bioihbjkbjnl/mcl2 huggingface dataset:
Value of Radiological Follow up in Children Hospitalized With Lobar Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      The study intends to assess the utility of performing a follow up X rays in children admitted
      to pediatric wards with lobar pneumonia. Usually those children are discharged with a
      recommendation for a follow up X rays but there are no enough studies proving that this
      recommendation is really necessary.
    

Detailed description: 
      Thew study will include follow up data in a group of about 200 patients admitted with lobar
      pneumonia during the years 2006 to 2007. All the clinical and laboratory data will be
      collected and also the X rays findings.

      The findings of follow up X rays if they were performed will also be summarized.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Retrospective data obtained from electronic files
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All pediatric patients admitted during the years 2006 and 2007 with the diagnosis of lobar
        pneumonia.
      
Keywords: X rays findings
eMotiph: E-mental Health Solution for Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Although the main objective of current schizophrenia intervention programs is the reduction
      of symptoms, its rates are around 36%, and recovery rates are 16.5%. Between 30 and 50% of
      people with schizophrenia obtain little benefit with conventional therapy. They are
      considered resistant to treatment. Therefore, the development of innovative evidence-based
      interventions adjunctive to pharmacological and psychological treatment are necessary for
      improving results in patients with treatment-resistant schizophrenia (TRS). Studies with
      digital solutions have shown feasibility, acceptability and even preliminary efficacy data.
      But no earlier published study has focused on TRS.

      The eMOTIPH is an innovative solution addressed to TRS and born from the outcomes of the
      previous study eMOTIPH Part 1 (study of beliefs, needs, and limitations associated with
      current intervention in TRS patients).
    

Detailed description: 
      A prospective non-randomised feasibility trial will be performed. People with a diagnosis of
      treatment-resistant schizophrenia and their informal caregivers will test the digital mental
      health solution eMOTIPH for 6 months. Psychiatric treatment and psychological intervention
      (based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders;
      Farchione et al., 2012) will be delivered to patients.

      The aim of the study is to evaluate the feasibility, acceptability, usability, satisfaction
      and perceived quality of life after using the eMOTIPH digital solution.
    

Intervention name(s): eMotiph
Intervention type(s): Device
Intervention description(s): Mobile application for patients with schizophrenia.
Intervention model: Single Group Assignment
Intervention model description: A prospective non-randomised feasibility trial
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: mHealth; Treatment resistent schizophrenia
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
Condition: Non-small Cell Lung Cancer; Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Icotinib at different
      dose levels in combination with whole brain radiotherapy for NSCLC patients with brain
      metastases and EGFR mutation.
    

Detailed description: 
      The long-term control of brain metastases becomes a clinical challenge. Whole brain
      radiotherapy, the standard treatment for patients with multiple brain metastases, can only
      bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its
      proven activity in non-small cell lung cancer may provide clinical benefits in such patients.
    

Intervention name(s): icotinib; Whole brain radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity.
Level 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity.
Level 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity.
Level 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity.; Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
Other intervention name(s): BPI-2009, Conmana; RT; XRT; Radiotherapy; WBRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; EGFR-TKI; NSCLC; Icotinib; WBRT
Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal
      intubation in patients with presumed difficult airway and compare the classical laryngoscopy
      and this method in matter of glottis visualisation and tracheal intubation.
    

Detailed description: 
      The rigid tube for laryngoscopy is a 15 to 30 cm long metallic tube with a bevel end and a
      diameter of 0.5-2.0 cm , an instrument used to inspect the larynx and surrounding areas. It
      resembles a rigid bronchoscope but it is shorter. When in use, it has to be attached to a
      light source.

      The hypothesis of the study stands that the rigid tube for laryngoscopy could be more
      efficient in tracheal intubation for difficult airway patients when the classical intubation
      with a curved blade laryngoscope is unsatisfactory.

      The retromolar approach in both sides together with bougie(intubating tube introducer)
      intubation is the technique of intubation used in this study.
    

Intervention name(s): classical laryngoscopy; rigid tube for laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.; the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Other intervention name(s): laryngoscopy with McIntosh curved blade laryngoscope
Intervention model: Single Group Assignment
Intervention model description: A group of patients with difficult airway criteria will be intubated using the rigid tube for laryngoscopy. A classical laryngoscopy with a McIntosh laryngoscope will be performed prior intubation and the Cormack-Lehane grade of glottis visualisation will be noted. If the Cormack -Lehane grade of glotic visualisation 2b, 3 or 4, the intubation maneuvre is carried further with the rigid tube. If the Cormack-Lehane glottic visualisation grade is less than 2b (1 or 2a) the intubation is accomplished with the MacIntosh laryngoscope (conventional laryngoscope) and the patient is excluded from the study from that point further.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laryngoscopy; retromolar
Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)
      therapy in chronic kidney disease (CKD).
    

Detailed description: 
      We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for
      CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs
      t, which will be derived from biopsies of their bone marrow. Assessments will be performed at
      1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR)
      were evaluated by scan isotope.
    

Intervention name(s): Intravenous injection
Intervention type(s): Biological
Intervention description(s): Intravenous injection of bone marrow derived MSC in patients with CKD.
Other intervention name(s): Intravenous transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous bone marrow mesenchymal stem cells chronic kidney disease
A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion
      150 mg Extended-Release Tablet to that of Wellbutrin SR® 150 mg Tablet after a single,
      one-tablet dose in subjects fed a standard meal.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study
      of Bupropion Extended-Released Tablets Formulation in Normal, Healthy Man Following a
      Standard Meal

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Abrika Bupropion 150 mg Extended-Released Tablet; Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrika formulated products under fed conditions; B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
Other intervention name(s): Bupropion; Bupropion
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Bupropion; Healthy subjects
Vaccine Therapy in Healthy Volunteers With or Without Previous Exposure to Cytomegalovirus
Condition: Cytomegalovirus Infection; Healthy, no Evidence of Disease
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and the best dose of vaccine therapy in healthy
      volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a
      gene-modified virus may help the body build an immune response and may help prevent
      cytomegalovirus infection.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To establish a biological optimal dose of the cytomegalovirus (CMV)-modified vaccinia
      Ankara (MVA) Triplex vaccine (multi-CMV epitope modified vaccinia Ankara vaccine).

      II. To determine if the vaccine is safe and well tolerated in healthy volunteers at these
      doses.

      SECONDARY OBJECTIVES:

      I. To provide preliminary evidence of CMV-MVA Triplex vaccine driven expansion of
      CMV-specific immune responses that would support further evaluation of this vaccine in
      hematopoietic cell transplantation (HCT) recipients.

      II. To confer CMV-specific immunity to CMV-negative volunteers and to determine the duration
      of immune enhancement of CMV-specific cell mediated immunity (CMI) function up to 12 months
      following immunization of healthy volunteers.

      OUTLINE: This is a dose-escalation study.

      Participants receive multi-CMV epitope modified vaccinia Ankara vaccine intramuscularly (IM)
      followed by a booster injection 28 days later in the absence of unacceptable toxicity.

      After completion of study treatment, participants are followed up for 12 months.
    

Intervention name(s): multi-CMV epitope modified vaccinia Ankara vaccine; laboratory biomarker analysis
Intervention type(s): Biological; Other
Intervention description(s): Given IM; Correlative studies
Other intervention name(s): CMV-MVA triplex vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study is to

        -  evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with
           Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently
           diagnosed Type 1 Diabetes

        -  evaluate how the above mentioned treatments influence the immune system of the subjects
           and interact with any viral infections

        -  evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd)
           plus Vitamin D on the immune system, viral infections, and on preservation of residual
           insulin secretion in recently diagnosed Type 1 Diabetes
    


Intervention name(s): GAD-Alum (Diamyd) 20 µg; GAD-Alum (Diamyd) 20 µg X 2; Vitamin D; Ibuprofen
Intervention type(s): Biological; Biological; Drug; Drug
Intervention MeSH terms: Vitamin D; Ibuprofen; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diamyd; Diabetes; Juvenile Diabetes; Diabetes type 1; Autoimmune Diabetes; Insulin dependent Diabetes; Type 1 diabetes; Type 1 diabetes mellitus; rhGAD65; GAD; GAD65; GAD-alum; Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Vitamin D; Ibuprofen
Healthy Volunteer Study Using 3 Different Formulations of Firategrast
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate how 3 types of drug formulations are absorbed by the body. This
      study is termed 'open-label', which means volunteers will be aware of which treatment they
      are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new
      formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in
      this study. Volunteers will also receive a single dose of a formulation used in previous
      trials (reference formulation), so a proper comparison with the new formulations can be made.
      The new fomulations will be administered with food and the reference formulation will be
      given without food. In Part 2, volunteers will receive only one of the 3 formulations as a
      repeat dose for 7 days. Each of these doses will be given with food.
    

Detailed description: 
      The present study will be conducted in two parts in healthy male volunteers. Part 1 will
      investigate the pharmacokinetics and tolerability of single doses of firategrast administered
      as the existing immediate release tablet formulation, as a modified release tablet (3hr)
      formulation and as a simulated gastro-retentive formulation to be administered via a
      naso-gastric tube. Subjects will receive each formulation in a randomised 3-way single dose
      crossover fashion.

      Part 2, based on the review of safety, tolerability and pharmacokinetic data from the first
      two study treatment periods of Part 1, will investigate the pharmacokinetics and tolerability
      of multiple doses of firategrast administered as the existing immediate release tablet
      formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive
      formulation to be administered via naso-gastric tube for a period of 7 days.
    

Intervention name(s): Firategrast immediate release tablet; Firategrast modified release tablet; Firategrast gastro-retentive solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.; Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.; Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: firategrast; pharmacokinetics, modified release, firategrast,; simulated gastro-retentive; pharmacokinetics; healthy volunteers, simulated gastro-retentive; healthy volunteers; modified release
Incentives for Adherence in Adolescent Asthma
Condition: Asthma; Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Financial incentives have been suggested as a possible means for increasing adherence to
      asthma medications. This study will evaluate an incentive strategy (daily small reward for
      adherence) in maintaining high levels of adherence as tracked by adherence sensors in
      adolescents with asthma.
    

Detailed description: 
      Two groups will be enrolled. The control group will have mediation monitoring sensors placed
      on their controller inhalers. The treatment group will also have the monitoring sensors
      placed on their medications, however they will be paid up to $1 per day for perfect adherence
      for 3 months. Both groups will be monitored for 4 months. 10 subjects will be chosen from
      each group to complete semi-structured phone interviews
    

Intervention name(s): Incentives; Medication device monitoring and reminders
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the treatment arm will be paid up to $1 per day over 3 months for perfect medication adherence. Adherence rates will then be compared between the 2 groups.; Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Adherence; Incentives
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Condition: Post Traumatic Stress Disorder; Adjustment Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Adjustment Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological
      First Aid" used with a group of children (11-16 years) in high risk of developing
      psychological problems. Participants are recruited from a low-threshold program ("The
      Children's House in Oslo") where counseling is given to children suspected of being
      physically or sexually abused, or having witnessed domestic violence. The study includes
      twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological
      problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed
      at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be
      assessed daily.
    


Intervention name(s): Psychological First Aid
Intervention type(s): Behavioral
Intervention description(s): A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder; Anxiety symptoms; Depressive symptoms; Externalizing behavior; Reduced quality of life
Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes
Condition: Sleep; Sleep Disturbance; Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias
Study type: Interventional

Summary: 
      A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of
      plant derived cannabinoids on sleep and overall health outcomes
    

Detailed description: 
      This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult
      participants per study arm, age 21 and older and residing in the United States.

      Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness
      to refrain from taking cannabinoids during the study period, and (3) express acceptance in
      taking a product and not knowing its formulation until the end of the study.

      Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to
      become pregnant, or breastfeeding will be excluded. Those taking medications that warn
      against grapefruit consumption will be excluded.

      Self-reported data are collected electronically from eligible participants over 5 weeks.
      Participant reports of health indicators will be collected during baseline, throughout the
      active period of study product use, and in a final survey. All study assessments will be
      electronic; there are no in-person visits or assessments for this real-world evidence study.
    

Intervention name(s): Rest Study Product Usage
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking: Double (Participant, Investigator)
Primary purpose: Other
GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose
      regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in
      Sub-Saharan Africa. Data from the current study are needed in order to complement existing
      extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™
      may be administered safely and will induce immune responses in populations from and living in
      Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.
    

Detailed description: 
      In Phase A of the study, healthy females between 9 and 12 years of age will be randomized
      (4:1) to receive the 3-dose regimen of GARDASIL™ or placebo, and those between 13 and 26
      years old will receive GARDASIL™. In Phase B of the study, participants who received placebo
      in Phase A will have the option to receive the 3-dose regimen of GARDASIL™.
    

Intervention name(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™); Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cervical cancer; vulvar cancer; vaginal cancer; genital warts; human papillomavirus