bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Supracondylar Humerus Fracture NIRS Study
Condition: Supracondylar Humerus Fracture
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Observational

Summary: 
      The purpose of this study is to use a device to compare the blood flow in the patient's
      injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for
      this device for a child's forearm and may in the future help us detect children that have
      injured the blood vessels that go to the forearm when they have an elbow fracture. The
      patient will be one of approximately 100 people involved in this research project at
      Carolinas Medical Center, and the patient's participation will last until the patient is
      discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the
      readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also
      hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS
      device will be different than on the uninjured arm.
    

Detailed description: 
      Supracondylar humerus fractures (fracture just above the elbow) are common in children.
      Supracondylar humerus fractures account for 60% of the elbow fractures in children. Some
      supracondylar fractures injure the brachial artery and a small percentage of children present
      with an absent radial pulse after supracondylar humerus fracture, and these injuries may
      result in insufficient blood flow to the ipsilateral forearm. This can lead to compartment
      syndrome and/or ischemic contracture of the forearm muscles, and may result in permanent
      disability. Currently, physicians do not have objective data to determine whether or not the
      forearm muscles below a supracondylar humerus fracture are receiving adequate blood flow and
      must rely on the clinical exam of the wrist and hand distally. The purpose of this study is
      to use near infrared spectroscopy (NIRS) to compare the blood flow in the forearm muscle
      compartments of an injured arm compared to an uninjured arm. This will provide data to
      establish normal readings for this device for a child's forearm, and may then help clinicians
      detect children with insufficient perfusion of the forearm muscles after supracondylar
      humerus fracture.
    

Intervention name(s): Near Infrared Spectroscopy Pads
Intervention type(s): Device
Intervention description(s): NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.
Other intervention name(s): NIRS pad; NIRS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children presenting to the Levine Children's Hospital / CMC Emergency Department with
        displaced supracondylar fractures.
      
Keywords: supracondylar; pediatric; humerus; NIRS; near Infrared spectroscopy; compartment perfusion
The Effectiveness of Virtual Reality Based Rehabilitation in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      We aimed to investigate the effects of virtual reality based rehabilitation program on
      patients with knee osteoarthritis.
    

Detailed description: 
      Sixty volunteer participants with knee osteoarthritis aged 40 to 65 years who were at stage
      of 2-3 according to the Kellgren Lawrence radiological evaluation were included in the study.

      Participants were randomly divided into two groups as virtual and control group. While a
      conventional physiotherapy program consisting of electrotherapy and exercise program was
      applied to both groups 5 days a week for 6 weeks, a virtual reality program was added to the
      virtual group for 6 weeks, 5 days a week. At the beginning of the treatment and at the end of
      the sixth week, ROM, pain, kinesiophobia, proprioception, balance, muscle strength and
      functional status were evaluated between groups.
    

Intervention name(s): Virtual Reality based Rehabilitation Program
Intervention type(s): Other
Intervention description(s): Virtual reality-based rehabilitation was implemented via MarVAJED system. At first the sensors of MarVAJED® were placed under and above the knee joint and then it was calibrated. The content of the game programs included in the MarVAJED system and how to perform these games with the exercises were explained to the participants. We used games called "Crazy Wings and Blasting Ball" included in the MarVAJED®.There was a bird figure in Crazy Wings game and represented knee joint of participants. Although the bird figure moved upwards during knee flexion, it moved downward in knee extension, there were some obstacles on the way of the bird went. The subjects were asked to follow the bird figure visually and to pass through the obstacles by flexing or extending their knees when they encountered obstacles.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; Virtual reality; Rehabilitation; Balance; Kinesiophobia
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      To determine if women can understand the instructions, carry out the test, and interpret the
      test results. Women will be recruited to complete a test instruction and comprehension
      assessment and a usability assessment.
    

Detailed description: 
      To determine if women can understand the instructions, carry out the test, and interpret the
      test results. Women will be recruited to complete a test instruction and comprehension
      assessment and a usability assessment. Study participants will be a convenience sample of
      women seeking health services. Participants will first be asked to review the instructions
      for the Congo Red Dot Test and complete a short written questionnaire that assesses their
      comprehension of the test instructions. Participants will then be asked to perform the test
      using a test control and to interpret the results obtained by answering a second written
      questionnaire. After the woman performs the test, a healthcare provider will use a matched
      control to perform a second test.
    

Intervention name(s): Congo Red Test (GV-005)
Intervention type(s): Device
Intervention description(s): The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women attending Centre de Salud Beatriz Velasco de Aleman for health services
      
Biospecimen description: 
      urine samples collected
    
Keywords: Congo Red Dot Test
An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthma is a chronic inflammatory disease of airways and lungs that results in
      hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed
      to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with
      asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and
      eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects
      will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7
      years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained
      by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given
      three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not
      successful, the parent/guardian will be able to help instruct the subject on the correct use
      of the ELLIPTA DPI, for two more attempts. The subjects who will be enrolled in the study
      will take placebo ELLIPTA DPI once daily. After 28 days subjects will be randomized in 1:1 to
      receive a questionnaire (Version A and B). After completion of the questionnaire on ELLIPTA
      DPI ease of use, subject's ability to use ELLIPTA DPI correctly will be re-assessed.
      Approximately 219 subjects will be screened to participate in the study. The study will be
      conducted for 28 days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of
      companies.
    


Intervention name(s): Placebo DPI; ELLIPTA DPI; Ease of use questionnaires
Intervention type(s): Drug; Device; Other
Intervention description(s): Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.; Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK; Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI.
Intervention model: Single Group Assignment
Intervention model description: Subjects from the age group of 5 to 11 years with documented history of symptoms of asthma or diagnosis of asthma for at least 6 months prior to Visit 1 will be assessed for the ease of use of ELLIPTA DPI.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Dry Powder Inhaler; Metered Dose Inhaler; Long Acting beta 2 Agonist; ELLIPTA
Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound
Condition: Healthy Volunteers; COPD GOLD I to IV; Asthma GINA 1 to 4
Study type: Interventional

Summary: 
      This study is aiming at evaluating whether low frequency ultrasound spectroscopy is a
      sensitive tool to detect broncholytic effects in patients with obstructive airway diseases.
    


Intervention name(s): Low frequency ultrasound spectroscopy after broncholysis
Intervention type(s): Device
Intervention description(s): Low frequency ultrasound spectroscopy is a novel non-invasive approach to real-time diagnostics of the lungs. Low frequency ultrasound at 10 to 1000 kHz permits monitoring of the air and water contents of the human thorax.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism
Condition: Healthy Children Undergoing Routine Care; Children With Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      The investigators hypothesize that children seen in a clinic that uses a compute based system
      known as CHICA, which reminds pediatricians to screen at defined time point for autism, will
      be screened more consistently for autism and receive more timely diagnostic a treatment
      services.
    

Detailed description: 
      To be eligible for this trial, participants must receive their care at one of four primary
      care clinics in Indianapolis where the CHICA system is used.
    

Intervention name(s): Computer based care reminders
Intervention type(s): Other
Intervention description(s): Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: autism; well child care; screening; computer; reminders
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of pitavastatin with that of
      simvastatin.
    


Intervention name(s): Pitavastatin; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin once daily; Simvastatin once daily
Intervention MeSH terms: Simvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia; kowa; dyslipidemia; pitavastatin; NK-104; Primary Hypercholesterolemia or Combined Dyslipidemia
PI-88 in Hepatocellular Carcinoma After Hepatectomy
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor
      recurrence in patients with hepatocellular carcinoma following hepatectomy.
    

Detailed description: 
      Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is
      rarely cured and recurs frequently after regional therapy or transplantation. Hepatic
      resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC
      have been detected by molecular techniques in 88% of patients at the time of surgery, and
      probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a
      curative resection have been tried, including various regimens of adjuvant and neoadjuvant
      therapy.

      In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC
      patients after curative hepatic resection. The efficacy endpoints, including tumour
      non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated.
      Several risk factors associated with tumour recurrence are also being analysed.
    

Intervention name(s): PI-88
Intervention type(s): Drug
Intervention description(s): Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PI-88; post resection hepatoma; adjuvant therapy; hepatectomy; hepatoma
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      patients with previous failed ART cycles with high peripheral NK cells will be divided into 2
      groups: one group of patients with previous failed ART cyles will undergo standard treatment
      but the other group will have in addition lipid emulsion &prednisolone & LMWH
    

Detailed description: 
      patients with previous failed ART cycles with high peripheral NK cells will be divided into 2
      groups: one group of patients with previous failed ART cyles will undergo standard treatment
      but the other group will have in addition lipid emulsion begin in the cycle before embryo
      transfer &prednisolone begin with the start of lipid emulsion & LMWH begin with the day of ET
    

Intervention name(s): combination therapy for high peripheral NK cells
Intervention type(s): Combination Product
Intervention description(s): lipid emulsion & prednisolone & LMWH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers
Condition: Placenta Vascular Malformation
MeSH terms: Vascular Malformations
Study type: Observational

Summary: 
      Pregnancy complications called PVP are mainly responsible for perinatal mortality. In these
      cases, the placenta is smaller and often the centre of thrombotic lesions. The estimation of
      the placenta volume by 3D ultrasound coupled with growth factors and D-Dimers measures could
      improve the understanding of these pathologies to optimize their detection.
    

Detailed description: 
      Pregnancy complications called Placental Vascular Pathologies (PVP) are mainly responsible
      for perinatal mortality. In these cases, the placenta is smaller and often the centre of
      thrombotic lesions. The estimation of the placenta volume by 3D ultrasound coupled with
      growth factors and D-Dimers measures could improve the understanding of these pathologies to
      optimize their detection. Thus, the identification of predictive factors of the risk of
      occurrence or recurrence of PVP could allow us to propose a monitoring of patients at risk,
      to anticipate corticoids administration for the foetuses pulmonary maturation and perhaps
      later to adapt anti hypertensive and antithrombotic therapeutics.
    

Intervention name(s): blood sample
Intervention type(s): Other
Intervention description(s): biological markers evaluated : D-Dimer, sEPCR
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      plasma and serum samples
    
Keywords: preeclampsia; eclampsia; retroplacental hematoma; vascular IUGR; IUFD; placental volume
A Study of Combination Therapy in Children With ADHD
Condition: ADHD; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder With Hyperactivity; Mental Disorders Diagnosed in Childhood; Attention Deficit and Disruptive Behavior Disorders
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines
      such as methylphenidate. Lack of sufficient food intake has been shown to have negative
      effects on weight and height as well as learning and memory.

      There is no current treatment to prevent this loss of appetite except discontinuation or
      reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the
      return of ADHD symptoms.

      The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug,
      cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression
      associated with methylphenidate.
    


Intervention name(s): Methylphenidate ER; Cyproheptadine
Intervention type(s): Drug; Drug
Intervention description(s): Watson generic, starting dose 18mg QD; cyproheptadine hydrochloride
Other intervention name(s): Concerta; Periactin
Intervention MeSH terms: Cyproheptadine; Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methamphetamine; Methylphenidate; ADHD
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Healthy lifestyle factors are associated with maintenance of erectile function in men. To
      determine the effect of weight loss and increased physical activity on erectile and
      endothelial functions in obese men.

      Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or
      hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or
      less on the International Index of Erectile Function (IIEF).

      The 55 men randomly assigned to the intervention group received detailed advice about how to
      achieve a loss of 10% or more in their total body weight by reducing caloric intake and
      increasing their level of physical activity. Men in the control group (n = 55) were given
      general information about healthy food choices and exercise.
    


Intervention name(s): Lifestyle - detailed advice; Control - general information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity; General information about healthy food choices and exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Lifestyle changes
European Compliance Study in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      In both symptomatic and asymptomatic disease, only about half of medicines are taken as
      prescribed1. Relatively little is known about how patients with Parkinson's disease take
      their medication. One of the challenges in the management of Parkinson's disease is the
      prevention and treatment of involuntary movements2,3 and wild fluctuations between being
      mobile and able to function against being slow, stiff and unable to move which recurs as a
      delayed (several years) effect of taking antiparkinson medication. One theory of why this
      occurs is that it is due to pulsatile rather than continuous delivery of medication to the
      brain4. If patients take their medicines erratically and irregularly, this causes more
      fluctuations in blood and therefore brain drug levels may prime patients for complications in
      the future. This project will define the extent of irregular medication taking in Parkinson's
      disease, examine associated clinical and demographic characteristics and examine the ease of
      adherence to different drug regimes. Knowledge of therapy adherence will help support
      patients in using their medicines to best effect. In the present document the terms
      compliance and adherence are used with equal meaning.
    

Detailed description: 
      This is an observational study of how patients with Parkinson's disease take their
      medication. Antiparkinson medication will be monitored using electronic pill bottles, MEMS,
      Aardex®, Switzerland (which contain a microprocessor in the cap that records the time and
      date of bottle openings). This gives information about the amount of prescribed medication
      taken (total compliance), the percentage of days when the correct number of doses is taken
      (daily compliance), and the percentage of doses taken at the correct time interval (timing
      compliance).

      Five countries will be involved, (UK, Germany, Italy, Spain and France). The total number of
      patients recruited across Europe will be 144. The study size has been calculated based on a
      single centre study in Glasgow where 2/3 of 120 patients were scheduled to undergo electronic
      monitoring as part of a different study design. Accordingly data is available which has
      informed the expected number of patients completing the study (around a 10% drop out rate)
      and in order to test 6 key variables with potential influence on therapy compliance and using
      the general statistical guide that between 10 and 20 patients should be studied per variable
      to be examined, a sample size of around 120 evaluable patients has been calculated.
    

Sampling method: Non-Probability Sample