bioihbjkbjnl/mcl2 huggingface dataset:
Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction
Condition: ACL Injury; Stiffness of Knee, Not Elsewhere Classified; Sport Injury
MeSH terms: Wounds and Injuries; Athletic Injuries; Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The role of hamstring has been studied in anterior cruciate ligament (ACL) injury prevention,
      mainly to counteract the anterior tibial translation , especially when contracting
      eccentrically, but also with passive stiffness. However, little is known about the passive
      hamstring stiffness after ACL reconstruction (ACLR).

      The primary objective of this study is to evaluate the passive stiffness of hamstring muscles
      after ACLR by using an isokinetic device. Secondary, we aimed to test the individual and
      surgical characteristics associated with hamstring stiffness and the impact of hamstring
      stiffness on RTS and knee re-injury.

      The hypotheses are that hamstring stiffness will be lower in the ACLR leg compared to the
      uninjured leg and to healthy individuals.

      Also, we hypothesized that hamstring stiffness will be lower after hamstring autograft
      compared to patellar tendon autograft and will increase progressively after ACLR to be
      symmetrical at the time for RTS.

      Also, we hypothesized that hamstring stiffness could be associated with better outcomes at
      RTS (RTS at same level and lower re-injury rates)
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ACLR group: All patients included in the sport medicine follow-up protocole with isokinetic
        muscular assessment at 4 months and 8 months after ACL reconstruction surgery since January
        2017

        Control group: Age- and sexe- matched healthy volunteers with regular sport practice
Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1
      ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by
      rocuronium.
    

Detailed description: 
      Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the
      encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role
      of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma,
      antinociceptive action and neuroprotective effects. However, its use is limited because
      magnesium potentiates non-depolarizing neuromuscular blocking agents.

      Primary outcome: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio
      after reversal with sugammadex deep and moderate neuromuscular blockade induced by
      rocuronium.

      Secondary outcome: evaluate the occurrence of severe respiratory events, the incidence of
      residual neuromuscular block in the post-anesthetic recovery room, evolution of T1 high, and
      postoperative pain.
    

Intervention name(s): Magnesium Sulfate; Saline
Intervention type(s): Drug; Drug
Intervention description(s): After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).; After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).
Other intervention name(s): magnesium sulphate; NaCl 0,9%
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiological Effects of Drugs; Rocuronium; Sugammadex sodium; Magnesium; Neuromuscular block, antagonism
Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2, randomized, placebo controlled, dose ranging study of piromelatine
      (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on
      efficacy (cognitive performance), safety and tolerability in patients with mild dementia due
      to AD.
    


Intervention name(s): Piromelatine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Neu-P11
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognition; mild Alzheimer's disease; Sleep
The Role of Brain-derived Neurotropic Factor in the Relationship Between Executive Function and Physical Training
Condition: Executive Dysfunction; Motor Activity; Child
Study type: Interventional

Summary: 
      This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in
      the relationship between physical fitness/activity and executive functions in typically
      developing children and children with Autism Spectrum Disorder, Development Coordination
      Disorder , Attention Hyperactive Disorder.
    

Detailed description: 
      Nowadays children are getting more inactive and participate less in sports or daily physical
      activity. Previous studies have shown that a good physical fitness is associated with
      improved cognitive functions. While being physical active, physiological changes take places
      in the brain. Brain-derived neurotropic factor is one of the neurotropins that plays a
      crucial role in this process. Executive functions are cognitive processes that are
      responsible for organizing and controlling goal-directed actions. These functions are
      developing during childhood and play an important role in daily- and school functioning.

      This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in
      the relationship between physical fitness/activity and executive functions in children.

      In a first trail the effect of physical fitness and physical training on executive
      functioning and levels of Brain-derived neurotropic factor will be studied.

      In a second trail the research question is expanded by investigating the same relations in
      children with Autism Spectrum Disorder, Development Coordination Disorder , Attention
      Hyperactive Disorder.

      Protocol trail 1: The included (typically developing) children will be randomized and
      stratified for level of physical fitness into 2 groups: the intervention group and the
      control group. The intervention group will receive physical activity training 2 times a week
      during 8 weeks. The control group will receive no additional training. At the beginning and
      the end of the training period both the intervention and control group will be tested for
      physical fitness and level of executive functioning.

      Protocol trail 2: Identical protocol to trail 1 except the participants will be children with
      Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder
      in stead of typically developing children.
    

Intervention name(s): physical training
Intervention type(s): Behavioral
Intervention description(s): physical activity program, 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Brain-derived neurotropic factor; Executive function
Physical Activity and Cognition Study
Condition: Aging
Study type: Interventional

Summary: 
      The goal of this research study is to examine whether an intervention to increase physical
      activity using a body-worn sensor affects cognitive (thinking) processes.
    

Detailed description: 
      The overall duration of participation in this research study is approximately 4 months.
      During this time, three study visits will be required. The first visit is for informed
      consent and screening, the second visit is for baseline fitness and cognitive testing, and
      the third visit is for follow-up fitness and cognitive testing after a 12-week physical
      activity monitoring program. Participants will be randomized to one of two study arms, a
      physical activity monitoring arm and a flexibility and balance arm. Both study arms involve
      wearing a physical activity sensor and monitoring physical activity for a duration of 12
      weeks.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Trainer-guided at-home behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cognition; Learning; Memory; Executive Function; Attention; Neuropsychological Tests; Physical Activity; Physical Fitness; Exercise; Resistance Training; Walking; Muscle Stretching Exercises; Exercise Test; Balance; Flexibility; Body Composition
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to determine whether supplementation of glutamine and fish oil can
      improve peripheral skeletal muscle function and metabolism in patients with heart failure.
      The investigators propose a randomized, double-blind, placebo controlled study comparing the
      combined supplementation of fish oil and glutamine with placebo in patients with stable heart
      failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish
      oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this
      study is the change in muscle functional capacity measured as changes in maximum muscle
      strength and fatigability, peak VO2 and exercise time after supplementation. A secondary
      outcome is the measurement of systemic and local markers of inflammation.
    


Intervention name(s): Glutamine and Fish Oil Supplementation; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.; This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Skeletal Muscle Function; Metabolism; Inflammation; Glutamine; Fish oil; Muscle Function
A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Condition: Hyperopia; Myopia; Astigmatism
MeSH terms: Myopia; Astigmatism; Hyperopia
Study type: Interventional

Summary: 
      Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye
      with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized
      excimer laser.
    

Detailed description: 
      Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to
      be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer
      laser and the fellow eye will be treated with a wavefront optimized excimer laser.
    

Intervention name(s): LASIK and PRK
Intervention type(s): Procedure
Intervention description(s): Wavefront-guided versus wavefront-optimized LASIK or PRK.
Other intervention name(s): Allegretto Wave Eye-Q 400 Hz excimer laser; Visx CustomVue excimer laser; Laser in-situ keratomileusis; Photorefractive keratectomy; Wavefront-guided; Wavefront-optimized
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia; Hyperopia; Astigmatism; PRK; LASIK
iPad as a Distraction Tool During Facial Laceration Repair
Condition: Anxiety; Laceration Repair; Children
MeSH terms: Lacerations
Study type: Interventional

Summary: 
      Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency
      department with facial lacerations requiring suture repair will be eligible to participate in
      the study. Participating children will be randomized to standard care versus standard care
      plus iPad use during the procedure. Children's anxiety levels assessed using a validated
      scale will be measured from video recordings made of the procedure. Parent and provider
      satisfaction surveys will be completed following the procedure. The primary study aim is to
      determine how iPad use affects children's anxiety levels during facial laceration repair. The
      secondary study aim is to determine how iPad use affects parent and provider satisfaction
      regarding a child's facial laceration repair. Hypothesis is that iPad use decreases
      children's anxiety levels during facial laceration repair and increases parent and provider
      satisfaction regarding a child's facial laceration repair.
    


Intervention name(s): iPad; Standard Care
Intervention type(s): Device; Other
Intervention description(s): iPad with age-appropriate applications, videos, and music; All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Prospective, Randomized, Controlled Study Comparing Three Tibial Component Designs in Total Knee Arthoplasty
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three
      tibial tray designs for patients undergoing total knee arthroplasty. This study is designed
      to address the clinically important issues of tibial component modularity and fixation in
      total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved device and in
      this study will be used with 1) a modular tibial tray inserted with cement and 2) a
      non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted
      without cement. The insertion of total knee components without cement has been done
      clinically for over 20 years but has not been specifically approved by the FDA. Thus
      treatment arm 3, a non-modular tray inserted without cement, would involve the so-called
      off-label use of the device.

      136 cases will be assigned to each arm of the study. Each patient will be assessed two months
      after surgery, one year after surgery, two years after surgery, five years after surgery, and
      every three to five years thereafter. The principal outcome measures will be the Knee Society
      Clinical rating scale, the SF-36 and the presence of significant lucent lines.. These
      measures will be compared among patients in the 3 trial arms at 5 years post surgery (or at
      the last follow-up point for those who drop out or become lost to follow-up). The Knee
      Society scores and SF-36 scores will be analyzed using analysis of variance models Rates of
      significant lucencies, perioperative mortality, as well as complications such as deep vein
      thrombosis, pulmonary embolus, neurovascular complication, and infection will be compared
      among the groups using chi-square tests . Rates of revision surgery will be compared among
      the groups using survivorship methods.

      PURPOSE The primary aim of the study is to compare the results obtained with each of three
      tibial designs for patients undergoing total knee arthroplasty. Those results will be
      measured with disease-specific (Knee Society Scores), global (SF-36), and outcome measures.
      Radiographic results consisting of standing alignment, lateral and skyline views of the
      surgical knee will be recorded and analyzed. Completion of the intial investigation will
      occur at the 5-year interval after the last enrolled patient.
    


Intervention name(s): The Zimmer NexGen Legacy Knee System, modular cemented tibia; The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.; The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia
Intervention type(s): Device; Device; Device
Intervention description(s): modular cemented tibia; non-modular cemented tibia.; non-modular uncemented tibia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents
Condition: Vitiligo Vulgaris
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 1

Summary: 
      Vitiligo is a common hypopigmentation disorder with significant psychological impact if
      occurring before adulthood. One study investigating the use of Ginkgo biloba for the
      treatment of vitiligo in adults reports effectiveness, but has significant flaws. We endeavor
      to conduct an open label pilot clinical trial replicating the previous trial on 12
      adolescents 12 to 18 years old. The purpose of the pilot is to test the feasibility of
      recruitment and patient retention, variability of outcome measures, and identify major safety
      concerns. The pilot will use 60 mg of standardized G. biloba two times per day (BID) for 12
      weeks. The primary outcome will be the validated Vitiligo European Task Force (VETF)
      evaluation form, secondary outcomes will include the Vitiligo Area Scoring Index (VASI),
      assess repigmentation via photographs, and will monitor and report adverse reactions.
    


Intervention name(s): Ginkgo biloba
Intervention type(s): Dietary Supplement
Intervention description(s): 60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitiligo; leucoderma
Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center trial to assess safety and efficacy of a combined regimen of oral
      valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17
      years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat
      protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA
      "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes.
      Outcome measures will include blood chemistries, functional testing, pulmonary function
      testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative
      assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign
      parameters. Six centers will enroll a total of 90 patients.
    

Detailed description: 
      This is a multi-center phase II trial of a combined regimen of oral valproic acid (VPA) and
      carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a
      double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 -
      8 years of age. Subjects will undergo two baseline assessments over 4 to 6 week period, then
      will be randomized to treatment or placebo for the next six months. All subjects will then be
      placed on active treatment for the subsequent six month period. Cohort 2 is an open label
      protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of
      efficacy outcomes. Subjects will undergo two baseline assessments over a four to six week
      period, followed by one year active treatment with VPA and carnitine. Outcome measures are
      performed every 3 to 6 months, and include blood chemistries, functional testing, pulmonary
      function testing, electrophysiological evaluations, PedsQL quality of life assessment,
      quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and
      vital sign parameters. Six centers will enroll a total of 90 patients.
    

Intervention name(s): Valproic Acid and Levocarnitine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VPA,sprinkle cap; Levocarnitine, syrup; dosage is by weight
Other intervention name(s): Depakote; VPA; Carnitor
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy (SMA); SMA Type 2; SMA Type 3
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the effect of food with various amounts of fat on
      the absorption of an oral testosterone undecanoate formulation.
    

Detailed description: 
      Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat,
      normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes
      after the initiation of the meal.
    

Intervention name(s): Oral testosterone undecanoate (containing 300 mg T)
Intervention type(s): Drug
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary hypogonadism; Secondary hypogonadism