bioihbjkbjnl/mcl2 huggingface dataset:
Tooth Wear and Associated Risk Factors
Condition: Tooth Wear
MeSH terms: Tooth Wear; Tooth Attrition
Study type: Interventional

Summary: 
      This study compares the associated risk factors between adults with tooth wear and age- and
      sex-matched controls without tooth wear.
    

Detailed description: 
      Some people are at greater risk due to their eating and brushing habits. Poor oral health
      behaviors and malnutrition are the leading causes of tooth surface loss in adults. Fluid
      consumption trends have changed, and the increased consumption of carbonated drinks coincides
      with a decline in the consumption of dairy products and increases in the use of packaged
      products. Frequent and faulty brushing with abrasive oral hygiene products can also increase
      TW. Individuals unhappy with the color of their teeth may also frequently use whitening
      toothpaste.

      Saliva is considered the biological factor with the greatest potential to modify the
      progression of TW. There are several potential mechanisms by which saliva may protect enamel
      from dietary acid erosion. Saliva protection mechanisms include the dilution of erosive
      agents in the mouth, neutralization, effects of calcium and phosphate ions, and slowing of
      the rate of enamel dissolution.

      The loss of dental tissue can lead to the character's loss of precision and form, and in
      advanced stages the dentin surface can be exposed. TW is initially painless and
      unrecognizable. In the next stage, complaints often include tenderness and non-aesthetic
      factors. It is difficult to recognize the signs of TW and very important to avoid premature
      diagnosis, as TW can often be diagnosed by a dentist. Correct diagnosis is an important part
      of the treatment and will help the dentist determine recommendations for the patient.
    

Intervention name(s): GC Saliva-Check BUFFER
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluating the saliva flow rate, saliva pH and saliva buffering capacity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tooth wear, risk factors, saliva, diet, oral hygiene
MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions
Condition: Solid Tumor
Study type: Interventional

Summary: 
      The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for
      estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a
      19-gauge needle. How it compares to the conventional technique of tissue acquisition during
      EUS-FNA is uncertain.

      The objective of this study is to evaluate the quantity and quality of tissue, and the
      diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic
      analysis.
    

Detailed description: 
      To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when
      compared with the conventional combined histologic-cytologic analysis in a randomized
      controlled study.
    

Intervention name(s): Macroscopic on-site evaluation; Control
Intervention type(s): Procedure; Other
Intervention description(s): Macroscopic on-site evaluation: any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). Length of MVC will be measured to determine the adequacy of that puncture.; Conventional EUS-FNA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Phase 1 Study for Safety and Tolerability of HL036
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, local tolerability and pharmacokinetic characteristics after
      administration of eye-drop HL036 in healthy Korean male volunteers
    

Detailed description: 
      A total of 10 subjects will be dosed in each group with subjects randomized 8:2 to HL036 or
      placebo. Three of 10 subjects will be randomized to the sentinel dosing in each group. A
      safety data review as masking will be performed for 3days prior to the other subjects
      treatment. Treatment of high dose will proceed following a review of safety data from low
      dose.
    

Intervention name(s): HL036; Vehicle
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is
      known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is
      the source of local and/or systemic infection or sepsis. The local inflammation and infection
      destroy healthy surrounding tissues and extends the original damage. In order to prevent
      these complications, and in order to minimize the risk of infection, it is imperative to
      evaluate the burn and remove all of the offending eschar at the earliest possible
      opportunity. This removal of dead tissue is termed "debridement".

      The most direct debridement method for eschar removal is surgery. Traditional, conservative
      non-surgical debridement is a lengthy process which often involves many complications.

      The objectives of this study are as follows:

        1. To evaluate the safety and efficacy (exploratory) of DGD in hospitalized patients with
           Partial Thickness (mid and deep dermal) thermal burns of 4-30% total body surface area
           (TBSA), but with total burn wounds of no more than 30% TBSA. Measures have already been
           taken in previous studies involving deeper wounds to control safety parameters (such as
           pain, fever and infection). Nevertheless, as part of the effort to expand the burn
           population in the future phase 3 study to the more superficial wound group, it is
           important to first explore these parameters in a small group involving this burn
           population.

        2. To explore DGD absorption as measured by Pharmacokinetic testing.
    

Detailed description: 
      on-going recruitment, children and adults
    

Intervention name(s): DGD
Intervention type(s): Drug
Intervention description(s): DGD is a mixture of lyophilized enzymes derived from purified Bromelain from pineapple stem.
Two grams or 5 grams of Debrase powder are dissolved in 20 grams or 50 grams of Gel Vehicle to obtain DGD. DGD is applied to the burn wound at a dose of 2g Debrase/20g Gel per 100 cm2 of skin or 5g Debrase/50g Gel per 250 cm2 for a duration of four hours. In an average human adult, 100 cm2 represents approximately 1% of Total Body Surface Area (TBSA).
Please note that for individuals of exceptional size (e.g. children), it is important to calculate the dosage based on the 100 cm2 measurement.
The Debrase powder and the Gel Vehicle are to be mixed at the patient bedside for a maximum of 15 min prior to use.
DGD should not be applied to more than 15% TBSA in one session. If the wound area to be treated is more than 15% TBSA, DGD should be applied in two or more separate sessions.
DGD should not be applied more than twice to the same burn wound area.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rabies Immunization Concomitant With JEV in Children
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      Background. The World Health Organization recommends pre-exposure vaccination (PreP) to
      protect children living in canine rabies endemic countries. Including PreP in national
      childhood immunization programs (EPI) is a viable option.

      Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to
      receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM
      (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of
      Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or
      JEV alone was administered concomitantly one year after primary vaccination. Safety was
      evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to
      booster and on days 7 and 28 post-booster, and at two and three years post primary
      vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA,
      JEVNA).
    


Intervention name(s): Rabies vaccine
Intervention type(s): Biological
Intervention description(s): 1.0 mL IM day 0,7,28 and 1 year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rabies vaccination; pre-exposure prophylaxis; rabies virus neutralizing antibody; Antibody response; immunologic memory of rabies vaccination; Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes
3D Ultrasound Validation for Measuring Stomach Volume
Condition: Healthy
Study type: Observational

Summary: 
      The goal is to study the accuracy of 3-dimensional ultrasound (which does not involve
      radiation) to measure the size of the stomach, comparing it with a previously validated
      method that involves radiation. This will make it possible to check the stomach function of
      children without exposing them to radiation. A second goal is to measure the size of the
      stomach and the effect of a standard meal on stomach volume in adolescent boys and girls.
    

Detailed description: 
      Specific Aims

        1. To compare the fasting and postprandial volumes measured by 99mTc- SPECT (standard test)
           and 3-D ultrasound in 12 healthy adults in order to test latter's external validity

        2. To assess the performance characteristics of 3-D ultrasound for the measurement of
           gastric volumes during fasting and in response to a standard meal, specifically, the
           intra- and inter-individual coefficient of variation in 12 healthy adults who undergo
           two estimations of fasting and postprandial volumes

        3. To develop normative data for fasting and postprandial gastric volumes in 24
           asymptomatic adolescents.

      Study Design

      The study will be conducted in 2 parts: first, 12 healthy adults will undergo SPECT and 3-D
      ultrasound in random order (aim 1); one week after the first ultrasound examination, a second
      Ultrasound examination will be conducted in all participants (aim 2) In the second part, 24
      adolescents (12 in each gender, 12 aged 13-15, 12 aged 16-18)) will undergo a single
      determination of fasting and postprandial gastric volumes during fasting and post-prandially.
      The methods and validation of the SPECT study have been previously published (2). Three D
      ultrasonography will be conducted using state of the art equipment following methods
      published in the literature. (3)

      The study will screen 80 healthy adults or adolescents in order to enroll 12 healthy adulkts
      for the first two aims, and 24 adolescent healthy subjects for the third aim.

      For subjects in group 1, the order of SPECT and 3D- ultrasound tests will be randomized.

      The randomization assignments will be made according to a pre-study schedule prepared by the
      Section of Biostatistics. Medical investigators will be blinded to assignment, allocation
      will be concealed
    

Intervention name(s): 3D ultrasound
Intervention type(s): Other
Intervention description(s): measurement of stomach volume by 3D ultrasound
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ealthy adolescents and adults: The study will screen up to 80 healthy adults or adolescents
        in order to enroll 12 healthy adults for the first two aims, and 24 adolescent healthy
        subjects for the third aim
      
Keywords: stomach; accommodation; volume; SPECT; 3 dimensional ultrasonography; healthy volunteers
A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate of absorption and oral bioavailability of a test formulation of
      Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent
      oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer
      Inc. administrated to healthy subjects after a 10-ghour overnight fast
    

Detailed description: 
      Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period
      crossover study

      Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of
      Sertraline 100 mg Tablets Under Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Sertraline HCl 100 mg tablets, single dose; Zoloft® 100 mg tablets, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental SSubjects received Purepac formulated products under fasting conditions; B: Active comparator Subjects received Pfizer formulated products under fasting conditions
Other intervention name(s): Sertraline; Sertraline
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Sertralin; Healthy subjectse
Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
Condition: LVM; Type 2 Diabetic Patients With IHD; Endothelial Function
MeSH terms: Heart Diseases; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiovascular complications account for the highest mortality in type 2 diabetic patients,
      mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2
      diabetes is understandably directed toward treating coronary artery conditions. However there
      are other treatable culprits in these patients.

      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even
      in the absence of hypertension. It is a strong predictor of cardiovascular events and
      all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality
      than either multivessel coronary disease or impaired left ventricular function. Regression of
      LVH has been associated with an improved prognosis, independent of change in blood pressure
      (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will
      be reduced if we can find novel therapies to regress LVH.

      Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can
      regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study,
      we will treat patients with pioglitazone, and we will also metformin as control.
    


Intervention name(s): pioglitazone group; Metformin group
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; left ventricular mass; pioglitazone
FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, multicenter, open-label, active-controlled study of the treatment of
      anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.
    

Detailed description: 
      This is a randomized, multicenter, open-label, active-controlled study of the treatment of
      anemia in subjects with CKD on dialysis. Eligible subjects are randomized to FG-4592 or
      epoetin alfa at a ratio of 2:1. The primary endpoint is Hb mean change from baseline averaged
      over Weeks 23 to 27.
    

Intervention name(s): FG-4592; Epoetin Alfa
Intervention type(s): Drug; Drug
Other intervention name(s): Li Xue Bao
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease
Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
Condition: Hay Fever
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.
      The purpose of this study is to demonstrate the clinical efficacy and safety of a
      subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic
      rhinoconjunctivitis compared to placebo.
    


Intervention name(s): Placebo solution; gpASIT+TM
Intervention type(s): Biological; Biological
Intervention description(s): 4 x 2 injections over 21 days; 4 x 2 injections over 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multiple Dose Opioid Challenge Study
Condition: Moderate or Severe Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and
      duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in
      patients with moderate or severe opioid use disorder.
    

Detailed description: 
      This is a multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the
      degree and duration of action of multiple doses of CAM2038 q1w in blocking the effects of a
      mu opioid agonist (hydromorphone) in patients with moderate or severe opioid use disorder.
      The study will involve 4 phases: Screening, Qualification, Treatment, and Follow-up.

      The study will enroll a sufficient number of subjects to ensure that at least 48 subjects
      complete the study (24 subjects per group with at least 16 females in total). Replacement
      subjects may be added at the discretion of the sponsor with the agreement of the
      investigator.
    

Intervention name(s): CAM2038
Intervention type(s): Drug
Intervention description(s): CAM2038 subcutaneous injection
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy
Condition: Prevention of BMD Loss After THR; Serum Markers of Bone Turnover; Functional Outcomes
Study type: Interventional
Phase: Phase 3

Summary: 
      Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy
      under mechanical unloading after THR implantation, further compromises the longevity of
      implant. The prospective randomized study is aimed to investigate the periprosthetic bone
      loss after primary total hip replacements.
    

Detailed description: 
      This study is a prospective, randomized, open-label clinical trial. The study will be
      performed in patients after obtaining informed consent. Group assignment is by drawing a
      sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta®
      (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year
      after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is
      given to the patients. Only the unilateral coxarthrosis will be recruited for the study.
      Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and
      SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified
      examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24
      months.
    

Intervention name(s): Aclasta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aclasta once annually for 2 years; No IV aclasta
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bisphosphonate; Total hip replacement; functional outcomes; bone mineral density
Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate
Condition: Other Conditions of Brain
MeSH terms: Brain Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during
      electroencephalography in patients with neurological disorders. The hypothesis is that this
      drugs provides similar changes in EEG pattern.
    

Detailed description: 
      Patients with chronic neurological disorders such as cerebral palsy or autism need to be
      sedated during electroencephalography (EEG). However, various sedatives and hypnotics affect
      the outcome of the review and is not shown. Chloral hydrate (CH) is widely used in children,
      but in this patients it is less effective.Recently, dexmedetomidine (DEX) has been tested
      because preliminary data suggests that this drug does not affect the EEG. The aim of the
      present work was to compare the electroencephalogram (EEG) pattern during CH or DEX sedation,
      to test the hypothesis that both drugs exert similar effects in EEG.Seventeen patients were
      evaluated during sedation with DEX or CH on separate occasions.The EEG was subjected to
      qualitative and quantitative analysis. Clinical variables were also compared.
    

Intervention name(s): Dexmedetomidine; Chloral Hydrate
Intervention type(s): Drug; Drug
Intervention description(s): 1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1; Initial dose=50 mg/kg
Other intervention name(s): Dexmedetomidine: Precedex, Abbott Laboratories; Chloral Hydrate 10% solution (100 mg/ml)
Intervention MeSH terms: Dexmedetomidine; Chloral Hydrate
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sedation; Electroencephalography; Dexmedetomidine; Chloral hydrate