bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth
Condition: Malocclusion; Crowded Teeth; Surgical Incision
MeSH terms: Malocclusion; Surgical Wound
Study type: Interventional

Summary: 
      Applying flapless piezocision corticotomies on the alveolar bone and separating anterior
      mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very
      accurate incisions without any sutures following this procedure) may improve the speed of
      tooth alignment during orthodontic treatment. This study consists of two groups, patients
      will be randomly assigned to one of these two groups. The levels of pain and discomfort of
      this procedure on 18 patients (experimental group) will be evaluated,whereas the second group
      (control group) will receive a traditional orthodontic therapy.
    

Detailed description: 
      According to the American Association of Orthodontists (AAO), the length of comprehensive
      orthodontic treatment ranges between 18-30 months, depending on treatment options and
      individual characteristics. In addition, orthodontic treatment time ranges between 25-35
      months for extraction therapies, respectively. Reducing orthodontic treatment time is one of
      the main goals for orthodontists, due to problems such as root resorption, periodontal
      disease and caries that are associated with prolonged treatment time.

      Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and
      non-surgical. The surgical approach is the most clinically applied and most tested with known
      predictions and stable results. Surgical approaches usually vary from total block osteotomies
      to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment
      efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps
      elevation) might have limited their widespread acceptance among orthodontists and patients.
      Therefore, more conservative flapless corticotomy techniques have recently been proposed.
      These procedures can be accomplished in a reasonably short periods that might produce less
      pain and discomfort, so we will gain better patient acceptance. Although various techniques
      of flapless corticotomy have been reported to be successful in practice, scientific evidence
      on their acceptance and compatibility is little in the literature.
    

Intervention name(s): Piezosurgery
Intervention type(s): Procedure
Intervention description(s): The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.
Other intervention name(s): Piezocision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: corticotomy; minimally invasive; piezosurgery; piezocision; pain; discomfort
A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      -To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.
    

Detailed description: 
      -The primary objective of the study is to evaluate the safety and tolerability of escalating
      single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis.
    

Intervention name(s): MEDI 545; Placebo
Intervention type(s): Biological; Other
Intervention description(s): IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg; IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
Intervention MeSH terms: Sifalimumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
Condition: Obstructive Sleep Apnoea Hypopnoea Syndrome; Biomarkers of Fibrin Clot Structure; Biomarkers of Vascular Endothelial Injury
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Observational

Summary: 
      Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of
      females.

      OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping
      breathing at night). As well as affecting tiredness, mood, concentration and quality of life
      - there is growing concern that it can increase the risk of high blood pressure, heart
      problems, strokes and thromboses (clots in the veins).

      It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily
      it also causes damage to the lining of the blood vessels (endothelial injury). These effects
      seem independent of other risk factors such as obesity, smoking, family history of clots etc.

      The investigators are testing new biomarkers: gel point and fractal dimension developed at
      the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a
      similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies
      (Controls) Also markers of vascular inflammation are being measured.
    

Detailed description: 
      Primary objective:

      The primary outcome of this study is to test the null hypothesis that no significant
      difference exists between fractal dimension (Df)and vascular injury markers including serum
      amyloid A (SAA), C-reactive protein (CRP), vascular cell adhesion molecule-1 (VCAM-1) and
      intercellular adhesion molecule-1 (ICAM-1)in patients with OSAHS and sleepy, snoring controls
      of similar age, gender and BMI.

      Secondary objectives:

        1. To test the null hypothesis that there is no significant difference in measured markers
           before and after a night's sleep in OSAHS and controls.

        2. To test the null hypothesis that there is no significant difference in measured markers
           following 1 month of CPAP treatment, in those with OSAHS.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects are recruited prospectively from a specialist sleep-disordered breathing clinic in
        Prince Philip Hospital, Hywel Dda Health Board. They are referred from both primary and
        secondary care with varying degrees of symptoms suggestive of OSAHS (daytime sleepiness,
        snoring and/or nocturnal apneas).
      
Biospecimen description: 
      Frozen aliquots of citrated plasma
    
Keywords: Clot structure; Haemostasis; Gel point; Fractal dimension; serum amyloid A; C-reactive protein; vascular cell adhesion molecule-1; intercellular adhesion molecule-1
Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture
Condition: Ankle Syndesmosis Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of
      these lesions is advised and the options currently used all have in common a rigid fixation
      of the syndesmosis which results in residual stiffness and a high level of secondary surgery,
      mostly to remove the implant.

      The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a
      dynamic fixation to a static fixation suggesting that the dynamic fixation method will
      improve the Olerud-Molander functional score of more than 15 points at the 3 months
      follow-up.
    


Intervention name(s): TightRope System- Arthrex® / Dynamic Implant; Screw fixation - Synthes® / Static Implant
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.; Patients are operated on using a static implant, the rigid four-cortices 3,5 mm screw fixation by Synthes®. The ankle is immobilized in a plaster boot for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankle fracture with syndesmotic ligament rupture; ankle syndesmosis rupture
Stroke Feasibility Study
Condition: Atrial Fibrillation; AFib
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when
      placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose
      is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who
      are unable to take Oral Anticoagulants.
    


Intervention name(s): AtriClip LAA Exclusion Device
Intervention type(s): Device
Other intervention name(s): LAAØ; PRO1; AtriClip™ LAA Exclusion System; AtriClip™ LAA Exclusion System w/ preloaded Gillinov-Cosgrove™ Clip; AtriClip LAA Exclusion System and Delivery System (LAAØ); AtriClip LAA Exclusion System and Delivery System (PRO1)
Intervention MeSH terms: Protein S
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Left Atrial Appendage; LAA; Atrial Fibrillation; AFib; AF; IRB approved; clinical; Stroke; TIA; contraindication to oral anticoagulation therapy; Arrhythmias, Cardiac; OAC; trial; study; LAA occlusion; occluded; prevent
Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children
Condition: Acute Hepatitis A; Hepatitis
MeSH terms: Hepatitis A; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to collect epidemiological and clinical data to assess the
      vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals
      after the introduction of Havrix™ into the Expanded Program of Immunization.
    

Detailed description: 
      This is an observational, prospective, multi-centre, sentinel based study in 3 hospitals in
      Panama. Hospitals are selected based on population density or hepatitis A disease burden.

      The Pan American Health Organization (PAHO) definition for a possible case of acute hepatitis
      A are used for subjects aged between >1 month and <15 years.

      Data regarding clinical and epidemiologic information are collected and serum samples are
      collected to test hepatitis A markers and determine if infection with hepatitis A virus has
      recently occurred.

      Surveillance will be for a period of approximately 2.5 years from the date of study
      initiation.
    

Intervention name(s): Serum sample
Intervention type(s): Procedure
Intervention description(s): Serum samples collected
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged >1 month and <15 years of age being seen for possible acute hepatitis A
        during the study time period at the selected sentinel hospitals of Panama
      
Biospecimen description: 
      Serum
Apixaban in Patients With Left Ventricular Thrombus
Condition: Left Ventricular Thrombus
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Open label randomized controlled clinical trial to evaluate the efficacy and safety of
      apixaban versus warfarin in treating left ventricular thrombus in patients with acute or
      recent myocardial infarction (MI).
    


Intervention name(s): Apixaban; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg twice daily, on top of standards of care.; Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations
Other intervention name(s): Eliquis
Intervention MeSH terms: Warfarin; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      STOP PEDS is a pilot study of children with CF ages 6-18 across 10 sites in North America.
      The primary goal is to assess the acceptability and feasibility of a multicenter randomized
      trial comparing immediate antibiotics versus tailored therapy for pulmonary exacerbation
      (PEx) treatment in this population.
    

Detailed description: 
      STOP PEDS is a pilot study of children with CF ages 6-18 across 10 sites in North America.
      The primary goal is to assess the acceptability and feasibility of a multicenter randomized
      trial comparing immediate antibiotics versus tailored therapy for pulmonary exacerbation
      (PEx) treatment in this population. The primary endpoint is the proportion of participants in
      the tailored arm who did not take any oral antibiotics in the 28 days following
      randomization.

      Ultimately, we want to learn:

        -  What is the best way to treat pulmonary exacerbations?

        -  Should everyone with a pulmonary exacerbation take antibiotics?

        -  Do the benefits of starting antibiotics at the first signs of illness outweigh the
           possible risks, like side effects and antibiotic resistance?

      This pilot study is designed to determine if an interventional study to help answer these
      questions is feasible. Up to 120 participants will be enrolled and followed through their
      well state of health, then for 28 days following their first randomized exacerbation.
      Enrollment will stop after 80 pulmonary exacerbation events have been randomized, even if
      this does not require 120 participants. Due to the nature of the study, the identity of
      treatment assignment will be known to investigators, research staff, and patients (ie, not
      blinded).

      Total duration of this pilot study is expected to be approximately 18 months: 6 months for
      participant recruitment and 12 months for follow up. Participants could be monitored for up
      to 18 months if they do not have an exacerbation. However, it is anticipated that the
      majority of participants will experience a randomizable PEx event and therefore have a
      shorter follow up period.
    

Intervention name(s): Immediate Antibiotics; Tailored Treatment
Intervention type(s): Other; Other
Intervention description(s): increase airway clearance/start oral antibiotics right away; increase airway clearance and start oral antibiotics later if symptoms get worse or do not get better
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cystic fibrosis; oral antibiotics; pulmonary exacerbation; pediatric
Milrinone Inhaled in Cardiac Surgery
Condition: Valvular Stenosis; Valvular Insufficiency; Hypertension, Pulmonary; Coronary Artery Disease
MeSH terms: Hypertension, Pulmonary; Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac
      surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of
      being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the
      pulmonary artery.
    

Detailed description: 
      This controlled, randomized, double-blind study will aim at confirming the efficiency as well
      as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary
      hypertension before the cardiopulmonary bypass (ECC) circulation. In addition, the
      pharmacokinetic and echo graphic repercussions of administering the medication will be
      analysed. At the present time, there is no data on the pharmacokinetics of the medication
      when it's administered through inhalation. For this reason, we would like to study the serous
      rate of the medication in the minutes following its administration through inhalation.
    

Intervention name(s): Milrinone; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): inhaled milrinone 5 mg (as for the injectable solution); 5 ml normal saline by inhalation over 15 min
Other intervention name(s): Milrinone Cardiac Surgery; Milrinone inhaled; Inhaled milrinone reduces pulmonary artery pressure; Placebo; Comparator
Intervention MeSH terms: Milrinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Valvular surgery; pulmonary artery pressure
Gaze Holding in Cerebellar Patients
Condition: Gaze Holding in Humans; Rebound in Humans
Study type: Interventional

Summary: 
      The long-term goal of this research is to advance the investigators knowledge of how the
      cerebellum a) controls gaze holding and compensates for impaired gaze stability and b)
      modulates vestibular information that is forward-ed from the labyrinth and brought to
      perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy
      human subjects, patients with chronic (degenerative) cerebellar disorders are inable to
      stabilize gaze in eccentric positions, resulting in eye drift towards primary
      (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary
      position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can
      be observed in these patients. Unlike patients with de-generative cerebellar disorders,
      patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with
      acute deficits of gaze holding and verticality perception.

      While a linear relationship between the amount of eye velocity drift and eccentricity of eye
      position has been proposed in healthy human subjects, others suggested non-linear behaviour.
      The strategy of this research is to characterize gaze holding and verticality perception in
      healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic
      degenerative cerebellar disorders and to relate eye movement findings with structural imaging
      of the cerebellum. The investigators will therefore analyze key cerebellar structures with
      regards to loss of volume and relate these imaging findings with the participants' ability to
      hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the
      flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality
      perception in humans.
    


Intervention name(s): visual stimulus to follow
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Relacorilant Food Effect Study in Healthy Subjects
Condition: Healthy; Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-dose, 3-period crossover, Williams' design,
      food-interaction (fasted and fed arms) study conducted in healthy subjects.
    

Detailed description: 
      This food-interaction study will be conducted in healthy subjects. Each subject will have a
      screening visit (within the 21 days prior to the first study drug administration to confirm
      eligibility), 3 single-dose treatment periods separated by a 7- to 14- day washout between
      doses, and an outpatient end-of-study follow-up visit 14 +/- 2 days after the last dose of
      study medication. During each treatment period, subjects will receive a single 350-mg
      relacorilant dose. Based on randomization to 1 of 6 sequences, each subject will receive the
      relacorilant dose once after a 10.5 hour fast; once 30 minutes after the start of a high-fat
      meal; and once 30 minutes after the start of a moderate meal.

      During the first treatment period only, regardless of randomized sequence, subjects will
      report to the clinical research unit on the morning of Day -1 for baseline laboratory
      assessments and to collect samples for assay of messenger ribonucleic acid (mRNA) expression
      of glucocorticoid-modulated genes to explore the normal range over the day in healthy
      subjects. For the subsequent 2 treatment periods, subjects will report to the CRU on the
      evening of Day -1.

      Blood samples for assay of plasma concentration of relacorilant and its main metabolites will
      be collected pre-dose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72,
      and 96 hours post-dose. Subjects and will remain in the clinic until after the 24-hour blood
      samples are collected and then be discharged and scheduled to return for the later samples.

      Additional samples will be collected for possible future pharmacogenomic analysis.
    

Intervention name(s): Relacorilant Fasted; Relacorilant with a high fat breakfast; Relacorilant with a moderate breakfast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast; Relacorilant presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a high fat breakfast; Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a moderate breakfast
Other intervention name(s): Relacorilant; CORT125134; Relacorilant; CORT125134; Relacorilant; CORT125134
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, single-ascending dose Phase Ⅰa study to
      evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002
      following intravenous infusion in healthy subjects
    


Intervention name(s): STSA-1002 injection; Placebo; STSA-1002 injection; Placebo; STSA-1002 injection; Placebo; STSA-1002 injection; Placebo; STSA-1002 injection; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment