bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The purpose of the study was to find out if children 5 through 8 years of age who are getting
      influenza vaccine for the first time should get one or two doses.
    

Detailed description: 
      Currently, two doses of influenza vaccine are recommended for children younger than 9 years
      receiving influenza vaccine for the first time. While the scientific support for 2 doses of
      vaccine in infants and toddlers is sound, the need for 2 doses of vaccine for adequate
      immunogenicity in older children is less certain. If the immunogenicity of a one-dose vaccine
      regimen is comparable to a two-dose regimen, then one dose would be preferable for reasons of
      safety, practicality and economics, and would reduce a major barrier to vaccination in this
      injection-adverse age group. This study compared the immunogenicity and reactogenicity of one
      versus two doses of influenza vaccine in children aged 5 to 8 years old receiving influenza
      vaccine for the first time. All children enrolled in the study received two doses of vaccine,
      and the immune response after one dose of vaccine was compared to the immune response after
      two doses of vaccine.
    

Intervention name(s): 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Vaccination; Immunization; Flu; Immunogenicity
Severe Influenza Cohort
Condition: Influenza; Severe Respiratory Infection
MeSH terms: Infections; Influenza, Human; Respiratory Tract Infections
Study type: Interventional

Summary: 
      Influenza is a major cause of morbidity and mortality. The investigators first goal is to
      evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death
      from Influenza respiratory illness in adult and pediatric patients hospitalized in
      reanimation. Secondly, the investigators collected respiratory samples in order to study the
      transcriptomic profiles of influenza-infected patients with severe symptoms.
    


Intervention name(s): influenza cohort
Intervention type(s): Other
Intervention description(s): Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial
Condition: Knowledge, Attitudes, Practice; Literacy; Confidence, Self
Study type: Interventional

Summary: 
      How health-related information is communicated affects what is understood and might influence
      how people make decisions and how confident they feel in participating in clinical shared
      decision-making.

      The CICERO trial will compare three different communication tools providing information on
      fictional interventions for a common medical problem (i.e. social anxiety disorder) both in
      terms of how well interventions work (benefit) and also possible harms associated (risk). The
      three communication tools ("Summary of Findings table", "Kilim plot", and "Vitruvian plot")
      differ in how they present information: exclusively written, primarily written and partially
      graphical, or mixed written and visual. Each participant will be asked to go through one
      clinical scenario.

      The investigators will ask participants to familiarise themselves with the tool they have
      been allocated to (either a plot or a table) and then answer some validated questionnaires to
      measure how useful and efficient the communication strategy was.

      The entire study occurs online in a single study session (about 20 minutes).

      The results of the CICERO trial will inform how to communicate research findings to the
      general population, facilitating their implementation in clinical shared decision-making.
    


Intervention name(s): Vitruvian plot; Kilim plot; Summary of findings table
Intervention type(s): Device; Device; Device
Intervention description(s): Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool; Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool; Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: shared decision-making
Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of the Domiciliary care- Activities
      of Daily Living program on activities of daily living (ADL), motor, cognition, perception,
      sensory, quality of life, and depression for patients with stroke.
    

Detailed description: 
      Administering ADL and recovery of ADL functions are the primary efficacy indicators in
      long-term care and the main treatment goals in rehabilitation for patients with stroke.
      Residential rehabilitation is a direct way to observe patients' living environment and
      provides feasible ADL treatment plans for patients with stroke living at home or in the
      community. The purpose of this study was to investigate the effects of the Domiciliary care-
      Activities of Daily Living program on activities of daily living, motor, cognition,
      perception, sensory, quality of life, and depression. The eligible participants were
      recruited and assigned into two groups: ADL home program and control group who received
      traditional rehabilitation in hospital. The primary outcome measures were the Canadian
      Occupational Performance Measure, the Barthel Index-based Supplementary Scales, the Frenchay
      Activities Index, and ADL domain of the Stroke Impact Scale. The secondary outcome measures
      were the Fugl-Meyer Assessment, the Mini Mental State Examination, the Test of Visual
      Perceptual Skills-Third Edition, and the Center of Epidemiological Study-Depression.
    

Intervention name(s): Domiciliary care - Activities of Daily Living
Intervention type(s): Other
Intervention description(s): Home-based ADL training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Validation of Ventriject Determined Maximal Oxygen Uptake
Condition: Healthy
Study type: Observational

Summary: 
      This study aims to validate the use of the Ventriject product to estimate VO2 max, through a
      non-physically active test using ECG, echoseismography and echosonography.
    

Detailed description: 
      this study will be composed of the following tests:

        -  blood sample for measurement of blood values

        -  blood pressure measurement to rule out risks affiliated with maximal effort testing

        -  DXA body composition scanning

        -  Measurement on ECG, echosonography and echoseismography with accelerometer, microphone
           and ECG wires

        -  Measurements with phone (iPhone)

        -  VO2 max assessment by maximal oxygen uptake testing on a training bike, using online
           oxygenmeasurement equipment

        -  Hand-grip strength assessment
    

Intervention name(s): Ventriject validation
Intervention type(s): Other
Intervention description(s): comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy adults
      
Biospecimen description: 
      blood samples for testing blood values
Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules
      of Ohm Laboratories Inc., with Altace® capsule 10 mg (containing ramipril 10 mg) manufactured
      by King Pharmaceuticals Inc, Bristol and Distributed by Monarch Pharmaceuticals Inc, Bristol
      in healthy, adult, male, human subjects under fed condition.
    

Detailed description: 
      A single oral dose of ramipril 10 mg capsule was administered with 240 mL of drinking water
      at ambient temperature 30 minutes after start of a high-fat high-caloric breakfast under the
      supervision of trained study personnel.

      A total of thirty-two (32) subjects were randomized to receive a single oral dose of the test
      (T) and reference (R) formulation of ramipril 10 mg capsule. One subject (subject No. 18) was
      withdrawn and one dropped out (subject No. 10) from the study in period I. One subject
      (subject No. 20) dropped out and two subjects were withdrawn (subject No. 27, 29) from the
      study in period II.

      A total of twenty-seven (27) subjects completed both the periods of the study.
    

Intervention name(s): Ramipril 10mg capsules
Intervention type(s): Drug
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Ramipril fed condition
Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      It is hypothesized that different inhalation profiles (inhalation flow rate versus time
      curves) result from different forms of patient training. Furthermore, significant
      inter-subject variability in these profiles should exist that can, under some circumstances,
      depend on the design of different inhalation devices; this is because dry powder inhalers
      have different airflow resistances. The investigators also hypothesize that the spread of
      flow rate versus time profiles for inhalation can be collected. Finally, these profiles can
      be analyzed from a group of human subjects and used to define a mean and statistical range of
      inhalation flow rate versus time curves.

      The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy
      volunteers after they have (a) read a typical inhaler package insert and (b) been formally
      trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used
      from this pilot study to (a) show the inter-subject variability in the inhalation profiles
      used by adults inhaling through realistic airflow resistances (like those in inhalers)
      following different types of training (b) show how formal training changes inhalation
      technique and (c) provide a database of typical inspiratory profiles for use and improvement
      of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers
      greatly depends upon the way patients inhale through them, this research will result in a
      database to improve the design and in vitro characterization of inhalers.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Greater Richmond Area, Virginia
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the
      marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the
      evaluation of the pathological complete response after 8 instillation of gemcitabine. 46
      patients are requested.
    


Intervention name(s): Gemcitabine; docetaxel; cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
Condition: Cataract, Juvenile
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic
      capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV.

      Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective
      randomized control clinical trial. Methods: Patients were randomly assigned to two groups:
      optic capture without AV (Group 1) or in-the-bag implantation with AV (Group 2). The
      following variables were compared: visual acuity, intraocular pressure, refractive errors,
      IOL tilt and decentration, lenticular astigmatism, anterior-posterior synechia, inflammatory
      cell deposits on IOL and post-operative complications.
    


Intervention name(s): optic capture; In-the-bag implantation of Intraocular lens
Intervention type(s): Procedure; Procedure
Intervention description(s): optic capture of Intraocular lens without anterior vitrectomy; in-the-bag implantation of Intraocular lens with anterior vitrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
Fentanyl Test in Children's Adenotonsillectomy
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to discuss the relationship between the result of fentanyl test
      and required dosage of morphine for children with OSAS after adenotonsillectomy；and to
      evaluate the ability of predicting requested dosage of morphine postoperatively.
    

Detailed description: 
      All the patients were intubated. Sevoflurane was used for maintenance without any opioids.
      Before the end of the procedure, spontaneous respiratory was recovered. All the patients were
      given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined
      as spontaneous respiratory rate decreased more than 50%, the others were defined as negative
      result. All the patients were given morphine for pain relief according to our protocol after
      extubation.
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure.
Other intervention name(s): Fentanyl test
Intervention MeSH terms: Fentanyl
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic
        nasopharyngoscope and underwent selective adenotonsillectomy
      
Keywords: adenotonsillectomy; fentanyl
A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and clinical characteristics of a
      quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16
      will be subsequently used in viral challenge studies with new compounds that are intended to
      treat respiratory diseases.
    

Detailed description: 
      This is an open-label study in which all participants know the investigational substance
      being tested. Participants will be inoculated in the nose with HRV-16 and evaluated for the
      occurrence of cold symptoms and other indicators. There will be 3 phases: a screening phase,
      an HRV-16 infection phase, and a follow-up phase. The dose of virus being tested in this
      study has been previously used in other challenge studies. The total length of participation
      in the study will be about 4 weeks. Participant safety will be monitored.
    

Intervention name(s): HRV-16 (100 TCID50); HRV-16 (1000 TCID50)
Intervention type(s): Biological; Biological
Intervention description(s): Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.; Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer; Rhinovirus; Cold virus; HRV-16
A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder
Condition: Phobic Disorders
MeSH terms: Anxiety Disorders; Phobia, Social; Phobic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of
      treatment in participants with Social Anxiety Disorder (SAD).
    

Detailed description: 
      This is a Phase 2a randomized (study drug assigned by chance), double-blind (neither the
      Investigator nor the participants know about the study intervention), placebo-controlled,
      parallel-group, multi-center study of JNJ-42165279 in participants with social anxiety
      disorder. Participants will receive 25 milligram (mg) JNJ-42165279 or matching placebo orally
      once-daily from Day 1 up to 12 weeks. Participants will primarily be assessed for the change
      from baseline in Liebowitz Social Anxiety Scale (LSAS) at Week 12. Safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-42165279; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.; Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.
Intervention MeSH terms: JNJ-42165279
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; JNJ-42165279
EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The goal of this project is the development of an EEG-cap (min. 21 electrodes) with
      user-friendly active dry electrodes that meets the expectations of the users regarding
      comfort and esthetics, without losing sight of the functional and technical demands for
      recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical
      neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that
      hospital admission in the EMU can be avoided for some patients and an increasing number of
      patients can be examined.

      Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.

      Phase 3a of the project will comprise of an EEG-registration with the different types of
      electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on
      EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the
      EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each
      EEG-recording will take approximately 10 minutes.

      Minimum 2 - maximum 10 epilepsy patients will be included.

      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical
      evaluation of the EEG-signals. User experience will also be collected.
    


Intervention name(s): EEG
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Angina Pectoris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and
      haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor
      (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF)
      gene therapy in patients with severe chronic occlusive coronary artery disease.
    

Detailed description: 
      In recent clinical trials, vascular endothelial growth factor (VEGF) delivered as plasmid DNA
      percutaneously by a catheter-based, intramyocardial approach, have been demonstrated to be
      safe and to be associated with a reduction in angina and an increase in exercise time or an
      improvement in regional wall motion in "no-option patients" with chronic myocardial ischemia.

      It has been demonstrated, that BM-derived stem cells mobilized by cytokines as granulocyte
      colony stimulating factor (G-CSF) were capable of regenerating the myocardial tissue, leading
      to improve the survival and cardiac function after myocardial infarction.

      These data suggested that a combination therapy with exogenous administration of gene
      vascular growth factor combined with G-CSF mobilization of bone marrow stem cells might
      induce both angiogenesis and vasculogenesis in ischemic myocardium
    

Intervention name(s): VEGF-A165 plasmid
Intervention type(s): Genetic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gene therapy; VEGF; Stem cells; myocardial ischemia; angiogenesis
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose
      combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin
      1000 mg administered together.
    


Intervention name(s): Linagliptin/Metformin FDC; Linagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment