bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

Summary: 
      Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL
      reconstruction and one of the main focus of rehabilitation is to improve strenght of these
      muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to
      improve the strenght of the quadriceps
    

Detailed description: 
      Returning to sport after ACL reconstruction is not at desired level among athletes.
      Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL
      reconstruction. Cross-over training is recomended during rehabilitation after ACL
      reconstrucion. Yet duration of the training, frequancy and type of exercise interention are
      not clear for the cross-over training. Ain of the study is to investigate the effects of
      cross-over training on muscle strenght
    

Intervention name(s): Traditional rehabilitation; Cross-over training
Intervention type(s): Other; Other
Intervention description(s): traditional ACL rehabilitation program; Cross-over training addition to the traditional rehabilidation
Other intervention name(s): Standard post-operative ACL rehabilidation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: knee; rehabilitation; ACL; Contralateral training
Age-related Longitudinal Changes in Aviator Performance
Condition: Memory Impairment
Study type: Observational

Summary: 
      Our overall goal has been twofold: 1) to evaluate whether there are significant age-related
      changes in flight simulator performance near age 60, and 2) to assess whether there is an
      alternative model that can explain longitudinal flight simulator performance on the basis of
      measures of cognitive function and expertise.
    

Detailed description: 
      Our overall goal has been twofold: 1) to evaluate whether there are significant age-related
      changes in flight simulator performance near age 60, and 2) to assess whether there is an
      alternative model that can explain longitudinal flight simulator performance on the basis of
      measures of cognitive function and expertise. Such a model might be able to predict change in
      aviator performance better than what could be predicted by chronological age alone.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy older pilots holding active airplane license
      
Biospecimen description: 
      saliva
    
Keywords: Memory; Aviation
Pain Management After Forefoot Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both
      administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol
      in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.
    


Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hallux valgus; Forefoot; transdermal fentanyl
Vitamin K2 Intervention in Patients With Vitamin K Antagonists
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the SAFE K study is to demonstrate that in patients treated with the
      antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally
      produced by the ferments used in fermented dairy products, does not upset the balance of
      anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo
      for four months after a 4-month run-in period.In addition, the study evaluates if regular
      consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment
      and improve the markers of bone mineralisation.
    

Detailed description: 
      Randomisation of the study subjects will be done by two randomisation lists depending on
      whether the dose of VKA is high or low. Randomisation will be balanced and stratified
      depending on the average dose of VKA before the inclusion in order that each arm would have
      the same number of patients receiving a dose lower than the used anticoagulant treatments.

      The level of vitamin K intake will be determined during the study visits using dietary
      questionnaire.
    

Intervention name(s): Vitamin K2
Intervention type(s): Dietary Supplement
Intervention description(s): 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention
Other intervention name(s): phylloquinone,; menaquinone
Intervention MeSH terms: Vitamin K; Vitamin K 2; Vitamin K 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: anticoagulant therapy; INR; vitamin K2; vitamin K antagonist
A Pharmacokinetics Study of Intravenous Ascorbic Acid
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic
      Acid.
    

Detailed description: 
      The objectives of this study are:

        1. To evaluate the single-dose pharmacokinetics of AA administered intravenously (IV).

        2. To evaluate the safety and tolerability of AA administered intravenously.
    

Intervention name(s): Ascor L 500® (Ascorbic Acid Injection, USP)
Intervention type(s): Drug
Intervention description(s): A sterile, solution containing 500 mg ascorbic acid per mL
Other intervention name(s): Ascorbic Acid
Intervention MeSH terms: Ascorbic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Visual Maturation in Premature Newborns According to Factors Influencing Its Development
Condition: Delayed Visual Maturation
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose is to describe the level of visual maturation of premature newborns at term
      equivalent age.

      The secondary purpose is to determine factors associated to an altered level of visual
      maturation, through an exploratory approach.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Premature babies, born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy,
        evaluated at term equivalent age.
      
Keywords: Infant; Premature; Diseases
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Condition: Pain, Postoperative; Pain, Back
MeSH terms: Pain, Postoperative; Back Pain
Study type: Observational

Summary: 
      In our study, we aimed to calculate the ideal measurement of the distance of the erector
      spina muscle to the skin and to find the best ultrasonography image at different thoracic
      levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to
      improve the quality of the block in patients who will undergo erector spina plan block.

      Our primary goal is to determine which thoracic level the erector spinae muscle is closer to
      the skin and whether the USG screen image is better. Our secondary goal is to find out in
      which position the erector spinae muscle is closer to the skin and the USG screen image is
      better.
    

Detailed description: 
      1- Abstract Introduction Erector spina plana block can be performed in different positions
      (sitting-lateral-pron) and at different thoracic levels. In our study, we aimed to calculate
      the ideal measurement of the distance of the erector spina muscle to the skin and to find the
      best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in
      other positions (lateral-sitting-pron) to improve the quality of the block in patients who
      will undergo erector spina plan block. Material and Methods A total of 80 patients (40
      females and 40 males, ASA I-II) aged 18-65 years were included in the study. The erector
      spinae muscle was determined at T1-T2, T5-T6, and T11-T12 levels and in lateral, sitting, and
      prone positions, respectively, with a high frequency 10-15 millihertz linear probe of
      ultrasound, The distance from the skin to the midline of the ultrasound screen was measured,
      and the best ultrasound screen image was recorded. Erector spina plan block, distance
      measurement, different positions, interfascial plan block.
    

Intervention name(s): Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography
Intervention type(s): Other
Intervention description(s): Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18-65 years with ASA (American Society of Anaesthesiologists) I-II patients
      
Keywords: Erector spinae plane block; interfascial plan block.
Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study examined whether the Pediatric Asthma Control and Communication Instrument for the
      Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency
      department accurately assess a child's asthma control.

      This study involved an intervention with the doctors in the emergency department of an urban
      pediatric hospital. The intervention was done when one of the doctors involved in the study
      treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the
      PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED
      results and half were not. The two groups of doctors were compared on their ability to
      correctly identify asthma control categories, whether a child's asthma was worsening or
      improving, whether the family was administering controller medications as often as they
      should, and how much burden the child's asthma was for the family.
    


Intervention name(s): PACCI-ED use
Intervention type(s): Behavioral
Intervention description(s): Attending physicians were allowed to view the patient's PACCI-ED prior to completing the assessment form. Attendings were told at the time of the child's ED visit that the PACCI-ED is used to assess a child's asthma control and medication adherence, and that they could use it to complete the outcomes assessment form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: asthma; pediatrics; control; medication adherence
Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The aim is to determine the effect of investigational products on serum LDL cholesterol.
    


Intervention name(s): Product that contains plant stanol ester; Placebo product
Intervention type(s): Other; Other
Intervention description(s): Product with active ingredient; Product without active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple
      iv injection in healthy male subjects.
    


Intervention name(s): LC28-0126; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LC28-0126; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
Condition: Hepatitis D, Chronic; Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Coinfection; Hepatitis D; Hepatitis D, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5
      mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected
      with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic,
      biochemical, and histological response will be evaluated.
    


Intervention name(s): Peginterferon alfa-2b (PegIntron, SCH 54031)
Intervention type(s): Biological
Intervention description(s): Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.
Other intervention name(s): SCH 54031, PegIntron
Intervention MeSH terms: Peginterferon alfa-2b; Interferon-alpha
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis D; Hepatitis B
Effects of Walking Analysis on Surgical Outcomes
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of pre-operative gait analysis testing
      on surgical outcomes in children with cerebral palsy who have problems walking.
    

Detailed description: 
      Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment
      plans for children with gait abnormalities, particularly children with cerebral palsy.
      Previous studies have shown that gait analysis testing significantly impacts surgical
      decision-making for these patients. However, no controlled studies have been done to
      determine whether gait analysis and the subsequent changes in surgical decision-making affect
      clinical outcomes. Consequently, the use of gait analysis in clinical practice remains
      controversial. The purpose of this study is to conduct a randomized controlled trial to
      assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children
      with cerebral palsy.

      Comparison: Surgery with information from gait analysis testing compared with surgery without
      information from gait analysis testing.
    

Intervention name(s): Surgery with gait analysis report; Surgery without gait analysis report
Intervention type(s): Procedure; Procedure
Intervention description(s): Orthopaedic surgery with access to gait analysis report; Orthopaedic surgery without access to gait analysis report
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gait; walking; orthopedic surgery; orthopaedic surgery
Intelligent and Adaptive Control Applied to Powered Walkers
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The research is towards an advanced control and computer learning strategy that will
      intelligently drive a powered walker for people with walking disabilities. The aim of the
      control strategy is to provide powered assistance that optimally reduces the metabolic cost
      of walking. The goal of the proposed intelligent walker is to reduce the workload of walking,
      keeping this population walking longer, providing critical exercise, continued muscle
      development and improved quality of life.
    


Intervention name(s): SurePace Powered Walker User
Intervention type(s): Device
Intervention description(s): Participants will be asked to perform one baseline 5-minute trial with the lab's instrumented walker in passive mode (no powered locomotion) and two 5-minute trials with the walker in active mode (powered locomotion).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
Condition: Tricuspid Regurgitation
MeSH terms: Tricuspid Valve Insufficiency
Study type: Observational

Summary: 
      Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested
      as independent prognosticator for predicting long-term prognosis in patients with isolated
      severe TR undergoing corrective surgery We attempted to explore whether early postoperative
      echocardiography provides additional prognostic information on top of preoperative clinical
      and echocardiographic variables.
    

Detailed description: 
      We prospectively recruited patients with isolated severe TR undergoing corrective surgery.
      Comprehensive preoperative echocardiography was performed in all patients, with the
      performance of early postoperative echocardiography in all patients. During follow-up,
      clinical events, defined as operative mortality (death within 30 days after surgery or before
      discharge), cardiovascular death, repeated open heart surgery, and readmission due to
      cardiovascular problems were investigated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We prospectively recruited consecutive patients with isolated (without any other valvular
        dysfunction) severe TR who underwent corrective surgery.
      
Keywords: tricuspid regurgitation, severe
Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim of this study is to determine if the addition of an individual polygenic risk
      score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk
      Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer
      in making a decision to take (or not take) medications to prevent breast cancer
    

Detailed description: 
      This trial is a prospective pilot study looking to integrate a novel and retrospectively
      validated polygenic risk score (PRS), based on 77 Single Nucleotide Polymorphisms (SNPs),
      into a standard breast cancer prevention consultation for non-BRCA women. In order to be
      eligible for trial participation, women will need to have a BCRAT estimate of ≥3% for the 5
      year risk of developing breast cancer (which corresponds to the United States Preventative
      Services Task Force threshold for moderate to strong benefit from breast cancer preventing
      medications such as tamoxifen or raloxifene.

      At the time of the breast cancer prevention consultation, women will be offered participation
      in this study by a clinical trials nurse and informed written consent will be obtained. For
      consenting patients, a single 7 to 10 ml blood sample will be taken and couriered to the MAYO
      clinic for sample analysis and several surveys will be administered. One of the surveys will
      assess the participants understanding and intention to take or not take breast cancer
      preventing medications. The decision to take or not take a breast cancer preventing
      medication will be deferred until a subsequent follow up visit.

      On the second visit, the PRS test results will be reviewed with the patient and a
      recommendation regarding preventive medications will be made. The PRS score will risk
      stratify patients into one of three lifetime risk categories of developing breast cancer (low
      risk (<15 % lifetime risk), above average risk (15 to <40% risk) and high risk (>40%)).
      Participants will then answer a second survey in which their understanding of their breast
      cancer risk and intention to take breast cancer preventing medications will be assessed.
    

Intervention name(s): Polygenic Risk Score
Intervention type(s): Genetic
Intervention description(s): A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 77 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (>40%).
Other intervention name(s): PRS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BCRAT; IBIS; PRS; breast cancer; Tyrer-Cuzick
Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions
Condition: Enamel Erosion
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study will evaluate the performance of fluoride delivered from a new dentifrice
      formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by
      testing four dentifrices covering a range of sodium fluoride concentration.
    


Intervention name(s): sodium fluoride; no added fluoride in a silica base
Intervention type(s): Drug; Drug
Intervention description(s): fluoride as sodium fluoride; no added fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment