bioihbjkbjnl/mcl2 huggingface dataset:
Apexification Treatment With MTA(Mineral Trioxide Aggregate) and Ca(OH)2
Condition: Immature Teeth
Study type: Interventional

Summary: 
      Ninety immature teeth with necrotic pulps and periapical lesions on patients (aged 16-40y)
      were treated with AT using MTA (45 teeth) or CH (45 teeth) between 2015 and 2018. The
      patients were contacted for follow-up examination at 12 to 48 months after treatment. The
      treatment outcome based on clinical and radiographic criteria was assessed by calibrated
      examiners and dichotomized as "healed+healing" or "not healed". The age, gender, stage of
      root development, preoperative signs and symptoms of apical periodontitis and size of
      periapical lesion were recorded.
    

Detailed description: 
      The aim of the study was to evaluate and compare the influence of various predictors on
      outcomes of apexification treatment (AT) using either mineral trioxide aggregate (MTA) or
      calcium hydroxide (CH) to treat permanent immature anterior teeth with necrotic pulps and
      periapical lesions in adults. Ninety immature teeth with necrotic pulps and periapical
      lesions on patients (aged 16-40y) were treated with AT using MTA (45 teeth) or CH (45 teeth)
      between 2015 and 2018. The patients were contacted for follow-up examination at 12 to 48
      months after treatment. The treatment outcome based on clinical and radiographic criteria was
      assessed by calibrated examiners and dichotomized as "healed+healing" or "not healed". The
      age, gender, stage of root development, preoperative signs and symptoms of apical
      periodontitis and size of periapical lesion were recorded. The effect of potential clinical
      variables on the treatment outcome of AT was evaluated clinically and radiographically during
      a 12-48-month follow-up. In order to assess the cumulative successes of CH and MTA after AT,
      Kaplan-Meier survival analysis and log-rank test was used(p>0.05).
    

Intervention name(s): Mineral trioxide aggregate; Calcium hydroxide
Intervention type(s): Other; Other
Intervention description(s): Apexification treatment was done with mineral trioxide aggregate; Apexification treatment was done with calcium hydroxide
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: apexification treatment; calcium hydroxide; mineral trioxide aggregate
Effect of Maitland Mobilization With Low Level Laser Therapy in Treatment of Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Background: Osteoarthritis is a common cause of chronic pain and disability in elderly
      people.

      Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with
      Maitland mobilization and conventional physical therapy in patients with chronic knee
      osteoarthritis.

      Design: Pre-test post-test randomized control trial.
    

Detailed description: 
      Knee OA is associated with pain and disability, high treatment costs, decreased productivity,
      and absence from work and thus has a substantial and growing burden on society Objective: To
      evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland
      mobilization and conventional physical therapy in patients with chronic knee osteoarthritis.

      Participants: Seventy five subjects of both genders with age range from 50 to 65 years, with
      proven bilateral knee OA diagnosed and referred by orthopaedist were recruited for the study
      and randomly assigned into three groups.
    

Intervention name(s): Low Level laser therapy; Maitland mobilization technique
Intervention type(s): Device; Other
Intervention description(s): is a non-invasive light source treatment that generates a single wavelength of light. It emits no heat, sound, or vibration. It is also called photobiology or bio-stimulation; is a process of examination; assessment and treatment of musculoskeletal disorders by manipulative physiotherapy where a chain of oscillatory joint mobilization grades based on the pathological limit of tissue are used
Other intervention name(s): LLLT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Symbicort with budesonide alone for the treatment of
      asthma in children aged 6 to 15 years
    


Intervention name(s): budesonide/formoterol (Symbicort); budesonide
Intervention type(s): Drug; Drug
Other intervention name(s): Symbicort
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: asthma; children; adolescents; Symbicort; budesonide/ formoterol; budesonide
A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure
Condition: Heart Failure; Decompensated Heart Failure; Acute Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of
      CXL-1427 in hospitalized patients with systolic heart failure.
    

Detailed description: 
      This is a dose finding, randomized, double-blinded, placebo-controlled study of continuous
      6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure which
      will first evaluate up to four ascending dose levels of CXL-1427 in up to four cohorts of 8
      patients each (the "Dose Escalation" cohorts). Subsequently, up to three of the initial dose
      levels of CXL-1427 may be assessed in the additional "Expansion" cohorts of up to
      approximately 16 patients to gain further confidence in the results at these dose levels. The
      CXL-1427 dose that will be evaluated in the first cohort will be 3µg/kg/min. The dose levels
      for the next three sequential Dose Escalation cohorts will be dependent on clinical safety
      and tolerability, as well as the results of the invasive hemodynamic measurements.
    

Intervention name(s): CXL-1427; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): BMS-986231; 5% Dextrose & 10mM potassium acetate as same IV solution diluents used in active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute Heart failure; Hemodynamics; Pharmacokinetics; Renal Function
Serum Pro-Diabetes Inflammation Biomarkers in Patients With Apical Periodontitis.
Condition: Apical Periodontitis; Insulin Resistance; PreDiabetes; Diabetes; Stable
MeSH terms: Periodontitis; Periapical Periodontitis; Diabetes Mellitus; Insulin Resistance; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Inflammation is a common factor of chronic periodontitis and diabetes. However, to date,
      there is no scientific evidence supporting a causal effect of the inflammation created by
      apical periodontitis on the onset of insulin resistance and on metabolic derangement in the
      condition of pre-diabetes or diabetes.

      A case control study has been designed in order to evaluate serum levels of pro-diabetes
      inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or
      without apical periodontitis,before endodontic treatment and at 6 and 12 months
      post-treatment. The aim of the study is to evaluate any relation between the presence of
      chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset
      of insulin resistance, and whether endodontic treatment can reduce these factors, thus
      preventing a pro-diabetes status.
    

Detailed description: 
      Healthy, consenting and informed patients of both gender under 55 years of age with apical
      periodontitis will be enrolled as cases. Healthy, consenting and informed patients of both
      gender under 55 years of age without apical periodontitis will be enrolled as control
      subjects. The study has been designed to assess the serum level of TNF-α, IL-1β, IL-6, IL-8
      by ELISA assay.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dental Hospital
      
Biospecimen description: 
      Blood Sample
    
Keywords: Endodontics; Apical Periodontitis; Insulin Resistance; Diabetes; Pro-Diabetes Inflammation Markers
A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the
      efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes
      Mellitus (T2DM).
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled study designed to evaluate the
      efficacy, safety, and PK of MEDI0382 administered as multiple daily SC doses to participants
      with T2DM. Approximately one hundred and seven participants will be enrolled across 6
      cohorts. In cohorts 1-3 the participants will be randomized to MEDI0382 or placebo (2:1). In
      Cohort 4, participants will be randomized to MEDI0382 or placebo (1:1). In cohort 5 and 6
      participants will be randomized to MEDI0382 or placebo (3:1).
    

Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI0382 administered subcutaneously.; Placebo administered subcutaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI0382, diabetes
Evaluate Patients With Chronic Hepatitis by Three-dimensional Force-controlled Ultrasound Measurement
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      Ultrasound (US) B mode image is an alternative method to measure tissue structure and has
      proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing
      the transducer onto the skin with too much force will significantly reduce the subcutaneous
      adipose tissue thickness. In this study, a force controlled system combined with US
      transducer was used for 3D subcutaneous fat imaging and reconstruction.
    

Detailed description: 
      The diagnosis of fatty liver (steatosis) is made when fat in the liver exceeds 5-10% by
      weight. Fatty liver (FL) is commonly associated with alcohol or metabolic syndrome (diabetes,
      hypertension, obesity, and dyslipidemia), but can also be due to any one of many causes. Most
      people were detected from serum lipid abnormalities in the physical examination, and
      confirmed as the fatty liver disease by ultrasound imaging. In some previous studies,
      ultrasound was reported to provide an accurate and reliable measurement tool for the
      thickness measurements of subcutaneous adipose tissue. This method can overcome some
      limitations of the skinfold thickness measurements. Ultrasound (US) B mode image is an
      alternative method to measure tissue structure and has proven to be an accurate technique to
      measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too
      much force will significantly reduce the subcutaneous adipose tissue thickness. In this
      study, a force controlled system combined with US transducer was used for 3D subcutaneous fat
      imaging and reconstruction. Finally, the correlations between body fat percentage and
      subcutaneous fat in steatosis patients have been investigated. The body fat percentage was
      determined by dual energy X-ray absorptiometry (DEXA, GE Lunar iDXA canner) and bioelectrical
      impedance analysis (BIA, Omron，HBF-370), and then, the correlation between body fat
      percentage and subcutaneous adipose tissue in normal and steatosis patients have been
      evaluated.
    

Intervention name(s): Ultrasound (US) B mode image
Intervention type(s): Device
Intervention description(s): Ultrasound (US) B mode image is an alternative method to measure tissue structure
and has proven to be an accurate technique to measure subcutaneous fat thickness.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Thromboelastogram During Total Knee Replacement
Condition: Orthopedic Procedures, Tranexamic Acid
Study type: Observational

Summary: 
      Verify the changes in coagulation system during total knee replacement surgery with
      tranexamic acid single bolus infusion.
    

Detailed description: 
      The study was set to reveal changes in the coagulation and fibrinolytic systems during total
      knee surgery and especially during tourniquet placement, tourniquet removal and
      revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post
      operative day 1.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        As described in eligibility criteria
Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
Condition: Periodontal Disease
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Observational

Summary: 
      Sialic acid (SA) is the generic term given to a family of acetylated derivatives of
      neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to
      regulate innate immunity. SA is present in several acute phase proteins which are known to be
      associated with periodontitis. There exists a need for a biomarker, for early detection of
      disease evolution and more robust therapy efficacy measurements. Till date, there is very
      little data regarding simultaneous estimation and comparison of total SA content in saliva.
      IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines
      such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in
      both healthy and diseased human periodontal tissues and is reported to be reduced in patients
      infected with Aggregatibacter actinomycetemcomitans.

      The present study was therefore undertaken with an aim, to not only assess the levels of
      TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage
      2(moderate) periodontitis patients
    

Detailed description: 
      Selection of patients by grading the patients according to criteria stage 1 and 2
      Periodontitis

      Obtaining consent from patients participating in the study

      Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree
      Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool
      box indicated for laboratory samples and transported to the lab for investigations. It will
      be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be
      determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be
      measured in mg/dl,IL10 as in direct measurement.
    

Intervention name(s): sialic acid; IL10
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): sialic acid level estimation in salivary samples; IL10 estimation in salivary samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore
      
Biospecimen description: 
      Sialic acid and IL10 are assessed by taking salivary samples
    
Keywords: sialic acid; IL10; stage 1 periodontal disease; stage 2 periodontal disease
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of
      MP-214 in patients with schizophrenia.
    


Intervention name(s): MP-214 3mg; MP-214 6mg; MP-214 9mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.; Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.; Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic Agents; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Central Nervous System Agents
Heart Rate Variability in Children With a Functional Gastrointestinal Disorder
Condition: Abdominal Pain
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain
Study type: Observational

Summary: 
      The current study is designed to assess relationships between anxiety/stress, autonomic
      nervous system balance, and electrical activity in the stomach before and after
      eating/drinking in children with abdominal pain.
    

Detailed description: 
      Chronic or recurrent abdominal pain in children is a very common complaint in children and
      adolescents, and is most often associated with the presence of a functional gastrointestinal
      disorder (FGID). It is likely that the clinical symptoms in FGIDs are the result of an
      interaction between biologic, psychologic, and social factors. The psychologic factor most
      implicated is chronic stress or anxiety. Stress may influence gastrointestinal function and
      symptoms through altering the balance of the autonomic nervous system (ANS). Imbalance in the
      ANS has potential effects on gastrointestinal mechanosensitivity, motor function (e.g.
      stomach emptying and accommodation), and electrical rhythms. All of these can be associated
      with abdominal pain. Theory and early evidence from studies done with healthy adult
      populations suggest that ANS imbalance can reduce the body's ability to respond electrically
      to food/water consumption. However, the relationships between chronic stress/anxiety, ANS
      balance/imbalance, and electrical activity in the stomach before and after eating/drinking
      remain to be fully explored in children with FGIDs. The current study is a two-part pilot
      study designed to assess these relationships. Part I involves assessment of anxiety/stress
      (i.e., BASC parent- and self-reports) along with ANS balance (i.e., heart rate variability)
      and electrical activity in the stomach (i.e., electrogastrography) measured in the fasting
      state and following a test meal. Part II involves the same assessments with rapid water
      loading replacing the test meal. Results will be analyzed by specific FGID, as well as for
      the group as a whole. We expect to enroll 75 children ages 8-17 in each part, including 30
      healthy controls and 45 children with an FGID. Elucidating these relationships is a necessary
      first step in developing more effective treatments for children with recurrent abdominal pain
      and, ultimately, reducing the personal and societal costs of this common pain entity.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with IBS, FD, or IBS and FD, as well as healthy controls without these conditions.
      
Keywords: Abdominal Pain; Functional Gastrointestinal Disorders; Stress; Anxiety; Autonomic Nervous System
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This Post Marketing Surveillance study will be performed as an open-label, prospective,
      non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected
      patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine
      extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and
      pre-treated patients switching from nevirapine immediate release or other anti-retroviral
      therapy (ART) will be included in the study. The decision to initiate treatment with
      nevirapine extended release is independent of this study and is based entirely on individual
      patient need and the judgement of the treating physician. The aim of the study is to assess
      the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1
      infected patients in routine clinical practice. It is planned to document five visits for
      each patient over a twenty four week observational period.
    

Detailed description: 
      Study Design:

      non-interventional uncontrolled observational study
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-1 infected patients
Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome
Condition: Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly
      regarding protective dilator reflexes of upper airway. Preliminary results have suggested
      that the use of this parameter in diagnosis algorithm such as linear discriminant analysis
      and random forest could predict the presence of sleep apnea syndrome in almost 98% of
      patients. Our study aims at validating a new diagnosis method of sleep disordered breathing
      which will be compared with nocturnal polysomnography, the reference method to diagnose sleep
      disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device
      which allows an automatic measurement of the pharyngeal sensation. The use of this parameter
      in diagnosis algorithm will be compared with polysomnographic results.
    


Intervention name(s): Measurement of pharyngeal sensitivity (SENSITEST)
Intervention type(s): Device
Intervention description(s): Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: sleep apnea; pharyngeal sensitivity; pharyngeal dilator reflex; diagnosis algorithm; patients with suspected sleep apnea syndrome