bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of RV-Dysfunction in Fallot Patients
Condition: Tetralogy of Fallot
MeSH terms: Tetralogy of Fallot
Study type: Interventional

Summary: 
      In the presented study TDI will be used as a modern technique to characterize RV-function in
      Fallot patients at rest and during different exercise conditions.
    

Detailed description: 
      Tissue Doppler imaging (TDI) presents a modern technique to depict the velocity of tissue
      motion within a distinct area of the myocardium providing amendatory characterization of
      diastolic and systolic function of the heart. TDI is hypothesized to be of additional value
      in the evaluation of adult congenital heart disease, especially tetralogy of Fallot (TOF),
      which is one of the most common conditions. In particular, Fallot patients are at risk of
      developing right ventricular (RV) dysfunction due to pulmonary valve defects or alterations
      of the outflow tract. It is pivotal to recognize this progression at an early stage before
      irreversible changes occur. Aim of the study is to test feasibility of TDI in Fallot patients
      as a new technique that provides new parameters to characterize RV dysfunction, more precise
      than common methods. Additionally TDI is performed at rest and during different endurance
      testings (passive Leg Raising (PLR), handgrip (HG) and cardiopulmonary exercise (CPX), as
      certain changes might be compensated at rest, first apparent during exercise.
    

Intervention name(s): Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
Intervention type(s): Other
Intervention description(s): Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Transthoracic echocardiography including TDI is performed at rest, during PLR, HG and CPX in Fallot patients and healthy controls. In Fallot patients, transthoracic ultrasound at rest and during CPX are part of the routinely follow-up. PLR and HG were performed additionally as part of the investigator's study to analyze TDI parameters during various endurance testings
Masking: None (Open Label)
Primary purpose: Other
Keywords: Tetralogy of Fallot; Tissue Doppler Imaging; Exercise testing
A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium
      bromide 400 mcg 2x a day will be given as an active comparator.
    

Detailed description: 
      This is a randomized, six-way crossover study to determine the efficacy and dose-response
      profile of SUN101. The study population will consist of subjects 40 to 65 years-old
      (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will
      be given as an active comparator. The study will be double-blind for SUN-101 and placebo and
      will be open-label for aclidinium.
    

Intervention name(s): Placebo; SUN101 3 mcg; SUN-101 6.25 mcg; SUN-101 12.5 mcg; SUN-101 50 mcg; Aclidinium
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo; SUN-101 3 mcg bid; SUN-101 6.25 mcg bid; SUN-101 12.5 mcg bid; SUN-101 50 mcg bid; Aclidinium 400 mcg bid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults
Condition: West Nile Fever Encephalitis
MeSH terms: West Nile Fever; Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis,
      coma, and death. The purpose of this study is to test the safety of and immune response to a
      WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed
      against dengue virus.
    

Detailed description: 
      WN is widely distributed in Africa and Europe, where it is usually associated with mild
      illness. In the United States, WN is considered a public health threat because severe illness
      caused by WN infection has caused paralysis, coma, and death, especially in the elderly. This
      study will evaluate the safety and immunogenicity of a live attenuated chimeric virus,
      WN/DEN4-3'delta30, which is derived from the DEN4 dengue virus and wild-type WN serotypes.

      This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive
      the lowest dose of WN/DEN4-3'delta30 or placebo at study entry. Cohort 2 will begin only
      after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a
      higher dose of WN/DEN4-3'delta30 or placebo. Cohort 3 will begin only after safety review of
      all participants in Cohort 2. Participants in Cohort 3 will receive the highest dose of
      WN/DEN4-3'delta30 or placebo. Immediately after receiving their injections, participants will
      be observed for 30 minutes for immediate adverse reactions.

      After vaccination, participants will be asked to monitor their temperatures every day for 16
      days and on Day 19. Study visits will occur every other day after vaccination until Day 16,
      followed by 5 additional visits at selected days through Day 180. Blood collection and a
      targeted physical exam will occur at each study visit. Some participants will be asked to
      undergo a skin biopsy or additional blood collection at selected visits.
    

Intervention name(s): WN/DEN4-3'delta30; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses); Placebo for WN/DEN4-3'delta30 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Chimeric Virus Vaccine; West Nile Virus; Dengue Virus
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a)
Condition: Elevated Lipoprotein(a)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.
    


Intervention name(s): IONIS-APO(a)-LRx; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome
Condition: Healthy Volunteer, Autistic Disorder, Asperger's Syndrome
MeSH terms: Syndrome; Autistic Disorder; Asperger Syndrome
Study type: Observational

Summary: 
      This multi-center, non-drug study will explore the relationship between exploratory
      biomarkers and functional dimensions in male adult individuals with Autistic Disorder or
      Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of
      assessments on study visit Day 1.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        High functioning (IQ >70) male adult individuals with Autistic Disorder or Asperger's
        Syndrome and age and IQ matched healthy male volunteers
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      Double-blind, randomized, two period crossover comparison of the cognitive and behavioral
      effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
    

Detailed description: 
      This study is a double-blind, randomized, two period crossover design. The study consists of
      6 visits over a 21 week period. Forty six (46) normal healthy subjects will be treated with
      both Eslicarbazepine acetate (ESL, 800 mg/day) and Carbamazepine (CBZ, 800mg/day) for 6 weeks
      and 3 days each (maintenance 4 weeks and taper 3 days). Each antiepileptic drug (AED)
      treatment period will be followed by a four day taper and washout period off AED for the
      remainder of the month. Cognitive and behavioral testing along with safety testing will be
      conducted at pretreatment baseline, the end of each randomization AED maintenance period, and
      after the final washout period.
    

Intervention name(s): Eslicarbazepine; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg daily) . After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.; Healthy adults will be titrated onto Carbamazepine (400 mg bid). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.
Other intervention name(s): Aptiom; Tegretol
Intervention MeSH terms: Carbamazepine; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eslicarbazepine; Carbamazepine; cognition
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
Condition: Colostomy Stoma
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to
      standard of care (SOC; control) in subjects with open surgical wounds.
    

Detailed description: 
      This is a phase IIa open-label, randomized study to compare the safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of NM-IL-12 (rHuIL-12) to standard of care in
      subjects with open surgical wounds following colostomy takedown allowed to heal by secondary
      intention.
    

Intervention name(s): NM-IL-12; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): single 12 µg unit subcutaneous (SC) dose of NM-IL-12; single subcutaneous dose
Other intervention name(s): rHu-IL12, HemaMax
Intervention MeSH terms: Interleukin-12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NM-IL-12, HemaMax, Safety, Stoma Takedown, Wound closure
Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain affects about 60% to 90% of the working-age population in modern industrial
      society. Chronic mechanical low back pain (CMLBP) is the most common problem of the
      working-age population in modern industrial society; it causes a substantial economic burden
      due to the wide use of medical services and absence from work. The purpose of this trial was
      to evaluate the short-term effect of acupuncture dry needle in treatment of chronic
      mechanical low back pain.
    

Detailed description: 
      Low back pain affects about 60% to 90% of the working-age population in modern industrial
      society. Chronic mechanical low back pain (CMLBP) is the most common problem of the
      working-age population in modern industrial society; it causes a substantial economic burden
      due to the wide use of medical services and absence from work. The purpose of this trial was
      to evaluate the short-term effect of acupuncture dry needle in treatment of chronic
      mechanical low back pain. Thirty patients their age ranged from 20 - 45 years participated in
      our study and divided randomly into two equal groups suffering from nonspecific low back
      pain. The first group (A) consist of 15 patients receiving acupuncture dry needle over
      trigger points of back muscles followed by stretching and strengthening exercises for back
      muscles, the second group (B) consist of 15 patients receiving only stretching and
      strengthening exercises for back muscles. The following parameters including pain severity,
      functional disability and lumbar range of motion (flexion, extension, right side bending and
      left side bending) were measured before and after treatment.
    

Intervention name(s): Acupuncture dry needle
Intervention type(s): Other
Intervention description(s): The muscles that have been treated iliocostalis lumborum, quadratus lumborum, gluteus medius and piriformis muscles. The patients received 2 sessions per week for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture dry needle; Chronic mechanical low back pain
Dexmedetomidine and Ketamine in MRI
Condition: Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to examine the effects of two commonly used anesthetic
      drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in
      children, adolescents, and young adults.

      The results of this study will help in making the best decisions regarding the anesthesia
      medications used for sedation outside of the operating room.
    

Detailed description: 
      Upper airway obstruction is a common problem in spontaneously breathing patients under
      anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on
      the muscle tone and airway configuration in children under anesthesia. The hypothesis is
      adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology
      when compared to previously collected data using dexmedetomidine alone.
    

Intervention name(s): Dexmedetomidine; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): 2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h; Bolus dose 2 mg/kg after first set of research images are obtained
Intervention MeSH terms: Dexmedetomidine; Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sedation; MRI; Dexmedetomidine; Ketamine; General anesthesia; MRI of Brain; MRI of Brain/Spine
Stem Cells in Rapidly Evolving Active Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomised, double-blind crossover study to study the effect of intravenous
      treatment with autologous (derived from the individuals themselves) mesenchymal stem cells
      (MSCs) in patients with multiple sclerosis (MS).
    

Detailed description: 
      Current treatments for MS target the immune system and are not curative. There is much
      interest in MSCs as they have the potential to not only affect the immune system but may also
      promote repair. This study will use MSCs that are harvested from the bone marrow and grown
      for up to 52 days before being given back to the person from whom they were harvested. This
      avoids any chemotherapy so is therefore safer than other types of stem cells. In this
      crossover study, everyone will receive their own stem cells back but in half of the patients
      it will be delayed by 24 weeks.

      The primary outcomes are to check that the procedure is safe and to measure any changes on
      the MRI at 24 weeks. Other more exploratory measures will try to assess effects on repair in
      the central nervous system (CNS).
    

Intervention name(s): Mesenchymal stem cells; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0-2.0 million cells/kg body weight; Placebo
Other intervention name(s): Mesenchymal stromal cells; Sham
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; mesenchymal stem cells; bone marrow; rapidly evolving
Point of Care Testing of Inflammatory Markers in Tears
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes
Study type: Observational

Summary: 
      To evaluate the use of a point of care device to measure markers of inflammation in various
      eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is
      an enzyme that plays a role in inflammation. The value obtained with the point of care device
      will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the
      same sample. These data will be compared to clinical exam findings and questionnaires to help
      the investigators better understand the role of this marker of inflammation in eye diseases
      and possibly improve diagnostic abilities.
    

Detailed description: 
      As a participant in the study a sample of tears will be collected in a non-invasive manner by
      sitting comfortably at the slit lamp (a slit lamp is the standard device used to examine the
      eye and merely requires the participant to sit upright and place their chin on a chin rest
      and their forehead up against the slit lamp apparatus). The participant will then be asked to
      look upwards and while gently lowering the lower eyelid, a sterile blunt glass pipette will
      be used to collect tears from the natural tear lake (the tear lake is a reservoir of tears
      that sits on the surface of the eye and above the lower eyelid). Collected tears will then be
      taken for analysis of inflammatory markers.

      In addition, a survey to evaluate the symptoms and the symptoms impact daily life (Ocular
      Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire-
      25).
    

Intervention name(s): Eye inflammation; Without eye inflammation
Intervention type(s): Other; Other
Intervention description(s): This group will have a regular eye exam with the collection of tears. In addition, a the Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25 may be administered.; This group will have a regular eye exam with the collection of tears.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18-90 years of age that present to our North Central Florida Tertiary
        Referral University Eye Clinics for evaluation. Patients with and without evidence of eye
        inflammation will be eligible for this study.
      
Biospecimen description: 
      de-identified tear samples
    
Keywords: Ocular Inflammation; Matrix Metalloproteinase 9
SVT-40776 in Patients Suffering From Overactive Bladder Syndrome
Condition: Overactive Bladder (OAB)
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and
      tolerability compared to placebo and tolterodine
    


Intervention name(s): SVT-40776
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Clinical Trial for Vespa Amino Acid Mixture (VAAM®)
Condition: Sports Injury
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then
      followed by the generation of lactic acid. However, this process can only be maintained for a
      short time, approximately one minute, because the accumulation of lactic acid in the muscles
      may affect muscle performance. The efficiency of lactic acid metabolism is one of the most
      important reasons for endurance improvement. The purpose of this study was to evaluate the
      impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®)
      beverage on blood parameters that are related to fatigue, muscle damage and immunity in
      healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of
      amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive
      required speed and strength running tests.
    

Detailed description: 
      The subjects were instructed to maintain their usual dietary habits in addition to drinking
      VAAM® (two cans every day) for 10 weeks. In detail, on the 6 days/week of supervised running
      tests, participants were instructed to consume one drink before their warm-up exercise and
      the other drink while running. During their sessions and without supervision (1 day/week),
      participants were also instructed to consume one drink in the morning after breakfast and the
      other drink in the evening after dinner.

      The subjects were divided into three groups for the running tests: 3 males were assigned to
      group 1, which involved training for the 1500-meter race; 2 males were assigned to group 2,
      which involved training for the 800-meter race; and 1 male and 3 females were assigned to
      group 3, which involved training for the 400-meter race. The running exercises began with a
      45 min warm-up (including jogging, leg stretching, etc.) followed by running their specific
      races. The experimental procedure was conducted 6 days/week for 10 weeks.
    

Intervention name(s): Vespa amino acid mixture
Intervention type(s): Dietary Supplement
Intervention description(s): 17 kinds of amino acids mixture in specific proportion
Other intervention name(s): VAAM®
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Vespa amino acid mixture (VAAM®); Young athletes; Nutrition; lactic acid accumulation; Anaerobic metabolism; ATP; Sports damage
Mechanism of Hypersensitivity Reactions to Iron Nanomedicines
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies; Hypersensitivity
Study type: Observational

Summary: 
      Iron deficiency is common and when oral treatment is not sufficient intravenous application
      is indicated. Hypersensitivity to intravenous iron nanomedicines is rare but does occur and
      little is known about the underlying mechanism but complement activation has been suggested.

      This is a purely exploratory study as it is not yet known whether in vitro complement
      activation can be stimulated by titration with iron preparations. These data will provide
      first empirical evidence of whether and to what extent complement activation occurs in this
      population.
    


Intervention name(s): hypersensitivity reaction
Intervention type(s): Behavioral
Intervention description(s): Previous hypersensitivity reaction
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        participants with a previous hypersensitivity reaction to an iron nanomedicine application
        and participants without a hypersensitivity reaction to a previous iron nanomedicine
        application
      
Keywords: hypersensitivity