bioihbjkbjnl/mcl2 huggingface dataset:
Metacognition Assessment in Patient With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study will assessed the level of consciousness of MS patients suffering of cognitive and
      motor disorders. Understanding the awareness of the disease is crucial to allow better
      management of these patients. It has been shown, for other neurological pathologies, that a
      lack of awareness of deficits leads to inefficient rehabilitation and a disorder of
      understanding the impact of deficits in daily activities. Metacognition could be altered with
      age, so we will include participants between 18 and 60 years old.
    

Detailed description: 
      Subject who have to do neurological assessement by the Multiple sclerosis Functional
      Composite (MSFC) will be enrolled.

      The patient will estimate the time to undergo the test. This time will be compared to the
      time really make by the patient to realise test.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be proposed to subject :

          -  Male or female with diagnosis of MS,

          -  admitted in neurological unit for passing the MSFC (Multiple Sclerosis Functionnal
             Composite) test

          -  who respect selection criteria.
      
Keywords: Multiple Sclerosis; Multiple Sclerosis Functional Composite (MSFC); Metacognition
Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Juvenile secondary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the
      fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud's
      Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed
      connective tissue disease. When children with secondary Raynaud's are exposed to chilly or
      cold conditions from weather, cold temperatures, or even holding cold items from the
      refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The
      investigational drug, Pletal(cilostazol), which has been approved for other conditions,
      inhibits the ability of one type of blood cell, platelets, to form blood clots, and also
      widens narrowed blood vessels. It has been used in a variety of other conditions in which
      blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol)
      to lessen the severity of the symptoms and decrease the number of secondary Raynaud's
      episodes in juvenile patients.
    


Intervention name(s): Pletal
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Secondary Raynaud's; circulatory; vascular; scleroderma; lupus; mixed connective tissue disease
Seasonal Variation of Ambulatory Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure
      during winter and summer in well controlled treated hypertensives.
    

Detailed description: 
      Two 24hour ambulatory blood pressure monitorings, 4 to 6 months apart, will be performed on
      hypertensive subjects on a stable antihypertensive drug therapy for at least 4 weeks.

      The correlation of weather and temperature with the 24hour ambulatory blood pressure
      monitoring will be explored.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC
      
Keywords: TREATMENT OF HYPERTENSION
Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder
      (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe
      any change in compliance after treating with other drugs intended to treat ADHD for over 3
      weeks
    

Detailed description: 
      This is an Observational, survey study. The survey is designed to be administered in two
      stages. In the first stage, patients who were prescribed Immediate-Released Methylphenidate
      (IR-MPH) for over 3 months, who are also on IR-MPH 1 month prior and who meet inclusion
      criteria will be enrolled. On survey day 1, the patients, parents/caregivers, and clinicians
      will assess patient drug compliance. For patients considered non-compliant, the Investigator
      will decide whether or not to change current medication. Those patients whose medication is
      changed from IR-MPH to another treatment for ADHD, will be enrolled into the second stage. On
      survey day 1, Clinical Global Impression (CGI) and the effects of the medication on sleep
      quality, decreased appetite, dizziness and or headache, and gastrointestinal upset will be
      assessed based on clinical interview. Any other side effects shown during medication
      treatment will be also recorded in the first stage. Parent/Caregivers will need to complete
      the Swanson, Nolan and Pelham (SNAP) Questionnaire which will evaluate the ADHD child's
      symptoms of inattention, hyperactivity, impulsivity and oppositional defiant disorder. In the
      second stage, those ADHD patients who meet the definition of non-compliance will be treated
      with other medications for over three weeks. On the first visit back after starting treatment
      with other medications, drug compliance, CGI, any change in negative parent-child
      interaction, overall classroom behavior, overall academic performance, the effects on sleep
      quality, decreased appetite, diziness and or headache, and gastrointestinal upset will be
      assessed by Investigator interview. Parent/Caregivers will need to complete SNAP Questionaire
      which will evaluate the ADHD child's symptoms of inattention, hyperactivity, impulsivity and
      oppositional defiant disorder. It is a survey type of study. No study drug has been used in
      the study.
    

Intervention name(s): Observational treatment compliance survey
Intervention type(s): Other
Intervention description(s): Observational treatment compliance survey
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 6-16 years old with clinical diagnosis of DSM-IV ADHD
      
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Methylphenidate; MPH; Extended-Release Methylphenidate
Validation of a Digital Visual Analogue Scale for Appetite Measurement
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the study is to validate a newly developed digital visual analog scales with
      a mobile app for measuring human appetite and compare it with a traditional paper-based
      visual analog scales for appetite measurement.
    


Intervention name(s): Breakfast meal
Intervention type(s): Other
Intervention description(s): A meal consisting of breakfast biscuits and water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users
Condition: Spinal Cord Injuries; Exercise Training
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This randomized controlled trial will determine the effects of 12-weeks of wheelchair
      user-modified upper-body rowing on both traditional cardiometabolic risk factors in SCI
      manual wheelchair users.
    

Detailed description: 
      This randomized controlled trial aims to determine the effects of 12-weeks of wheelchair
      user-modified upper-body rowing on both traditional (insulin resistance, obesity,
      dyslipidemia (including low HDL-C and elevated TG and blood pressure) and novel (inflammatory
      status, autonomic nervous system function, vascular structure and function, and
      cardiorespiratory fitness level) cardiometabolic risk factors in SCI manual wheelchair users.
      As secondary objectives, this trial will investigate the effects of the exercise intervention
      on free-living physical activity, shoulder pain, and indices of quality of life.

      Men and women, aged 18-65 years; chronic SCI (≥1 year since injury); individuals with
      sufficient sparing of arm function to participate in upper-body rowing; using a manual
      wheelchair as a primary tool for mobility will be included in the trial.

      The exercise training will be conducted as wheelchair-modified upper-body ergometer rowing.
      The training will be performed for up to 30 min, 3 times per week with moderate-to-vigorous
      intensity, with at least one rest day between sessions.

      Outcome measurements will be performed immediately before (baseline), after (post) 12 weeks
      of training, and 6 months after the termination of the intervention period (follow up). This
      approach allows for assessment of the short term effects of exercise training as well as any
      residual effects from the training intervention on cardiometabolic risk, shoulder pain,
      indices of quality of life, and free-living physical activity
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Upper-body rowing performed while participants are sitting in their own wheelchair.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Basic Science
Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital
Condition: Sepsis; Adult Disease; Severe Sepsis; Emergency Department
MeSH terms: Sepsis; Toxemia; Emergencies
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution
      (MDW) parameter to current standard of care improves a clinician's ability to recognize
      sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics
      from time of ED presentation for sepsis patients (simulated primary endpoint), with
      concomitant reductions in length of stay and in-hospital mortality for those patients
      (secondary endpoints).
    

Detailed description: 
      The objective of this study is to develop a method for identifying sepsis patients from
      electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be
      identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours
      of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The
      patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements
      will be extracted to complete case report form. Furthermore, objectives include to confirm
      the clinical validity and performance of MDW in a control population of sepsis patients where
      MDW is measured but not reported to physicians. This study is an observational study which
      will simulate the decision impact of MDW on sepsis identification and patient management
    

Intervention name(s): CBC-DIFF Monocyte Volume Width Distribution (MDW)
Intervention type(s): Diagnostic Test
Intervention description(s): MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of
        care
PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme
Condition: Type 2 Diabetes; Chronic Disease; Obesity
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      To investigate whether the interactive family based lifestyle programme leads to behaviour
      change at 6 months with the primary outcome being increased levels of moderate to vigorous
      physical activity (MVPA).
    

Detailed description: 
      To investigate whether the lifestyle programme results in changes to the following outcomes 3
      and 6 months after baseline assessment (Child)

        -  An increase in objectively measured total amount of physical activity

        -  An increase in the proportion meeting MVPA guidelines (measured objectively)

        -  Reduction in time spent sedentary (measured objectively and self-reported)

        -  Change in self-reported physical activity

        -  Reduction in measures of adiposity (body mass index percentile, per cent body fat)

        -  Improvement in psychological factors that may mediate physical activity participation
           (self-efficacy, motivation, attitudes, social support and enjoyment of physical
           activity; and physical self-perceptions)

        -  Change in healthy food provision and parenting practices for healthy food

        -  Improvement in diet composition.

        -  Improvement in knowledge of physical activity and nutrition.

        -  Improvement in cardio-metabolic variables (blood pressure, glucose, HbA1c, cholesterol)

      The Investigators will also include qualitative data collected from:

        -  Evaluation forms following each intervention workshop session which will be completed by
           the Parent/guardian, child and facilitator

        -  Feedback from focus groups to be held following completion of the total intervention
           i.e. 8 sessions

      To investigate whether the lifestyle programme results in changes to the following outcomes 3
      and 6 months after baseline assessment (Parent(s)/guardian(s))

        -  An increase in objectively measured total volume of physical activity

        -  An increase in the proportion meeting MVPA guidelines (measured objectively)

        -  Reduction in time spent sedentary (measured objectively and self-reported)

        -  Change in self-reported physical activity

        -  Reduction in measures of adiposity (body mass index percentile, per cent body fat)

        -  Change in healthy food provision and parenting practices for healthy food

        -  Improvement in diet composition.

        -  Improvement in knowledge of physical activity and nutrition.
    

Intervention name(s): Interactive Lifestyle programme workshop
Intervention type(s): Behavioral
Intervention description(s): Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Central Catheters Used for Chemotherapy in Women With Breast Cancer
Condition: Catheter Related Complications
Study type: Interventional

Summary: 
      The overall aim of this study is to evaluate two different central venous lines, PICC-lines
      (PICC) and subcutaneous venous access ports (SVAP) used for chemotherapy in women with breast
      cancer. The study will compare complications, material wear of the catheters used, patients'-
      and health care professionals' experiences, and costs. The study will give knowledge about
      which central venous access that is the most advantageous regarding adjuvant chemotherapy for
      women with breast cancer in the aspects of safety, quality of care, and quality of life.
    

Detailed description: 
      N=250 women between 18 and 70 years of age with invasive breast cancer who are allocated to
      adjuvant or neo adjuvant chemotherapy during 18 weeks at the Department of Oncology at
      Karolinska University Hospital , Stockholm Sweden are eligible to participate in the present
      study. Exclusion criteria are cognitive dysfunction and/or inability to understand Swedish.
      Before participation an informed consent will be collected. The patients will be randomized
      to receive a PICC or a SVAP. Complications will be registered as well as the treatments.

      Bacterial cultures will be taken at removal of PICC/SVAP. The used PICC/SVAP will be
      transported to the Royal Institute of Technology (KTH) and subjected to material analyses.
      Comparison with reference materials from the in-vitro study and with new reference catheters
      will be performed. Patient assessments with questionnaire concerning HRQL, illness
      perception, body imaging, life style and sleep disturbance will be collected at baseline and
      at the last chemotherapy session. Interviews with the patients about life situations will be
      conducted half through the chemotherapy treatment period.In- and out-patients costs, i.e.
      medication, materials, costs related to the care of the PICC/SVAP, costs for complications,
      additional costs for the patients regarding the treatment, etc., will be monitored and
      registered. In- and out-patient costs will also be monitored. Data from medical records
      concerning treatments for complications will also be taken into consideration.
    

Intervention name(s): FEC75 (or EC90) x 6; FEC100 + Taxotere (EC90 + Taxotere) 3+3; Paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type of Chemotherapy; Type of Chemotherapy; Type of Chemotherapy
Intervention MeSH terms: Paclitaxel; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: picc-line; central venous access port; catheter related complications; Infections; thrombosis; Material degradation; Health economic costs; Bio-material; Health related quality of life
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
Condition: Indolent B-Cell Non-Hodgkin's Lymphomas
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection
      in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.
    


Intervention name(s): Bendamustine hydrochloride injection
Intervention type(s): Drug
Intervention description(s): Bendamustine is a bifunctional alkylating agent. It cross-links DNA single strand and double strand by alkylation,then destroys the function and synthesis of DNA, and makes the DNA and protein, protein and protein cross-linking, has potential to treat various tumors
Intervention MeSH terms: Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum
Condition: Venous Thromboembolic Diseases
MeSH terms: Thromboembolism
Study type: Interventional

Summary: 
      The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH
      (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for
      venous thrombosis.
    

Detailed description: 
      Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the
      developed and developing world. Pulmonary embolism and deep vein thrombosis are the two
      components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with
      an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The
      highest incidence occurring during the post partum period. There are many researches done a
      broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using
      the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them
      alone and both together against a control group. Also according to our knowledge there are no
      published literature on thromboprophylaxis after vaginal delivery
    

Intervention name(s): Bemiparin; Enoxaparin
Intervention type(s): Drug; Drug
Intervention description(s): Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days.; Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.
Other intervention name(s): Hibor; Laboratories Rovi Pharmaceuticals; Clexane(Sanofi aventis)
Intervention MeSH terms: Enoxaparin; Bemiparin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deep vein thrombosis; Pulmonary embolism; Low molecular weight heparin; Enoxaparin; Bemiparin
Trial of Montelukast in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of
      dysphagia and food impaction in patients with EE.

      Also evaluate tolerance and safety of oral montelukast in treatment of EE.
    

Detailed description: 
      We will randomize in a double blind manner 60 consecutive consenting patients being evaluated
      at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily
      for six months? time. Patients will be in remission after treatment with topical fluticasone
      therapy before enrollment. Patients will fill out a validated dysphagia and side effect
      questionnaire before, during, and at the end of therapy.
    

Intervention name(s): Montelukast/ Singulair; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg daily for six months; Placebo 20 mg daily for 6 months
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment