bioihbjkbjnl/mcl2 huggingface dataset:
Power Production in Older Adults With Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Knee osteoarthritis is an important cause of functional disabilities at old age. Previous
      research has demonstrated that individuals with knee osteoarthritis have reduced
      knee-extensor strength in comparison to healthy individuals. However, rapid power production
      declines more than strength as a consequence of ageing and is more predictive of functional
      capacity. However, limited research has investigated whether individuals with knee
      osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced
      maximal strength capacities, which is the primary aim of the current study.
    


Intervention name(s): Muscle function test
Intervention type(s): Diagnostic Test
Intervention description(s): Power and strength tests of the knee-extensor muscles, handgrip strength, functional capacity tests
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults between 50 and 80 years with or without knee osteoarthritis. Subjects are sedentary
        or recreationally active.
      
Keywords: Knee osteoarthritis; power production; functional capacity
Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors
Condition: Brain Tumor; Glioblastoma
MeSH terms: Glioblastoma; Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate
      (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as
      either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2)
      malignant tumors originating elsewhere in the body that have spread to the brain at least
      once. Otherwise, there are no limitations to the number of prior recurrences. There are no
      limitations to the number or types of prior therapies.
    

Detailed description: 
      Malignant brain tumors are defined as any World Health Organization grade III-IV glioma and
      any solid tumor metastasis (spread) to the brain. Recurrent malignant brain tumors (RMBTs)
      are defined as either: 1) malignant tumors, originating in the brain, that have recurred at
      least once or 2) malignant tumors originating elsewhere in the body that have spread to the
      brain at least once. They share an increasing incidence, clinical and radiographic
      characteristics, lack of effective therapies, tendency to recur, and poor outcome.
      Importantly, recurrent malignant brain tumor's shared characteristics may be usefully
      exploited by an emerging class of biologic agents called metabolic modulators of which
      Dichloroacetate (DCA) is the drug in the class most thoroughly investigated clinically. DCA's
      mechanism of action and tolerability have been extensively demonstrated in the treatment of
      chronic metabolic disorders. Furthermore, the preciseness of DCA's mechanism of action
      appears to target abnormal tumor cell metabolism.
    

Intervention name(s): Dichloroacetate
Intervention type(s): Drug
Intervention description(s): Subjects after passing the inclusion criteria are given a dose of dichloroacetate 4mg/kg bid for thirty days. While in the clinical research center they participate in a breath test where they exhale through a straw into a glass tube. This will measure CO2. They are monitored every two weeks for side effects and return to the clinical research center for evaluation in thirty days. They undergo another breath test and if all health parameters are within normal limits they are given a month's supply of dichloroacetate. The cycles continue unless a serious adverse event occurs or the PI judges the side effects preclude another 30 days of medication
Other intervention name(s): DCA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain tumors, Glioblastoma and DCA; Brain tumor,Glioblastoma recurrent
Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Nerve Degeneration
Study type: Interventional

Summary: 
      The long-term objective is to further establish the role of Tysabri in preventing
      neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient
      new markers for neurological degeneration in MS. The study intends to correlate cognition
      with two instruments and their measurements-MRI and OCT (optical coherence tomography).
    

Detailed description: 
      The specific aims are:

        1. To determine the effects of Tysabri on cognition (memory, thought processes, etc.)

        2. To determine the effects of Tysabri on specific MRI markers for cognitive dysfunction

        3. To determine the effects of Tysabri on retinal nerve fiber layer thickness (RNFL) using
           optical coherence tomography (OCT), a special instrument used in ophthalmology
    

Intervention name(s): Tysabri
Intervention type(s): Drug
Intervention description(s): Infuse TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Tysabri will be infused every four weeks.
Other intervention name(s): Natalizumab
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRI; OCT; Tysabri; Multiple Sclerosis; cognition
mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers
Condition: Cancer; Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility, acceptability, and gather
      preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity
      among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention
      control group.
    

Detailed description: 
      Adolescent and young adult (AYA) survivors are not meeting recommended physical activity
      guidelines for cancer survivors, and few interventions to date have focused specifically on
      promoting physical activity among AYAs or capitalized on new technologies to deliver them.
      This is a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability,
      and gather preliminary data on outcomes of a 3-month mHealth intervention to promote PA among
      AYA survivors compared to a delayed intervention control group. This project will focus on
      how to best integrate self-monitoring with wearable trackers, increase self-efficacy, enhance
      autonomous motivation, and promote social support in a mobile health behavioral intervention
      that promotes moderate-to-vigorous intensity physical activity (MVPA) among AYA survivors.
      Participants will be AYA cancer survivors (N=60), diagnosed at age 15 or older and currently
      age 18-39. AYA cancer survivors will be recruited from the three comprehensive cancer centers
      in North Carolina to participate in this study. The behavioral intervention will consist of
      an activity tracker, Facebook group, weekly email lessons, and weekly tailored feedback
      emails. Assessments of objectively-measured physical activity and other outcomes will be
      completed at baseline, 3, and 6 months.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Individual session, physical activity tracker, online intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: adolescent and young adult; cancer survivor
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely
      leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive
      monitoring is required.
    


Intervention name(s): pitavastatin; atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): pitavastatin 2mg per daily; atorvastatin 10mg per daily
Other intervention name(s): LIVALO; LIPITOR
Intervention MeSH terms: Atorvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors; hyperlipidemia
Effect of Trunk Support on Academic Engagement of Children With Severe Disability
Condition: Cerebral Palsy; Traumatic Brain Injury; Metabolic Disease; Hypotonia
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Muscle Hypotonia; Metabolic Diseases
Study type: Interventional

Summary: 
      This study evaluates the effect of optimizing trunk support based on segmental principles of
      trunk control, on academic engagement of children in academic settings.
    

Detailed description: 
      Head and trunk posture control are foundational skills, impacting vision, communication,
      swallowing, eating, reaching, and gait. Vision, communication and upper extremity skills are
      critical for participation in educational settings. From an academic point of view,
      participants with poor trunk stability have difficulties staying erect and keeping their head
      and trunk steady. This interferes with concentration, reduces ability and aptitude for
      learning and can lead to fatigue and reduced time on task. Examination of the effect of
      optimal trunk support may yield critical information regarding academic engagement in
      children with moderate to severe disability.

      The investigators propose to facilitate use of a segmental approach by physical and
      occupational therapists in educational settings. Activities will include identifying level of
      trunk control and applying segmental principles to adapt participant's positioning devices
      for optimal function.
    

Intervention name(s): customized posture support
Intervention type(s): Device
Intervention description(s): We will provide customized modifications for seated or standing or walking devices based on the child's segmental level of control
Intervention model: Single Group Assignment
Intervention model description: Single Subject Research Design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: posture; trunk control; assistive device
Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose Bioequivalence Study of Esomeprazole From Stomopral 40 mg
      Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium
      40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) in Healthy Human
      Volunteers Under Fasting Condition.
    

Detailed description: 
      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. Minimum of 24 subjects will participate in the study. All dosed subject
      samples will be analyzed and their data will be included in the final study report.

      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0-72 and AUC0-∞ for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0-72 and AUC0-∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Stomopral; Nexium
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule contains 40 mg Esomeprazole; 1 capsule contains 40 mg Esomeprazole
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate Satisfaction in Adult Participants With the Aesthetics of the Periorbital Area After JUVÉDERM® Fillers and BOTOX®/VISTABEL® Injections
Condition: Facial Corrections; Facial Lines
MeSH terms: Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      Different studies have shown the negative effects of aging around the area of the eyes. Signs
      of aging may contribute to erroneously projected emotions (e.g., anger, tiredness, or
      sadness) that do not reflect the individual's true feelings affecting interpersonal
      relationships. Minimally invasive aesthetic treatments with botulinum toxin and hyaluronic
      acid (HA) fillers are used to treat wrinkles and volume deficiencies associated with the
      appearance of most of the signs of aging.

      This Phase 4 post-marketing study is an open-label study in which all subjects will receive
      active study treatment. The purpose of this study is to evaluate the subject's satisfaction
      after the treatment of JUVÉDERM® fillers and BOTOX®/VISTABEL® on the upper and/or mid face,
      which includes areas around the eyes, under the eyes, eyebrows, the temple, and the cheek.

      This study will enroll approximately 80 healthy male and female subjects ages 40 to 65 across
      10 sites in Australia, Belgium, and United Kingdom. Each subject will be in the study for
      approximately 90 days. The initial treatment of the JUVÉDERM fillers (Juvéderm VOLBELLA with
      lidocaine, Juvéderm VOLIFT with lidocaine, and/ or Juvéderm VOLUMA with lidocaine) will be
      given on Visit 2, and if needed, a touch-up treatment will be given. On Visit 4, the Juvéderm
      VOLBELLA with lidocaine filler, may be given, followed by a touch-up treatment, if needed. On
      Visit 6, subjects will receive study drug BOTOX/VISTABEL. All subjects will return for the
      study exit visit on Day 90.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, checking for side
      effects, and completing questionnaires.
    


Intervention name(s): BOTOX®/VISTABEL®; Juvéderm® VOLBELLA® with Lidocaine; Juvéderm® VOLIFT® with Lidocaine; Juvéderm® VOLUMA® with Lidocaine
Intervention type(s): Drug; Device; Device; Device
Intervention description(s): Facial Injection; Facial Injection; Facial Injection; Facial Injection
Intervention MeSH terms: Lidocaine; Botulinum Toxins, Type A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: JUVÉDERM fillers; BOTOX/VISTABEL
Health Effects of Different Types of Bread
Condition: IBS
Study type: Interventional

Summary: 
      Dietary fiber is well known to have health promoting effects, including reduced blood glucose
      and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian
      diet. Production of bread has changed from the traditionally use of sourdough, to yeast
      (Saccharomyces cerevisiae) as the dominating leavening agent in modern industrial production.
      Sourdough naturally contains bacteria, and through the fermentation process these bacteria
      release several components that are not found in modern bread using yeast. It has been shown
      that sourdough may have positive health effects, including on blood glucose regulation. The
      aim of the project is to investigate if intake of sourdough may give positive health effects
      compared to beard with yeast.
    

Detailed description: 
      The investigators aim to include approximately 20 participants in this randomized controlled
      double-blind cross-over study lasting for 5 weeks.

      All participants will be given bread baked with yeast for a 2 weeks run-in period. The
      participants will then be randomly assigned to either 1 week intervention with bread baked
      with yeast or sourdough, before a 1 week wash-out period with yeast bread. During the last 1
      week intervention period the participants starting with bread baked with yeast will be given
      sourdough and vice versa.

      Questionnaires (GSRS-IBS, BSC, FFQ), blood samples, and feces samples will be collected
      before and after the intervention periods.
    

Intervention name(s): Intervention group
Intervention type(s): Other
Intervention description(s): intervention group: bread with sourdough control group: bread with yeast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
Condition: Intraoperative Ventilation
Study type: Interventional

Summary: 
      The purpose of this research study is to compare difference between breathing by oneself or
      with the partial help from an anesthesia machine in children under general anesthesia.
    

Detailed description: 
      The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and
      allows the patient to breathe in and out adequately under general anesthesia (GA). The
      ProSeal™ LMA (PLMA™) is a specialized type of LMA with a design that permits the delivery of
      higher pressures to help the patient breathe in and out (ventilate) and also contains a
      channel to suction the stomach.

      Children under GA may breathe through a PLMA in different ways. Spontaneous ventilation
      consists of the children breathing on their own through a PLMA™. Pressure support ventilation
      allows the patient to breathe on their own with additional help from the anesthesia machine.
      Pressure control ventilation allows the patient to breathe with the help of an anesthesia
      machine.

      A child undergoing surgery requires a deep level of general anesthesia which negatively
      affects their ability to ventilate. Thus, children may not breathe in oxygen and carbon
      dioxide out adequately at this level of anesthesia and it may be beneficial to provide some
      level of support to enhance carbon dioxide exchange and to avoid hypoventilation.

      This study will attempt to determine whether pressure support ventilation improves
      ventilation in children undergoing outpatient surgery.
    

Intervention name(s): Spontaneous ventilation; Pressure support Ventilation; Pressure control ventilation
Intervention type(s): Procedure; Device; Device
Intervention description(s): The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.; The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.; The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Proseal™ LMA; children; ventilation; general anesthesia; Children under general anesthesia for outpatient surgery
Study of Cyclosporine in Post-LASIK Patients
Condition: Laser In Situ Keratomileusis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops
      administered twice daily before and following LASIK surgery.
    


Intervention name(s): Cyclosporine 0.010% eye drops; Cyclosporine 0.005% eye drops; Placebo (Vehicle for Cyclosporine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.; Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.; Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation
Condition: Ultrasound; Arterial Catheterization; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Conventionally, long-axis in-plane (LA-IP), short-axis out-of-plane (SA-OOP) and dynamic
      needle tip positioning based on SA-OOP views are commonly used method to image the target
      vessel during cannulation under US guidance. A modified SA-OOP that add developing line on
      the ultrasonic probe improve the success rate of cannula insertion into the radial artery on
      the first attempt.
    


Intervention name(s): Modified dynamic needle tip positioning under ultrasound-guidance; Long-axis technique
Intervention type(s): Procedure; Procedure
Intervention description(s): The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.; The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of
      CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18
      Years
    


Intervention name(s): CSL Limited Influenza Virus Vaccine; CSL Limited Influenza Virus Vaccine; CSL Limited Influenza Virus Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single or two-vaccination regimen (0.25mL); Single or two-vaccination regimen (0.5mL); Single vaccination regimen (0.5mL)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention