bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance
Condition: Walking Cast Right Leg Immobilisation Effects; Aircast Right Leg Immobilisation Effects
Study type: Interventional

Summary: 
      Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving
      performances are unknown. Therefore, clinicians and legislators cannot put forth
      recommendations for road safety for patients requiring such immobilizations. The objective of
      the present study was to evaluate the effects of different orthopedic immobilizations on
      braking performances in simulated driving conditions.

      Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions:
      wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right
      limb, a walking cast and an Aircast walker. A computerized driving simulator was used to
      measure the maximum force applied on the brake pedal during braking, the braking reaction
      time and the total braking time during emergency braking with and without a distracter.
    


Intervention name(s): Driving with running shoes; Plaster cast; Driving with Aircast
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Participant was asked to do all the experiments with their own running shoes; The participant was ask to do all the experiments with a plaster cast molded on his right leg; The participant was ask to do all the experiments with a aircast on his right leg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: car driving simulator; orthopedic leg immobilisation; braking time; braking force
Use of MRI for Assessing Stomach Relaxation in Response to a Meal
Condition: Dyspepsia; Healthy Volunteers
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to test new way of measuring the relaxation of the stomach after a
      meal (called gastric accommodation) by using a MRI scan. This new test will be compared with
      the standard test of measuring stomach relaxation that uses radioactive tracers. These tests
      will be compared in healthy volunteers and people with upper abdominal symptoms (known as
      dyspepsia).
    


Intervention name(s): MRI
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Amniotic Fluid Index Between Before and After Maternal Position Change in Upright and Left Lateral Decubitus Position
Condition: Pregnancy Related
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      Comparison of amniotic fluid index between before and after maternal position change in
      Upright and left lateral decubitus maternal position
    

Detailed description: 
      Amniotic fluid has many important roles in fetal development such as the development of the
      digestive tract and respiratory system. The quantity of amniotic fluid can be measured by
      ultrasonography, measuring the deepest pocket in 4 quadrants of uterus then summarize as one
      value known as "amniotic fluid index"(AFI). The AFI has the normal range between 5-25 cm. The
      low AFI (< 5 cm) is associated with abnormal fetal heart rate, and the abnormal AFI does
      affect to the treatment during the antepartum and intrapartum phase. However , there is the
      study shown that when compared to the single deepest pocket (SDP) , AFI could detect the
      oligohydramnios more which might led to the unnecessary labor induction or operative delivery
      without the significant change of perinatal outcome. To increase the accuracy of AFI, we
      theorize that maternal position change might affect the amniotic fluid position which would
      increase the visual of the amniotic fluid as well.
    

Intervention name(s): Amniotic fluid index
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasonography of the amniotic fluid level in each 4 quadrants of uterus then summerize as one value to measure the quantity of amniotic fluid index
Other intervention name(s): AFI
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Factorial 2-by-2 open labeled randomised controlled trial
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Amniotic fluid index
Self-Management for Anxiety, Depression and Somatoform Disorders
Condition: Anxiety Depression (Mild or Not Persistent); Major Depressive Disorder, Single Episode, Unspecified; Neurotic, Stress-related and Somatoform Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Somatoform Disorders
Study type: Interventional

Summary: 
      Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often
      these conditions remain undiscovered and/or untreated.

      In order to ease this urgent health care problem in the future, the investigators conduct a
      cluster-randomized controlled trial, implementing a tandem working cooperation between a
      nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its
      own practise.

      The CA's task is to enhance the patients abilities to engage in a better self-management of
      their psychological symptoms and complaints, to enhance self-efficacy and empower the
      patients to tackle problems of daily living.
    

Detailed description: 
      Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often
      these conditions remain undiscovered and/or untreated. Managing it is time-consuming and
      communication-intensive. Furthermore, the management is restraint by the high
      contact-frequencies in primary care practices in Germany.

      In order to ease this urgent health care problem in the future, the investigators conduct a
      cluster-randomized controlled trial, implementing a tandem working cooperation between a
      nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its
      own practise.

      The CA's task is to enhance the patients abilities to engage in a better self-management of
      their psychological symptoms and complaints, to enhance self-efficacy and empower the
      patients to tackle problems of daily living.
    

Intervention name(s): Psychosocial Counseling; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms; Depending on the conditions, patients get usual care of their general practitioner
Other intervention name(s): Minimal Psychological Intervention; Self-Management Support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
Condition: Pulmonary Diseases; Intraoperative Complications
MeSH terms: Intraoperative Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the sealing efficacy and safety of TachoSil®
      (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary
      management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung
      malignancies with or without metastases.
    


Intervention name(s): Fibrinogen (human) + thrombin (human) (TachoSil)
Intervention type(s): Drug
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: standard surgical treatment for air leakage in pulmonary lobectomy
Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in
      type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring
      inflammatory markers, circulating number of endothelial progenitor cells, brachial artery
      endothelial function, and arterial stiffness.
    


Intervention name(s): Ticagrelor; Prasugrel
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 90mg twice daily for 5 weeks; Prasugrel 10mg once daily for 5 weeks
Other intervention name(s): Brilinta; Effient
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetic Patients With Non-ST Elevation
The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging
Condition: Myocardial Ischemia; Left Ventricular Systolic Dysfunction; Elevated Cardiac Enzymes
MeSH terms: Myocardial Ischemia; Ventricular Dysfunction, Left; Ischemia
Study type: Observational

Summary: 
      Using blood testing and cardiac magnetic resonance imaging (MRI), the investigators aim to
      determine if there are necrotic areas of myocardium in participants who complete a marathon.
      In addition, the investigators aim to describe the acute and chronic structural abnormalities
      that occur as a result of endurance training. The study hypothesis is that myocardial
      necrosis is present in runners completing a marathon competition.
    

Detailed description: 
      MARATHON-MI is a prospective, observational study of twenty-five (25) participants with plans
      of completing the Detroit Free Press Marathon in Detroit, Michigan on October 19, 2008. All
      participants will undergo a rigorous pre-marathon screening process which will include: 1)
      blood testing, 2) complete cardiopulmonary exercise testing, 3) ECG testing, 4) Holter
      monitoring, 5) cardiac MRI. Blood work will be check after the marathon immediately after and
      one day after the event. Cardiac MRI will be repeated within 12 hours of finishing the
      marathon. Using the information derived from the blood work and radiological testing, we will
      attempt to determine if there is an association between marathon running and myocardial
      necrosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Twenty-five (25) participants with plans of completing the Detroit Free Press Marathon in
        Detroit, Michigan on October 19, 2008.
      
Biospecimen description: 
      Serum
    
Keywords: Marathon Running; Cardiac Ischemia; Magnetic Resonance Imaging
Bioavailability Study of Candesartan Cilexetil 8mg Tablet Under Fasting Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, randomized, single dose, two-way crossover study. Each subject
      will participate in both treatment periods and will receive single oral doses of candesartan
      cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods
      will be separated by a washout period of at least 7 days and no greater than 14 days. This
      study aims to determine the relative bioavailability of an 8mg test formulation tablet of
      candesartan cilexetil (GW615775) compared to an 8mg reference tablet of candesartan cilexetil
      in healthy adult subjects. ATACAND is a registered trademark of the AstraZeneca group of
      companies.
    


Intervention name(s): Candesartan cilexetil (GW615775, Test formulation); Candesartan cilexetil (Reference treatment)
Intervention type(s): Drug; Drug
Intervention description(s): Test formulation candesartan cilexetil 8 mg will be supplied as round, biconvex pink tablets with PX 8 embossed in one face.; Reference treatment of candesartan cilexetil 8 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (008 embossment in the plain face and A CG in the scored face).
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Candesartan cilexetil; Healthy adult human subjects
Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      A single center, stratified, randomized and double-blind phase II clinical trial was
      conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic
      influenza A vaccine (H5N1).
    


Intervention name(s): split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pandemic Influenza A Vaccine; Immunogenictiy; Safety
Optimal End-Tidal (ET) Sevoflurane and Desflurane Concentration for Extubation of Supreme Laryngeal Mask Airway (LMA) in Adults
Condition: Airway Complications
Study type: Interventional

Summary: 
      The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and
      desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.

      Null hypothesis: there is no significant difference between the optimal end tidal
      concentration of sevoflurane and desflurane for Supreme LMA removal.
    

Detailed description: 
      The manufactures' instructions for removal of the LMA recommend waiting until protective
      reflexes have returned. However, the appropriate timing for removal remains controversial. A
      more frequent incidence of airway hyperreactivity and complications has been reported by some
      studies when the LMA was removed in the awake state versus the anesthetized state. Techniques
      that reduce the time from LMA removal to the return of protective airway reflexes would
      minimize the risk of aspiration, contamination, or airway obstruction.

      With increasingly common use of Supreme LMA in anaesthetic practice, a safe and suitable
      depth for removal of the Supreme LMA requires research.

      Thus the determination of the optimal end-tidal concentration of commonly used volatile
      agents ie. Sevoflurane and Desflurane for Supreme LMA removal requires research, both for
      patient safety and minimising anaesthetic costs in dealing with airway complications.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation; Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: end tidal concentration
Microarray Analysis of Scalp Biopsies After Minoxidil Treatment
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Minoxidil treatment affects hair growth in
      patients with male pattern baldness or androgenetic alopecia.
    

Detailed description: 
      The most common type of hair loss is androgenetic alopecia (AGA), also known as male pattern
      balding, or hereditary thinning. In AGA, there is a gradual transformation of large terminal
      hair follicles to miniaturized ones under the influence of circulating androgens that produce
      smaller and finer hairs with a shorter anagen cycle. This transformation, which can be seen
      as early as the prepubescent years, occurs only in certain regions of the scalp: the frontal
      hairline, top and vertex scalp. The temporo-occipital region is largely unaffected even in
      those with extensive balding.

      The first drug to be approved for the FDA for the treatment of AGA was topical minoxidil
      solution (TMS). Despite its successful use, the mechanism of action of TMS is not well
      understood. Minoxidil is a potent vasodilator and potassium channel opener, but its mechanism
      of action in promoting hair regrowth appears to be independent of its vasodilation
      properties. Improved knowledge of the changes in gene expression associated with AGA before
      and after treatment with TMS and compared to placebo may lead to a greater understanding of
      the underlying mechanisms of action of TMS. Furthermore, there is potential for
      identification of those patients who would best respond to or benefit from treatment.
    

Intervention name(s): Minoxidil; Placebo
Intervention type(s): Other; Other
Intervention description(s): Over the counter Rogaine, twice a day for 8 weeks
Other intervention name(s): Rogaine
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Androgenetic Alopecia; Minoxidil; Microarray
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of midostaurin in combination with
      daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single
      agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid
      leukemia (AML).
    


Intervention name(s): Midostaurin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Midostaurin 50 mg [two 25 mg capsules] will be administered twice per day by mouth on day 8-21 during induction and consolidation phase; then continuously during continuation phase; Placebo two capsules will be administered twice per day by mouth on day 8-21 during induction and consolidation phase ; then continuously during continuation phase.
Other intervention name(s): PKC412
Intervention MeSH terms: Midostaurin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: midostaurin; PKC412; cytarabine; daunorubicin; acute myeloid leukemia; combination treatment; FLT3; acute myeloid leukemia (AML); acute myelogenous leukemia (AML)
Characterization of Metabolic Biomarkers in Varying Subjects
Condition: Obesity; Type 2 Diabetes
Study type: Observational

Summary: 
      Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven
      relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2
      Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain
      elusive. More positively, the identification of a scientific resolution for obesity and T2D
      in the short-term is not outside the bounds of reality. Because the complexity of metabolic
      regulation is likely to include already characterized biomarkers, as well as other
      unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity,
      body mass distribution, dietary habits, exercise habits, medication requirements, and disease
      states to discover associations and pathways related to the restoration of normal metabolism.
    

Detailed description: 
      As an observational study design, study investigators will prospectively identify potential
      subjects from various primary care and/or specialty care clinics in Western New York. Prior
      to the commencement of any study procedures, subjects will document informed consent and
      acknowledgement of HIPPA rights. Following approval from their practitioner, subjects may be
      asked on multiple occasions to complete or undergo any or all of the following types of study
      procedures:

        -  Medical record review and follow-up

        -  Fasting blood sample (volume limitations stipulated within)

        -  Pre-meal, during meal, and post-meal blood sample (volume limits within)

        -  Short-term and/or long-term dietary intervention (MD approved)

        -  Short-term and/or long-term exercise intervention (MD approved)

        -  Blood glucose log

        -  Food and exercise diaries

        -  Pre- and post-medication blood sampling (neutraceutical or Rx products)

        -  24-hour urine sampling

        -  Spot urine sampling

        -  Stool microbiologic sampling

        -  Intestinal microbiologic sampling (gastric bypass subjects only)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits,
        exercise habits, medication requirements and disease state burdens
      
Biospecimen description: 
      Blood, stool, urine