bioihbjkbjnl/mcl2 huggingface dataset:
School Inner-City Asthma Intervention Study (SICAS-2)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators goal is to determine the efficacy of school/classroom based environmental
      intervention in reducing asthma morbidity in urban schoolchildren.
    

Detailed description: 
      Our proposal builds upon our established, successful school-based infrastructure to determine
      whether a school/classroom intervention will efficiently and effectively improve asthma
      morbidity by reducing these exposures. Our goal is to determine the efficacy of
      school/classroom based environmental intervention in reducing asthma morbidity in urban
      schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse
      allergen, mold, and particulate pollutants will decrease asthma morbidity in students with
      asthma. The investigators plan to test this hypothesis in an intervention study of 300
      elementary students with asthma from multiple classrooms in inner-city elementary schools.
      Our clinical trial aims are to determine the effectiveness of a school/classroom based
      environmental intervention (school integrated pest management and classroom air purifying
      filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test
      the hypothesis that effects of school/classroom-based environmental interventions on
      symptoms/other measures of asthma control occur through changes in gene methylation or
      expression in pathways (and secondarily, in genes) relevant to airway function and asthma.
      This will expand our understanding of asthma immunopathogenesis and create opportunities to
      identify potential novel targets for asthma therapy.
    

Intervention name(s): integrated pest management; air purifier; No intervention (control)
Intervention type(s): Other; Other; Other
Intervention description(s): integrated pest management and environmental strategy; air purifiers; no integrated pest management and sham air purifier
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part I:

      To investigate whether and to what extent donepezil affects single dose pharmacokinetics of
      BI 409306

      Part II:

      To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics
      of donepezil
    


Intervention name(s): BI 409306; Donepezil low dose; Donepezil high dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Donepezil; BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to determine the effectiveness and safety of WR 279,396, a topical cream for
      the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo
      control under double-blind conditions in a local population group in Tunisia where
      leishmaniasis is endemic.
    

Detailed description: 
      WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being
      effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in
      previous clinical studies. The goal of this study is to expand those observations in a
      larger, more rigorous study to clearly define the efficacy of this product and collect
      information about adverse effects. Subjects will be randomized to receive either WR 279,396
      or vehicle placebo; applied twice a day for 20 days.
    

Intervention name(s): WR 279,396; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion; Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion
Other intervention name(s): Paromomycin topical cream; Topical vehicle placebo
Intervention MeSH terms: Paromomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cutaneous leishmaniasis topical treatment safety efficacy
A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
Condition: Bipolar Disorder; PTSD
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR),
      an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning,
      quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.
    


Intervention name(s): Eye Movement Desensitization Reprocessing (EMDR)
Intervention type(s): Other
Intervention description(s): EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: EMDR; bipolar disorder; trauma; subsyndromal symptoms; PTSD
Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
Condition: Nausea; Vomiting; Cesarean Section
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to investigate if the incidence of nausea and vomiting
      that subjects experience during and after a Cesarean section can be reduced by giving a shot
      of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.
    

Detailed description: 
      This research project is designed to study the medication ephedrine, when it is given as a
      routine part of the anesthesia for elective Cesarean section. Ephedrine is a medication that
      is widely used in labor and in vaginal and operative (Cesarean section) deliveries to help
      maintain a woman's blood pressure within its normal range, especially after spinal and
      epidural anesthesia has been administered. The purpose of this study is to determine if
      ephedrine, when given intramuscularly (<IM> as a shot in the muscle), at the time of spinal
      anesthesia administration, can help to decrease the incidence of nausea and vomiting subjects
      experience during and after a Cesarean section. This study will compare women who receive
      ephedrine to a similar group of women who receive a normal saline placebo. In addition to
      looking at the difference in the incidence of nausea and vomiting perioperatively, this study
      will also evaluate if the administration of IM ephedrine helps the baby to receive more blood
      from the placenta after anesthesia has been administered to the mother. This will be
      evaluated by performing a simple blood test, drawn from the umbilical cord, after the baby is
      born.
    

Intervention name(s): Ephedrine [Synonyms: Ephedra, Ephedrinum]; Saline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg, IM (in the muscle), one time; 0.5 mL, IM (in the muscle), one time
Intervention MeSH terms: Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Nausea; Vomiting; Cesarean Section
Study of BLZ-100 in Pediatric Subjects With CNS Tumors
Condition: Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Many types of cancer are primarily treated with surgery and patient survival is directly
      related to the extent to which the tumor is able to be removed. It is often difficult for
      surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have
      spread from the original tumor site, resulting in incomplete removal of the tumor and reduced
      patient survival. In some sites, such as the brain, it is critical to avoid damage to normal
      tissue around the tumor to prevent adverse effects of surgery on function. The investigators
      hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the
      edges of the tumor and small groups of cancer cells that have spread to other sites in
      real-time as they operate. This is a safety study to assess the safety of BLZ-100 in
      pediatric patients with central nervous system tumors.
    

Detailed description: 
      Subjects who provide voluntary written informed consent, or have it provided by their legally
      acceptable representative, will be screened for eligibility. Subjects meeting all of the
      inclusion and none of the exclusion criteria will be eligible to participate.

      Subjects will be required to arrive at the hospital for dosing at least 1 hour before the
      planned surgical excision. Following dosing, subjects will be monitored for safety and
      surgical excision will occur at least 1 hour after study product administration.
    

Intervention name(s): BLZ-100
Intervention type(s): Drug
Other intervention name(s): Tumor Paint; tozuleristide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: central nervous system tumor; BLZ-100; pediatrics; Tumor Paint; brain cancer; tozuleristide
Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants
Condition: pOSitional Changes of Premature Infants
Study type: Interventional
Phase: Phase 4

Summary: 
      Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside
      investigation of cerebral oxygenation in newborn infants. Using this technique we
      investigated the effect of positional changes on cerebral oxygenation in preterm infants.
    

Detailed description: 
      The changes in cerebral perfusion have an important role on the development of
      intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy
      offers the possibility of noninvasive and continuous bedside investigation of cerebral
      oxygenation in newborn infants. Using this technique we investigated the effect of positional
      changes on cerebral oxygenation in preterm infants.
    

Intervention name(s): Device: near infrared spectroscopy: INVOS 5100; invos 5100
Intervention type(s): Device; Device
Intervention description(s): NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.; near infrared spectroscopy: invos 5100
Other intervention name(s): invos 5100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: NIRS
ACR | LAB Urine Analysis Test System Evaluation of Performance
Condition: Diabetes; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD)
      device. The test is for the qualitative and semi- quantitative detection of Albumin,
      Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a
      smartphone application using an image recognition algorithm.

      The degree of agreement of the ACR | LAB as compared to the comparator device will be tested.
      Urine samples will be tested by a separate professional user on each device.
    


Intervention name(s): ACR LAB
Intervention type(s): Device
Intervention description(s): The ACR | LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
Condition: Preterm Infants; Clinical Outcome; Pharmaceutical Care
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication
      Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation
      with iron supplementation. The purpose of this study is to evaluate clinical outcome in the
      PPMTM program compared with usual care in an integrated health care system.
    

Detailed description: 
      This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication
      Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation
      with iron supplementation. As a result, the Committee on Nutrition of the American Academy of
      Pediatrics (AAP) recommends daily oral iron supplementation, of at least 2-4 mg/kg/day from 2
      weeks of age, to prevent iron deficiency in extremely premature infants. The purpose of this
      study is to evaluate clinical outcome in the PPMTM program compared with usual care in an
      integrated health care system.
    

Intervention name(s): pharmacists involved PPMTM
Intervention type(s): Other
Intervention description(s): This was an open labelled randomised study. Preterm Infants With iron supplementation were recruited and arbitrarily divided into the intervention group (usual care plus PPMTM) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pharmaceutical Care; Medication Adherence; Iron Supplementation
The Incidence of Artifacts in the Anesthesia Information Management System Database.
Condition: Artifacts; Integrated Advanced Information Management Systems
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the incidence of artifacts in the developed AIMS
      database
    

Detailed description: 
      At first, the authors evaluated the accuracy of the traditional, manually completed
      paper-based documentation, which sets a benchmark for the accuracy that the electronic
      documentation and database provides.

      At the second portion, the investigators used the paper-based documentation as a standard to
      compare the electronic documentation. The incidence of artifact was double checked by two
      investigators.

      At the third portion, the authors calculated the artifact incidence in the AIMS database,
      using paper based and electric document anesthesia records as the standard respectively.
    

Intervention name(s): paper-based anesthesia record; electronic documents
Intervention type(s): Other; Other
Intervention description(s): to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record; to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients undergo general or regional anesthesia for surgery
      
Keywords: Artifacts; anesthesia information management system
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
Condition: Varicella; Rubella; Mumps; Measles
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess non-inferiority of two different vaccination regimens
      using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and
      one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™
      administered at 9 months of age followed by concomitant administration of Priorix™ with
      Varilrix™ at 15 months of age in a measles endemic environment such as India.
    


Intervention name(s): GSK Biological's investigational MMRV vaccine 208136; Priorix™; Varilrix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subcutaneous injection; Subcutaneous injection; Subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mumps; Immunogenicity; Vaccines; Safety; Rubella; Combined Vaccine; Varicella Vaccine; Children; Measles; Humans
Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      This study will test the impacts of real time fMRI neurofeedback in patients with Borderline
      Personality Disorder. This is a pilot study in a small number of people enrolled in clinical
      programs at Yale New Haven Hospital.
    


Intervention name(s): real time fMRI neurofeedback
Intervention type(s): Behavioral
Intervention description(s): Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Lesinurad Monotherapy Extension Study in Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the serum uric acid lowering effects and safety of lesinurad over a
      long-term timeframe.
    

Detailed description: 
      This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy
      and safety of lesinurad monotherapy in subjects who completed the double-blind treatment
      period in Study RDEA594-303.
    

Intervention name(s): lesinurad
Intervention type(s): Drug
Intervention description(s): Tablets, 400 mg QD
Intervention MeSH terms: Lesinurad
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Tolerability Assessment of a Probiotic Dietary Supplement
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The dietary supplement being investigated is a formula containing a combination of eight
      probiotic strains. The combination formula was developed to support general gastrointestinal
      and immune health. Each of the strains in the formula have previously been studied in human
      subjects, including several clinical populations. However, the present eight strain
      combination formula has not previously been evaluated in human subjects. This prospective
      study will evaluate the tolerability of the eight strain formula in healthy adults.
    

Detailed description: 
      Background & Significance:

      The dietary supplement being investigated is a formula containing a combination of eight
      probiotic strains. The combination formula was developed to support general gastrointestinal
      and immune health. Each of the strains in the formula have previously been studied in human
      subjects, including several clinical populations. However, the present eight strain
      combination formula has not previously been evaluated in human subjects.

      Research Design & Methods:

      This prospective study will evaluate the tolerability of the eight strain formula in healthy
      adults over a 10-day period. The primary aim of the study is to assess tolerability as
      determined by the frequency of study participants who withdraw from the study due to adverse
      events.
    

Intervention name(s): Probiotic Dietary Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement containing a combination of 8 probiotic strains
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or
      severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult
      subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic
      Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the
      underlying disease condition.
    

Detailed description: 
      A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in
      Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days,
      treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will
      receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by
      300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the
      same fashion. Participants will primarily be assessed for incidence rate of moderate or
      severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be
      monitored throughout the study.
    

Intervention name(s): MEDI8968 600 mg IV, 300 mg SC; Placebo
Intervention type(s): Biological; Other
Intervention description(s): MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.; Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); MEDI8968