bioihbjkbjnl/mcl2 huggingface dataset:
Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide
Condition: Pulp Disease, Dental; Dental Caries
MeSH terms: Dental Caries; Dental Pulp Diseases; Stomatognathic Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of application of bioactive glass in
      different protocols on the formation of dentin bridge after indirect pulp capping using resin
      composite with its adhesive both are containing bioactive glass.
    


Intervention name(s): Bioactive Glass; Light cured calcium hydroxide
Intervention type(s): Other; Other
Intervention description(s): Bioactive glass was incorporated in resin composite and its adhesive; Light cured calcium hydroxide
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Fructose-Induced Palmitate Synthesis in Overweight Subjects
Condition: Elevated Triglycerides; Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Overweight; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin
      resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15
      overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride
      palmitate made by the liver from each single oral dose of fructose (0.5 g/kg),
      fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the
      synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose
      and 2) show a dose-response. The lipogenic responses will be compared and correlated with
      markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results
      will serve as a guide to the development of a new outpatient probe of the de novo lipogenic
      pathway in subjects who vary in their lipogenic response to oral fructose. These studies
      should ultimately yield valuable new information about the mechanisms linking dietary
      carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.
    


Intervention name(s): Fructose; Fructose and Glucose; Fructose and Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fructose, 0.5 g/kg; Fructose:Glucose 1:1, 1 g/kg; Fructose:Glucose 1:1, 2g/kg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Elevated triglycerides; Diabetes; Cardiovascular disease
Study Comparing Treatment With Alluzience vs Reconstituted Toxin
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to
      investigate subject treatment perception and Investigator treatment experience when using
      Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of
      glabellar lines (GL).
    

Detailed description: 
      This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to
      investigate subject treatment perception and Investigator treatment experience when using
      Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of
      glabellar lines (GL).
    

Intervention name(s): Alluzience; powder BoNT-A (BOTOX/Vistabel)
Intervention type(s): Biological; Biological
Intervention description(s): Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection; Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use Of GW274150 In The Prophylactic Treatment Of Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric
      oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of
      NOS, and therefore NO, may be an effective technique for the prevention of migraine headache.
      GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory
      activity in migraine through a novel mechanism of action. The intent of this study is to
      investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine
      headache.
    


Intervention name(s): GW274150; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The tablets used in this study will contain either 5mg or 30mg of GW274150; Placebo to Match GW274150
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Productivity; Efficacy; without aura; iNOS; Safety; Nitric Oxide; Pharmacokinetics; GW274150; with aura; Migraine; Prophylaxis; Quality of Life
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Condition: Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the systemic and local safety profile of purified
      inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28
      days interval up to Month 7 after the first IC51 vaccination in a pediatric population from
      endemic regions.
    

Detailed description: 
      Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to < 18
      years. Subjects aged ≥ 2 months to < 12 months were randomized in a 2:1 ratio to receive IC51
      (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to < 3 years and
      ≥ 12 years to < 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose < 3
      years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator.

      For subjects aged ≥ 3 years to < 12 years, a dose finding run-in phase was performed. A total
      of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51,
      and the appropriate dose was determined based on an interim analysis. After this run-in
      phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of
      IC51 or HAVRIX®720.

      Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to < 12 months;
      125 children aged ≥ 12 months to < 3 years and 140 children ≥ 12 years to < 18 years. For the
      age group of ≥ 3 to < 12 years immunogenicity was assessed in the 200 children enrolled
      during the dose-finding run-in phase.
    

Intervention name(s): IC51 Japanese Encephalitis; Havrix®720; Prevnar
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 6 mcg or 3 mcg im. at day 0 and day 28; 0.5 ml im. at day 0 and month 7; 0.5 ml im. at day 0 and day 56 and month 7
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric; Japanese Encephalitis Vaccine; endemic countries; to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51
Effects of the Face Mask on Physical Fitness in Children
Condition: Physical Fitness; Health; Childhood ALL; Emotional Stress; Sedentary Behavior; Cardiorespiratory Fitness
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      The aim of this multicenter randomized crossover design study is to evaluate a sample of 500
      boys and girls from public and private schools in the Principality of Asturias, aged between
      6 and 12 years, with the objective of determining the level of physical condition, as well as
      to evaluate the effect of the use of FFP2/N95 face masks during the execution of the ALPHA
      Fitness battery, and the emotional effects caused by the use of these masks. This is a sample
      obtained by accessibility, in which the sampling will be stratified by age and academic year.
    


Intervention name(s): Mask
Intervention type(s): Device
Intervention description(s): Physical Fitness is evaluated with the use of a face mask
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children between 6 an 12 years that attend classes in state or private schools.
      
Keywords: Exercise; Alpha fitness battery; Kids; N95/FFP2; Physical Activity; CDI
Staged Bilateral Percutaneous Nephrolithotomy
Condition: Stone, Kidney; Urolithiasis
MeSH terms: Urolithiasis; Kidney Calculi; Nephrolithiasis
Study type: Observational

Summary: 
      To determine the optimal time between the first and second operations in patients with
      bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral
      kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4
      weeks and 4-6 weeks after the first operation will be compared.
    

Detailed description: 
      The aim of the study is to determine the optimal time between the first and second operations
      in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the
      contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to
      the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.
      With the guidance of preoperative and postoperative data, it is aimed to determine the
      optimal time with the lowest complication and highest operational success.
    

Intervention name(s): Patients who underwent percutaneous nephrolithotomy
Intervention type(s): Procedure
Intervention description(s): Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the percutaneous nephrolithotomy operation
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with stones of 2 cm or more in each kidney
The Effect of Juice Types on the Responses to Air Pollution
Condition: Air Pollution
Study type: Interventional

Summary: 
      The study hypothesis is that drinking different juices will affect the body's responses to
      air pollution. Subjects will be exposed to air pollution during a 2-hour car ride on the NJ
      (New Jersey) Turnpike. Each subject will be asked to do this twice. Before one car ride, the
      subject will be asked to drink orange juice. Before the other car ride, the subject will be
      asked to drink beet juice. Samples of blood and exhaled breath will be collected before,
      immediately after, and 24 hours after each car ride. Levels of nitrites/nitrates will be
      measured in the blood and breath.
    

Detailed description: 
      Subjects will participate in two exposure sessions. The air pollution exposure consists of a
      2-hour car ride along the NJ Turnpike. Samples will be collected at 3 time points for each
      exposure session: pre-exposure, immediately post-exposure, and 24 hours post-exposure. Blood
      samples will be collected immediately before and after a 5-minute occlusion at each time
      point. The subject will also be asked to provide samples of exhaled breath and complete
      symptom and stress questionnaires at each time point.

      Blood samples will be analyzed for serum nitrite. Exhaled breath samples will be analyzed for
      nitrates and nitrites.
    

Intervention name(s): Beet juice; Orange juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 cups of beet juice will be given before the car ride; 2 cups of orange juice will be given before the car ride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: air pollution; food; nitrites; nitrates; breath tests/methods
Diabetes Outcomes in COVID-19 Pandemic
Condition: Diabetes; Covid19; Isolation, Social
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Diabetes management and follow-up has become a challenge during the COVID-19 pandemic.
      Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain
      of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes.
      In the health sector, especially in low-income countries such as Pakistan, there has been a
      shift of resources and staff reassignment from stable chronic illnesses to support COVID-19
      pandemic. Disruption of routine outpatient health services and travel restrictions increase
      the risk of worsening diabetes control and diabetes-related health outcomes. Additionally,
      social isolation amidst an atmosphere of fear and uncertainty contributes to stress further
      affecting glycaemic control.
    

Detailed description: 
      An observational cross-sectional study was conducted using telephone interview method in
      Diabetes Management Centre (DMC), Services hospital, Lahore. The study participants were 1282
      diabetic patients selected randomly from electronic medical record (EMR) database of the
      Centre. A structured questionnaire was used to evaluate parameters which included patients'
      demographic information; diabetes self-care and general health profile; COVID-related
      questions and its impact on quality of life (QoL); financial and social support issues.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Diabetic subjects already registered with and on regular follow-up with DMC and had visited
        DMC for consultation more than once between 1st August 2019 to 15th March 2020.
      
Keywords: COVID-19; diabetes mellitus; telesurvey
Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
Condition: Pharmacokinetics and Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic
      relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The
      secondary objective is to determine the safety and tolerability of fentanyl sublingual spray
      in opioid naive subjects.
    


Intervention name(s): Fentanyl; Fentanyl Citrate
Intervention type(s): Drug; Drug
Intervention description(s): Fentanyl Sublingual Spray (FSS); Fentanyl Citrate IV (FCIV)
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries
Condition: Peripheral Perfusion; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      One of main risk of controlled hypotension during nasal surgeries is impaired perfusion.
      Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So,
      evaluation of perfusion of non-vital organ is considered to be adequate measure of patient
      safety during surgery.

      Many hypotensive agents such as dexmedetomidine, B blockers, magnesium sulfate and
      nitroglycerine had been used but we are in need to investigate its effects on peripheral
      perfusion.

      Postoperative pain related to nasal surgeries due to surgical trauma itself which induces the
      release of inflammatory mediators from neuronal and immune cells resulting in peripheral and
      central sensitization significantly affects recovery of patients. Magnesium sulfate and
      labetalol have analgesic actions besides their hypotensive effects but with different
      mechanisms.
    

Detailed description: 
      To compare between the effects of magnesium sulfate and labetalol infusion during induced
      hypotension on peripheral perfusion and postoperative pain in nasal surgeries

      OBJECTIVES:

      To measure peripheral perfusion index (PPI) as an indicator for peripheral perfusion To
      calculate the total postoperative rescue analgesic requirements.

      Double -blind randomized comparative Clinical Study. All Patients will be randomly allocated
      into two equal groups (group M and Group L).

      Using computer generated randomization table, each group will be 25 patients.
    

Intervention name(s): Magnesium Sulfate Injection; Labetalol Injectable Solution
Intervention type(s): Drug; Drug
Intervention description(s): will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.; will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
Other intervention name(s): magnesium sulfate; labetalol
Intervention MeSH terms: Magnesium Sulfate; Labetalol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS
Condition: Polycystic Ovary Syndrome (PCOS); Overweight; Obesity
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of
      childbearing age, which is usually characterized by hormonal imbalance and metabolism
      problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral
      contraceptives, which effectively reduces circulating androgens and are treatment for
      hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1
      Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and
      weight control by inhibiting of gastric emptying and reducing food intake. This study aims to
      evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35
      combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic
      ovarian syndrome (PCOS) patients.
    

Detailed description: 
      Groups:

      Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

      Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

      Time Point:

      Initial treatment;

      Post-treatment (4w);

      Post-treatment (8w);

      Post-treatment (12w);

      Assess reproductive functions and cardiovascular risk factors.
    

Intervention name(s): Metformin-GLP-1 Receptor Agonist; Metformin-Oral Contraceptive(OC)
Intervention type(s): Drug; Drug
Intervention description(s): metformin oral with exenatide/liraglutide subcutaneous injection.; metformin with Diane 35 oral intake.
Other intervention name(s): Metformin-exenatide/liraglutide Therapy; Metformin, Diane 35
Intervention MeSH terms: Metformin; Liraglutide; Exenatide; Contraceptive Agents; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome (PCOS); Overweight; Obesity; GLP-1 Agonist; Oral contraceptives (OCs); Metformin; Reproductive Disorders; Cardiovascular risk factor; Lipid Metabolism
Motivational Interviewing for Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to begin to examine the efficacy of a motivational interviewing
      intervention to increase African Americans' screening colonoscopy rates. The results from
      this pilot study will allow us to estimate the magnitude of the intervention and mediation
      effect sizes.
    

Detailed description: 
      Compared to other racial groups, African Americans have the highest colorectal cancer (CRC)
      morbidity and mortality rates. Screening colonoscopy can aid in the early detection and
      prevention of CRC. A motivational interviewing (MI) intervention holds strong promise to
      increase African Americans' screening colonoscopy adherence and, by doing so, decrease CRC
      disparities. There is a great need to conduct a randomized clinical trial (RCT) that tests
      the efficacy of an MI intervention to increase screening colonoscopy adherence in African
      Americans. The first critical and necessary step in this line of research is to pilot test
      such an RCT.

      Objective/hypotheses: The primary objective of the proposed study is to conduct pilot testing
      for a future RCT which will formally test the effects of MI on screening colonoscopy
      adherence in African Americans. The results from this pilot study will directly inform the
      development of a future RCT.

      Specific aims: 1) To estimate the magnitude of the MI intervention effect size; and 2) To
      estimate the magnitude of the mediation effect sizes (drawn from Self Determination Theory).
    

Intervention name(s): Motivational Interviewing; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A brief motivational interviewing session; Participants will be asked to discuss the sources (e.g., the Internet) in which they receive information about their health. This group is designed to control for potential beneficial effects of meeting with an interventionist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Motivational Interviewing; Screening Colonoscopy; Cancer Prevention
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
Condition: Flexible Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling
      high degrees of foot pronation. It is essential to administer patients foot orthoses with
      different inverted angles, with higher angles prescribed when greater reduction of foot
      pronation is indicated. However, there is shortage of clinical knowledge regarding the
      inverted angle in terms of biomechanical changes. The aim of this study is to investigate the
      effect of different inverted angles of foot orthoses on the walking kinematics in females
      with flexible flatfeet.
    


Intervention name(s): Inverted foot orthoses
Intervention type(s): Device
Intervention description(s): Inverted functional orthoses will be used in this study based on Blake (1986) inverted orthotic technique. Two groups of foot orthosis will be fabricated with two different inverted angles: 25° inverted angle and 15° inverted angle.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment