bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effect and safety of Varisolve® 0.125% [0.2%]
    

Detailed description: 
      In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major
      accessory veins, with venous disease manifested by both symptoms and visible varicosities:
      using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% [0.2%] as
      assessed by the elimination of SFJ reflux and/or occlusion of the treated vein
    

Intervention name(s): Polidocanol Endovenous Microfoam 0.125%
Intervention type(s): Drug
Intervention description(s): Polidocanol Endovenous Microfoam 0.125%, single dose
Other intervention name(s): Varisolve 0.125%
Intervention MeSH terms: Polidocanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Varicose Veins
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
Condition: Vascular Diseases; Vascular Malformation; Capillary Malformation-Arteriovenous Malformation; Port-Wine Stain; Sturge-Weber Syndrome; Vascular Tumor
MeSH terms: Hemangioma, Capillary; Sturge-Weber Syndrome; Neoplasms, Vascular Tissue; Vascular Neoplasms; Brain Stem Infarctions; Vascular Diseases; Arteriovenous Malformations; Vascular Malformations; Congenital Abnormalities; Port-Wine Stain
Study type: Interventional
Phase: Phase 4

Summary: 
      Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT
      is based on the selective photothermolysis it causes the first-degree burns. While being
      typically benign by affecting only the epidermis, or outer layer of skin, the burn site is
      remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is
      known for both bactericidal and bacteriostatic effects, it likely decreases the potential for
      infection postoperatively. Furthermore, after fibrin replaces the superficial structure
      "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of
      signals required for the tissue regeneration processes. Objective of the study was to examine
      the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications
      in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with
      transdermal patches.
    


Intervention name(s): Haemoblock; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Delivering with transdermal patches; Delivering with transdermal patches
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vascular Diseases; Laser treatment; Capillary Malformation; Port-Wine Stain; Vascular Tumor
Prognostic Factors and Mortality in Older Stroke Patients With Mechanical Thrombectomy
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      The study focus on the elderly patient (older than 80 years of age) who had acute ischemic
      stroke and received mechanical thrombectomy. The investigators analyze different factors in
      the stage of before, between, after procedure and trying to figure out if there is any
      difference between the 30-day-mortality group versus non-30-day-mortality group.
    

Detailed description: 
      With the constant improvements in health care, standard of living and the decrease birth
      rate, the percentage of the elderly population ( above 80 years old) is expected to double in
      Taiwan by the year 2044, according to data from the National Development Council.
      Consequently with the increase in the proportion of senior citizens, there will be an surge
      number of patient suffering from cardiovascular and cerebrovascular diseases, most
      importantly acute ischemic stroke. In recent years, mechanical thrombectomy has become the
      gold standard in the treatment for acute stroke patients, however, many studies have excluded
      the patients above the age of 80 years old as the benefits of the procedure have been very
      controversial and there is no clear evidence proving favorable a outcome. There are a few
      studies which state that though elderly patients had higher risk of complications when
      receiving mechanical thrombectomy as compared to younger patients, the prognosis was still
      superior to those didn't receive any intervention. Previous studies put more emphasis on the
      overall prognosis, morbidity and mortality rate, they didn't focused on the cause of
      mortality.

      The study focuses on analyzing of the cause of mortality and whether there is a significant
      difference between 30-day-mortality group versus non-30-day-mortality group.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. elderly (older than 80 years old)

          2. acute ischemic stroke in anterior circulation

          3. NIHSS more than 8
      
Keywords: Thrombectomy,acute ischemic stroke
Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Prospective, single arm, open label, multi-center study to evaluated the effectiveness of
      intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
    

Detailed description: 
      This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic
      low back pain for a minimum of 6 months with conservative care. Participants will receive the
      Intracept System procedure to ablate the basivertebral nerve within the vertebral body.
      Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI
      from L3-S1.
    

Intervention name(s): Intracept
Intervention type(s): Device
Intervention description(s): Radiofrequency ablation of the basivertebral nerve using the Intracept System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vertebrogenic Low Back Pain
Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction
Condition: Cardiac Rupture
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Heart Rupture; Infarction; Rupture
Study type: Observational

Summary: 
      The purpose of this study is to validate a practical risk score to predict the mechanical
      complication of ST-elevation myocardial infarction (STEMI).
    

Detailed description: 
      STEMI patients chewed 300 mg aspirin and 600 mg clopidogrel in the emergency department,
      followed by oral 100 mg aspirin and 75mg clopidogrel daily for at least 12 months. STEMI
      patients received low molecular weight heparin (LMWH), β-blockers, and angiotensin converting
      enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) according to the STEMI
      guideline, unless there were contraindications to these drugs. Peripheral blood samples were
      collected from patients within 2 hours of admission for blood routines and blood biochemistry
      examinations. White blood cell counts and level of hemoglobin were assessed with automated
      cell counters via standard techniques. The investigators followed up patients in validation
      group for three month to observe the cardiac rupture events and other adverse cardiac events
      .
    

Intervention name(s): Grouping by different risk stratification
Intervention type(s): Other
Intervention description(s): A simple risk score system based on 7 baseline clinical variables divided patients into four groups
Other intervention name(s): Risk stratification
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ST-elevation myocardial infarction patients who were admitted from January 2012 to January
        2013
      
Keywords: ST-elevation myocardial infarction; Cardiac rupture; Risk assessment
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at
      low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle
      interventions", with use of drugs only if the LDL-C levels cannot be controlled with such
      lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason
      is the following: a simple "dietary advice" has been shown (Cochrane review and
      meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The
      review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to
      0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An
      average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control
      the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep
      dieting. In this context, use of supplements would significantly amplify the result of diet.

      A significant proportion of ischemic cardiovascular events are believed to be supported by
      the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension,
      dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a
      significant increase in the risk of cardiovascular events.

      Observational studies shown the existence of a relationship between cholesterolemia and
      coronary heart disease, clearly showing that subjects with even modestly increased total
      cholesterol values over time develop both fatal and non-fatal vascular events with a higher
      frequency compared to subjects with similar characteristics, but with lower basal values of
      cholesterol.

      Numerous controlled intervention studies, on the other hand, have shown that there is a close
      correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the
      plasma concentration of total and LDL-C, obtained through lifestyle modification or specific
      drugs, result in reductions in the incidence of major coronary events. The effectiveness of
      these interventions has been demonstrated both in subjects in primary prevention and in
      patients in secondary prevention.
    


Intervention name(s): Dietary supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary supplement formulated with 400 mg Bergamot d.e. obtained from different parts of the Citrus Bergamot whole fruit (Citrus bergamia Risso et Poiteau, fructus), specifically from fresh fruits collected from November to February (Brumex TM).
Oral administration: 1 tablet/day at evening meal; Oral administration: 1 tablet/day at evening meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial of Chemo & Radiation Therapy for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and
      external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic
      cancer.
    

Detailed description: 
      During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose
      followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day)
      delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab,
      gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will
      continue throughout the course of external beam radiation therapy, and will be discontinued
      following the conclusion of external beam radiation therapy. All patients will have a central
      venous access device placed to facilitate chemotherapy administration.

      During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000
      mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for
      3 weeks followed by one-week rest for four cycles.
    

Intervention name(s): Gemcitabine/Fluorouracil with External Beam Radiation
Intervention type(s): Drug
Intervention description(s): This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Other intervention name(s): EGFR Expression; Cetuximab & Radiosensitization of Cetuximab
Intervention MeSH terms: Gemcitabine; Fluorouracil; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation
Pilot Study,Diode Laser 808 nm Supported Direct Pulp Capping in Permanent Teeth
Condition: Haemostatic; Bacterial De-contamination; Bio-stimulation; Reparative Dentine Formation; Pain Reduction
MeSH terms: Dentin, Secondary
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study was to compare the conventional and diode 808 nm laser-assisted
      techniques in direct pulp capping in permanent teeth .The present study was based on a series
      of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this
      paper was laser supported direct pulp cap-ping has proven effectiveness by its capacity to
      stimulate reparative dentine formation by pulp cells, de-contamination ability of irradiated
      areas, its ability in the fast and better haemostatic, and pain reduction.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study was carried out on 10 patients, aged between 12 and 40 years, with an average
        age of 26 years, who underwent conservative treatment for deep caries of permanent teeth (2
        anterior and 8 posterior).
      
Keywords: Pulp capping, Diode laser 808 nm, Tertiary dentin, RM-GIC
A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
Condition: Single Ventricle Cardiac Anomaly
MeSH terms: Univentricular Heart; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 1

Summary: 
      An initial feasibility and safety study evaluating the use of autologous tissue engineered
      vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in
      children with single ventricle anomalies.
    

Detailed description: 
      This investigation is a prospective, nonrandomized phase 1 clinical trial determining the
      safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Primary end
      points of the study will include determination of graft failure rates and graft related
      morbidity and mortality. Graft failure will be defined as any graft narrowing/occlusion or
      dilation/rupture requiring surgical or endovascular intervention. Graft related morbidity and
      mortality will include any post-operative complication such as any thromboembolic or
      infectious event that requires treatment and is thought likely to be caused by the tissue
      engineered vascular graft as determined by the investigators and confirmed by the data safety
      monitoring board. All appropriate patients requiring EC TCPC who meet study
      inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. After
      obtaining informed consent from the patient's parents, patients with single ventricle cardiac
      anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and
      monitoring will follow an established, standardized, clinical algorithm in which the
      patient's clinical status including complications and measurements of graft function will be
      serially evaluated and recorded over a three year period using physical examination,
      echocardiography, and MRA.
    

Intervention name(s): Tissue Engineered Vascular Grafts
Intervention type(s): Combination Product
Intervention description(s): Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tissue engineered vascular graft
Tryptase and Coronary Heart Disease
Condition: Acute Coronary Syndrome With ST Elevation on Electrocardiogram; Acute Coronary Syndrome Without ST Elevation on Electrocardiogram; Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent; Aortic Aneurysms
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Aneurysm; Acute Coronary Syndrome; Aortic Aneurysm; Coronary Stenosis; Syndrome
Study type: Observational

Summary: 
      The main aim of this study will evaluate differences in serum levels of tryptase in study
      population. Will be selected a number of 350 patients hospitalized for coronary heart
      disease.
    

Detailed description: 
      A series of scientific studies have evaluated the tryptase as a biomarker of coronary plaque
      instability, in the course of ischemic heart disease. Among these, the most recent and
      'outcome' is better defined by Meixiang Xiang study, which has been conducted in 2011 on 270
      patients. This study evaluated and compared the levels of tryptase in four populations:

        1. acute myocardial infarction (31 subjects)

        2. unstable angina (108 subjects)

        3. stable angina (36 subjects)

        4. coronary artery disease with coronary stenosis <50% (95 subjects). In this Chinese
           population the final evaluations have led to define the tryptase as a marker independent
           of instability of the atheromatous plaque.

      In reference to the fact that there is still some correlation between tryptase and coronary
      plaque instability and clinical symptoms, we propose a verification study of the role of
      tryptase as a biomarker in acute coronary conditions by studying a large population of
      Italian subjects in the acute phase of pathology and follow up.

      The work will be conducted on 4 patient population:

        1. acute coronary syndrome with ST elevation on electrocardiogram;

        2. acute coronary syndrome without ST elevation on electrocardiogram (acute myocardial
           infarction with ST-segment depression on electrocardiogram and unstable angina)

        3. noncritical coronary artery disease with coronary stenosis <50%;

        4. aortic aneurysms. Secondary endpoints will evaluate the role of tryptase in the event of
           major cardiovascular events.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Italian subjects in the acute phase of disease and follow up. The work will be on 4 patient
        populations:

          1. sindrome coronary acute ST elevation on electrocardiogram

          2. sindrome ACS without ST elevation on electrocardiogram (acute myocardial infarction
             with ST-segment depression on electrocardiogram and unstable angina)

          3. malattia critical coronary artery stenosis <50%

          4. aneurismi aorta.
      
Biospecimen description: 
      Venous blood
    
Keywords: tryptase; coronary; stemi; nstemi
Implementation of the Low Risk Ankle Rule
Condition: Ankle Injury
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Ankle injuries are a very common injury in children. Each year approximately 35000 kids
      present to Ontario emergency departments (ED) with this problem. Right now, about 90% of
      these children get x-rays of the injured ankle, even though only 12% of these x-rays show a
      break in the bone. Some excellent research has created some rules that doctors can use to
      help them decide which children really need x-rays. Unfortunately, even though these rules
      have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using
      these rules.

      Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low
      Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we
      can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If
      we show that doctors can safely use this rule regularly and the number of ankle x-rays will
      be significantly less, this will lessen unnecessary potentially harmful radiation exposure in
      children, these children will spend less time in an ED, and the health care system will save
      money.
    


Intervention name(s): LRAR Implementation
Intervention type(s): Other
Intervention description(s): Pre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up.
Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Paediatric; Emergency Department; Ankle; Injury; Low risk ankle rule
Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used
      traditional Chinese Medicine is effective and safe in the treatment of Parkinson's disease
      when combined use with L-dopa.
    

Detailed description: 
      This study is to focus on the effects of Lingzhi on non-motor symptoms of Parkinson's
      diseases as the primary outcome and on delaying the disease progression using the delay start
      design as the secondary outcome measurement. Two dosage groups and one placebo control group
      with total 360 subjects will be recruited. The treatment is one year.
    

Intervention name(s): Lingzhi (Ganoderma)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Traditional Chinese Medicine; Lingzhi