bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars
Condition: Extensively Decayed Primary Molars
Study type: Interventional
Phase: Phase 4

Summary: 
      An experimental prospective double-blind, randomized clinical trial (RCT) with parallel
      design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and
      mineral trioxide aggregate (MTA®) as a control.
    

Detailed description: 
      When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not
      indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover
      the rest with a suitable material is required. The Purpose of this study is to check the
      success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents:
      (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use
      of the materials has no side effect or complications as it is a routine dental procedure.

      The participants are healthy children aged between 3 and 9 years old, and the study is taking
      place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in
      duration of 4 years, which include 20 months for participants recruitment.

      After placing the material, the tooth is restored with stainless steel crowns, and the
      participant was asked for follow up to check the tooth and to take dental x-ray every 6
      months.
    

Intervention name(s): Totalfill; MTA
Intervention type(s): Drug; Drug
Intervention description(s): Totalfill® Bioceramic Root Repair Material -Fast Set Putty is a pre-mixed, bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.; ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.
Other intervention name(s): Totalfill® Bioceramic Root Repair Material -Fast Set Putty; ProRoot White MTA®
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Totalfill; MTA; Bioactive; calcium silicate cement; Pulpotomy; Primary molars; Bioceramics
Estimation of Plasma Folate Apparent Volume of Distribution in Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to calculate the plasma apparent volume of distribution of natural
      folate to give a more accurate value for use in a mathematical model of apparent folate
      absorption.
    

Detailed description: 
      Bioavailability is a major determinant of nutritional status. In order to determine a safe
      level of folate fortification, its bioavailability must be assessed, so that risk-benefit
      analysis can be carried out. Recently, a mathematical model of folate true absorption which
      takes into account the liver first pass was devised (ref 1). In this model, the volume of
      distribution is a convenient method for describing how well a nutrient is removed from plasma
      and distributed into tissues.

      In this study, volume of distribution will be more accurately estimated using an intravenous
      dose of labelled (13C5) dose of natural folate (5-methyltetrahydrofolic acid) in healthy
      adults aged 18-65, over a wide body mass index (BMI) range.

      Healthy adults will be given an IV dose of a small amount of 13C5 5-methyltetrahydrofolic
      acid, and blood samples will be taken at regular time points via a cannula over a 2hr time
      period.

      The primary objective is to estimate the sampled plasma pool volume of distribution in order
      to quantify the fraction of any folate test dose, or folate metabolites, appearing in
      systemic plasma circulation in future studies of bioavailability.
    

Intervention name(s): 13C5-labelled 5-methyltetrahydrofolic acid
Intervention type(s): Dietary Supplement
Intervention description(s): one intravenous bolus dose of no more than 500nmole 13C5-labelled 5-methyltetrahydrofolic acid, followed by multiple blood samplings at regular time intervals. Total 2hr "intervention".
Other intervention name(s): 13C5-labelled 5 methyltetrahydrofolic acid, calcium salt; 6S-5-CH3-H4-Pte[13C5] Glu-Ca
Intervention MeSH terms: Tetrahydrofolates
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: folates; 5-methyltetrahydrofolic acid; pharmacokinetics; bioavailability; biotransformation
Discovering the Effect of Venous Insufficiency on Nocturia
Condition: Nocturia; Venous Insufficiency of Leg; Fluid Overload
MeSH terms: Venous Insufficiency; Nocturia
Study type: Interventional

Summary: 
      With this prospective controlled trial, we hope to obtain more information about the
      coexistence between venous insufficiency and nocturia.

      In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation
      in the lower limbs due to moving around all day. When laying down during nighttime, this
      fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus
      an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal
      frequency and urine production before and after surgical treatment of venous insufficiency.
    


Intervention name(s): Questionnaires; Frequency Volume Chart; Collect urine during 1 day; Blood sample; Measurement of the circumference of the lower legs
Intervention type(s): Other; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI; Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.; Volunteers are asked to collected their urine during the last day of the frequency volume chart. Volunteers get 2 jars: One for collection during the day, and 1 for overnight collection of urine. Osmolality and sodium of urine is tested; Blood collection to measure plasma sodium and osmolality.; Circumference of the lower legs wil be measured twice:
After awakening, when still laying dowing in bed
Before goin to sleep
Circumference should be measured 2 cm above the medial malleolus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Repeated use and/or abuse of opioid medications is generally associated with a characteristic
      withdrawal syndrome that develops after cessation of drug administration. The present study
      is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal
      symptoms.
    

Detailed description: 
      Opioid-induced cytokine release and glial activation has been proposed to directly contribute
      to the affective and physiological aspects of withdrawal. Furthermore, cytokine release
      following opioid administration has been hypothesized to be a limiting factor in both the
      duration and magnitude of opioid-induced analgesia. The two primary goals of our study are to
      assess AV411's ability to 1) reduce the opioid-withdrawal syndrome and 2) increase and
      prolong the analgesic effects of the mu-opioid agonist, oxycodone. To explore whether AV411
      decreases opioid-induced glial cell activation, some participants assigned to the placebo and
      high dose AV411 groups (n = 6 for each dose condition) will be studied twice with
      [11C]PK11195, a positron emission tomography (PET) radiotracer used to measure the peripheral
      benzodiazepine receptor (PBR) in the human brain. The PBR is a receptor located on the
      mitochondria of the microglia and can be used to examine microglial activation in various
      brain regions.
    

Intervention name(s): AV411; Placebo (PCB)
Intervention type(s): Drug; Drug
Intervention description(s): Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks; Placebo drug will be administered orally twice a day (BID) for two consecutive weeks
Other intervention name(s): ibudilast; PCB or 0 mg
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: opioid withdrawal, analgesia
Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, dose escalation study using the classical 3+3 design to
      determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA
      therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic
      hepatitis B patients.
    

Detailed description: 
      The patients enrolled in the trial will be successively allocated into three cohorts for
      HB-110 1mg, 2mg, and 4mg in combination with Entecavir according to the classical 3+3
      protocol design. They will be administered by Electroporation device.

      The scheduled assessments and visits will be carried out over three periods: run-in period,
      treatment period, and follow-up period.

      The run-in period includes the screening visit where a written informed consent is obtained
      and the screening period where patients are assessed for eligibility. It will be completed
      within 14 days prior to Visit 1. The patients meeting inclusion criteria will start the
      treatment period.

      During the treatment period, subjects will be administered HB-110 by Electroporation at each
      visit in combination with antiviral drug, Entecavir.

      The Follow-up period starts once subjects complete the treatment period and will continue
      until the follow-up visit.
    

Intervention name(s): HB-110
Intervention type(s): Genetic
Intervention description(s): Each patient will be administered HB-110 by Electroporation for 20 weeks based on the protocol and take one pill of Entecavir(0.5 mg) per day during the study period. The Dose of HB-110 will be determined by the classical 3+3 dose escalation schedule and dose levels are 1mg, 2mg, 4mg respectively. The number of patients will be ranged from 9 to 18.
Other intervention name(s): Baraclude(Entecavir); TriGrid™ Delivery System
Intervention MeSH terms: Entecavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis, Chronic; Virus Diseases; DNA Virus Infections; Hepatitis B; Liver; Chronic Disease; HBV
Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous results from the investigators' Center have shown that combination treatment with
      Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to
      replicate these findings with this study.
    


Intervention name(s): Chantix; Zyban; Nicotine patches
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.
Other intervention name(s): Varenicline; Bupropion; NRT
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Nicotine addiction; Cigarette smoking; Smoking cessation; Zyban; Chantix; Nicotine patches; varenicline; bupropion
A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Clinical response, as defined by improvement in asthma quality of life, to bronchial
      thermoplasty in patients with severe refractory asthma can be predicted through the use of
      clinical, physiologic, biologic and imaging markers.
    

Detailed description: 
      Primary Aim To assess the relationship between baseline clinical, physiologic, biologic and
      imaging markers and response to bronchial thermoplasty, defined by improvement in asthma
      quality of life, in patients with severe refractory asthma.

      Secondary Aims

        1. To assess the relationship between baseline clinical, physiologic, biologic and imaging
           markers and response to bronchial thermoplasty, defined by reduction in severe
           exacerbations or healthcare utilization, in patients with severe refractory asthma.

        2. To evaluate if baseline clinical, physiologic, biologic and imaging markers are related
           to safety of bronchial thermoplasty in patients with severe refractory asthma.

        3. To evaluate and validate statistical models that predict response to bronchial
           thermoplasty in patients with severe refractory asthma.
    

Intervention name(s): Alair system
Intervention type(s): Device
Intervention description(s): Bronchial thermoplasty
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject Population - Severe Refractory Asthma
      
Biospecimen description: 
      DNA and RNA extraction, serum, plasma and sputum
Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi
Condition: HIV; AIDS
Study type: Observational

Summary: 
      The aim of this study is to identify reproductive health priorities among individuals living
      with HIV.This study also seeks to explore factors that influence fertility, family planning,
      and sexual behavior among individuals with HIV who are receiving antiretroviral therapy
      (ART).
    

Detailed description: 
      The aim of this study is to identify reproductive health priorities among individuals living
      with HIV.This study also seeks to explore factors that influence fertility, family planning,
      and sexual behavior among individuals with HIV who are receiving antiretroviral therapy
      (ART).

      This is a mixed method study in which subjects will participate in focused group discussions
      and complete a questionnaire. Discussions will be 1-2 hours in length aimed to evaluate
      fertility intentions, family planning, and sexual health behaviors. Data collected from the
      focus groups will be analyzed for common themes to generate questionnaires to assess
      reproductive health knowledge, attitudes and practices related to family planning, and
      fertility and sexual health among persons living with HIV.
    

Intervention name(s): Focus Group; Questionnaire
Intervention type(s): Other; Other
Intervention description(s): Subjects will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Discussions will be 1-2 hours in length. Groups will be conducted among men and women.; Participants will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health. The questionnaire will take no longer than 30 minutes to complete.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Persons living with HIV in Lilongwe, Malawi recruited from The Lighthouse Trust Clinic
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm
      722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control
      when compared to subjects using the Paradigm 715 insulin pump only.
    

Detailed description: 
      Glycemic control remains a significant challenge for both adult and adolescent Type 1
      diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record
      continuous, retrospective glucose measurements which aid in identification of glycemic
      excursion patterns. This data is then used to make therapy change recommendations for the
      future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump
      every 5 minutes, allowing users to view their current glucose values, as well as to review
      glycemic excursions and trends over a 24-hour period. This System will alert users to high
      and low glucose levels, and will allow subjects and their clinicians to treat to a
      therapeutic target HbA1c under monitored conditions.

      Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm
      715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).
    

Intervention name(s): Paradigm 722 sensor augmented pump; Paradigm 715 insulin pump
Intervention type(s): Device; Device
Intervention description(s): Subjects use the Paradigm 722 sensor augmented pump; Subjects use the Paradigm 715 insulin pump
Other intervention name(s): 722 pump; 715 pump
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Continuous Glucose Monitoring; Glycemic Control
Leptin Biology in Adipose Tissue
Condition: Obesity
Study type: Interventional

Summary: 
      Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are
      high in obese subjects indicating resistance to the actions of leptin. High leptin levels
      have been associated with increased cardiovascular and metabolic risks, but it is not clear
      if increased leptin or leptin resistance contributes to the increased cardiovascular risk.
      Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue
      functions are not completely investigated in humans. Based on preliminary data the
      investigators hypothesize that resistance to leptin action in obese adipose tissue is
      responsible for altering the expression of adipose tissue proteins which contribute to the
      development of cardiovascular and metabolic dysfunction. To test this hypothesis the
      investigators propose a novel study directed at investigating the leptin dependent changes in
      adipose tissue protein expression using adipose tissue obtained from lean and obese human
      subjects
    


Intervention name(s): obesity
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)
Condition: Healthy Volunteer
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2
      Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability,
      pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.
    

Detailed description: 
      To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of
      multiple oral doses of ertugliflozin.
    

Intervention name(s): Ertugliflozin; Placebo to Ertugliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast; Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
Other intervention name(s): PF-04971729; MK-8835
Intervention MeSH terms: Ertugliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Hedonic Perception and Brain Activity Response to Meal
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the relationship between brain activity and the
      perception of subjective hedonic sensations in response to a meal using functional MRI.
    

Detailed description: 
      Functional MRI brain imaging will be performed in patients with functional dyspepsia and
      healthy controls in basal conditions and after a palatable test meal. During the study, the
      cognitive response and the hedonic dimension will be measured using 10 score scales.
    

Intervention name(s): Functional brain MRI; A warm ham and cheese sandwich and a 200 ml fruit juice
Intervention type(s): Device; Dietary Supplement
Intervention description(s): Functional brain MRI before and after test meal ingestion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Functional brain MRI; functional dyspepsia; hedonic response
Narrowband UVB for Children With Moderate to Severe Atopic Eczema
Condition: Moderate to Severe Atopic Eczema
MeSH terms: Dermatitis, Atopic; Eczema
Study type: Observational

Summary: 
      To assess prospectively, the response of moderate to severe atopic eczema to a standard
      course of narrowband ultraviolet B phototherapy by using validated objective and subjective
      scoring systems.
    

Detailed description: 
      Children with moderate to severe atopic eczema prescribed a course of narrowband UVB
      phototherapy were scored (using validated scoring systems) objectively and subjectively
      before, during and after the course of treatment, as well as 3 and 6 months post treatment
      (to determine length of remission). Their scores were compared to a control group. The
      control group comprised children with moderate to severe atopic eczema who were offered UVB
      but were unable to undertake the treatment.
    

Intervention name(s): Narrowband Ultraviolet B phototherapy
Intervention type(s): Radiation
Intervention description(s): Twice weekly exposures for a total of 24 exposures using a standard phototherapy protocol.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 3-16 years
      
Biospecimen description: 
      saliva
    
Keywords: Atopic Dermatitis