose of this study is to determine which technique for catheter placement in
      continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2)
      nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained
      post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with
      pain scores for the first 48 hour post-FNB.
    

Detailed description: 
      Continuous femoral nerve block (cFNB) is a widely used regional anesthetic technique for many
      lower limb operations, such as total knee arthroplasty (TKA), anterior cruciate ligament
      repair, tibial osteotomy and patellar surgery. It provides superior pain relief, faster
      ambulation, shorter hospital stays and less risk of side effects in comparison to patient
      controlled analgesia (PCA), local anesthetic wound infiltration, or single shot femoral nerve
      block (FNB).

      Stimulating catheters were introduced in 1999 to provide an objective end point to guide
      continuous nerve block catheter position by maintaining the desired evoked muscle response
      with nerve stimulation (NS). The main advantages of stimulating catheters are faster onset of
      sensory and motor block and reduction of local anesthetic drugs consumption. In recent years
      the precise insertion of continuous catheters has improved especially with the introduction
      of ultrasound (US)-guided imaging to regional anesthesia practice and advances in scanning
      techniques. That led to a call to reduce cost by switching to non-stimulating catheters.
      However, most studies comparing both catheters lacked anesthetic technique standardization
      and adequate sample size.

      In this prospective randomized controlled trial, we compared postoperative analgesic efficacy
      and opioids consumption in patients having cFNB insertion using US alone and that of US
      combined with NS.
    

Intervention name(s): Ultrasound; Ultrasound + Nerve Stimulation
Intervention type(s): Device; Device
Intervention description(s): Femoral catheter inserted using ultrasound only; Femoral catheter inserted using ultrasound and nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Correlational Study of PPV in Various VT in Mechanically Ventilated Patients
Condition: Respiration, Artificial
Study type: Interventional

Summary: 
      Mesquida, J et al showed there was a significant linear correlation between pulse pressure
      variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase
      of severe sepsis and septic shock. No study revealed the actual relationship between various
      PPV under different VT. So we hypothesized that there were relationship between various PPV
      in different tidal volume settings. The objective of this study was to examine the
      relationship between various PPV.
    


Intervention name(s): 300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation
Intervention type(s): Other
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Intervention model: Single Group Assignment
Masking: None (Open Label)
Dexmedetomidine in Seizure Patients
Condition: Seizure Disorders
MeSH terms: Seizures; Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique
      properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical
      patients frequently come to the operating room on anticonvulsant therapy with a history of
      seizures. The investigators clinical experience suggests that these patients are resistant to
      the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic
      interaction between the anticonvulsant medications and dexmedetomidine or the higher
      dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the
      underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic
      and pharmacodynamic differences of dexmedetomidine between patients receiving and not
      receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for
      these differences.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Epilepsy; Dexmedetomidine; Seizure
A Study of LY2979165 in Healthy Subjects
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study. Part A is a multiple-ascending dose study in up to 6 different
      groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A will
      allow investigation of up to 6 different doses of LY2979165. The drug will be administered
      for a total of 14 days. Subjects will be resident in the clinical research unit (CRU) from
      Day -1 (the day before dosing) until Day 15.

      Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12
      subjects. The drug will be administered for a total of 14 days. In addition to the same
      assessments as would have been completed in Part A, subjects in Part B will also have
      cerebrospinal fluid samples taken from the lower lumbar region of their spine.
    


Intervention name(s): LY2979165; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Attidutes and Understanding of Oat Fibre Claims on Food Labels
Condition: Consumer Research; General Population
Study type: Observational

Summary: 
      Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for
      heart health. Oat and fibre claims on food labels should help people find heart healthy food
      choices; however consumer attitudes and understanding of such claims are unknown.

      The objective of this study was to evaluate the attitudes and understanding to different
      types of permitted oat fibre claims.
    


Intervention name(s): Mock Package Questionnaire
Intervention type(s): Behavioral
Intervention description(s): Within a online questionnaire we exposed participants randomly to 4 mock cereal packages differing only by the nutrition claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A subsection of the Canadian Consumer Monitor Panel - a national representative online
        consumer panel comprised of 30,000 Canadians
      
Keywords: Attitudes and understanding of oat fibre claims; Food labels; General Canadian population
Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open label clinical study to evaluate the safety and the efficacy of MesenCure, an
      allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19
      patients
    

Detailed description: 
      Primary endpoint: The IV administration of MesenCure is safe under the following conditions:
      in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical
      situation and radiologic findings.

      Secondary endpoint: The IV administration of MesenCure is efficacious under the following
      conditions:

      Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA
      O2 saturation, hospitalization duration.

      ______________________________________________________ Laboratory findings: leukocyte and
      lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.

      ______________________________________________________ Radiologic findings: pulmonary
      infiltrates, pleural effusion.
    

Intervention name(s): MesenCure
Intervention type(s): Biological
Intervention description(s): Three administrations of MesenCure in addition to standard care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
N-of-1 Trials Using mHealth in Chronic Pain
Condition: Musculoskeletal Pain; Chronic Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Study type: Interventional

Summary: 
      Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in
      a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and
      see if the treatment is successful. If the treatment is unsuccessful, they will try a
      different treatment. The disadvantage to this method is that it may take a long time to find
      a successful treatment.

      The purpose of the PREEMPT Study is to test whether using a mobile phone application
      ("Trialist app") that allows patients and their health care providers to run personalized
      experiments comparing two pain treatments is more effective than usual care. Patients
      download the app, and working with their clinicians, set up a personalized trial that makes
      sense for them. Every day they answer questions to track levels of pain and side effects of
      treatment, such as fatigue and constipation. Once the personalized trial has ended, the
      responses to these daily questions on each treatment will be compared. During a regular
      clinic visit, the patient and the clinician will review visual displays of the results to
      facilitate treatment decision-making. Approximately 250 patients will be enrolled in the
      study. Half the patients will use the app and review results with the clinician, and half the
      patients will continue with their regular care (i.e., will not use the app). The two groups
      will be compared to see if using the app is successful in improving long term pain outcomes.
      The goal of the intervention using the Trialist app is to help patients engage actively and
      collaboratively with their clinicians and identify effective treatments more quickly.
    


Intervention name(s): Trialist Intervention; smartphone
Intervention type(s): Behavioral; Device
Intervention description(s): Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.
Other intervention name(s): Trialist smartphone app; mobile health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Musculoskeletal pain; Chronic pain; Patient centered outcomes research; Physician patient relationship; Mobile applications
Finger Muscle Reaction After Electrical Stimuli to the Human Finger Pulley System; a Pilot Study
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP
      joint ligamento-muscular reflexes and their role is.
    

Detailed description: 
      Encapsulated nerve endings called mechanoreceptors are end components of afferent nerves and
      have specialized end organs surrounding the nerve terminal. Those receptors are concentrated
      in various human periarticular tissues. It is believed that these mechanoreceptors in the
      periarticular tissues are related to muscle reflexes. However, it is still unknown which type
      of mechanoreceptors contribute to the muscle reflexes and whether the mechanoreceptors excite
      and/or inhibit muscle activation. In the investigators previous studies, mechanoreceptors in
      the human proximal interphalangeal (PIP) joint and surrounding structures have been
      extensively examined. The investigators have identified that Pacini-like nerve endings in the
      PIP joint were found in substantial numbers in the junction of the C1 pulley and accessory
      collateral ligaments. The investigators hypothesize that the Pacini-like nerve endings in the
      junction of the C1 pulley generate activity in the associated flexor muscle/tendon in the
      finger.
    

Intervention name(s): Guided insertion of electrodes; Electromyographic (EMG) recording
Intervention type(s): Procedure; Procedure
Intervention description(s): Fine-wire needle electrodes (30mm x 27gauge needle with a pairs of 0.051mm, insulated, hooked wires, Motion Lab Systems, Baton Rouge, LA) guided by sonographic evaluation of the pulley system using a Philips iU22 Ultrasound Machine (Philips Ultrasound Systems, Bothell, WA), a 17-5 MHz linear array transducer, and standard ultrasound gel.; EMG signal recording, performed with an MA 300 EMG system (Motion Lab Systems, Baton Rouge, LA).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: Mechanoreceptors; PIP joint; Ligamento-muscular reflexes
Calcium Intake and Fat Excretion
Condition: Fat Excretion; Energy Excretion
Study type: Observational

Summary: 
      The overall purpose of this study is to examine the effect of calcium on fecal fat and energy
      excretion.
    

Detailed description: 
      Several reports have found inverse associations between calcium intake and body weight. Few
      intervention studies have shown that a high calcium diet resulted in a greater body weight
      loss than a low calcium diet. The mechanism is not clear, but one possible explanation is
      reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps
      or binding of bile acids which impairs the formation of micelles.

      The aim of this study is to examined for an association between habitual calcium intake and
      fecal energy and fat excretion, concentrations of substrates involved in energy metabolism,
      blood pressure and body weight
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Residents of Copenhagen and Sjælland
      
Biospecimen description: 
      Whole blood, urine and faeces
    
Keywords: Calcium intake; Fat excretion; Energy excretion; Gut micro flora