bioihbjkbjnl/mcl2 huggingface dataset:
Video Discharge Instructions for Fever and ED Recidivism
Condition: Children Who Present to the ED With Minor Febrile Illnesses
MeSH terms: Fever
Study type: Interventional

Summary: 
      To evaluate the effect of video discharge instructions on return visits to the ER or ED
      within 72 hours of the original visit for children with febrile illnesses.
    

Detailed description: 
      This is a randomized prospective convenience study of children presenting to the ED. Children
      greater than 8 weeks and up to and including their 18th birthday are enrolled. Patients were
      randomly assigned to one of two study groups: video + written fever specific discharge
      instructions and only written fever specific discharge instructions. Parents assigned to the
      video group watched the DVD in the emergency department (ED) and take it home along with the
      written instructions. At 72 hours both groups received a phone call asking whether they
      returned to the ED and the usefulness of discharge instructions (DVD and/or written).
      Critically ill children and those with chronic medical conditions were excluded. The primary
      outcome is a return ED visit for fever confirmed in our electronic medical record and
      questionnaire response. The secondary outcome is reported parental usefulness of the
      discharge instructions.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Other intervention name(s): Video (DVD) discharge instructions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; fever; emergency department
Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10
Condition: Pneumococcal Infections
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study are to assess the persistence of immunity against vaccine serotypes
      (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.
    

Detailed description: 
      The primary objective is to evaluate the long-term persistence of humoral immunity to
      vaccine-related pneumococcal serotypes after vaccination with PCV10.
    

Intervention name(s): 10-valent pneumococcal conjugate vaccine, PCV10
Intervention type(s): Biological
Intervention description(s): 10-valent pneumococcal conjugate vaccine, PCV10
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children born in 2008-2010 in the Hospital District of Southwest Finland. These children
        participated in the Finnish Invasive Pneumococcal Disease (FinIP) Vaccine Trial before
        introduction of PCV10 into the national immunization program in 2010. Serum samples from
        the children were collected in The Steps to the Healthy Development and Well-being of
        Children (STEPS) Study at the ages of 13 months, 2 years and 3 years.
      
Biospecimen description: 
      Serum samples collected at 13 months, 2 years or 3 years from children vaccinated with PCV10
      with 2+1 or 3+1 schedule
    
Keywords: Streptococcus pneumoniae; antibody
Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision
Condition: Sexual Behavior; Dis-inhibition
Study type: Interventional

Summary: 
      The purpose of this study is to measure the behavioral effects of learning information about
      male circumcision and HIV risk on sexual behavior and the demand for male circumcision.
    


Intervention name(s): Information; Control
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Malawi; Risk Compensation; Male Circumcision; Demand
Hydrogen Sulfide Production by Oral Microflora
Condition: Oral Malodor (Halitosis)
MeSH terms: Halitosis
Study type: Observational

Summary: 
      Oral malodor is a common condition. In most cases this condition results from the proteolytic
      activity of anaerobic oral bacteria. These bacteria produce volatile sulfide compounds which
      are fowl smelling and are felt during exhalation and speech. the aim of the present study is
      to examine a simple method of detecting these bacteria in samples taken from the oral cavity
      of oral malodor patients.
    


Time perspective: Prospective
Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo® and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the therapeutic equivalence and safety of
      Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo®
      (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment
      of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and
      reference products over the vehicle (placebo) control in the treatment of acne vulgaris.
    


Intervention name(s): Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%; Epiduo® Gel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.; Epiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days.; Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%; Epiduo®
Oxytocin's Effects on Face Attentional Processing
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on
      attentional processing of emotional faces.
    

Detailed description: 
      In a placebo-controlled double-blind between-subject design experiment, investigators plan to
      investigate the effect of oxytocin treatment on attentional processing of emotional faces.
      Subjects complete questionnaires in Chinese versions before treatment administration,
      including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory,
      Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This
      experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search
      Task. In the first task, subjects need to make a response to judge the position of target
      after a cue-target is presented. In the second task, subjects are asked to search the target
      "U" or inverted "U" placed on the nose of emotional/neutral faces and make an choices based
      on their oorientation. During these phases, subjects' response accuracy, response time and
      electrophysiological activity (ERP) are recorded.
    

Intervention name(s): oxytocin treatment; placebo treatment
Intervention type(s): Drug; Drug
Intervention description(s): intranasal administration of oxytocin (24IU); intranasal administration of placebo (24IU)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; emotional faces; attention; N2pc
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
Condition: Phase 1 Pharmacodynamic Study
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at
      night and to compare these results with those obtained with a placebo control and with
      commercially available nasal calcitonin.
    

Detailed description: 
      Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting
      reduction of osteoclast activity. It is theorized that a dose administered before bedtime
      will be more effective than a dose administered in the morning. See protocol summary for
      information.
    

Intervention name(s): Oral rsCT tablet; Oral Placebo Tablet; Oral rsCT tablet; Fortical (rsCT) nasal spray
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.; Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.; Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.; Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
Other intervention name(s): rsCT; Placebo; Fortical nasal spray
Intervention MeSH terms: Salmon calcitonin; Calcitonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080
Condition: Clinical Trials, Phase I as Topic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first in human study that will investigate the safety, tolerability and
      pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled,
      randomized, single center design. In addition the influence of itraconazole and food on the
      pharmacokinetics of BAY1817080 will be investigated.
    


Intervention name(s): BAY1817080; Placebo; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast]); Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food [Continental breakfast]); Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      One year antibody persistence after the fourth dose boost or two catch-up doses administered
      starting from 12 months of age and to evaluate the response to a a third dose boost or two
      catch-up dose starting at 24 months of age.
    


Intervention name(s): rMenB+OMV NZ
Intervention type(s): Biological
Intervention description(s): Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Meningococcal disease; Prevention; Vaccination
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study in healthy participants is to characterize the plasma
      pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine
      formulations administered sublingually.
    


Intervention name(s): OTF 1; OTF 2; OTF 3; OTF 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive (S)-ketamine administered sublingually through OTF 1.; Participants will receive (S)-ketamine administered sublingually through OTF 2.; Participants will receive (S)-ketamine administered sublingually through OTF 3.; Participants will receive (S)-ketamine administered sublingually through OTF 4.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Antimicrobial Photodynamic Therapy as an Adjunct Treatment for Periodontal Disease in Down's Syndrome Patients
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases; Down Syndrome
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effectiveness of antimicrobial photodynamic therapy
      as an adjuvant of scaling and root planning for treatment of periodontal disease in patients
      with Down's Syndrome. After scaling and root planning, half of patients received
      antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were
      repeated after 3, 7 and 14 days. The other half received only scaling and root planning.

      .
    

Detailed description: 
      Antimicrobial photodynamic therapy (aPDT) has been widely used in Periodontics to obtain
      reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal
      bacterial resistance. Therefore, a good adjuvant alternative for periodontal disease
      treatment arises, especially for patients with Down syndrome (DS) who present greater
      severity and high prevalence of periodontal disease. Usually aPDT is used as an adjunct
      therapy to scaling and root planning.
    

Intervention name(s): Antimicrobial photodynamic therapy; Scaling and root planning; red laser; methylene blue dye
Intervention type(s): Procedure; Procedure; Device; Drug
Intervention description(s): Described in arm/group; Described in arm/group; 658nm; 0.1W; 2229J/cm², 10s per point
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents; Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontal Diseases; Down Syndrome
A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effects of therapeutic and supratherapeutic oral doses of
      CBP-307 on the QTc interval in healthy subjects.
    

Detailed description: 
      This will be a Phase I, randomized, double-blind, double-dummy, placebo-controlled,
      positive-controlled, multi-site, 3-arm study to investigate the effects of therapeutic and
      supratherapeutic oral doses of CBP-307 on the QTc interval in healthy male and female
      subjects.
    

Intervention name(s): CBP-307; Placebo-matched CBP-307; Moxifloxacin (Avelox); Placebo-matched Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CBP-307 capsules oral administration.; Placebo-matched CBP-307 capsules oral administration.; Moxifloxacin tablets oral administration。; Placebo-matched Moxifloxacin tablets oral administration.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Condition: Streptococcus Pneumoniae Infections
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Observational

Summary: 
      This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus
      influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged
      12-18 months in order to estimate the prevalence of pathogens that commonly cause infection
      in Chinese young children. The antibiotic resistance of all isolates and the serotypes
      distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal
      carriage will be collected.
    


Intervention name(s): Nasopharyngeal swab
Intervention type(s): Other
Intervention description(s): Nasopharyngeal swab
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Children 12 to 18 months old
      
Biospecimen description: 
      Nasopharyngeal swab
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Condition: Chronic Obstructive Pulmonary Disease; Hypertension, Pulmonary
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic
      hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in
      human. The purpose of this study is to determine if DHEA is effective in the treatment of
      respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease
      (COPD) on exercise capacity and haemodynamic variables. Patients will receive after
      randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation
      concerns clinical parameters, echocardiography and right catheterization after and before
      treatment. Primary end-point is the six-minute walk test. This is a prospective double blind,
      randomised, placebo controlled study which will be realized in four university hospitals in
      France : Bordeaux, Strasbourg, Toulouse and Limoges.
    


Intervention name(s): DHEA Treatment; DHEA Treatment
Intervention type(s): Drug; Drug
Intervention description(s): DHEA : 200 mg/day hard gelatine capsule; DHEA : 25 mg/day hard gelatine capsule
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension, pulmonary; DHEA; six-minute walk test; pulmonary arterial pressure
Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, three-period, cross-over study to investigate the effect
      of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan
      200 mg.
    

Detailed description: 
      This is a randomized, double-blind, three-period, cross-over study to investigate the effect
      of single doses of sumatriptan (Imitrex) 100 mg on the pharmacodynamics of single doses of
      lasmiditan 200 mg. The study will last approximately 6 weeks including up to 3 weeks for
      screening and 22 days on study. Screening will be conducted within approximately 21 days of
      the first dose of study medication. Each dosing period will last 3 days (Day 1, Day 1, and
      Day 2). A wash-out period of 6 days will take place between each dose. The End of Study Visit
      (EoS) will take place 5 (+/- 2) days after the third dosing period is completed.
    

Intervention name(s): lasmiditan 200 mg; Sumatriptan; matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): drug including single placebo tablet; drug including single placebo tablet; single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet.
Other intervention name(s): LY573144
Intervention MeSH terms: Sumatriptan; Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Optimal Low B-value in Intravoxel Incoherent Motion Diffusion-weighted MR Imaging of the Brain
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Our research aims to reveal whether the low b-values distribution and the number of NEX for
      each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in
      brain.
    

Detailed description: 
      As an improved MRI technique, diffusion-weighted imaging (DWI) is considered the most
      sensitive for early pathological changes. Perfusion measurement has been shown to improve
      sensitivity and predictive value for tumor grading and prognosis, also as a predicator of
      recovery with reperfusion in patients of acute ischemic stroke.Our research aims to reveal
      whether the low b-values distribution and the number of NEX for each b value will influence
      the accuracy of pseudodiffusion parameter derived from IVIM in brain.
    

Intervention name(s): different low b-values distribution
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy volunteers
      
Keywords: IVIM; brain; diffusion-weighted imaging