bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions.
Condition: Deep Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The present study will be performed to evaluate:

      The remineralizing effect of Aloe Vera versus Diode laser on deep carious dentin after
      selective caries removal.
    

Detailed description: 
      This study was conducted on 45 teeth selected from patients according to inclusion and
      exclusion criteria. They were selected from the dental clinic in faculty of oral and dental
      medicine for girls, Al-Azhar University. The procedure was explained and written informed
      consent was obtained from each patient. The possible discomforts, risks, and benefits were
      fully explained to the patients. Ethical committee approval was obtained.

      Protocol of caries removal was Applied Subsequently, the central cariogenic biomasses and
      superficial part of the necrotic and demineralized dentin was excavated, leaving the leathery
      dentin layer.

      Sample grouping:

      The patients were randomly assigned into three main groups according to the material used (15
      for each) which were assessed at different time intervals (B1) after three months,(B2) after
      six months.

      A1: cavities will be sealed directly by temporary restorative material (conventional glass
      ionomer) without any treatment.

      A2: cavities will be treated by Diode laser then sealed directly by temporary conventional
      glass ionomer.

      A3: cavities will be treated with Aloe Vera then sealed directly by temporary conventional
      glass ionomer.

      Evaluation of the remineralization effect of Each group will be assessed radiographically
      immediately at base line (B0), after three months (B1) and six months (B2) to evaluate the
      dentin remineralization.
    

Intervention name(s): no intervention; diode laser; Aloe Vera
Intervention type(s): Other; Device; Dietary Supplement
Intervention description(s): treatment of deep carious lesions; laser light for cavity disinfection; herbal dietary supplement for treatment of deep carious lesions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
Condition: Inguinal Herniorrhaphy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, randomized, double blind, placebo and active controlled study with an
      Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open
      inguinal herniorrhaphy with mesh.
    

Detailed description: 
      A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose
      Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in the
      Management of Postoperative Pain After Open Inguinal Herniorrhaphy.
    

Intervention name(s): CPL-01; Naropin 150 MG Per 20 ML Injection; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive a single dose; Subjects will receive a single dose; Subjects will receive a single dose
Other intervention name(s): Infiltration of study drug; Infiltration of study drug; Infiltration of study drug
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics
Condition: Fontan Physiology
Study type: Interventional

Summary: 
      In patients with Fontan circulation blood is not pumped to the lungs from a ventricle.
      Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery
      and blood flow to the lungs occurs passively along this Fontan pathway. This passive blood
      flow to the lungs occurs best when the patient is breathing on their own (spontaneous
      ventilation). However for certain surgeries and procedures patients need to have an
      endotracheal tube inserted and need to be muscle relaxed and receive positive pressure
      ventilation. Prior studies have shown that positive pressure ventilation can reduce blood
      flow to the lungs and consequently blood returning to the heart resulting in less blood
      pumped out to the rest of the body (cardiac output). The purpose of this study is to
      investigate if changing the volume of the positive pressure ventilation (tidal volume)
      affects blood flow to the lungs and cardiac output in patients with Fontan circulation.
    

Detailed description: 
      If it can be shown that changing the tidal volume does affect the blood flow to the lungs and
      cardiac output in patients with Fontan circulation the information can be used to learn from
      this study to optimize the tidal volume ventilation, and therefore pulmonary blood flow and
      cardiac output when Fontan patients come for general anesthesia. This is important because
      the population of patients with Fontan circulation is increasing and an increasing number
      will present for cardiac and non cardiac surgery when positive pressure ventilation will be
      required. They may also spend time on the cardiac intensive care unit on a ventilator and
      improving our knowledge on how best to ventilate them may help improve their overall hospital
      outcomes.
    

Intervention name(s): Small volume breath and fast breathing rate for 5 minutes; Large volume breath and slow breathing rate for 5 minutes
Intervention type(s): Other; Other
Intervention description(s): Small volume breath and fast breathing rate delivered via mechanical ventilator.; Large volume breath and slow breathing rate delivered via mechanical ventilator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Effect of Milk Protein and Prebiotics in Combination With Vitamin D on Innate Immunity in Elderly People
Condition: Immunosenescence; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Rationale: The immune system in the ageing population becomes compromised with age (termed
      "Immunosenescence"). Therefore, elderly people have a decreased ability to respond to
      infection and vaccination. Furthermore, many of the health issues associated with ageing are
      linked to inflammation ("Inflammaging"). It has been suggested that this compromised immune
      function is in part due to reduced Toll-like receptor (TLR) function, which is part of the
      innate immune system. Milk and dairy based products have been shown to have beneficial
      effects on inflammation and immunity. This effect may be mediated via support of the innate
      immune response and promotes TLR7 signaling in in vitro assays (unpublished observation).
      Also prebiotics have been suggested to influence markers of innate immune function.
      Furthermore, TLR function has been suggested to be correlated to vitamin D status. Therefore,
      in the current pilot study, the potential of milk protein, prebiotics and vitamin D to
      support innate immune function in elderly will be investigated.

      Objective: Aim of the current study is to evaluate the effect of milk protein on the innate
      immune response in elderly in a pilot study. Furthermore, support of this effect by
      prebiotics and Vitamin D will be studied.

      Study design: The study will be a double-blind placebo-controlled pilot study. Study
      population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1:
      Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk
      protein + prebiotics + Vitamin D or placebo.
    


Intervention name(s): Milk protein, prebiotics, vitamin D; Placebo product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 weeks supplementation with milk protein only, followed by 3 weeks milk protein + prebiotics, followed by 3 weeks milk protein + prebiotics + vitamin D; 3 periods of 3 weeks placebo product
Intervention MeSH terms: Vitamin D; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Immunity; Elderly; Inflammation; Milk protein; Prebiotics
Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in
      the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v.
      PCA.
    


Intervention name(s): Oxycodone; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours; dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours
Other intervention name(s): Oxycodone Injection; Morphine Injection
Intervention MeSH terms: Morphine; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians
Condition: Obesity; Cardiovascular Risk Factor; Physical Activity
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide
      inter-individual variability after exercise training explored mainly in adults but not in
      adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the
      concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e.,
      percentage of subjects who experienced a non-change/worsened response after training in some
      metabolic outcomes).
    


Intervention name(s): Concurrent training (CT)
Intervention type(s): Behavioral
Intervention description(s): The core part of each session included resistance training (RT) followed by aerobic training exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Behavioral
Masking: Single (Investigator)
Primary purpose: Prevention
Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV
Condition: Lung Cancer
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to conduct a randomized controlled trial to evaluate the effect
      of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt
      in patients received one-lung ventilation
    

Detailed description: 
      Population:

      The target population comprises all adult aged 45-65 years who was diagnosed lung cancer and
      to receive video-assist thoracoscopic lobectomy under general anethesia.The study sample will
      include 50 subjects of both gender and any race or ethnicity.

      Procedures:

      Eligible and consented patients will be enrolled into the study if all eligibility criteria
      are met and will be randomly allocated to one of the two study arms:Budesonide inhalation
      group vs Normal saline inhalation group

      Study Duration:

      Overall duration of the study is 10 months.
    

Intervention name(s): preoperative budesonide inhalation; preoperative normal saline inhalation
Intervention type(s): Drug; Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Exercise in Insulin-Resistant Minority Adolescents
Condition: Insulin-Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      Insulin resistance, often accompanied by obesity, plays a major role in the development of
      type 2 diabetes. This phenomenon may be related with the fact that American adolescents are
      now becoming less physically active in early puberty, explaining the largely pubertal and
      post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has
      been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and
      adolescents, the magnitude of exercise training-induced improvement in the risk factors for
      type 2 diabetes has been only recently studied in adults and studied very little in pediatric
      populations. It is clear that exercise, diet, and genetics all contribute to the development
      of type 2 diabetes in children. However, the few studies that have been done to dissect the
      relative contributions of these three risk factors have generally used only lipid profiles as
      the end point. There have been a number of recent advances in our understanding of the
      molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways
      modulated by exercise within muscle tissue.
    

Detailed description: 
      Insulin resistance, often accompanied by obesity, plays a major role in the development of
      type 2 diabetes. This phenomenon may be related with the fact that American adolescents are
      now becoming less physically active in early puberty, explaining the largely pubertal and
      post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has
      been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and
      adolescents, the magnitude of exercise training-induced improvement in the risk factors for
      type 2 diabetes has been only recently studied in adults and studied very little in pediatric
      populations. It is clear that exercise, diet, and genetics all contribute to the development
      of type 2 diabetes in children. However, the few studies that have been done to dissect the
      relative contributions of these three risk factors have generally used only lipid profiles as
      the end point. There have been a number of recent advances in our understanding of the
      molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways
      modulated by exercise within muscle tissue.
    

Time perspective: Prospective
Keywords: Insulin Sensitivity; Moderate intensity; Insulin Resistance; Exercise Intervention
Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the persistence of immune response against the three
      pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and
      anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study
      vaccines or Boostrix® during V113_01 study.

      There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw
      after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood
      was withdrawn.

      No vaccine was administered and no safety data was collected in this study.
    


Intervention name(s): aP booster; TdaP booster; Licensed TdaP booster (Boostrix®)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Acellular pertussis vaccine:
Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.; Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Other: Saline solution Subjects received one injection of saline solution at one month after vaccination.; Licensed TdaP booster vaccine Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Other: Saline solution Subjects received one injection of saline solution at one month after vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Insulin is a chemical that the body needs in order to use or store sugar. It is made by a
      type of cell called a beta cell which resides in an organ known as the pancreas. Type 2
      diabetes is a disease where the beta cells are unable to meet a person's insulin needs. Sugar
      levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new
      beta cells in the pancreas, and to improve the ability to produce insulin in type 2 diabetic
      patients.
    


Intervention name(s): INGAP-Peptide; INGAP-Peptide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.5 mL, once daily, self-administered SC injection for 90 days; 1.5 mL, once daily, self-administered SC injection for 90 days; 1.5 mL, once daily, self-administered SC injection for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes
Bausch Health Thermage FXL for Use on Lower Face and Submentum Area
Condition: Skin Wrinkling
Study type: Interventional

Summary: 
      This study is designed to evaluate the safety and efficacy of sequential use of monopolar
      radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum
      and submandibular area for fat reduction and improvement of skin laxity.
    

Detailed description: 
      This research study will study subjects who have mild to moderate skin laxity on lower jaw
      and submentum areas. This will be measured by conducting a treatment using the Thermage FLX
      system on the lower face and submentum area of the participants. Biopsies will be done on
      several locations throughout the 12 week trial to assess skin laxity through laboratory
      measures. Finally, the subject will be asked to complete questionnaires to provide
      satisfaction and tolerability feedback.
    

Intervention name(s): Thermage FLX
Intervention type(s): Device
Intervention description(s): Monopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area.
Intervention model: Single Group Assignment
Intervention model description: Prospective, single-center, non-randomized, interventional cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Skin Sterility After Ethyl-Chloride Spray
Condition: Skin Sterility After Use of Ethyl-chloride Spray.
MeSH terms: Infertility
Study type: Observational

Summary: 
      The aim of this study is to investigate sterility of ethyl-chloride topical anesthetic spray
      when used prior to an injection. The hypothesis is that the spray does not change the
      sterility of the injection site after skin is prepped.
    

Detailed description: 
      This is an IRB-approved, prospective, blinded, controlled study. In the first set of
      experiments, skin sterility is assessed. Healthy adult subjects are prepared for mock
      injections of shoulders and knees. No injection is performed. Each site has a set of 3 skin
      cultures: 1) prior to the alcohol prep (pre-prep), 2) post-alcohol prep (pre-spray), and 3)
      after ethyl-chloride was sprayed on the site (post-spray). In the second set of experiments,
      sterility of ethyl chloride is tested directly by culturing the liquid from the spray
      bottles.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healty adult (18-85) volunteers
      
Keywords: Topical; Skin; sterility; ethylchloride; ethyl; chloride; spray
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The overarching goal is to develop a mHealth App that can use smartphone embedded sensors to
      objectively collect physical function data in individuals with knee osteoarthritis (KOA) in
      the context of daily life.
    

Detailed description: 
      The goal is to develop a mHealth App using smartphone embedded sensors to objectively collect
      physical function data in individuals with knee osteoarthritis (KOA) in the context of daily
      life. It will be performed technical development of an internet-interactive App to collect,
      analyze and transfer the subjects' data. As a proof-of-concept, the mHealth App will execute
      algorithms that automate deployment of three well-established physical function tests. In a
      laboratory setting, it will be evaluated usability, acceptability and reliability of the
      mHealth App compared with traditional performance tests among focus groups of individuals
      with KOA. It will then evaluate its usability and acceptability when used in the
      participants' home environments. As an early indicator of construct validity, it will be
      examined if the physical function test measurements can detect diurnal variation in the
      impact of KOA.
    

Intervention name(s): Mobile health App - Test
Intervention type(s): Other
Intervention description(s): Beta Testing 1: The Beta test 1 will be performed with participants inside the Research Center. The purpose of this phase is to increase usability, acceptability and reliability of the mHealth App in participants with knee osteoarthritis (KOA).
Beta Testing 2: The Beta test 2 will be performed with patients outside the Research Center, at their houses. The purpose is to focus on the mHealth App remote usability, acceptability, and data collection.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes subjects who are greater than 50 years old and meet the ACR criteria
        for knee osteoarthritis.
      
Keywords: Chronic Diseaase; Technology; Pain; Function