bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Assessment of Glass Carbomer Cement
Condition: Dental Caries Class II
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study will evaluate the clinical performance of glass carbomer cement restorations in
      restoring proximal lesions in primary molars compared to that of resin modified glass ionomer
      cement and composite resin restorations. Teeth will be randomly assigned to one of the three
      restoration groups and the restorations will be evaluated clinically and radiographically
      every six months.
    

Detailed description: 
      Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from
      traditional glass ionomer cement (GIC) and contains nano-sized powder particles of
      hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties
      and better bonding to dentin, in addition to continues fluoride release.

      The study is a randomized controlled clinical trial where teeth will be randomly assigned to
      one of the three restoration groups.

      Following medical and dental history, bilateral bitewing radiographs will be taken for each
      patient to assess the presence of proximal lesions. Suitable teeth will then be randomly
      assigned to one of the restoration groups. A single operator using local anesthesia and
      rubber dam isolation will then prepare standardized Class II cavities and place the
      designated restorations according to the manufacturer's instructions.

      The quality of the 3 types of restorations will be clinically evaluated at baseline and every
      six months for color match, marginal discoloration, anatomic form, marginal adaptation, and
      secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will
      be performed by 2 calibrated examiners.

      Following placement of the restorations, bitewing radiographs will be taken to evaluate the
      restorations and will be repeated every six months for detection of recurrent caries.
    

Intervention name(s): Glass Carbomer Cement; Composite Resin; Resin Modified Glass Ionomer Cement
Intervention type(s): Other; Other; Other
Intervention description(s): Restoration of proximal lesions in primary molars using glass carbomer cement; Restoration of proximal lesions in primary molars using composite resin.; Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Other intervention name(s): GCP Glass Fill; Hydroxyapatite enhance glass ionomer cement; Filtek Z250; GC Fuji II LC Capsule
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proximal Dental Caries; Glass Carbomer; Hydroxyapatite Enhanced Glass Ionomer; Primary Teeth
Renal Response to Lower Body Negative Pressure in Pre-hypertensive States
Condition: Hypertension; Obesity; White Coat Hypertension; Resistant Hypertension
MeSH terms: Hypertension; White Coat Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether in pre-hypertensive and hypertensive states
      such as white coat hypertension, obesity related hypertension or resistant hypertension,
      renal function is more sensitive to orthostatic stress.
    


Intervention name(s): Lower body negative pressure (LBNP); Candesartan cilexetil
Intervention type(s): Other; Drug
Intervention description(s): Lower limbs are put in in LBNP device for one hour (-30 mbar); candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: hypertension; obesity; white coat hypertension; resistant hypertension
EUS-PPG vs HVPG in Portal Hypertension
Condition: Cirrhosis; Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the correlation of the calculated portal pressure
      gradient (PPG) obtained by direct portal and hepatic pressure measurements with a
      conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using
      the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.
    


Intervention name(s): EUS-PPG and HVPG
Intervention type(s): Diagnostic Test
Intervention description(s): EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained.
On the same day or on successive days HVPG measurement will be performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EUS; Endoscopic ultrasound; Portal Hypertension; Portal pressure gradient; Hepatic venous pressure gradient
The Accuracy of Noninvasive and Continuous Hemoglobin Measurement by Pulse CO-Oximetry™ in Children Undergoing Volume Expansion
Condition: Continuous Hemoglobin Measurement
Study type: Observational

Summary: 
      Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion
      during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes
      noninvasive monitoring of venous hemoglobin level (SpHb).

      The objective of this study

        -  to compare the simultaneous level of tHb and SpHb during operation and after volume
           expansion in children

        -  to assess the accuracy of amount of acute change of SpHb on Masimo and tHb
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children under 10 years old who were planned to take elective surgery which may cause
        patients' hemodynamic unstability.

        Patients who require intraoperative invasive arterial blood pressure monitoring.
      
Keywords: Pulse CO-Oximetry™; children; noninvasive
Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      In patients with at least moderate persistent allergic asthma controlled with inhaled
      steroids, omalizumab (administered per US product label), when compared to placebo, will
      provide the participants with significantly improved tolerability of specific allergen
      immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).
    

Detailed description: 
      Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is
      designed to give omalizumab 13 weeks prior to administering rapid build up of specific
      allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster
      therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.
    

Intervention name(s): Placebo; Xolair
Intervention type(s): Drug; Drug
Intervention description(s): placebo; Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Other intervention name(s): Omalizumab (Xolair)
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic; Asthma; Immunotherapy
Drug Interaction & Methadone & Buprenorphine
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed
      dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in
      subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with
      the stable dose of Buprenorphine.
    

Detailed description: 
      IND number: 101,943

      Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy
      subjects
    

Intervention name(s): Methadone; DCV 3DAA FDC; BMS-791325; Buprenorphine; Naloxone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Buprenorphine; Methadone; Naloxone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC
Condition: Prostate Cancer; Quality of Life; Recovery Programm
Study type: Interventional

Summary: 
      There are few published data on the benefit of Enhanced recovery program in radical
      prostatectomy in the management of localized prostate cancer. All the studies available on
      the subject are retrospective (1-3).

      This randomized comparative study is proposed in order to compare in a homogeneous population
      (place and time) the interest of RAAC specifically in this surgery.
    

Detailed description: 
      The implementation of RAAC programs in healthcare establishments would improve the quality
      and safety of patient care (functional development and rapid convalescence of patients and
      reduction in postoperative morbidity through active prevention of perioperative
      complications) and optimization of care costs for health establishments and for health
      insurance (reduction in length of stay and convalescence, reduction in postoperative
      complications). Its implementation requires a strong involvement of all the teams and a
      transversal and multidisciplinary coordination, specifically dedicated to one type of
      intervention. This approach must therefore show its effectiveness by specialty and then by
      pathology within the same specialty.

      There are few published data on the benefit of RAAC in radical prostatectomy in the
      management of localized prostate cancer. All the studies available on the subject are
      retrospective (1-3).

      This randomized comparative study is proposed in order to compare in a homogeneous population
      (place and time) the interest of RAAC specifically in this surgery.
    

Intervention name(s): Follow-up patient program
Intervention type(s): Behavioral
Intervention description(s): An additional paramedical visit will be carried out before the surgery. The interview is carried out by the healthcare team. An organization within the service has been set up so that a nurse can be totally seconded for the RAAC mission. The consultation lasts 30 to 45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotic assisted
Impact of Exercise on Immune System and Metabolism in Football Players
Condition: Healthy
Study type: Observational

Summary: 
      Physical exercise, especially of high intensity, is a significant burden to the athlete's
      body. It should be emphasized that achieving high results in competitive sports requires
      significant, sometimes extreme, exercise loads during training, which may result in
      homeostasis disorders, adversely affecting athletes' fitness. Intense and prolonged physical
      exercise elevates reactive oxygen species, potentially impacting immune function. The
      mechanism, particularly in high-intensity activities, remains incompletely understood.
      Excessive oxygen radicals may induce metabolic changes, causing rapid erythrocyte damage and
      elevated redox-active free iron. This iron increase can be harmful, increasing oxidative
      stress and immune system activation. The sustained negative impact that may be observed even
      during post-workout recovery needs further exploration.

      "This study aims to explain the impact of an intense exercise test on the immune system,
      pro-antioxidant balance, and iron metabolism in athletes with varying training levels. The
      primary questions it seeks to address are:

        1. How do athletes' experience and training background influence the immune system's
           response, pro-antioxidant balance, and iron regulation?

        2. Can the level of adaptation to physical exercise (training status) affect the rate of
           regeneration and the time required to return to pre-exercise homeostasis?"
    

Detailed description: 
      The study included 40 football players (19 juniors and 21 seniors). The average training
      experience for junior players was 8.37 years, and for the senior group, it was 16.4 years.
      All athletes underwent the Multistage 20-meter shuttle run test (Beep Test). Players were
      informed about the test procedures and additionally motivated by the trainer to exert maximum
      effort. Each attempt was preceded by a warm-up, consisting of a 5-minute low-intensity jog.
      The Beep Test was supervised by the Team trainer using a program as a monitoring tool to
      examine changes in the level of cardio-respiratory fitness across all age groups. Blood
      samples were collected at rest, before the exercise test, then 1 minute after the end of the
      exercise test, after 3 hours of recovery, and finally, after 24 hours. Blood was drawn from
      the antecubital vein, with 12 ml collected each time.
    

Intervention name(s): Exercise test
Intervention type(s): Other
Intervention description(s): Beep Test for measuring aerobic power
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Forty healthy football players, aged from 22 to 37 years. The average training experience
        for junior players was 8 years and 16 for the senior group.
Advanced Glycation End Products as a Biomarker for Accelerated Ageing
Condition: Primary Open Angle Glaucoma; Normal Tension Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Low Tension Glaucoma
Study type: Observational

Summary: 
      Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact
      pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is
      advancing age. The rate of ageing is not the same in all age matched individuals. The concept
      of accelerated ageing suggests that the presence of a number of specific genetic,
      environmental or systemic risk factors may cumulate to accelerate the ageing process in some
      individuals and lead to the development of age-related disease. Understanding the factors
      that influence accelerated ageing is vital.

      Advanced glycation end products (AGEs) are a complex group of compounds that are naturally
      formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the
      body where they adversely affect structure and function. Circulating AGE levels can be
      influenced by oxidative stress levels and dietary intake. Recent research has found that
      sustained exposure to high levels of circulating AGEs could be a major factor in the
      development of a number of chronic age-related degenerative disorders, including POAG.

      To date there have been few clinical studies that have been able to non-invasively explore
      the association between AGE levels and the development and progression of glaucomatous optic
      neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary
      intake make to total tissue AGE levels in such patients. Furthermore little is understood
      about the relationship between AGE levels and retinal vascular function, a parameter known to
      be altered in GON that also could be influenced by AGE levels.

      The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with
      parameters of retinal vascular function, oxidative stress, dietary intake and the presence of
      GON. Establishing this association could increase our understanding of the pathogenesis of
      GON and allow a new biomarker for accelerated ocular ageing to be realised
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy controls, ocular hypertension, primary open angle glaucoma and normal tension
        glaucoma groups aged 50 years and older will be studied. Different parameters will be
        looked at with an aim to understand ageing in glaucomatous optic neuropathy.
      
Biospecimen description: 
      Plasma samples will be analysed within the study time frame. They will be used for this study
      only and will be destroyed as per HTA guidelines once no longer needed for this study.
Investigation of the Efficacy of PNF and Schroth Treatment
Condition: Scoliosis; Adolescence
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      our study was to compare the advantages of Schroth and PNF methods used in AIS treatment
    

Detailed description: 
      there are studies showing that Schroth and PNF are effective on AIS seperately. While there
      are studies showing that Schroth is particularly effective on AIS, the number of studies on
      PNF is insufficient. However, no evidence was found comparing the efficacy of Schroth and
      PNF. Therefore, the aim of our study was to compare the advantages of Schroth and PNF methods
      used in AIS treatment
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): participants were between ages 10-18, volunteered for the study, were diagnosed with adolescent idiopathic scoliosis, were Cobb angle between 10-30 degrees, were 0-3 Risser sign, and were Lenke curve type 1.
Other intervention name(s): PNF group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
Condition: Diphtheria; Tetanus
MeSH terms: Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate
      against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
    

Detailed description: 
      Primary objective:

      To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and
      tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

      Secondary objectives:

        -  To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and
           tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

        -  To evaluate a boosting response by comparing before and after the administration through
           measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with
           BR-TD-1001 and Td-pur-inj.

        -  To evaluate safety by observing solicited local and systemic adverse events that have
           occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj.

        -  To evaluate safety by observing unsolicited adverse events that have occurred for 28
           days after vaccination with BR-TD-1001 and Td-pur-inj.
    

Intervention name(s): BR-TD-1001; Td-pur inj
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus
The Influence of BMI on Core Stability in Healthy Adults
Condition: Overweight and Obesity; Balance; Distorted
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study will be conducted to investigate the influence of body mass index (BMI) on core
      stability (CS) in healthy subjects. The participants in this study will be 90 healthy
      subjects with right dominant lower limb (49 females and 49 males) they will be recruited from
      College of Applied Medical Sciences, Jazan University.
    

Detailed description: 
      Subjects will be categorized according to BMI into three groups:

      Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI<25
      kg//m^2)) Group II (overweight subjects): 30 individuals (15 male, and 15 female students)
      with (BMI, 25-30 kg//m^2)).

      Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI>30
      kg//m^2)).

      Motor control element of CS will be investigated by assessing bilateral static balance with
      open and close eye, right foot balance test, and dynamic balance test using Prokin System for
      balance. Data of this study will be statistically analyzed by performing descriptive (Mean
      and standard deviation) and inferential statistics (One way ANOVA, Unpaired T test) at level
      of significance p=<0.05.
    

Intervention name(s): Core Stability Assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
Other intervention name(s): Balance Assessment
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 3x3 factorial design, according to body mass index (Independent variable)subjects will be divided into three groups (Group I - normal subjects-BMI<25 kg/m2, Group II -overweight subjects-BMI, 25-30 kg/m2), Group III -obese subjects- BMI>30 kg/m2). Core stability (dependent variable) will be measured by three tests : bilateral static balance with open and close eye, uni-pedal static balance test, and dynamic balance test using Prokin System for balance
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: BMI, Core Stability, Healthy Adult
Efficacy of MYCOBIOTIC® in Children and Adults With Abdominal Symptoms.
Condition: Abdominal Symptoms; Stool Culture Positive for Candida Species
Study type: Interventional

Summary: 
      This is a prospective, randomised, double blind, placebo controlled, parallel arm,
      cross-over, multicentre study conducted in a population of children and adults with abdominal
      symptoms observed at outpatient primary health care centres.
    


Intervention name(s): Mycobiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 sachet/day, 21 days, oral; 2 sachet/day, 21 days, oral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomised, double blind, placebo controlled, parallel arm, cross-over
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stool culture; Candida sp.; probiotic; abdominal symptoms