bioihbjkbjnl/mcl2 huggingface dataset:
Profiling the Endocannabinoid Response to Hedonic Eating
Condition: Obesity; Food Preferences
Study type: Interventional

Summary: 
      Study into the endocannabinoid response to consuming a palatable versus a neutral food.
    


Intervention name(s): Food palatability
Intervention type(s): Other
Intervention description(s): Food palatability is modulated
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial
Condition: Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Background The purpose of the present controlled clinical trial was to assess the effect of a
      single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory
      stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS)
      as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic
      activity of patients with temporomandibular disorder (TMD). Methods Sixty female subjects,
      selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in
      remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in
      the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and
      sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group
      were tested using the Wilcoxon test, while differences among groups were assessed by
      Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.
    


Intervention name(s): Transcutaneous electrical nerve stimulation; Placebo transcutaneous electrical nerve stimulation
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI
Condition: Pain
Study type: Interventional

Summary: 
      The aim of this prospective randomized study was to evaluate the impact of peroperative
      pupillometry monitoring on per and post-operative opioid consumption in major gynecological
      surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the
      intervention group, peroperative remifentanil target was guided by pupillometry. In the other
      group, remifentanil was administered according to standard practice.
    


Intervention name(s): Videopupillometer Algiscan; Standard practice; Propofol; Remifentanil
Intervention type(s): Device; Other; Drug; Drug
Intervention description(s): pupillary diameter measurement every five minutes per-operatively; remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice; TCI; TCI
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
Condition: Insomnia; Sleeplessness; Transient Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a small electrical current to the
      vestibular nerve (balance organ) will decrease the time it take for participants to fall
      asleep.
    

Detailed description: 
      This 2 arm study will look at the proposed treatment (electrical stimulation of the
      vestibular nerve) versus a sham or placebo device. The effect of the device will be evaluated
      in a study that uses normal sleepers and advances them(puts them to bed 5-hours earlier than
      normal) to see if they fall asleep faster in one group or the other. Stimulation in the
      treated or sham group is only for the first hour after lights off.
    

Intervention name(s): Electric stimulation of the Vestibular Nerve - "VirtuSom"; Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM
Intervention type(s): Device; Device
Intervention description(s): This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes.; This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electric Stimulation; Latency to Persistent Sleep (LPS); Transient Insomnia; Insomnia
Durvalumab in Pediatric and Adolescent Patients
Condition: Solid Tumor; Lymphoma; Central Nervous System Tumors
MeSH terms: Lymphoma; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor
      which stimulates the patient's own immune system to act against cancer cells in children and
      adolescents. This trial will assess the safety and tolerability of Durvalumab in children and
      adolescents and also study how Durvalumab is processed in their bodies.
    

Detailed description: 
      This trial will assess the safety and tolerability of Durvalumab in children and adolescents
      and also study how Durvalumab is processed in their bodies.
    

Intervention name(s): Durvalumab; MEDI4736
Intervention type(s): Drug
Intervention description(s): IV Infusion every 2 weeks for a maximum of 26
Other intervention name(s): Durvalumab
Intervention MeSH terms: Durvalumab; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Durvalumab; solid tumors; Immunotherapy; Check Point Inhibitor; pediatrics; children
Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, 2×3 crossover, randomized controlled, dispensing clinical trial to
      evaluate the visual performance (logMAR) and subjective vision responses of the Test Lens.
    


Intervention name(s): senofilcon A C3; Dailies Total 1® Multifocal Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): Test Lens; Control Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
Condition: Herpes Simplex Virus Infection
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a
      single subcutaneous dose of UB-621 in healthy volunteers.
    

Detailed description: 
      This is a phase I, open-label, single dose, dose escalation study in healthy volunteers.
      Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a
      study site. After administration of a single subcutaneous dose of UB-621, subjects will be
      followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics
      parameters.
    

Intervention name(s): UB-621
Intervention type(s): Drug
Intervention description(s): 100 mg/ml, subcutaneous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Lower Uterine Segment Following a Cesarean Section With Barbed Suture
Condition: Cesarean Wound; Dehiscence; Cesarean Section Complications
Study type: Observational

Summary: 
      This aim of this study is to investigate the LUS in the pregnancy following a previous
      cesarean section with the use of barbed or conventional smooth suture.
    

Detailed description: 
      To better assess the risk of uterine rupture, some authors have proposed sonographic
      measurement of lower uterine segment (LUS) thickness near term, assuming that there is an
      inverse correlation between LUS thickness and the risk of uterine scar defect. Recently,
      barbed suture has been employed for closing uterine wall after cesarean section,
      demonstrating the reduction of closure time of the uterine incision and estimated blood loss.
      Until now, the impact of barbed suture in future pregnancies has not been investigated.
    

Intervention name(s): Transvaginal ultrasound in the third trimester pregnancy
Intervention type(s): Procedure
Intervention description(s): Ultrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who underwent a previous elective cesarean section at term of pregnancy,
        during which the anteriore uterine wall was closed by using barbed or conventional smooth
        suture
      
Keywords: barbed suture; uterine lower segment; cesarean section
Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein
Condition: Healthy
Study type: Interventional

Summary: 
      A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85
      Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover
      design trial.
    

Detailed description: 
      A single-blind, randomised, repeat measure, crossover design trial will be used to study the
      glycaemic response and insulinaemic response following consumption of five products: one
      reference product (50 g available carbohydrate Glucose) and four test products (50 g
      available carbohydrate Glucose with 10 g NUTRALYS®S85 Plus pea protein, 50 g available
      carbohydrate Glucose with 20 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate
      Glucose with 10 g Whey protein concentrate and 50 g available carbohydrate Glucose with 20 g
      Whey protein concentrate).
    

Intervention name(s): 10 g NUTRALYS®S85 Plus pea protein; 20 g NUTRALYS®S85 Plus pea protein; 10 g Whey protein concentrate; 20 g Whey protein concentrate; 50 g Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g NUTRALYS®S85 Plus pea protein.; To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.; To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.; To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.; To determine the glycaemic response and insulinaemic response to 50g Glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single-blind, randomised, repeat measure, crossover design trial
Masking: Single (Participant)
Primary purpose: Basic Science
A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction
Condition: SBO - Small Bowel Obstruction
MeSH terms: Intestinal Obstruction
Study type: Observational

Summary: 
      The objective of the study is to review performance of water soluble contrast study in
      patients admitted with Small Bowel Obstruction(SBO), will improve quality and safety, and
      decrease length of stay and morbidity.
    

Detailed description: 
      Performance of contrast study has been a part of the protocols at multiple institutions of
      the southwestern surgical congress. Plan to perform a retrospective review of management
      protocols at these institutions. Wish to know whether the implementation of a standardized,
      protocol-driven pattern of practice involving the performance of water soluble contrast study
      in patients admitted with SBO, will improve quality and safety, and decrease length of stay
      and morbidity.

      The objective of the study is to review performance of water soluble contrast study in
      patients admitted with SBO, will improve quality and safety, and decrease length of stay and
      morbidity.

      Performance of contrast study has been a part of the protocols at multiple institutions of
      the southwestern surgical congress.

      Hypothesize that implementation of a standardized, protocol-driven pattern of practice
      involving the performance of water soluble contrast study in patients admitted with SBO, will
      improve quality and safety, and decrease length of stay and morbidity.
    

Intervention name(s): review performance of water soluble contrast
Intervention type(s): Other
Intervention description(s): review performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Previous studies found on an average 3.9 to 9.4% patient suffer from SBO. The disease
        incidence varies depending on the cause of obstruction. Assuming that 3.9% of the patients
        will be affected by SBO, the study would require a sample size of 504 for estimating the
        expected proportion with 3% absolute precision and 95% confidence.
Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Condition: Prostate Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to assess the detection rate of local relapse after radical
      prostatectomy with either PSMA or 64Cu-PET/CTs and whether the delineation of relapsed
      lesions using both methods can facilitate/change the therapeutic strategy of the radiation
      oncologist
    

Detailed description: 
      PET/TC is a diagnostic tool potentially able to detect, in a single session, both local and
      distant disease. However, the sensitivity of 18-F-PET/CT in the identification of relapse on
      the prostatic bed, varies greatly and depends on the value of PSA with which the examination
      is carried out, the size of the relapse in the lodge, the acquisition protocol and it is
      limited by the physiological hyperaccumulation of the tracer in the bladder. The sensitivity
      of 18F-Choline PET/TC in our hands is significantly higher than the one that is generally
      reported in the literature (76% with PSA values >1 ng/ml after radical prostatectomy), but
      still lower than the one of mpMR. PET/CT with 64Cu exceeds the limits of 18F-choline PET/TC
      in the study of the prostatic bed, as the tracer used (64Cu) is not excreted by urinary route
      and therefore does not accumulate in the bladder.

      This study has the following objectives:

      Primary objective: - To evaluate the detection rate of both 64Cu-PET/CT and PSMA-PET/CT of
      relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence;

      Secondary objectives are:

        -  to assess any change in radiation therapy strategy in terms of lesion delineation and
           dose distribution at planning.

        -  to evaluate the performance of both methods (mpMR and PSMA/64Cu-PET/CT) in assessing the
           response to radiotherapy with or without androgen deprivation
    

Intervention name(s): Pilot evaluation study on use PSMA and Cu-PET/CT
Intervention type(s): Device
Intervention description(s): This study aims at assessing the detection rate of both PSMA and Cu-PET/CT on tissue relapse, study whether this method is equivalent to mpMR
Intervention model: Single Group Assignment
Intervention model description: patients with metastatic prostatic cancer
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET-CT Scan; mpMRI; prostate neoplasms
A Comparison of Posture, Balance and Flexibility in Between Adolescent Ballet Dancers and Sedentary Individuals
Condition: Healthy
Study type: Observational

Summary: 
      Ballet dance are typical specific movement which require balance ability and postural
      control. Ballet dancers use specific balance exercises. It can be expected, that dancers have
      an advanced sense of awareness for the placement and motion of their bodies. The effect of
      ballet dancing on adolescents is still unclear. Therefore, the aim of this study is to
      determine whether ballet dance has an effect on balance, posture and flexibility in
      adolescents.
    

Detailed description: 
      Ballet is as a superlative combination of art and sport that requires high demands
      musculoskeletal conditioning which works on the development of coordination, balance and
      associated with efficient strength and flexibility. Balance is a key skill for dance
      performance for dancers especially for ballet. Ballet dancers use specific balance exercises.
      It can be expected, that dancers have an advanced sense of awareness for the placement and
      motion of their bodies. The support surfaces are variable in ballet training, this may also
      be the reason dancers can better use the information from the somatosensory and vestibular
      systems. It could be assumed that the effect of ballet training will have a positive effect
      on postural stability in standing. Postural balance is the act of achieving, maintaining or
      restoring a state of balance during any posture or activity. It is still unclear whether
      balance, flexibility and posture in adolescent ballet dancers is different than sedentary
      adolescent. Therefore, the aim of this study was to assess whether there are differences in
      balance between adolescent ballet dancers and sedentary adolescent and if these differences
      are associated with the flexibility and posture. To compare the postural balance between both
      groups the unipedal standing was chosen, which reduces the quantity of useful and accurate
      somatosensory information available to the postural control system. Posture analysis and
      flexibility tests were performed in both groups to compare flexibility and posture on
      balance. We purpose to compare balance parameters, posture and health quality parameters in
      adolescent ballet dancers and sedentary adolescent groups.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy adolescent ballet dancers and sedentary individuals
      
Keywords: Ballet; Adolescent; Posture; Balance; Flexibility; Physical activity; Dance
Evaluating Commercial Anti-Plaque Products and Oral Rinse
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and
      an oral rinse.
    

Detailed description: 
      This clinical research study was to train new examiners for short term plaque clinical
      methodologies.
    

Intervention name(s): Fluoride; Chlorhexidine digluconate; Fluoride, triclosan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Half mouth toothbrushing twice a day for four days.; Mouth rinsing with 15 ml for 30 seconds twice a day for four days.; Half mouth Brushing twice daily
Other intervention name(s): fluoride toothpaste; Periogard oral rinse; Total toothpaste
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Scleral Response to Intraocular Pressure (IOP)
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma, Open-Angle
Study type: Observational

Summary: 
      The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.
    

Detailed description: 
      Participants were glaucoma patients who during routine care were observed at different eye
      pressures. Images taken with an optical device that is routinely used in such patients were
      analysed.
    

Intervention name(s): there was no intervention
Intervention type(s): Other
Intervention description(s): patients were observed during routine care on separate times when their eye pressure was different on one day from another.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        glaucoma patients presenting for routine care
      
Keywords: biomarker
Effect of Krill Oil on Cognitive Function in Adults
Condition: Subjective Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Krill oil on cognitive function in adults with subjective memory impairment
      for 12 weeks.
    

Detailed description: 
      Previous animal studies have indicated that Krill oil may have the ability to improve
      cognitive function. Therefore, the investigators conduct a randomized, double-blind,
      placebo-controlled study to investigate the effects of Krill oil on cognitive function in
      adults with subjective memory impairment for 12 weeks; the safety of the compound are also
      evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function
      at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were
      administered either 500 mg of Krill oil or a placebo each day for 12 weeks.
    

Intervention name(s): Krill oil group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This group takes 500 mg/day Krill oil for 12 weeks.; This group takes 500 mg/day Placebo for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment