bioihbjkbjnl/mcl2 huggingface dataset:
Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans
Condition: Neuromuscular Electrical Stimulation
Study type: Interventional

Summary: 
      Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in
      order to increase or restore muscle capacities of hypoactive patients or patients with
      articular trauma. Although this technique seems to be particularly adapted to muscle
      rehabilitation, growing evidence is emerging regarding potential damaging effects of
      electrically- induced isometric contractions in healthy humans. Recent studies have reported
      a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased
      muscle soreness and impaired force production as a result of NMESs. On that basis, further
      studies should be conducted on these deleterious effects which might limit the clinical
      application of NMES.

      Over the last decade, many studies paid attention to branched-chain amino acids (BCAA)
      supplementation as a potential prophylactic/therapeutic approach. The rationale of this
      approach is that BCAA might increase protein synthesis and reduce protein breakdown through
      physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin).
      Additionally, BCAA could also be used as energetic substrate during exercise when glycogen
      stores are depleted. Overall, previous results have supported the efficacy of BCAA
      supplementation in attenuating muscle damage. Nevertheless, comprehensive studies
      investigating the effect of amino acid supplementation on markers of muscle damage are still
      scarce.

      Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS)
      are powerful non invasive tools allowing the exploration of skeletal muscle structure and
      energy metabolism.

      This ambitious project is devoted to the anatomical, functional and metabolic
      characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of
      muscle damage, including maximal voluntary force production, T2 values and apparent diffusion
      coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise
      (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance
      for improving our knowledge of anatomic, metabolic and functional events related to BCAA
      supplementation in the context of exercise-induced muscle damage
    


Intervention name(s): branched-chain amino acids (BCAA) supplementation; PLACEBO
Intervention type(s): Dietary Supplement; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing
      clinical trial to characterize the effects of an HEV-Blocker on several measures of visual
      function in a presbyopic population.
    


Intervention name(s): JJVC Investigational Multifocal Contact Lens TEST Lens; ACUVUE® OASYS Multifocal
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
Condition: Periodontal Disease; Systemic Inflammatory Markers
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single center, double blinded, randomized, controlled trial. Qualified subjects
      will be enrolled and randomized to either one of the two study groups: a) using 0.3%
      triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice
      (copolymer/fluoride/no triclosan) twice daily.
    

Detailed description: 
      The objective of this study is to comparatively evaluate the effects of Colgate Total®
      toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo
      toothpaste on markers of inflammation in the bloodstream and to correlate these findings with
      periodontal disease status in the oral cavity, as determined by the parameters assessed.
      Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will
      be assessed at baseline and after 2, 6 and 12 months of product use. Peripheral blood samples
      will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the
      effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).
    

Intervention name(s): Triclosan Containing Toothpaste; Triclosan Free Toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base; Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
Other intervention name(s): Active comparator; Total Toothpaste; Control toothpaste
Intervention MeSH terms: Triclosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
Condition: Primary Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this work is to evaluate efficacy and tolerability of preservative containing
      0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and
      preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In
      addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma
      patients.
    


Intervention name(s): Benzalkonium chloride (BAK); 0.0015% tafluprost
Intervention type(s): Drug; Drug
Intervention description(s): Benzalkonium chloride (BAK) is the most used preservative and is excellent for safety and stability of drug. However, it causes dry eye, corneal oedema, corneal erosion, and corneal toxicities, thus lowering the long-term tolerability for patients. A critical component when managing glaucoma patients is ensuring compliance.; Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue. It is used topically (as eye drops) to control the progression of open-angle glaucoma and in the management of ocular hypertension. In this study, tafluprost was used in all experimental group with equally concentration(0.0015%), only measured whether BAK was included or not.
Intervention MeSH terms: Benzalkonium Compounds
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: preservative-free, tafluprost
Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil
Condition: Intravenous Drug Usage
Study type: Interventional

Summary: 
      The investigators attempted to determine an adequate priming volume for our infusion system,
      and investigated the extent of a possible delay of the drug effect, that would result from
      mechanical defects of the infusion system, with or without priming the infusion system, using
      direct gravimetrical measurements of virtual infusate amounts during target controlled
      infusion of 2 remifentanil diluents.
    

Detailed description: 
      Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the
      atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20
      μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site
      concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical
      measurements of the delivered infusates reproduced actual predicted concentrations.
    

Intervention name(s): Remi50 with prime; Remi20 with prime
Intervention type(s): Device; Device
Intervention description(s): for using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING; For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING
Other intervention name(s): remi50 prime; remi20 prime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: priming; remifentanil; target-controlled infusion
Association Between Handgrip Strength, Skinfold Thickness and Trunk Strength
Condition: Young Adult
Study type: Observational

Summary: 
      The main objective was to explore relationship between skinfold measurement at multiple
      sites, hand grip strength, and trunk muscle strength (flexors and extensors) in healthy
      participants. Conclusion: There is a moderate association between hand grip strength, T score
      and trunk muscle strength, evident from the present research. Though no such association was
      seen for skinfold measurement.
    

Detailed description: 
      Objectives: The main objective was to explore relationship between skinfold measurement at
      multiple sites, hand grip strength, and trunk muscle strength (flexors and extensors) in
      healthy participants. Methods: Cross-sectional design, randomly recruited 40 participants.
      Finally only 39 participants were included. Measurements for demographic variable and
      anthropometric variables were done. Then the evaluation for hand grip strength and skin fold
      was done. Data Analysis: Quantitative variables were designated using means and standard
      deviations, and qualitative variables described by frequencies. The Repeated measure for
      Analysis of Variance (RANOVA) was used to analyse whether there was statistically significant
      interaction between the two groups (smoking vs non-smokers). The Pearson correlation
      coefficient was used to measure associations of anthropometric traits with grip strength.
      Multiple linear regression model was also carried to explore the linear relationship between
      dependent and independent variables.
    

Intervention name(s): hand grip strength
Intervention type(s): Other
Intervention description(s): Observational study
Other intervention name(s): trunk strength; skinfold measurement
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        College students within the age group of 18-25 years. We were interested in looking for
        Association between hand grip strength , Skinfold thickness and trunk strength
      
Keywords: Hand Grip Strength; Skinfold Thickness; Trunk strength
Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the absorption of Nevirapine from different regions of the Gastro
      Intestinal tract.
    


Intervention name(s): Nevirapine suspension, into Enterion™ capsule; Nevirapine suspension
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nevirapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Safety and Tolerability, as Well as the Pharmacokinetic and Pharmacodynamic Profiles of Single and Multiple Doses of Eplontersen Administered Subcutaneously to Healthy Volunteers and Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).
Condition: Healthy Volunteers; hATTR Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and tolerability, as well as the pharmacokinetic and pharmacodynamic
      profiles of single and multiple doses of Eplontersen administered subcutaneously to healthy
      volunteers and patients with Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).
    

Detailed description: 
      This will be a Phase 1/2, double-blind, randomized, placebo-controlled, dose-escalation study
      conducted at a single center for the healthy volunteer cohorts in up to 56 participants. It
      will consist of 1 single-dose cohort and 3 multiple-dose cohorts (n = 12 per cohort, 10
      active:2 placebo). The open-label, hATTR patient cohort portion of the study will be
      conducted at multiple centers.
    

Intervention name(s): ION-682884; Placebo; Vitamin A
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): ION-682884 administered SC; Placebo comparator calculated volume to match ION-682884 administered SC; Oral supplement
Other intervention name(s): Eplontersen; AKCEA-TTR-LRx; IONIS-TTR-LRx
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point and Tooth Point
Condition: Healthy
Study type: Interventional

Summary: 
      Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic
      dysfunctions by stimulating a specific point in the ear. Some studies prove that the
      acupoints on the pinna have a corresponding relationship to the areas of the body. Some
      research also show that acupuncture acupoints on the body can change the temperature of the
      corresponding area. In our study, we survey the skin surface's temperature change when using
      auricular acupuncture at jaw point and tooth point in each side of the ear in heatlhy people.
    

Detailed description: 
      Participants and Methods: A crossover study is conducted by comparing the in skin surface's
      temperature change before and after applying auricular acupuncture at Jaw point (LO1) and
      Tooth point (LO3) in each side of the ear in heatlhy volunteer. A total of 70 participants
      were randomly assigned to 2 group (A and B) and the allocation was 1:1. In group A:
      participants received auricular acupuncture at tooth point (LO1) three times: Left ear, Right
      ear and Sham accupunture. Similarly, LO1 point was replaced by LO3 point (Jaw point) for
      participants in group B. The primary outcome was change temperature of skin surface at the
      pinna and lower jaw when using auricular acupuncture at points: LO1 and LO3 in each side of
      the ear. This trial will be performed as 2-arm crossover design, randomized, controlled.
    

Intervention name(s): Auricular acupuncture
Intervention type(s): Procedure
Intervention description(s): Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. To conducting this intervention, we use press tack needles to perform auricular acupuncture.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2-arm crossover design, a pilot study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Auricular Acupuncture
Gustin Gene Polymorphism and 6-n-propylthiouracil (PROP) Taste
Condition: Dysgeusia
MeSH terms: Dysgeusia
Study type: Observational

Summary: 
      The investigators evaluate the possible association of PROP taste with gustin gene
      polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI. In addition, it has
      also been evaluated PROP taste sensitivity by recording monophasic potentials from the
      tongue.
    

Detailed description: 
      The investigators evaluate the possible association of PROP taste with gustin gene
      polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI.

      Furthermore, we apply direct measures of the gustatory system activation following
      stimulation with PROP, obtained by electrophysiological recordings from the tongue of
      subjects classified for taster status, genotyped for the specific receptor gene (TAS2R38),
      and in which papilla density was determined.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Seventy-five non-smoking volunteers (28 men and 47 women) were recruited for the study.
        Participants between 20-30 years were eligible for the study. Thresholds for the 4 basic
        tastes were evaluated in all subjects in order to rule out any gustatory impairment. The
        volunteers showed no variation of body weight > 5 kg over the last 3 mo. They were not
        following a prescribed diet or using medications that might interfere with taste
        perception; none had food allergies. They were assessed for cognitive eating behaviours
        using the Three-Factor Eating Questionnaire
      
Biospecimen description: 
      DNA and zinc analyses in saliva
    
Keywords: PROP taste sensitivity; Gustin (CAVI) polymorphism; Salivary zinc; BMI; Electrophysiological recording from the tongue
The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of low-sodium, high-potassium
      condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.
    


Intervention name(s): Low-sodium, high-potassium salt; Regular salt
Intervention type(s): Other; Other
Intervention description(s): Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, MSG, sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation; Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: blood pressure; sodium; salt; low sodium high potassium salt; potassium; Vietnam; randomized controlled trial
Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
Condition: CRC
Study type: Observational [Patient Registry]

Summary: 
      Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby
      integrating colon cleansing, screening and treatment into one procedure.

      The device creates turbulence within the colon using water jets. The colon's fecal fluids are
      evacuated by the system.
    

Detailed description: 
      63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled
      in the study. The assignment of the level of the bowel preparation agent was according to the
      physician decision. Following preparation, enrolled subjects were intubated and cleansed
      using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of
      the procedure, subjects were followed through discharge and at 48 hours post procedure for
      occurrence of adverse events.

      40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31
      subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to
      improvement made to the study device including the following:

        1. One head that irrigates and evacuates instead of two heads

        2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while
           keeping the same flow rate.

        3. System adjustment to the above changes including updated software version.
    

Intervention name(s): Motus Gl CleanUp System
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic ,
        surveillance)
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets
      under fasted conditions
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): 750 mg tablet
Other intervention name(s): KEPPRA
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine wether a modified propofol preparation shows any
      effect on the incidence of injection pain in children undergoing elective surgery under
      general anesthesia.

      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of
      injection pain in the study group.
    

Detailed description: 
      Pain on injection is the most frequently reported side effect associated with the use of
      propofol for induction of anesthesia. Various measures have been taken to reduce the pain on
      injection, e.g. administration of lidocaine or fentanyl prior to propofol administration,
      mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on
      injection had been reduced with some of the above mentioned methods, they may not be regarded
      as a satisfactory solution of the problem.
    

Intervention name(s): propofol (drug)
Intervention type(s): Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg
      tablets.
    

Detailed description: 
      The study is a phase I, open, randomised, crossover, single dose pharmacokinetic study
      performed in a single centre. The study consists of 2 treatment periods, during which the
      study subjects will receive the test product and the reference product in a randomised order.
      During both treatment periods, the study subjects will receive 1 mg of alprazolam as a single
      oral dose. The study treatments will be administered after an overnight fast (at least 10 h).
      Blood samples will be drawn during both treatment periods. The planned duration of the study
      per subject will be 4-5 weeks including a screening visit, 2 treatment periods with a
      wash-out between the study treatment administrations and a post-treatment period.
    

Intervention name(s): Alprazolam; Alprazolam
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg tablet one oral dose; 1 mg tablet
Other intervention name(s): Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alprazolam; bioequivalence