bioihbjkbjnl/mcl2 huggingface dataset:
Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The proposed test is intended to enable dentists to differentiate between cavitated and
      non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).
      In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays
      (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low
      sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,
      pain, root canals, and possible later loss of teeth.
    

Detailed description: 
      Tooth sites will be recorded by both tooth number, type of surface (mesial, distal,
      occlusal), cavitated, non-cavitated, healthy. Radiographs will similarly be scored. Although
      contrast agents are classified as drugs this is not a study of drug properties or effect on
      cells since the properties of the agent are already well known and its safety record well
      established. This study will be recording the radiopacity of the contrast agent on healthy
      tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. The outcome for
      each surface type will be presence or absence of a radiopacity on a radiograph which will be
      made at the one and only visit for each study subject. The radiograph contains the data from
      the intervention (placement of contrast agent) and the outcome will be assessed some weeks
      later after the completion of the data collection.
    

Intervention name(s): Sodium iodide
Intervention type(s): Device
Intervention description(s): Comparison of control radiographs made before application of sodium iodide and test radiograph after application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Observational

Summary: 
      The investigators retrospectively reviewed the medical records of 760 patients with thyroid
      nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients'
      thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System
      scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5
      -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle
      aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign,
      malignant).

      Documents of 88 patients who were included in the study and who underwent thyroidectomy were
      reviewed.Pathology reports of these patients were evaluated and surgical pathology was
      determined as benign in 58 patients and malignant in 30 patients.

      Then, a statistical study was performed between the cor needle biopsy (CNB) results of these
      participants and the surgical pathology and TI-RADS scores.
    


Intervention name(s): Thyroid biopsy with ultrasound
Intervention type(s): Procedure
Intervention description(s): Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.
Other intervention name(s): Total thyroidectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Thyroid biopsy data of 691 women and 69 men aged between 24-85 years were evaluated.
      
Biospecimen description: 
      Thyroid biopsy preparations Thyroidectomy specimen preparations
    
Keywords: TI-RADS score; Thyroid fine needle aspiration biopsy; Thyroid core needle biopsy; Surgical pathology
TLR4 Polymorphisms and Risk of Skin Cancer
Condition: Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Observational

Summary: 
      Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptor-4
      (TLR4) in particular, appears to play a role in susceptibility to cancer. Of 44 identified
      SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at
      nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads
      to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene. Pre-clinical
      studies from our laboratory have shown an association of TLR4 with ultraviolet radiation
      induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms
      and susceptibility to skin cancer.
    

Detailed description: 
      Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptors
      generally, and TLR4 in particular, appear to play a role in cancer susceptibility as well as
      tumor immunosuppression and stromal invasion. Of 44 identified SNPs (small nucleotide
      polymorphisms) in TLR4, the most common is an A-G substitution at nucleotide position +896,
      downstream of the cDNA start codon, a missense mutation which leads to an amino acid
      substitution Asp299Gly in the third exon of the TLR4 gene, and which was later shown to
      co-segregate with SNP Thr399Ile-also in the third exon of TLR4.1 This SNP, present in 10% of
      the general population, has been found associated with gastric cancer, prostate cancer, and
      nasopharyngeal cancer.2-4 Pre-clinical studies from our laboratory have shown an association
      of TLR4 with ultraviolet radiation induced skin cancer. Hence, in this study we will assess
      the pattern of TLR4 polymorphisms and susceptibility to skin cancer.
    

Intervention name(s): Detection of single nucleotide polymorphisms (SNP)
Intervention type(s): Diagnostic Test
Intervention description(s): Asp299Gly SNP in the third exon of the TLR4 gene will be detected in blood
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        400 patients age 50 and older (case group) will be enrolled at the time of presentation for
        skin cancer excision surgery. These patients will be stratified into melanoma and
        non-melanoma skin cancer subgroups, and the non-melanoma subgroup will be further divided
        into prior and no prior history of skin cancer. All groups will have blood drawn at the
        time of enrollment. 400 patients age 50 and older (control group) with no personal history
        of skin cancer will be enrolled at our clinical trials unit. These patients will be
        stratified into family history and no family history of skin cancer subgroups, and will
        have blood drawn at the time of enrollment.
      
Keywords: single nucleotide polymorphisms; Toll-like receptor-4
Photophlethysmography Evaluation of Pulse Waveform
Condition: Healthy
Study type: Interventional

Summary: 
      Aim 1. To explore a novel, non-invasive PPG technology for purposes of monitoring heart rate
      variability and pulse waveform by harmonic resonance analysis.

      Aim 2. To analyze collected data to determine whether it provides useful information about
      other measures of underlying health.
    

Detailed description: 
      The proposed study will first investigate whether a novel PPG device will be able to measure
      the harmonic-analysis indexes of the blood pressure waveform (BPWs) to provide information
      about arterial pulse transmission (by monitoring arterial pulse waveform, Cn) and
      cardiovascular regulatory activities (by monitoring coefficients of variation, CVn).

      Secondarily, data on Cn and CVn could be useful for detecting the arterial elastic properties
      induced by external stimulation such as exercise, cold stimulation, mental stress,
      acupuncture, medications such as antihypertensive drugs, or pathological factors such as
      metabolic syndrome, and breast cancer. The collected data may thus provide information about
      underlying health.

      Photoplethysmography (PPG) is a non-invasive optical technique for evaluating the pulse and
      hemodynamic changes in frequency. The device obtains a volumetric measurement of an organ via
      optical illumination (e.g LED). PPG has been used to determine the PaO2, heart rate, and
      blood pressure (systolic blood pressure, SBP and diastolic blood pressure, DBP) at fingertip
      and harmonic proportion at fingertip or from the radial artery waveform at the wrist.

      However, to the investigator's knowledge, this is the first preliminary study to determine
      the effects of physical activity on harmonic proportion evaluating by PPG at fingertip.
      Ultimately, this data may help to develop a non-invasive, external device that could rapidly
      detect information about cardiovascular and underlying health.
    

Intervention name(s): PPG during exercise
Intervention type(s): Device
Intervention description(s): PPG use for pulse waveform evaluation of healthy exercise group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Photophlethysmograph; device; pulse waveform
Comparison of Oral Health Related Quality of Life Changes Between Clear Aligners and Vestibular Fixed Appliances
Condition: Teeth Crowding
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Patients who have severe crowding that required four premolars extraction will be treated in
      this study. The effects of clear aligners therapy on oral health related quality of life
      (OHRQoL) in comparison with vestibular fixed appliances using the validated OHIP-14 tool
      during orthodontic treatment. So the aim of the study was to compare the changes in OHRQoL
      between patients receiving clear aligners or fixed appliances during the first year of the
      orthodontic treatment.

      There are two groups:

      First group (Experimental): the patients in this group will be treated using clear aligners.

      Second group (Control): the patients in this group will be treated using fixed appliances.
    

Detailed description: 
      For years, orthodontists and dentists have used removable appliances for orthodontic
      treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases
      with greater precision. They consists of a series of plastic aligners that are intended to
      replace conventional wire and bracket technology for many orthodontic cases. Each custom
      manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their
      original state to a final, treated state. Each aligner is worn for about two weeks, then
      replaced by the next in the series until the final position is achieved.
    

Intervention name(s): Vestibular fixed appliances; Clear aligners
Intervention type(s): Device; Device
Intervention description(s): The fixed appliances will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.; The clear aligners will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clear aligners; Oral health related quality of life; Orthodontic; Vestibular fixed appliances; Oral health impact profile
The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics
Condition: Healthy Subjects; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the
      effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics
      of selatogrel (ACT-246475).
    


Intervention name(s): Selatogrel
Intervention type(s): Drug
Intervention description(s): A single subcutaneous injection of 16 mg.
Other intervention name(s): ACT-246475
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Moderate hepatic impaired participants will be dosed after an interim analysis of at least 6 participants with mild hepatic impairment. Healthy participants will be matched to hepatic impaired participants.
Masking: None (Open Label)
Primary purpose: Other
The Effect of Red Blood Cells Storage Duration on Biochemical Changes in Pediatric Patients
Condition: Red Blood Cells Transfusion
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to detect if the storage duration of red blood cells has impact on
      some biochemical parameters after intra operative transfusion in pediatric trauma patient
    

Detailed description: 
      -  A pretransfusion draw of a few drops of patient venous blood, send for analysis by
           i-STAT Portable Clinical Analyser. Samples are processed immediately and provide
           laboratory quality results in 2 minutes using the CHEM 8+ i-STAT cartridge for
           measurement of:

             1. Potassium (K)

             2. Ionized Calcium (iCa)

             3. Glucose (Glu)

             4. Urea Nitrogen (BUN)/Urea

             5. Hemoglobin (Hb) and Hematocrit (Hct).

        -  Concurrently, a few drops of blood will be taken from the unit to be transfused will be
           analysed by i-STAT Portable Clinical Analyser for measurement of previous biochemical
           parameters.

        -  The details of the unit, such as draw date, volume of transfusion, and date of
           transfusion, will be recorded. The RBC unit will be delivered to the operative room from
           the blood bank in an insulated box.

        -  The transfusion is then given as clinically indicated at a rate of 50 to 150 mL/h based
           on the clinician's orders, the patient's weight, and the patient's clinical situation.

        -  Volumes will be transfused to children according to the following top-up transfusion
           equation: desired Hemoglobin (Hb) (g/dl) - actual Hemoglobin (Hb) (g/dl) x weight (kg) x
           3. (usually 10-20 ml/kg).

        -  A second patient blood sample will be drawn one hour after the transfusion and will be
           analyzed by i-STAT Portable Clinical Analyser.

        -  Patient information will be recorded for age, weight, sex, and primary diagnosis.

        -  Demographic and clinical variables will be collected, to include type and quantity of
           all blood products and fluids received and medications administered. All surgical
           procedures will be documented.
    

Intervention name(s): Red blood cells unit age 14 days or less; Red blood cells unit age more than 14 days
Intervention type(s): Biological; Biological
Intervention description(s): 30 Patients who will receive units of packed red blood cells stored stored for 14 days or less; 30 patients who will receive units of packed red blood cells stored for more than 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: RBCS,; Transfusion,; Pediatric; Changes
Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The overall goal of this project is to develop sensitive and objective clinical research
      tools for the assessment of head-neck motor control. In order to accomplish this goal, the
      investigators aim to quantify changes in head-neck motor control before and after osteopathic
      manipulative treatment. The investigators hypothesize that head-neck motor control will
      improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators
      will compare position and force head-neck motor control between healthy controls and neck
      pain patients. The investigators hypothesize that baseline tests of position and force
      head-neck motor control will be better in healthy individuals than neck pain patients.
    


Intervention name(s): Osteopathic manipulative treatment
Intervention type(s): Procedure
Intervention description(s): Up to 4 sessions of osteopathic manipulative treatment (once per week)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's
      hypothesis is that intravenous or inhalation anesthesia does not impair liver function as
      assessed by more elegant tests like markers indicating liver apoptosis. In the present
      randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will
      receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be
      determined.
    

Detailed description: 
      Female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol
      anesthesia will be recruited for the study. The type of anesthesia will be determined in a
      random way using a computer generated table.

      All patients will be preoxygenated for 3 minutes before induction of anesthesia. Patients
      assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a
      primed anesthetic circle system and anesthesia will be maintained with sevoflurane. In the
      propofol group patients anaesthesia will be induced and maintained with propofol.

      Blood samples for liver apoptotic markers will be collected before induction of anesthesia,
      after skin closure as well as 24 and 48 hours postoperatively.

      Blood samples will be centrifuged, stored at -80 degrees Celsius and analyzed for M30 and M60
      values with radioimmunoassay technique. Serum glutamic pyruvic transaminase (SGPT) and serum
      glutamic oxaloacetic transaminase (SGOT) levels will also be determined.
    

Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.; Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
Other intervention name(s): Sevorane, 2802252901023,; Lipuro, 2802467102017
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Liver Apoptosis
Interval Training in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity
      interval training compared to moderate intensity (same total work) on reducing the symptoms
      of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the
      investigators will establish what influence of gain to VO2max has on reducing symptoms.
    

Detailed description: 
      Physical exercise has significant effects on health promotion and the consequent reduction of
      the severity of bipolar disorder (BD). This review establishes a pattern of response of
      exercise and potential impact on the pathophysiology of BD; , as well as, produces hypotheses
      on how acute and chronic effect of exercises may act differently; and provides future
      perspectives with the focus of the exercise as an important and innovative model of treatment
      for BD and mental disorder. A critical evaluation of the literature was undertaken including
      the influence of exercise on health promotion in patients with mental disorders,
      neurochemical behavior exercise-induced, as well as reflective introduction of news
      perspectives of training control in severe exercise domain. The exercise induces significant
      changes in monoaminergic after, and with long-term training, and work with a threshold of
      exercise can modulate positive effects on mood. Fast adaptive effects from the high intensity
      interval training should be considered in BD patients. However, there must be caution in his
      administration. We speculate that exercise may be a way of maintaining euthymia in the case
      of BD, making it less vulnerable patient to stay longer at a time of neutrality. Future
      research is needed to adopt a training strategy that is both time efficient in the different
      areas and adequate for the population in question.
    

Intervention name(s): Interval Training; Continuous Training; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): High Intensity Interval Training at 100% VO2Max; Continuous Stimulous at 60% VO2Max; Only Dependent Variables Measures
Other intervention name(s): High intensity interval training; HIIT; HIT; Moderate Training; Endurance; No Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; VO2max; aerobic exercise
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess bioequivalence between a Combination caplet with
      loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium
      Express tablets-lyophilizate with loperamide HCl 2 mg (co-administered with Espumisan
      capsules with simethicone 40 mg), with respect to the single-dose pharmacokinetics of
      loperamide HCl. The maximum observed concentration (Cmax), and the area under the
      concentration-vs.-time curve until the last measurable concentration (AUC [0-t]) will be used
      to assess bioequivalence.
    


Intervention name(s): Combination Caplet with Loperamide HCl and Simethicone; Loperamide HCl; Simethicone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive combination caplet with loperamide HCl 2 mg and simethicone 125 mg as Test product A per assigned treatment sequence.; Participants will receive loperamide HCl 2 mg tablet-lyophilizate orally as part of Reference product B per assigned treatment sequence.; Participants will receive Simethicone 40 mg capsule orally as part of Reference product B per assigned treatment sequence.
Other intervention name(s): Imodium Express; Espumisan
Intervention MeSH terms: Simethicone; Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other