bioihbjkbjnl/mcl2 huggingface dataset:
SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1
Condition: Compartment Syndromes
MeSH terms: Compartment Syndromes
Study type: Interventional

Summary: 
      Compartment syndrome is a very serious musculoskeletal disorder, which can lead to
      potentially devastating consequences, such as limb amputation and life- threatening
      conditions. It is a well described medical condition considered to be an orthopaedic
      emergency affecting all ages.

      Even though compartment syndrome is a well described medical condition, the appropriate
      treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own
      risks. Furthermore, and of most critical importance is the timing for the intervention of a
      fasciotomy. The concerned limb may already have had severe, sometimes even irreversible,
      tissue damage due to high intra- compartmental pressure within 6 to 10 hours.

      The standard diagnostic method for compartment syndrome is an invasive intra-compartmental
      pressure measurement via insertion of a pressure monitoring device into the muscle
      compartment. Commercially available intra compartmental pressure monitors have a highly
      variable intra-observer reproducibility and user errors are common.

      Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring
      System (CPM#1) shows promising advantages for the clinical application. Not only is the
      technology used for the CPM#1 device safe and non-invasive for the patient with only initial
      training required for the healthcare professionals, but it has also demonstrated high intra-
      and inter- observer reproducibility (as per bench tests and clinical settings with
      prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device
      therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and
      avoids any further risks to the patients compared to invasive compartmental pressure
      diagnosis methods.
    


Intervention name(s): Measurement of compartment compressibility
Intervention type(s): Device
Intervention description(s): Application of the CPM#1 device for compartment compressibility ratio measurement - for each participant, a pre-defined number of measurements will be conducted per leg and forearm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
Condition: PK in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is designed to assess the impact of concomitant food intake on the relative
      bioavailability of a single oral fexinidazole tablet administration.
    


Intervention name(s): Fexinidazole
Intervention type(s): Drug
Intervention description(s): Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fexinidazole; Phase I; Bioavailability study; Food effect; Human African Trypanosomiasis
Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport
Condition: Brain Injuries, Traumatic; Brain Injury Traumatic Mild
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of the study is to assess the usability and tolerability of this jugular vein
      compression device in a population of helmeted and non-helmeted competitive high school,
      collegiate and professional athletes in the sports of football and rugby. This study differs
      from previous work in that it is designed to capture additional data related to the athlete
      experience wearing the jugular vein compression device in older and more elite playing
      levels.
    

Detailed description: 
      Significant morbidity, mortality, and related costs are caused by traumatic brain injury
      (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the
      field, designed to mitigate TBI resulting from blast trauma or concussive events, would save
      lives, and the huge costs incurred for life-treatment of surviving victims. An
      externally-worn medical device that applies mild jugular compression according to the
      principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Sports Science,
      LLC (Q30). Preliminary research suggests that the Device has the potential to reduce the
      likelihood of TBI. The currently developed collar has been approved for studies in humans and
      the results indicate safety for use during high demand and maximal exertion activities.
      Regarding safety, the externally worn collar is meticulously designed to mimic the body's own
      omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume
      increases not to surpass that of a yawn or the mere act of just lying down. This study will
      investigate the tolerability of this device in athletes participating in the competitive
      sports of football and rugby at the high school, collegiate or professional levels.
    

Intervention name(s): Q-Collar
Intervention type(s): Device
Intervention description(s): An externally-worn medical device that applies mild jugular compression
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy volunteers aged 14-49
      
Keywords: brain injury
Airway Deadspace in Children: Air-Q Versus Endotracheal Tube
Condition: Airway Deadspace
Study type: Observational

Summary: 
      The objective of this study will be to measure the airway deadspace associated with use of
      appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing
      between 5 and 20 kg and compare that to the airway deadspace associated with use of an
      endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.
    

Detailed description: 
      There is an increasing interest in the use of supraglottic airway devices in progressively
      younger and younger patients. One issue that has not been well evaluated is the contribution
      of these devices to airway dead space in young children and infants. Volumetric capnography
      is the only non-invasive technology available at the current time to evaluate airway
      deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the
      expired waveform one can determine different respiratory parameters including dead space.
      This is clinically important in young children as the clinician begins to evaluate whether or
      not to use an endotracheal tube or supraglottic airway in these patients. To perform this
      investigation the study team will use volumetric capnography to examine the airway dead space
      associated with these devices during and elective general surgery and urologic procedures in
      healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).

      Participants in the study will be given ETT or Air-Q as an intervention, but the investigator
      does not assign specific interventions to the study participants.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        To perform this investigation we will use volumetric capnography to examine the airway dead
        space associated with these devices during and elective general surgery and urologic
        procedures in healthy children between the ages of 0 and 5 years of age (roughly 5-20 kg).
      
Keywords: Ventilation; pediatrics; airway management; respiration
a/LCI-OCT Pilot in Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      This study will test a newly developed dual modality probe, including optical coherence
      tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human
      esophagus to determine 1) whether adequate tissue contact can be attained by the probe to
      acquire high quality images, and 2) to identify if these images can discern whether the
      imaged tissue is squamous or Barrett's Esophagus (BE) epithelium. This pilot study will test
      the operating characteristics of the probe and collect data for further optimization of the
      a/LCI-OCT device.
    


Intervention name(s): a/LCI-OCT imaging probe; esophageal biopsy
Intervention type(s): Device; Procedure
Intervention description(s): a/LCI and OCT imaging measurements of several locations in the esophagus; biopsies of esophageal tissue imaged by a/LCI-OCT probe
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Eight Units Extended Maxillary Fixed Retainer
Condition: Orthodontic Retention
Study type: Interventional

Summary: 
      Assessment of dental changes associated with an eight-unit extended maxillary fixed retainer
      in 3D. monitoring PDL response and evaluation of patient's satisfaction ,quality of life and
      speech with extended maxillary fixed retainer
    

Detailed description: 
      single-arm prospective clinical trial will be conducted to assess of dental changes
      associated with an eight-unit extended maxillary fixed retainer in 3D. monitoring PDL
      response and evaluation of patient's satisfaction ,quality of life and speech with extended
      maxillary fixed retainer.

      . Twenty-six patients who finished the active orthodontic treatment phase (14-28 years) will
      be recruited upon complying with the inclusion criteria. Eight-unit extended maxillary fixed
      retainer will be bonded to palatal surface of maxillary incisors, canines and first
      premolars, PDL assessment will be carried out and patient acceptance to the appliance through
      the valid questionnaire then the patients will be followed up for 6 months to document 3D
      post-treatment changes.
    

Intervention name(s): Extended maxillary fixed retainer
Intervention type(s): Device
Intervention description(s): Bonding extended maxillary fixed retainer from right first maxillary premolar to left maxillary first premolar for 6 months then assessment of relapse using 3D superimposition , little index , lateral cephalometric assessment along with PDL assessment with quality of life ,function and speech assessment
Intervention model: Single Group Assignment
Intervention model description: single arm prospect cohort study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Extended fixed retainer; 3D superimposition; Fixed retainers; PDL; Quality of life; Relapse
L-citrulline and Metformin in Duchenne's Muscular Dystrophy
Condition: Duchenne's Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to show that the intake of L-citrulline and metformin improves
      muscle function and delay of progression in patients with Duchenne's muscular dystrophy.
    

Detailed description: 
      This is a single center, randomized, double-blind, placebo controlled study. The study
      medication consists of L-citrulline and metformin, respectively placebo given orally; 2.5 g
      L-citrulline or placebo will be given 3 times daily, metformin containing 250 mg or placebo
      will be administered 3 times daily. The duration of the study is 26 weeks and comprehends one
      screening and three study visits.

      Amendment 1: Amended eligibility criteria
    

Intervention name(s): 750 mg metformin and 7.5 g L-citrulline daily p.o.; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne's muscular dystrophy; DMD
The Effects of Preservative-free Prostaglandin Eye Drops in Sign and Symptoms on the Eyes of Patients With Glaucoma
Condition: Ocular Hypertension; Open-Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to investigate corneal confocal microscopic findings, ocular
      signs and symptoms in patients on treatment with the preserved prostaglandin analogue
      latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free
      prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using
      latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion
      criteria including the specified ocular symptoms and signs, will switch from latanoprost
      0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve
      (12) months.
    

Detailed description: 
      Primary outcome measures:

        1. Change from screening in corneal confocal microscopic findings at month 12

        2. Change from screening in ocular symptoms upon non-instillation at month 12

        3. Change from screening in ocular signs at month 12

           Safety and QoL variables:

        4. Descriptive statistics, identification of change(s) from screening
    

Intervention name(s): Tafluprost 0.0015%
Intervention type(s): Drug
Intervention description(s): Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months.
Other intervention name(s): Taflotan®; Taflotan sine®; Saflutan®; Saflutan Conserveermiddelvrij®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Confocal microscopic findings; Ocular Hypertension; Open-Angle Glaucoma; Preservative-free eye drops
Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes
Condition: Insulin Resistance; Glucose Metabolism Disorders; Type 2 Diabetes; Lipid Metabolism Disorders
MeSH terms: Diabetes Mellitus; Insulin Resistance; Prediabetic State; Metabolic Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Metabolic problems represent one of the major health concerns which are attractive for being
      addressed by nutritional interventions, as these are directly connected to dietary
      habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes
      alleviation properties, but association between anthocyans and prediabetes need to be more
      firmly understood and established from robust clinical data. However, there is little human
      research that has reported on the efficacy of increased anthocyans bioactive consumption on
      insulin sensitivity in pre-diabetes.
    

Detailed description: 
      The investigators plan to conduct a randomized double-blind, placebo-controlled trial to
      characterize the potential effects of anthocyans, purified from bilberries and blackcurrants,
      on metabolic abnormalities commonly associated with type 2 pre-diabetes.
    

Intervention name(s): Anthocyanins; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants; Placebo capsules is identically packaged.
Other intervention name(s): Medox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tracing Changed Production of Red Blood Cells
Condition: Erythrocytosis; Erythropoiesis Abnormal
MeSH terms: Polycythemia
Study type: Interventional

Summary: 
      In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis
      can indirectly be identified by atypical fluctuations in key haematological variables.
      However, this method also has limitations and as it is known that some athletes still
      manipulate erythropoiesis it is necessary to develop new and more sensitive detection
      methods.

      The primary purpose of the study is to examine the importance of altered erythropoiesis for
      surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for
      the haematological characteristics of the erythrocyte, such as volume, haemoglobin
      concentration and concentration of glycosylated haemoglobin, to assess whether these can be
      used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these
      parameters are affected by freezer storage of erythrocytes.
    


Intervention name(s): Recombinant human erythropoietin
Intervention type(s): Drug
Intervention description(s): Recombinant human erythropoietin treatment three times per week for three weeks
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Difference Hydrodissection for CTS
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease
      the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively
      used in clinical practice, current researches contain small participant without control group
      or randomized leading to foreseeable selection bias. The investigators design a randomized,
      double-blind, controlled trial to assess the effect of different method of ultrasound-guided
      hydrodissection in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients with bilateral CTS will been randomized
      into intervention and control group. Participants in short-axis group received one-dose
      ultrasound-guided hydrodissection with short-axis approach and long-axis group received
      one-dose ultrasound-guided injection with long-axis approach. No additional treatment after
      injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome
      Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS),
      cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the
      median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as
      on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.
    

Intervention name(s): Ultrasound-guided short-axis hydrodissection with 5cc normal saline; Ultrasound-guided long-axis hydrodissection with 3cc normal saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve; Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hydrodissection; short-axis; long-axis
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a
      PEG based preparation prior to colonoscopy in adolescent patients.
    


Intervention name(s): PEG-ELS; BLI800
Intervention type(s): Drug; Drug
Intervention description(s): polyethylene glycol based bowel preparation; BLI800 bowel preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in
      patient's multiple sclerosis.

      In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded
      study is performed.
    

Detailed description: 
      We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .

      The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm
      treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the
      fatigue of multiple sclerosis.
    

Intervention name(s): 3,4-diaminopyridine
Intervention type(s): Drug
Intervention description(s): 3,4-diaminopyridine
Intervention MeSH terms: Amifampridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: multiple sclerosis; fatigue; 3,4-diaminopyridine
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Condition: Hepatocellular Carcinoma; Laser Ablation; Portal Vein Tumor Thrombus
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thrombosis
Study type: Interventional

Summary: 
      Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second
      most-common cause of cancer mortality. Liver resection is the first-line curative treatment
      for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from
      25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and
      advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no
      effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in
      eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray
      (γ-knife) can also be used to treat patients with PVTT. But there still lack of
      evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view
      of this, we aim to implement a randomized controlled study to find out an effective treatment
      for intermediate and advanced hepatocellular carcinoma patients with PVTT based on
      evidence-based research.
    


Intervention name(s): LA; 3D-CRT
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated; γ-knife treatment with radiation dose of 48-63 Gy/6-9 times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laser Ablation; Portal Vein Tumor; Thrombus