bioihbjkbjnl/mcl2 huggingface dataset:
Oral Fluoride Bioavailability by the Consumption of Meals Prepared With Fluoridated Water or Salt
Condition: Fluoridation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and
      solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared
      with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals
      (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or
      non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of
      food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion,
      unstimulated saliva and dental biofilm will be collected for determination of fluoride
      concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of
      mastication) will be collected for determination of fluoride concentration. Dental biofilm
      will be collected immediately after the ingestion of the meal. Saliva will then be collected
      after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an
      ion-specific electrode. In order to standardize biofilm formation, during lead-in and
      wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2.
      refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew
      sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each
      phase. Groups will be compared by ANOVA and Tukey test.
    


Intervention name(s): Meal
Intervention type(s): Other
Intervention description(s): Typical Brazilian meal consisting of rice, beans and meat with vegetables
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: water; salt; oral fluids; plaque; dental caries
Study for a Rational Management of Appendicitis in Children
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Despite the fact that appendicitis is one of the most frequent surgical pathology in
      children, its clinical management is still debated. Previous reports have shown rate of
      appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious
      complications or intestinal obstruction, is often between 5 and 10 % of published cases, and
      increase medical and social costs. Evidence-based medicine concept could therefore be
      worthwhile in that context, in order to promote rational diagnosis and treatment of that
      frequent medical condition.An algorithm describing management of children with suspicion of
      appendicitis was established, based on recent published data, in order to reduce delay
      between first clinical signs and confirmation of the diagnosis, and to define therapeutic
      indication such as conservative management and interval appendectomy or patient requiring
      laparoscopic approach. The main objective of the study is to decrease morbidity and
      unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.
    


Intervention name(s): appendectomy
Intervention type(s): Procedure
Intervention description(s): Randomisation will apply to the 8 participating centers as follow: During a first survey period of 6 month, the algorithm is not applied; The six following months, 4 randomised centers applied the algorithm, the others being still survey; The six last month, all centers will apply the algorithm
Masking: None (Open Label)
Keywords: Appendicitis; children
THA With and Without Computer Navigation
Condition: Hip Osteoarthritis; Avascular Necrosis of Hip
MeSH terms: Osteoarthritis, Hip; Necrosis
Study type: Observational

Summary: 
      The goal of this observational study is to compare postoperative results between patients who
      had total hip arthroplasty (THA) with and without the use of a computer navigation program.
      The main questions this study aims to answer are:

        -  Can using computer navigation produce better THA implant placement?

        -  Can using computer navigation make surgery more efficient?

      Participant data collected include their postoperative x-rays and total operative time.
    

Detailed description: 
      The goal of this retrospective study is to compare implant placement and operative time of
      patients who underwent direct anterior total hip arthroplasty with and without the use of a
      computer navigation program. X-rays are used to measure acetabular cup orientation, leg
      length discrepancy, and total operative time.
    

Intervention name(s): Intraoperative Fluoroscopic Computer Navigation
Intervention type(s): Procedure
Intervention description(s): Computer technology used during surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent DA THA with the principal investigator between August 2018 and
        February 2020 and received ACTIS stem and PINNACLE cup.
      
Keywords: total hip arthroplasty, computer navigation
Antimalarial and Covid 19 in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment
      of rheumatoid arthritis and systemic lupus erythematosus. These compounds lead to improvement
      of clinical and laboratory parameters, but their slow onset of action differ them from
      glucocorticoids and nonsteroidal antiinflammatory agents.

      Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin
      manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately
      active rheumatoid arthritis (RA).
    

Detailed description: 
      The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment
      of rheumatoid arthritis and systemic lupus erythematosus.(1) . These compounds lead to
      improvement of clinical and laboratory parameters, but their slow onset of action differ them
      from glucocorticoids and nonsteroidal antiinflammatory agents.

      Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin
      manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately
      active rheumatoid arthritis (RA).

      It is difficult to carefully evaluate the onslaught of information that has emerged regarding
      potential COVID-19 therapies within a few months' time in early 2020. A brief but detailed
      approach regarding how to evaluate resulting evidence of a study has been presented by F.
      Perry Wilson, MD, MSCE. By using the example of a case series of patients given
      hydroxychloroquine plus azithromycin, he provides clinicians with a quick review of critical
      analyses.
    

Intervention name(s): Hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): assess its role in the coarse of covid 19 virus infection
Intervention MeSH terms: Hydroxychloroquine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        rheumatoid arthritis patients
Oseltamivir Infant Influenza Safety Study
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A
      (H1N1). Although little is known about the pandemic influenza strain in children, during
      previous pandemics and influenza seasons children less than one year of age were shown to be
      at higher risk of influenza complications than older children. In light of the 2009 H1N1
      pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency
      (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat
      and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use
      in infants will dramatically increase due to the new authorizations for use in this
      population and high prevalence of H1N1 influenza circulating in the population. Ongoing
      safety surveillance is critical and this study will provide further data for evaluating the
      risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of
      both seasonal and pandemic influenza viruses circulating in the population. The study will
      also provide useful information on the dose and duration of treatment used in clinical
      practice and their relationship to adverse events.
    

Detailed description: 
      This study is a prospective, observational, multicenter short-term safety study of the use of
      oseltamivir (prophylaxis or treatment) in children 24 months of age or younger. An internal
      comparator group of children diagnosed with influenza and not treated with antiviral
      medications will be enrolled. The study includes a 30-day follow-up period and will be
      conducted in multiple sites in multiple countries within the European Union. The study will
      cover two consecutive influenza seasons: 01 October 2009 - 31 May 2010 and 01 October 2010 -
      31 May 2011. Data collection may be interrupted in the interim period between influenza
      seasons (June 1, 2010 - September 30, 2010), depending on whether the influenza season
      follows the expected cycle.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted in multiple sites in multiple countries within the European
        Union. Initially, five countries (United Kingdom, Austria, Finland, Poland, Germany) are
        selected for inclusion, but additional countries in Europe, are likely to be added. It is
        estimated that 3-12 sites per country will be enrolled, with a target of at least 900
        patients. If additional countries are added, the number of sites/patients recruited per
        country will be adjusted accordingly.
      
Keywords: Prospective, Observational Safety Study
A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A research study to see how safe and effective MK0217 is when taken weekly for the prevention
      and treatment of steroid induced bone loss.
    


Intervention name(s): MK0217/Duration of Treatment : 12 Months
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glucocorticoid
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)
      monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on
      percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a
      10-year Framingham risk score of 10% or less.
    


Intervention name(s): Evolocumab; Ezetimibe; Placebo to Evolocumab; Placebo to Ezetimibe
Intervention type(s): Biological; Drug; Biological; Other
Intervention description(s): Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection; Administered orally once daily
Other intervention name(s): AMG 145; Repatha; Zetia
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Cocaine Abuse and Attention Deficit Disorder - 3
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder
    

Detailed description: 
      To evaluate the safety and efficacy of methylphenidate and bupropion in treating individuals
      with adult Attention Deficit Disorder.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: cocaine dependence
Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multi-center, two-part, parallel-design study to assess the PK,
      safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single
      oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.
    


Intervention name(s): TR-701 FA; TR-701 FA
Intervention type(s): Drug; Drug
Intervention description(s): Oral TR-701 FA 200 mg will be given as a single oral dose; TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline
Intervention MeSH terms: Tedizolid phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: antibiotic; Adolescents receiving antibiotics
A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Some antiseizure medication levels are affected by hormones. This study is being done to
      determine if blood levels of lamotrigine or valproate are affected by the hormones in the
      birth control pill or the menstrual cycle itself.
    

Detailed description: 
      Participants will be given informed consent and will be asked to have two blood draws at
      specific times of the menstrual cycle or if on a birth control pill, during the active and
      inactive pill phases.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Two regional epilepsy centers
      
Biospecimen description: 
      Serum Samples for hormone testing
    
Keywords: epilepsy; menstrual cycle; valproate; lamotrigine; oral contraceptive
Effect of Charcoal on Gastrointestinal Absorption of Tiotropium
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess how efficiently activated charcoal will block absorption of tiotropium
      via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally
      administered tiotropium capsule with and without concomitant activated charcoal
      administration in healthy volunteers.
    


Intervention name(s): Tiotropium; Tiotropium
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule 20 μg; Oral capsule 20 μg
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based)
      treatment in chronic hepatitis B patients and to explore the most effective dosage and
      provide the rational for optimal dosing schedule.
    

Detailed description: 
      Second stage(76-144 weeks):

      In this follow-up stage the trial is open designed, and all the subjects completed the first
      stage study(0-76 weeks)

        1. Subjects with virological response but no serological response/with serological response
           but no virological response/neither virological nor serological response in the first
           stage, and be willing to continue the this follow-up study, will be treated by εPA-44
           900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.

        2. Subjects with both virological and serological response, will be followed-up to 144
           weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.

      The definition of response as below:

        1. Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;

        2. Serological response: serological conversion of HBeAg at 76 weeks.
    

Intervention name(s): εPA-44
Intervention type(s): Biological
Intervention description(s): subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Other intervention name(s): Therapeutic HBV vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; HBeAg positive; Therapeutic HBV Vaccine; HBV-specific Cytotoxic T Lymphocyte
A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of
      RDC5 given as a single dose to healthy volunteers at a number of different dose levels
    

Detailed description: 
      This is an open-label, randomised, single dose, 3-way crossover study to characterise and
      compare the PK, safety and tolerability of RDC5 in 15 healthy male volunteers. Eligible
      subjects will undergo 3 Treatment Periods, each separated by a washout period at least 14
      days. Subjects will receive a single dose of RDC5 during each of the three Treatment Periods
      in line with their randomized treatment sequence. A total of 4 dose levels will be evaluated
      within the study, though each subject will only receive 3 doses. A Data Review Team (DRT)
      will review the pharmacokinetic (PK) data from Treatment Periods 1 and 2 and select the doses
      to be evaluated in Treatment Periods 2 and 3. Subjects will return for a follow visit 21 days
      after the last dose of RDC5.
    

Intervention name(s): RDC5
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics
Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to test the possibility of preventing or delaying the development of
      type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma
      glucose concentrations by internet-based diabetes prevention program.
    

Detailed description: 
      Diabetes is common and rapidly increasing, because of obesity, unhealthy eating habits, and
      physical inactivity in Korea. Many studies reported that lifestyle modification related in
      the primary prevention of diabetes in multiethnic populations. The aim of this study is to
      determine whether internet-based interventions in those at high risk may delay the
      development of type 2 diabetes mellitus, and thereby reduce the incidence of cardiovascular
      diseases and strokes in Korean populations. In January 2008, participant recruitment began in
      Chung-ju city, a rural area in Korea. The subjects with impaired glucose tolerance or
      elevated fasting plasma glucose concentrations were selected from initial screening and then
      randomized to either a control or intensive lifestyle group to carry out intervention over 4
      years. The primary outcome of this study is the development of diabetes by ADA criteria. To
      confirm the onset of diabetes, all subjects have an OGTT at the interim 6-month and each
      annual visit. Also, systematic evaluation examination will be done at the same time. The
      proportion of subjects developing diabetes in each group and the factors relating the
      progression will be estimated using statistical analysis.
    

Intervention name(s): Lifestyle counseling; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.; In standard care group, counseling sessions are conducted only 6 times for 4 years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes prevention; Lifestyle modification; Obesity; Impaired glucose tolerance; Diet; Physical activity
Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter
Condition: Goiter
MeSH terms: Goiter
Study type: Interventional

Summary: 
      The aim of this three-arm randomized study was to evaluate results of different thyroid
      resection modes among patients with bilateral multinodular non-toxic goiter, with special
      emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.
    

Detailed description: 
      The extent of thyroid resection in bilateral multinodular non-toxic goiter remains
      controversial. Surgeons still continue to debate whether the potential benefits of total
      thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform
      total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal
      nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of
      total thyroidectomies are currently performed in high-volume endocrine surgery units, and the
      indication for this procedure include thyroid cancer, Graves disease and multinodular goiter.
      Recently there has been increasing acceptance for performing total thyroidectomy for
      bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers
      local recurrence rate and avoids the substantial risk of reoperative surgery, and involves
      only a minimal risk of morbidity. This common perception is based largely on
      single-institution retrospective data, a few multi-institutional retrospective experiences,
      and only a few prospective randomized studies comparing the outcomes of total vs. subtotal
      thyroidectomy.
    

Intervention name(s): Total thyroidectomy; Dunhill operation; Bilateral subtotal thyroidectomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Total thyroidectomy; Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy; Bilateral subtotal thyroidectomy
Other intervention name(s): TT; DO; BST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total thyroidectomy; Subtotal thyroidectomy; Dunhill operation; Recurrent nodular goiter; Completion thyroidectomy; Recurrent laryngeal nerve palsy; Hypoparathyroidism following thyroidectomy; Recurrent goiter