bioihbjkbjnl/mcl2 huggingface dataset:
Short Term Choline and Cardiovascular Health
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary
      choline, has recently been causally linked to atherosclerosis in animal models and has been
      shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort
      studies. The relevance of observations in animals to humans is unclear and little information
      is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays
      a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO
      impairs vascular function in humans is not known. The purpose of this study is to determine
      if short term supplementation of dietary choline, which increase TMAO, impairs vascular
      function.
    


Intervention name(s): Choline; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) for 28 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of choline bitartrate the evening before the third testing session to study its acute effects.; Participants will consume 1000 mg (2x500 mg) of placebo for 28 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of placebo the evening before the third testing session to study its acute effects.
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, placebo-controlled, crossover design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Choline; Trimethylamine N-Oxide; Vascular health
Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this dispensing study is to evaluate the clinical performance of habitual wearers
      of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
    

Detailed description: 
      This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study,
      reviewing the refit characteristics in a group of enfilcon A wearers switched to the
      fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist
      and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the
      dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.
    

Intervention name(s): fanfilcon A (test)
Intervention type(s): Device
Intervention description(s): contact lens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Clopidogrel on Allergen Challenge in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      In asthma, breathing in an allergen, such as house dust mite induces inflammation in the
      airways. This process appears to involve an interaction between two different sorts of blood
      cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose
      of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on
      platelets, reduces inflammation following breathing in house dust mite in people with mild
      asthma.
    


Intervention name(s): Clopidogrel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel 75mg daily for 7 days; Matched placebo
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment.
Condition: Trans Abdominal Ultrasound; Transvaginal Ultrasound; Lower Uterine Segment Thickness
Study type: Observational

Summary: 
      aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and
      transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS
      measured with manual caliper measurement during cesarean delivery.

      Study hypothesis: In women with previous cesarean delivery, determination of the LUS
      thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and
      compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery.

      Study question: considering transabdominal & transvaginal ultrasound, which of them would be
      more accurate in the assessment of LUS thickness?
    


Intervention name(s): transabdominal ultrasound and transvaginal ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Within a week before scheduled delivery,antepartum transabdominal and transvaginal ultrasound will be performed with moderately full bladder.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        130 pregnant women at term with a previous one cesarean section admitted for an elective
        cesarean delivery will be enrolled. LUS thickness will be measured using both TVS and TAS
        prior to the cesarean. The actual thickness of the LUS will be measured using a sterile
        metal ruler before the neonate had been delivered.
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
Condition: Hyperlipidemia; Hypertension
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan
      co-administration and Livalo fixed combination drug in healthy male subjects.
    


Intervention name(s): Livalo fixed combination drug; Pitavastatin, Valsartan
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin 4mg / Valsartan 160mg; Pitavastatin 4mg, Valsartan 160mg
Other intervention name(s): Livalo, Diovan
Intervention MeSH terms: Valsartan; Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pitavastatin; Valsartan
Flexibility of Cognition And Persistent Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      This observational study aims to determine the association between preoperative cognitive
      flexibility and the risk of developing PPSP by preoperative administration of cognitive
      tests.
    

Detailed description: 
      Postoperative pain is a normal, physiologic, protective response to tissue injury that
      routinely resolves after healing of the surgical site. However, in some patients, pain
      persists long after surgery. PPSP is a diagnosis of exclusion that has most consistently been
      defined as pain that (1) developed after a surgical procedure, (2) is not residual from a
      preexisting condition, (3) has lasted for at least two months, and (4) is not attributable to
      other causes. One suggested risk factor for PPSP is poorer performance on tests of cognitive
      flexibility. Two common tests of cognitive flexibility are the Trail Making Tests (TMT) A and
      B and the Color Word Matching Stroop Test (CWMST).

      Three hundred patients undergoing either total knee arthroplasty or thoracotomy/mastectomy
      will be enrolled. During preoperative evaluation, participants will complete the TMT and
      CWMST. Subjects will be followed prospectively and will complete surveys at one month, six
      months, and one year postoperatively to assess PPSP prevalence and intensity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are 18 to 85 years of age undergoing unilateral TKA for osteoarthritis,
        unilateral mastectomy for breast cancer, or thoracotomy or video-assisted thoracoscopic
        surgery for any non-cardiac indication will be recruited for participation in the study
        during their initial preoperative visit at the Washington University Center for
        Perioperative Assessment and Planning (CPAP). Patient eligibility will not be affected by
        the anesthetic plan including the potential use of regional anesthesia techniques.
      
Keywords: Total Knee Arthroplasty; Thoracotomy; Mastectomy; Video-Assisted Thoracoscopic Surgery (VATS); Persistent Pain; Cognitive Flexibility
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent
      JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the
      Methotrexate Prefilled Pen (including a label comprehension assessment and a device
      robustness evaluation).
    


Intervention name(s): methotrexate prefilled pen
Intervention type(s): Device
Intervention MeSH terms: Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Safety and Efficacy Study of an Edible Colonoscopy Preparation
Condition: Colon Prep for Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep
      Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.
    


Intervention name(s): ECP Colon Prep Kit; MoviPrep®
Intervention type(s): Drug; Drug
Intervention description(s): ECP Colon Prep Kit; MoviPrep®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Resistant Bacterial Infections in the Early Post LDLT Period
Condition: Transplantation Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Observational

Summary: 
      The purpose of this work was to study the incidence, types, risk factors and causative
      organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation.
      Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy
    

Detailed description: 
      This prospective descriptive study has been done at Tropical Medicine department in the
      period between January 2014 to November 2015.

      After the approval of the scientific and ethical committee of Ain Shams University Hospital,
      Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation
      Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the
      inclusion criteria) were included in the current study. Forty five patients were recruited
      and each one was followed-up during a period of 3 months following transplantation.

      Included patients were divided into 2 groups:

      Group 1 included patients who had a postoperative single episode of infection. Group 2
      included those patients who had more than 1 episode of postoperative bacterial infection whom
      were further evaluated for the presence of emerging strains and/or antibiotic resistance.
    

Intervention name(s): Living donor liver transplantation
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HCV patients who underwent living donor liver transplantation at Ain Shams Center for Organ
        Transplantation.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a National, Multicentre, Observational Registry to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth
      hormone treatment from hospital in the UK and to assess the level of adherence of subject
      receiving SAIZEN® via Easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      populationbased analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the Easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      - To assess the level of adherence of subjects receiving SAIZEN via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF-1) (i.e. above,
           below or within normal ranges)

        -  To assess the endocrinological profile including Triiodothyronine (T3), Thyroxine (T4),
           Thyroid-stimulating hormone (TSH), Insulin-like Growth Factor 1 (IGF-1) and Insulin-like
           Growth Factor-Binding Protein 3(IGFBP-3) levels

        -  Temporal profile of IGF-1 and IGFBP-3 levels
    

Intervention name(s): Easypod
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod
Other intervention name(s): Saizen; Somatropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; EasypodTM; Growth hormone; Pediatric subject
Chimeric Antigen Receptor T Cells Targeting Glypican-3
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I Clinical Study of Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CAR-GPC3
      T Cells) in Patients with Advanced Hepatocellular Carcinoma
    

Detailed description: 
      This is a phase I open-label, single-arm, multicenter clinical trial designed to observe and
      evaluate the safety, cell metabolokinetics, and efficacy of CAR-GPC3 T cells infused
      intravenously at single escalating doses in patients with advanced hepatocellular carcinoma.

      Primary objectives:

      - To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at
      escalating doses in patients with advanced hepatocellular carcinoma.

      Secondary objectives：

        -  To evaluate the metabolic kinetics of single infusion of CAR-GPC3 T cells

        -  To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells

        -  To observe the efficacy of CAR-GPC3 T cells in the treatment of advanced hepatocellular
           carcinoma
    

Intervention name(s): CAR-GPC3 T Cells
Intervention type(s): Biological
Intervention description(s): CAR-GPC3 T Cells injection
Other intervention name(s): Chimeric Antigen Receptor T Cells Targeting Glypican-3
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; CAR-T
DSJ-2016-07 ATTUNE® Cementless CR RP Japan
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The primary objective is to investigate the change from pre-operative baseline to two year
      postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP
      system as measured with the KOOS questionnaire (KOOS-ADL sub-score) in the Japanese patient
      population.
    

Detailed description: 
      -  Evaluate change from preoperative baseline in post-operative outcomes using additional
           patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and
           sub-scores), AKS and EQ-5D-3L.

        -  Evaluate change from preoperative baseline in pain and satisfaction over time as
           measured using a modified VAS Pain Score (discrete numbers rather than a continual
           scale) at 2yr.

        -  Evaluate type and frequency of Adverse Events

        -  Evaluate survivorship of the ATTUNE® Primary Cementless TKA system for the CR RP
           configurations using Kaplan-Meier survival analysis at 1 and 2yrs.

        -  Evaluate primary, cementless ATTUNE® TKA fixation through zonal radiographic analysis of
           the bone-implant interface at 6wk, 1yr, and 2yrs after surgery.

        -  Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component
           alignment at 2 years compared to the first postoperative radiographs.

        -  Radiographically characterize the postoperative ATTUNE patellar component alignment and
           positioning in Japanese population.
    

Intervention name(s): Cementless Total Knee Arthroplasty
Intervention type(s): Device
Intervention description(s): Patients will undergo a primary total knee replacement using the configuration of the ATTUNE Cementless knee (CR RP)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthroplasty; replacement; Knee; function; radiographic; survivorship
Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the effect of fish oil-enriched enteral and parenteral
      nutrition on blood oxygenation in critically ill patients.
    


Intervention name(s): Nutriflex Omega special + Oxepa; Nutriflex Lipid special + Pulmocare
Intervention type(s): Drug; Drug
Intervention description(s): 3-chamber-bag combined with enteral nutrition; 3-chamber-bag combined with enteral nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support
Treatment of Severe Heart Failure by Ultrafiltration
Condition: Severe Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with severe congestive heart failure show increased fluid body content which is
      often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients
      have frequent access to the emergency room and hospital for hemodynamic instability.
      Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The
      purpose of this study is to determine whether periodic ultrafiltration sessions maintain
      patients in stable clinical condition and reduce hospitalisations as well as access to
      emergency heart failure treatment.
    

Detailed description: 
      Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid
      overload will be randomized to ultrafiltration (UF group) or conventional medical treatment
      (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will
      be repeated during follow-up in case of body weight gain due to fluid accumulation.
      Ultrafiltration will be performed during short term hospitalization.
    

Intervention name(s): ultrafiltration
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ultrafiltration; heart failure; fluid overload
A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a
      free autogenous graft using donor tissue harvested from the subject's palate in the treatment
      of subjects who have an insufficient zone of attached gingiva associated with at least two
      non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment
      and control in the change in amount of attached gingiva over the 6 month observation period.

      Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft
      will be placed in the other. The grafts will be evaluated clinically to determine the change
      in the amount of attached gingiva and on at least three subjects, a small biopsy will be
      taken to allow histologic evaluation and comparison of both grafts.
    


Intervention name(s): Gintuit; autologous Free Gingival Graft (FGG)
Intervention type(s): Device; Other
Intervention description(s): Gintuit is prepared in a "S" fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture.; Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerance Evaluation of a Bio-revitalizing Product Containing Hyaluronic Acid With High and Low Molecular Weight
Condition: Malar and Sub-malar Volume Deficiency
Study type: Interventional

Summary: 
      Primary end point of the study was to evaluate clinically and by non-invasive instrumental
      evaluations tolerance and efficacy of a bio-revitalizing product containing hyaluronic acid
      with high (H-HA) and low (L-HA) molecular weight; the micro-injection of the study product
      was performed by a specialized dermatologist, bilaterally on the face (zygomatic
      protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular
      angle) of healthy female volunteers aged 30-60 years.

      It was also aim of this study to evaluate efficacy by the volunteers and tolerance both by
      investigator and volunteers.
    


Intervention name(s): Profhilo
Intervention type(s): Device
Other intervention name(s): IBSA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment