bioihbjkbjnl/mcl2 huggingface dataset:
Occupation and Asthma in an Urban Low Income Population
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Observational

Summary: 
      To study work-related asthma in a low-income, urban population.
    

Detailed description: 
      BACKGROUND:

      Work-related asthma is asthma that is attributable to, or is made worse by, environmental
      exposures in the workplace. Published estimates of the proportion of adult asthma
      attributable to occupational factors have varied widely, depending on population,
      methodology, and definitions, from 2 percent to 33 percent. Occupational asthma is of great
      public health importance because it is potentially preventable, can cause substantial
      disability, and in some cases is completely curable. Among adults in the United States,
      asthma has become a major public health problem, with rates most elevated among low income,
      urban, African American and Latino sectors of the population, and with substantial evidence
      suggesting potential occupational contributions to the excess rates. These important sectors
      of the U.S. population have, however, been inadequately represented in the occupational
      asthma research literature.

      DESIGN NARRATIVE:

      This was a case control study of physician-diagnosed asthma, occupation, industry, and
      workplace environmental exposures designed to evaluate the hypothesis that a substantial
      component of the asthma burden in a low income, urban, largely minority population was due to
      occupational factors. The study design addressed a variety of methodologic challenges
      including healthy worker effects, difficulty contacting and recruiting this potentially high
      risk population, large numbers of potential etiologic agents, mixed exposures, small
      workplaces, and low absolute incidence of occupational asthma.

      The study population was the catchment population of Bellevue Hospital, a general hospital in
      lower Manhattan, New York City, with busy ambulatory care services that serve low income
      working communities. Cases and controls were recruited from among outpatients and inpatients
      at Bellevue Hospital and interviewed face-to-face or by telephone. Occupation, industry, and
      occupational exposures were determined by questionnaire supplemented by a Job Exposure
      Matrix. Odds ratios (ORs) of association between asthma and specific industrial,
      occupational, and exposure categories, controlled for major confounders, were estimated. The
      ORs were used to calculate occupation- and industry-specific Attributable Fractions, and an
      overall Population Attributable Fraction of asthma attributable to occupational factors. New
      onset occupational asthma and work-aggravated asthma were investigated separately.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at Bellevue Hospital who were given a diagnosis between the dates of 1/1/1996 and
        6/30/2003.
CO2 (Carbon Dioxide) - Cerebral Oxygenation
Condition: Hypoxia, Brain
MeSH terms: Hypoxia, Brain; Hypoxia
Study type: Interventional
Phase: Phase 2

Summary: 
      Several projects in high altitude research in environments with a low oxygen partial pressure
      (hypobaric hypoxia) leading to hypoxemia showed, that cerebral perfusion and cerebral
      performance could be improved by adding C02 (cabon dioxide).

      The investigators hypothesize that adding 5% C02 to 02 (Oxygen) also under normobaric
      conditions increases the time until a significant cerebral hyopxia is measured by near
      infrared spectroscopy (NIRS) compared to the administration of 95% 02.

      lf this hypothesis proves to be true, this approach might be used in situations in which
      individuals are prone to cerebral hypoxia. In bariatric surgery, patients that experience an
      apnea phase are more prone to (cerebral) hypoxia due to the fact, that they have a higher
      body mass index (BMI) leading to a reduced functional residual capacity (FRC), which serves
      as the oxygen reserve in the body.
    

Detailed description: 
      On the day of surgery patients will be randomized. After induction of anesthesia and
      endotracheal intubation patients will be managed by the study team to perform the
      intervention and the measurements.

      According to randomization, investigational medical product (IMP) or comparator will be
      administrated by ventilator 1/ventilator 2.

      At time point 1 apnea will be performed by disconnecting the ventilator from the endotracheal
      tube until the NIRS value has dropped by 20% from baseline. After that, re-ventilation will
      be resumed immediately, until parameters have returned to baseline.

      During apnea time NIRS and vital signs will be recorded permanently, blood samples will be
      drawn at definite time points.

      Application of IMP (or comparator) will be performed in this cross-over study design in the
      same manner after the baseline level is reached again.

      At the end of the study procedure, after the baseline level of end-expiratory CO2 is reached
      again, patient will be taken over by the clinical anesthesia team and surgeons.
    

Intervention name(s): Oxycarbon (5% CO2+ 95% O2)
Intervention type(s): Drug
Intervention description(s): Oxycarbon will be administered by mechanical ventilation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Controlled, randomized, single blind, crossover
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cerebral hypoxia; CO2; cerebral perfusion; hypoxia
Study Evaluating Single Ascending Doses Of ILS-920
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study of ILS-920. This study will provide an initial assessment of
      the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after
      administration of ascending single intravenous (IV) doses to healthy adult subjects.
    


Intervention name(s): ILS-920
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute Ischemic Stroke
Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to
      2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine
      administered alone.
    

Detailed description: 
      The vaccine being tested in this study is called Tetravalent Dengue Vaccine (TDV). The study
      will assess the immunogenicity and safety on the co-administration of 9vHPV vaccine with TDV
      in healthy participants aged ≥9 to <15 years.

      The study will enroll approximately 614 healthy volunteers. Participants will be randomly
      assigned to one of the two treatment groups-

        -  Group 1

        -  Group 2

      All participants will receive recombinant 9-valent Human Papillomavirus Vaccine (9vHPV)
      intramuscular (IM) in combination with Dengue Tetravalent Vaccine (TDV) subcutaneous (SC)
      injection on Day 1 (Month 0 ) followed by 9vHPV on Day 90 (Month 3) and TDV on Day 180 (Month
      6) in Group 1. Participants will receive 9vHPV on Day 1 (Month 0) and Day 180 (Month 6) IM in
      Group 2.

      This multi-center trial will be conducted in Thailand. The overall time to participate in
      this study is 12 months. Participants will make multiple visits to the clinic, after last
      dose of study drug for a follow-up assessment.
    

Intervention name(s): 9vHPV Vaccine; Dengue Tetravalent Vaccine (TDV)
Intervention type(s): Biological; Biological
Intervention description(s): 9vHPV intramuscular injection; TDV subcutaneous injection
Other intervention name(s): TAK-003
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Drug therapy
A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501
      100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.
    


Intervention name(s): BI 695501 - higher concentration; BI 695501 - lower concentration
Intervention type(s): Drug; Drug
Intervention description(s): BI 695501 - higher concentration; BI 695501 - lower concentration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Etude (Study) Phase I Enox - UnFractionated Heparin (UFH)
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

        -  to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous
           bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg
           (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations
           of enoxaparin in Caucasian healthy subjects.

      Secondary objective(s):

        -  to compare the pharmacokinetic and the pharmacodynamic profile between 3 different
           timing of administration of the UFH

        -  to assess the tolerability of the different anticoagulation protocols
    


Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, randomised, 2-treatment period, single-dose crossover study to
      determine the comparative bioavailability and renal elimination following single-dose
      administration of 3.0 mg cytisine in healthy smokers under fed and fasted conditions.
    


Intervention name(s): cytisine
Intervention type(s): Drug
Intervention description(s): cytisine 1.5 mg film-coated tablets
Other intervention name(s): Tabex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cold Snare Endoscopic Resection for Duodenal Adenomas
Condition: Duodenal Adenomas
MeSH terms: Adenoma
Study type: Observational

Summary: 
      Non-ampullary sporadic duodenal adenomas (SDA) are rare lesions, incidentally discovered in
      up to only 5% of patients during routine endoscopy. In any case, these lesions require
      treatment due to their potential malignant transformation because of the adenoma-carcinoma
      sequence, occurring in 30-85% of cases. Endoscopic resection (ER) of SDA represents an
      attractive alternative to surgical resection in appropriately selected patients, with lower
      morbidity and mortality rates.

      However, most endoscopists are not keen to resect larger lesions due to the risk of
      complications. Indeed, endoscopic resection in the duodenum has unique challenges: thin wall,
      high vascularity, very limited space and harmful effects of bile and acid both acting on the
      ER defect.

      Cold snare endoscopic resection has been shown to be a viable method for removing colorectal
      lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic
      mucosal resection (EMR) and a promising safety profile. As a matter of fact, adverse events
      associated with hot snare resection technique such as delayed bleeding, post-polypectomy
      syndrome, and perforation are all related to electrocautery-induced injury.

      Performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have
      a major impact in the duodenum where the risk of delayed bleeding and perforation is
      consistent.

      The aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in
      term of safety and efficacy of cold snare endoscopic resection.
    


Intervention name(s): Cold snare endoscopic resection
Intervention type(s): Procedure
Intervention description(s): Cold snare endoscopic resection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with diagnosed large duodenal adenomas (>20 mm)
Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study
      designed to characterize and compare the PK properties and safety of a single subcutaneous
      dose of CSL324 in healthy Japanese and White subjects.
    


Intervention name(s): CSL324; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection; Sterile solution of CSL324 formulation buffer for injection
Other intervention name(s): Recombinant Anti G-CSF Receptor Monoclonal Antibody
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Background: Pediatric asthma is the most common chronic illness among children and is
      associated with poor quality of life, activity restriction, school absences, and thousands of
      physician visits annually. The purpose of this study is to measure the effectiveness of using
      an innovative tracking system (CareTRx) for the self-management of asthma, including daily
      and rescue medication use, among children and adolescents with pediatric asthma.
    

Detailed description: 
      The primary study objective is to measure the effectiveness of using an innovative tracking
      system (CareTRx) for the self-management of asthma, including daily and rescue medication
      use, among children with asthma. The study objectives will be achieved using a pre-post
      design for the participants. The investigators aim to enroll at least 26 participants for a
      3-month intervention period. With this pilot study, the investigators hope to examine the
      impact of self-management behaviors on health outcomes including asthma symptoms and quality
      of life measures.
    

Intervention name(s): CareTRx
Intervention type(s): Device
Intervention description(s): CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Registry for Asthma Characterization and Recruitment 2
Condition: Asthma
MeSH terms: Asthma
Study type: Observational [Patient Registry]

Summary: 
      There is a need for people to take part in research studies to learn more about diseases and
      how to treat them. The Registry for Asthma Characterization and Recruitment 2 (RACR2) will
      create a database of participants with asthma and nasal allergies, or risk factors for these
      conditions, who are potentially eligible for future Inner City Asthma Consortium (ICAC)
      trials. The registry database will include assessments of various asthma and allergy
      characteristics to achieve a more efficient, selective recruitment of these participants for
      other protocols.
    

Detailed description: 
      The overall goal of the Registry for Asthma Characterization and Recruitment 2 (RACR2) is to
      create a database of participants who are potentially eligible for future Inner City Asthma
      Consortium (ICAC) clinical research studies. The registry will provide an avenue to assess
      various asthma and allergy characteristics, which will result in more efficient recruitment
      for current and future ICAC protocols.

      Potential participants will be recruited via telephone or in person. Those deemed potentially
      eligible for a current protocol or protocol in development may be invited to the clinic for
      further data collection and assessments. This registry allows flexibility in selecting the
      eligibility criteria and data collection to match planned or upcoming ICAC protocols. At each
      stage of data collection, participants may be discontinued, put on hold, or invited to
      participate in further screening activities, depending on the likelihood that they will
      qualify for a future protocol. Participants may opt to withdraw their information or
      discontinue from the registry at any time, in person, by telephone, or in writing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who reside within the metropolitan statistical area of the clinical site and have
        clinician-diagnosed asthma, current symptoms of asthma, or risk factors for development of
        asthma. The population may at times include participants without asthma, atopy, and
        rhinitis.
      
Biospecimen description: 
      Blood samples
    
Keywords: Registry; Asthma; Inner City Asthma Consortium (ICAC) study eligibility
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
Condition: Skin Cancer; Kidney Transplantation
MeSH terms: Skin Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In a population of kidney transplant recipients having developed a first squamous cell
      carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2
      years in patients who are switched to rapamycin as compared to patients who are maintained
      under calcineurin inhibitors.
    


Intervention name(s): rapamycin; ciclosporine; tacrolimus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 to 5 mg/day; Blood residual level < or = to 125 ng/ml; Blood residual level < or = to 8 ng/ml
Other intervention name(s): Rapamune
Intervention MeSH terms: Sirolimus; Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Squamous cell carcinoma; kidney transplant recipients; rapamycin; Skin cancers in kidney transplant recipients
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      BI 691751 is currently being developed to inhibit growth and prevent rupture of
      atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in
      patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to
      investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and
      Japanese male volunteers.
    


Intervention name(s): Placebo to BI 691751; BI 691751 high dose; BI 691751 middle dose; Placebo to BI 691751; BI 691751 low dose 1; Placebo to BI 691751; Placebo to BI 691751; BI 691751 low dose 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo to BI 691751; BI 691751 high dose; BI 691751 middle dose; Placebo to BI 691751; BI 691751 low dose 1; Placebo to BI 691751; Placebo to BI 691751; BI 691751 low dose 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Osseodensification Versus Conventional Drilling Effect on Implant Stability
Condition: Implant Therapy
Study type: Interventional

Summary: 
      A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a
      split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed
      preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was
      measured with insertion torque and resonance frequency analysis (ISQ values). Secondary
      stability was measured by ISQ at abutment installation.
    


Intervention name(s): osseodensification drilling; conventional drilling
Intervention type(s): Procedure; Procedure
Intervention description(s): Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the osseodensification protocol.; Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the conventional drilling protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impulsivity, Neural Deficits and Cocaine Addiction
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Impulsive Behavior
Study type: Observational

Summary: 
      The purpose of this study is to assess neurocognitive and associated neural regions/circuitry
      disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship
      of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.
    

Detailed description: 
      This study is designed to explore putative differences in impulsive behaviors and decision
      making in cocaine-addicted and healthy control subjects using functional magnetic resonance
      imaging (fMRI), single photon emission tomography (SPECT), and neurocognitive tasks. We
      predict that cocaine-addicted subjects will demonstrate neurocognitive and neural alterations
      in measures of impulsivity and decision-making when compared to healthy controls. That is,
      cocaine-addicted subjects will show both decreased activation and decreased resting measures
      of regional cerebral blood flow (rCBF) of the brain structures associated with impulsivity
      and decision-making. Furthermore, neurocognitive and neural deficits associated with
      impulsivity and decision-making will be associated with each other and with measures
      indicative of an impulsive relapse and altered decision making.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from residential treatment programs at the VA North Texas Health
        Care System, Nexus Recovery Inc., and Homeward Bound Inc. Healthy controls will be
        recruited from the Greater Dallas community.
      
Biospecimen description: 
      urine, blood, plasma, and erythrocytes
    
Keywords: impulsivity; cocaine dependence; relapse; neuroimaging; functional magnetic resonance imaging (fMRI); single photon emission computed tomography (SPECT)