bioihbjkbjnl/mcl2 huggingface dataset:
Surface Hardness and Wear Characteristics of Prefabricated and CAD/CAM Milled Artificial Teeth
Condition: Surface Hardness and Wear Resistance of Artificial Teeth
Study type: Interventional

Summary: 
      Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and
      2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated)
      and CAD/CAM milled artificial denture teeth.

      material and methods: In a cross-over study design, ten completely edentulous patients were
      randomly chosen for this study and given two complete dentures. The first complete denture
      was constructed with pre-fabricated teeth. The second complete denture was constructed with
      CAD\CAM milled teeth. The complete denture teeth were 3D scanned at the time of insertion
      (T0), after three months (T3), and after six months (T6) of denture insertion. Utilizing 3D
      surface superimposition techniques, the vertical (2D wear), and Volumatic (3D wear) material
      loss were measured. The hardness of the teeth were evaluated at the time of denture insertion
      (T0) then after 6 months (T6) of denture insertion by Vickers hardness test. Statistical
      analysis was done using SPSS software. Paired groups were compared by paired t test.
      Significant difference was considered if P ≤ 0.05.
    


Intervention name(s): surface hardness test for denture teeth; wear resistance of denture teeth measurement
Intervention type(s): Other; Other
Intervention description(s): surface hardness test of denture teeth at insertion then after 6 months of use; 2D, Vertical wear, 3D Volumetric wear were measured for denture teeth
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites
Condition: Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Observational

Summary: 
      Multicentric, observational and prospective study with two groups of treatment: Refractory
      ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic
      blockers as primary or secondary profilaxis for variceal bleeding.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with hepatic cirrhoris and refractory or non-refractory ascites. These patients
        are going to be treated with beta blockers as primary or secondary prophylaxis of variceal
        bleeding
      
Keywords: Hepatic cirrhosis; Ascites; Beta blockers treatment
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg
      single oral dose of ZD4054 (Zibotentan)
    


Intervention name(s): ZD4054
Intervention type(s): Drug
Intervention description(s): one single 10mg dose
Other intervention name(s): Zibotentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ZD4054; Zibotentan; Healthy Volunteers
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers
Condition: Immunology
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of a novel positron
      emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of
      availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this
      tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following
      oral administration of Bristol Myers Squibb (BMS)-986020.
    

Detailed description: 
      End point Classification: Pharmacokinetics/Pharmacodynamics
    

Intervention name(s): BMS-986020; [11C]BMT-136088
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Constraint Induced Movement Therapy Summer Camp
Condition: Cerebral Palsy; Cerebral Palsy, Diplegic, Infantile
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy
      (CP). It is currently part of standard of care for children with unilateral CP, but is
      typically done one-on-one and with the child wearing a cast 24 hours a day during the
      duration of treatment. The purpose of this study is to assess the effects of an intensive
      group-based CIMT summer camp in which participants wear a removable cast on upper extremity
      function, occupational performance, and patient-specific goals. The investigators hypothesize
      that upper extremity skills and occupational performance will increase, and that patients
      will reach their individualized goals.
    


Intervention name(s): CIMT Camp
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemiparesis; Occupational Therapy
Intranasal Midazolam in Children as a Pre-Operative Sedative
Condition: Sedation, Conscious
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal
      midazolam makes giving the midazolam easier and more comfortable without affecting how the
      midazolam works as a sedative.
    

Detailed description: 
      Midazolam is often given before surgery to sedate a patient before anesthesia is given.
      Children are often given a small dose either by mouth or squirted into the nose. Children
      will often spit out the oral midazolam, making it difficult to know how much medicine, if
      any, they have received. Giving midazolam into the nose is more reliable, but children may
      complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also
      occur when midazolam is squirted alone into the nose. The purpose of this study is to see if
      adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam
      easier and more comfortable without affecting how the midazolam works as a sedative.
    

Intervention name(s): Midazolam; xylocaine; saline placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study participants will be randomly assigned to one of three treatment groups:
Group 1 - Placebo - Control patients will receive intranasal saline.
Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.
Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.; Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.; Placebo - Control patients will receive intranasal saline.
Other intervention name(s): versed
Intervention MeSH terms: Lidocaine; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children
Condition: Electroencephalography; Child; Dexmedetomidine; Melatonin; Sleep; Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine,
      given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep
      duration, their possible impact on vital functions and technical implementation of EEG.
    

Detailed description: 
      At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use
      electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes
      in children with (suspected) epilepsy. Since epileptiform activity can only be detected
      during sleep in some patients and because children with intellectual disabilities have
      sometimes problems with cooperation, EEG in induced sleep is required.

      In this study, the investigators will enroll 150 children who need EEG recorded in their
      sleep. The investigators will compare safety and efficacy of the two active substances, one
      of which will be given in two possible routes. Fifty children will receive melatonin in the
      form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of
      a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators
      will monitor the following parameters: the time in which the child falls asleep, vital
      functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency
      and heart rate frequency), the impact on the technical implementation of EEG, the depth of
      sleep and waking time. All parents will give their written consent for their child to
      participate in the study.
    

Intervention name(s): Electroencephalography; Monitoring of vital functions; Melatonin 0,1mg/kg oral syrup; Dexmedetomidine 3 mcg/kg sublingually; Dexmedetomidine 3 mcg/kg intranasally
Intervention type(s): Diagnostic Test; Diagnostic Test; Drug; Drug; Drug
Intervention description(s): Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.; Melatonine in the form of syrup will be given orally to child.; Dexmedetomidine in the form of a solution will be given to child sublingually.; Dexmedetomidine in the form of nasal spray will be given to child intranasally.
Other intervention name(s): EEG
Intervention MeSH terms: Dexmedetomidine; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Child; Dexmedetomidine; Melatonin; Electroencephalography; Autism Spectrum Disorder; Developmental Delay Disorder; Epilepsy; Sleep; Sleep induction
Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors
Condition: Dyslipidemia; Obesity
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia
      while no such studies with whole strawberries have been reported in the US population. The
      investigators propose to examine the effects of low and high doses of freeze-dried
      strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and
      inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and
      dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the
      low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories)
      group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and
      the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws,
      anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks
      of the study to determine chronic and acute effects of strawberry intervention. Serum or
      plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total
      cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of
      oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high
      sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated
      measures ANOVA will be performed using a 5% significance level. We anticipate a dose response
      effect in decrease in lipids, oxidative stress or inflammation following strawberry
      intervention versus controls.
    

Detailed description: 
      The overall objective of this clinical trial is to investigate the effects of low and high
      doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal
      adiposity and dyslipidemia versus age and gender-matched controls.
    

Intervention name(s): Freeze-dried strawberries; Dietary fiber
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 25g or 50g freeze-dried strawberries reconstituted in water; 4g or 8g dietary fiber blended in water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Strawberries; Heart health; Anthocyanins
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18
      years of age who are at risk of complications of influenza disease due to underlying
      diseases.
    


Intervention name(s): TIVc; TIV
Intervention type(s): Biological; Biological
Intervention description(s): Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain [A/H1N1-like, A/H3N2-like, and B-like]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere; A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain [A/ H1N1-like, A/H3N2-like, and B-like]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Flu; Children; Adolescents
Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
Condition: Zygomatic Arch Reduction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in
      cases of zygomaticomaxillary fracture.

      To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.

      To compare between esthetic appearance, orbital movement, wound healing, scaring, and
      postoperative ocular complications in both groups.
    


Intervention name(s): reduction of zygomatic arch in zygomaticomaxillary complex fracture
Intervention type(s): Procedure
Intervention description(s): ultrasound guided reduction of zygomatic arch
Other intervention name(s): open reduction of zygomatic arch in zygomaticomaxillary complex fracture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Condition: Postmenopausal Women With Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      - To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole
      monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer
      which participated in double blind study.
    


Intervention name(s): Letrozole
Intervention type(s): Drug
Other intervention name(s): FEM345
Intervention MeSH terms: Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aromatase inhibitor; letrozole; breast cancer
Swallowing and Voice Outcomes After Thyroidectomy
Condition: Functional Voice and Swallowing Outcomes
Study type: Observational

Summary: 
      Impairment in voice and swallowing functions are common after thyroidectomy. The
      investigators aimed to evaluate the objective functional voice and swallowing outcomes in a
      series of patients undergoing thyroidectomy.

      according to the study, even in the absence of recurrent laryngeal nerve injury, subjective
      and objective swallowing and voice alterations do occur after thyroidectomy.
    

Detailed description: 
      A total of 43 consenting patients who underwent thyroidectomy were prospectively recruited.
      Subjective evaluation of swallowing was assessed with 'Swallowing Impairment Score' and 'MD
      Anderson Dysphagia Inventory'. Fiberoptic endoscopic evaluation of swallowing (FEES) was
      applied for objective evaluation. Also, functional oral intake scale (FOIS) and functional
      outcome swallowing scale (FOSS) were used for swallowing assessment. Voice evaluation was
      assessed with videostrobolaryngoscopy (VSL) and 'The Multi-Dimensional Voice Program (MDVP)'
      was used for capturing and analyzing the voice samples. All evaluations were performed
      preoperatively and on 1st day, 2nd week and 6th months postoperatively.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who underwent thyroidectomy without recurren nerve injury
      
Keywords: Thyroidectomy; voice; swallowing problems; dysphagia
Acellular Dermal Matrix in Breast Reconstruction
Condition: Breast Cancer
Study type: Observational

Summary: 
      Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls
      reconstructions. However, it is solely used in breast reconstructions after breast carcinoma
      amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to
      current treatment options, however, this has to be proved.
    

Detailed description: 
      This is a prospective study, where patients undergoing breast reconstruction surgery using
      acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be
      included. The permanent breast implants will be implanted approximately half year during
      second surgery. Acellular dermal matrix is a soft tissue graft that is formed by
      decellularization, however with intact extracellular dermal matrix. Such structure is able to
      re-create adequate skeleton for host cells with subsequent incorporation and
      revascularization. The safety and appropriateness of such ADM in breast reconstruction
      surgery will be analyzed.
    

Intervention name(s): Acellular dermal matrix implantation
Intervention type(s): Other
Intervention description(s): Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.
Other intervention name(s): breast reconstruction
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort will be selected from patients with breast cancer and in remission, sent to
        plastic and reconstruction surgery clinics for breast reconstruction after therapeutical
        mastectomy.
      
Biospecimen description: 
      Acellular dermal tissue after primary reconstruction will be harvested prior to second
      surgery with permanent implant.
    
Keywords: Breast Implants; Acellular Dermal Matrix
Sedative Premedication: Efficacy On Patient Experience
Condition: Perioperative Anxiety
Study type: Interventional
Phase: Phase 3

Summary: 
      Seven French university hospitals will participate in this multicentric prospective, blinded
      and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo
      (microcrystalline celluloses) and no premedication at all. The third group (no premedication)
      is necessary in order to evaluate a placebo response, which may be significant on anxiety
      level and patients perceptions of care. It was calculated that 969 patients had to be
      included in order to obtain a 5 point difference between groups on the EVAN score with 80 %
      statistical power, leading to the inclusion of 1200 patients with an estimated maximum
      dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under
      general anesthesia can be included after information by an anesthesiologist in charge of the
      study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a
      counter indication to benzodiazepine, surgeries that could impair cognitive functions
      (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or
      former cognitive disease. The technique of anesthesia will be decided by the attending
      anesthesiologist, who will be unaware of the premedication technique, independently of the
      study protocol.
    


Intervention name(s): Lorazepam; no premedication; Placebo (microcrystalline celluloses)
Intervention type(s): Drug; Other; Drug
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment