bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting
Condition: Carotid Stenosis; Brain Ischemia; Laboratory Problem
MeSH terms: Carotid Stenosis; Brain Ischemia; Ischemia
Study type: Observational

Summary: 
      New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery
      stenting (CAS). The aim was to assess correlation between selected laboratory markers and
      occurrence of new brain infarctions after CAS.
    

Detailed description: 
      Methods: All consecutive patients 1) with internal carotid artery stenosis >70%, 2) indicated
      to CAS, 3) with signed informed consent were enrolled to the prospective study during 16
      months. All patients used dual antiplatelet therapy (acetylsalicylic acid [ASA] 100 mg +
      clopidogrel 75 mg per day) at least 7 days before CAS. Neurological examination and brain
      magnetic resonance imaging (MRI) were performed before and 24 hours after CAS in all
      patients. Venous blood samples were collected within 24 hours before CAS in all patients:
      hematology + reticulocytes, coagulation markers (PT, APTT, INR, Fbg, Clauss), vWF antigen,
      PAI-1 activity, PAI-1 polymorphism 4G/g, Multiplate (ASA and clopidogrel resistance test).
      Blood samples for the assessment of anti Xa activity were collected during CAS. T-test was
      used for statistical evaluation.
    

Intervention name(s): Carotid stenting
Intervention type(s): Procedure
Intervention description(s): Procedures will be carried out via the femoral approach following a Seldinger technique. All patients will be on long-term aspirin (100 mg/day) and a 525-mg loading dose of clopidogrel. A dose of 10 000 units unfractionated heparin will be administered at the beginning of the intervention. A cerebral protection device (FilterWire EZ™; Boston Scientific, Natick, Massachusetts, USA) will be use in all patients if possible. The type of covered stent and other specific intervention strategies will be left to the discretion of the interventional radiologists. After predilatation of the stenosis (if needed), an appropriate stent for each stenosis will be implanted and then dilated using a balloon catheter.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with internal carotid artery stenosis >70%, indicated to carotid stenting
      
Biospecimen description: 
      Blood samples collecting: hematology + reticulocytes, coagulation markers (PT, APTT, INR,
      Fbg, Clauss), vWF antigen, PAI-1 activity, PAI-1 polymorphism 4G/g, Multiplate (ASA and
      clopidogrel resistance test) anti Xa activity
    
Keywords: ischemic stroke; carotid stenting; MRI diffusion weighted imaging; Laboratory marker
Effect of Meal Replacement Beverage(Glucerna) on Body Composition,Lipid Metabolism and Blood Pressure
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood
      pressure
    

Detailed description: 
      The Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and
      blood pressure in Patients with Obesity
    

Intervention name(s): Glucerna
Intervention type(s): Dietary Supplement
Intervention description(s): Glucerna 52g meal replacement
Other intervention name(s): Glucerna （Abbort，SR）
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neovascularization Patterns in Corneal Graft Rejection
Condition: Corneal Transplant
MeSH terms: Neovascularization, Pathologic
Study type: Observational

Summary: 
      Corneal transplantation is the most commonly performed human tissue transplant worldwide.
      Over 40,000 corneal transplants occur in the US each year. .

      This study will determine specific corneal neovascularization (CN) patterns in human corneal
      allograft recipients to determine the characteristics that worsen the prognosis for graft
      survival. We will test the hypothesis that specific characteristics of CN are prognostic for
      corneal allograft rejection.
    

Detailed description: 
      The investigators hope to enroll 240 subjects into the study. These patients will be enrolled
      prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively,
      and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp
      biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is
      any neovascularization detected, permitting us to develop algorithms of CN characteristics
      that are predictive for corneal allograft rejection and failure. The corneal tissue removed
      during these patients' surgeries will be evaluated histopathologically to identify
      inflammation and neovascularization to confirm and compare to what is seen clinically. There
      will be two short questionnaires conducted at each visit to assess stress levels.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        subjects with indications of corneal transplant
Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Condition: Knee Osteoarthritis; Physical Activity; Education; Self-management; Exercise
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The primary purpose is to evaluate the benefit of an education action of exercise on the
      level of physical activity in patients with knee osteoarthritis with the waning of a spa
      treatment for three weeks, three months after the start of the cure.
    

Detailed description: 
      The aim of this study is to prove the effectiveness of an educational intervention in thermal
      environment on physical activity level with knee osteoarthritis patients.
    

Intervention name(s): 5 educational workshop; written information booklet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Physical activity level; Knee osteoarthritis; Randomized controlled trials; Alternate month design study; Self-management; Self-care; Education and exercise in knee osteoarthritis; Education; Non pharmacological treatment
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell
      Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term
      safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff
      tears versus a steroid treatment.
    

Detailed description: 
      The purpose of this investigation is to evaluate the safety and superior effectiveness in
      functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after
      the administration of a single injection of adipose-derived regenerative cells (ADRCs) into
      the partial-thickness rotator cuff tear compared to the administration of a single
      corticosteroid injection into the associated subacromial space.

      The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for
      extraction of an autologous regenerative cell mixture from the adipose tissue after a
      same-day limited liposuction procedure. A pilot clinical study was recently completed using
      an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results
      support the initiation of a pivotal study to study the same.
    

Intervention name(s): Adipose-derived stem cells; cortisone injection
Intervention type(s): Device; Device
Intervention description(s): 5cc adipose derived stem cells.; cortisone injection
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356
      BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg,
      and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)
    


Intervention name(s): BI 1356 BS - single rising dose; BI 1356 BS - multiple rising dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether MM-093 is safe and effective in the
      treatment of RA.
    

Detailed description: 
      To evaluate the safety and tolerability of 60 mg of MM-093 in patients who have active RA
      despite MTX background therapy.
    

Intervention name(s): MM-093
Intervention type(s): Drug
Intervention description(s): 60mg MM-093/week as a subcutaneous injection for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna
Condition: Central Line Complication
Study type: Observational [Patient Registry]

Summary: 
      It is widely known that positive mechanical ventilation increases the positive intrathoracic
      pressure which affects the pressure in the RIJV, resulting in an increase of the CSA.
      Currently, there appears to be a lack of studies in the literature that assess the effects of
      different modes of ventilation of this increase.

      The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV
      under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in
      head neutral and 30 degree rotated lateral position by using ultrasonography and to determine
      the ventilation mode that is most suitable for catheterization.
    


Intervention name(s): Ultrasonography
Intervention type(s): Other
Other intervention name(s): The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery
        under endotracheal intubation will be included in this random, prospective, clinical study.
Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial,
      whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3
      (Reuterin® D3) may improve the SCORAD in pediatric patients with mild to moderate atopic
      dermatitis
    

Detailed description: 
      Recent evidence suggests that childhood allergy development can be linked to an imbalance of
      the intestinal microbiota. The probiotic bacteria, which contribute to the balance of the
      intestinal microflora, may play a key role in the modulation of the immune response, looking
      as a potential resource in the prevention or treatment of allergic disorders.

      In this study the investigators will recruit pediatric patients with atopic dermatitis of
      mild-to-moderate degree, for which the standard treatment consists in using an emollient
      cream and topical steroids in case of exacerbation.

      The investigators assume that participants can receive significant benefits from the addition
      to their standard treatment of a food supplement containing L. reuteri DSM 17938 and vitamin
      D3, which, thanks to their beneficial effects on intestinal microbiota and on modulation of
      the immune response, may compensate for the inadequate capacity of these patients to produce
      antimicrobial peptides in response to cutaneous aggressions, improving, therefore, the
      severity of the disease.

      88 children of both sexes, between 1 and 4 years old, with a SCORAD of 25-50 will be selected
      as a part of routine outpatient visits at the Pediatric Allergy Department of the University
      Hospital of Verona.

      The study product (active or placebo) will be administered for 3 months, with a follow-up
      period of further 3 months. From all participants, at time 0 and after 3 months, blood and
      stool samples will be collected for the analysis of vitamin D and cathelicidin levels and for
      the analysis of microflora respectively.
    

Intervention name(s): Reuterin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide; sunflower oil, medium chain triglycerides, silicon dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: atopic dermatitis, probiotics, vitamin D3, L. reuteri
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Study design to demonstrate the safety and performance of the Epitomee Device
    

Detailed description: 
      Prospective, single center, open-labeled single arm study. The subjects will be enrolled in
      one investigational site. Subjects meeting eligibility criteria will receive multiple capsule
      intakes, 1 capsule twice daily for 12 weeks.
    

Intervention name(s): Epitomee Device
Intervention type(s): Device
Intervention description(s): A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.
Other intervention name(s): Tulip Device
Intervention model: Single Group Assignment
Intervention model description: Prospective, single center, open-labeled single arm study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obesity
The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses
Condition: Endoscopic Ultrasonography
Study type: Interventional

Summary: 
      A prospective study designed to show the superiority of contrast guided echoendoscopy versus
      conventional echoendoscopy
    

Detailed description: 
      A prospective study that compares the results using FNA contrast echoendoscopy versus
      standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors
    

Intervention name(s): Endosonography
Intervention type(s): Diagnostic Test
Intervention description(s): Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Contrast endosonograpy
Product Performance of a New Silicone Hydrogel Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the product performance of kalifilcon A, compared
      to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable
      contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when
      worn by current soft contact lens wearers on a daily disposable wear basis.
    


Intervention name(s): kalifilcon A; delefilcon A; senofilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): kalifilcon A daily disposable contact lens; DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses; Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Shared Decision-making Training for Inpatients With Schizophrenia
Condition: Schizophrenia; Schizo-affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      "Shared decision-making" is being promoted as a promising approach for engaging patients with
      schizophrenia in medical decisions and improving satisfaction and adherence.

      To implement shared decision-making, both physicians and patients should commit to it and
      engage in a mutual decision process. Most research, however, has addressed interventions that
      either focus on the doctors' side (e.g. "communication skills") or on informing patients
      about treatment options (e.g. "decision aids"). These approaches have been shown to be
      feasible in clinical practice but had no strong effects on treatment patterns or adherence,
      possibly because they were insufficient to motivate and enable patients to engage actively in
      decision-making. Moreover, these interventions still rely on the doctor's willingness to
      share decisions, which has been shown to vary considerably.

      To overcome these limitations and since many patients do not feel competent to participate in
      decision-making we developed an intervention that focuses on patients' communicative
      competencies. this intervention, a five session group-training, will be implemented for
      inpatients suffering from schizophrenia.
    


Intervention name(s): shared decision making training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study using two FDA approved medications: Testosterone and the study medication,
      Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will
      receive a placebo. The study medication will be taken for 12 months.

      The subjects participating in the study are men who are already taking their own testosterone
      supplement because they have low testosterone levels which may cause them to experience
      sexual function difficulties, have fatigue or other symptoms. Testosterone can have an
      adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH).

      Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent
      urinary symptoms and reduce the risk of surgery.

      The researchers would like to see if by taking dutasteride and testosterone at the same time
      they can prevent the adverse effects of testosterone and at the same time get the positive
      benefits of testosterone.

      There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS
      (TransRectal UltraSound), to evaluate prostate size. The six visits at will include
      consenting, blood work, two sexual function questionnaires, a physical examination, physical
      measurements, study medication teaching and dispensing of study medication.
    

Detailed description: 
      Termination criteria

        1. Serum AST or ALT > 3 times ULN

        2. Total serum bilirubin > 1.5 times ULN

             -  no study termination of a patient with documented Gilberts disease for an isolated
                bilirubin elevation unless it exceeds 2.5x the upper limit of normal.

        3. Hematocrit > 55%

        4. Subject experiences any unacceptable or intolerable adverse effect.

        5. Subject is non-compliant with the study protocol.

        6. Subject needs to take any medication that would interfere with study measurements

        7. Subject develops prostate or breast cancer
    

Intervention name(s): dutasteride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5mg by mouth one time per day for 1 year; one tablet per day for 1 year
Other intervention name(s): Avodart; chemical # c27H30F6N202; g1 198745; ind 64,789; code name nda 021319; Inactive substance
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low testosterone
A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial
      allergen challenge on lung function and hence provide proof of mechanism for this agent.
    


Intervention name(s): PF-03893787; Placebo; Montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, two doses 12 hours apart; Oral, two doses 12 hours apart; Oral, two doses 12 hours apart
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma Allergen Challenge
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of
      13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric
      vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and
      Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with
      13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune
      responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and
      immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 7-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.; 7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention