bioihbjkbjnl/mcl2 huggingface dataset:
Urban Training for COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This project plans on a training intervention by using public spaces and urban walkable
      trails, adapted to each patient needs and capabilities. Primary objective is to assess 12
      months effectiveness of the intervention with respect to: (primary outcome): physical
      activity level, and (secondary outcomes): COPD admissions, exercise capacity, body
      composition, quality of life, and mental health.
    


Intervention name(s): Urban training
Intervention type(s): Behavioral
Intervention description(s): Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: chronic obstructive pulmonary disease (COPD); urban training; physical activity; active aging
Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Observational

Summary: 
      This study is a longitudinal single-center pilot study designed to describe changes in lung
      function and levels of noninvasive biomarkers of airway inflammation in children ages 6-18
      years over two months following hospitalization for an acute exacerbation of asthma. Forty
      children ages 6-18 years with asthma who are admitted to Children's Hospital and Regional
      Medical Center (GCRC) for an asthma exacerbation will be enrolled and complete an initial
      study visit prior to hospital discharge. Children with asthma will be recruited from the
      inpatient medical unit. During their initial visit subjects will undergo a clinical
      assessment and perform spirometry to measure lung function. In addition, exhaled nitric oxide
      (eNO) concentration will be measured and a sample of exhaled breath condensate (eBC) will be
      collected during 20 minutes of tidal breathing. Breath condensate will be analyzed to
      determine the concentration of cysteinyl leukotrienes (CysLT), an important mediator of
      airway inflammation in asthma. Subjects with asthma will return to the GCRC pediatric
      satellite at Seattle Children's Hospital for follow-up study visits at 1 week, 2 weeks, and 4
      weeks following hospital discharge. During follow-up visits subjects will complete a
      questionnaire regarding symptoms and medication use since the most recent study visit, will
      perform spirometry, and have eNO concentration measured and breath condensate collected for
      CysLT analysis.

      The aims of this observational study are to:

        1. Assess the association of levels of exhaled nitric oxide and cysteinyl leukotrienes in
           breath condensate with measures of airflow obstruction (FEV1) and asthma symptoms
           during, and at one, two, and four weeks following hospital discharge for asthma
           exacerbation.

        2. Compare levels of exhaled nitric oxide and cysteinyl leukotrienes in breath condensate
           from children ages 6-18 years hospitalized for status asthmaticus to levels from
           age-matched healthy control subjects without asthma.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children ages 6-18 years hospitalized for an asthmat exacerbation, similar aged healthy
        control children
      
Biospecimen description: 
      Exhaled breath condensate
    
Keywords: Asthma, hospitalization, children, exhaled nitric oxide, lung function, breath condensate, cysteinyl leukotrienes
Nimotuzumab in Children With HGG
Condition: High Grade Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      Determination of efficiency of nimotuzumab in children with high grade glioma.
    

Detailed description: 
      High grade malignant gliomas are tumors grade III and IV according to WHO classification,
      that originate from oligodendroglia and astrocytes, where the latter are also known as
      anaplastic astrocytoma(WHO grade III) and glioblastoma(WHO grade IV). This also includes
      intrinsic pontine gliomas of adolescents, which are usually not documented histologically due
      to their localisation, but they have a similar clinical progress when compared to high grade
      malignant astrocytic tumors. Among various molecular alterations, malignant gliomas
      overexpress EGFR (epidermal growth factor) in nearly 50% of cases, which is particularly
      pronounced in glioblastoma.(Schlegel 2003) Standard therapy consists of radical surgery as
      extensive as medically responsible followed by radiotherapy dose of 60 Gy, which is aimed at
      the area with a safety margin. The long-term efficacy of additional chemotherapy has been a
      subject for controversy for several decades. The combination of all three treatment
      modalities in grade III tumors can lead to median survival times of 3-5 years in adults.

      For this treatment group reports of 5 year recurrence free periods in 33-50% of cases have
      been reported in children and adolescents.

      For glioblastoma(WHO grade IV) 5year recurrence free periods are 3% in elderly patients and
      10-20% for adolescents.(Schlegel 2003) In German speaking territories chemotherapy with
      Cisplatin, Etoposid and Ifosfamid is used as a postoperative treatment option for adolescents
      and this disease.(Wolff HIT-GBM) In case of recurrence therapy choices are even more limited,
      thus if medically feasible the enrolment in clinical trials is an option.

      In this study the aim is to use an antibody directed against the EGF-receptor to effect the
      proliferation of the tumor cells negatively. Pilot studies conducted in adults indicate that
      the median survival time for patients with malignant glioma can be prolonged by the antibody
      treatment.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children, adolescents
      
Keywords: astrocytoma, glioblastoma, intrinsic pontine glioma
Cocaine-Methylphendidate Interaction Study - 4
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to attempt to identify possible dangerous interactions between
      cocaine and methylphenidate (MPD). Additional objectives are to determine: a) if MPD reduces
      the craving and high for cocaine; b) if there are pharmacokinetic and pharmacodynamic
      interactions between cocaine and MPD; and c) the relationship between cocaine and
      benzoylecgonine (BE) levels in plasma and BE levels in urine.
    

Detailed description: 
      This study was conducted to evaluate the cardiovascular risk of prescribing up to 90 mg of
      methylphenidate (MPD) daily for treating cocaine dependence. This within-subject study was
      completed in an inpatient setting. It was non-blinded for MPD dose and single-blinded for
      cocaine dose. Each patient was given intravenous cocaine at 0, 20 and 40 mg while at three
      different steady state levels of MPD (0, 60 and 90 mg). Seven non-treatment seeking cocaine
      addicts, who were recruited from the community, completed the study. There were no cardiac
      rhythm abnormalities noted except for sinus tachycardia and sinus bradycardia. There were no
      incidences of seizures or myocardial ischemia. In a repeated measures ANOVA, MPD was shown to
      have an independent positive effect on heart rate (p=0.0001) but not on SBP or DBP. There was
      no cocaine by MPD interaction for any vital sign. Peak systolic blood pressure (SBP) and
      diastolic blood pressure (DBP) for any patient up to 60 minutes after infusion was 169 mm and
      108 mm, respectively. The first occurred when 60 mg of MPD and placebo cocaine were given and
      the second when no MPD and placebo cocaine were given. Peak heart rate for any patient up to
      60 min after infusion was 143/min at 60 mg of MPD and 40mg of cocaine. The number of adverse
      events reported when cocaine and MPD were given together was less than the number reported
      when either drug was given alone. The adverse events reported when cocaine and MPD were given
      together included headache, nervousness, and lightheadedness. Subjective ratings of drug
      effect revealed that MPD did not enhance patients' response to, or desire for, cocaine. MPD
      appears to be a safe drug to use in cocaine addicts who continue to use cocaine at the
      dosages tested.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Intervention model: Crossover Assignment
Primary purpose: Treatment
Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male
      subjects.
    

Detailed description: 
      Potential subjects will be screened to assess their eligibility to enter the study within 28
      days prior to the dose administration. Subjects will be admitted into the Clinical Research
      Unit (CRU) on Day -1 and be confined to the CRU until at least Day 8. On Day 1, subjects will
      receive a single oral dose of [14C]-saroglitazar magnesium. Subjects will be discharged if
      the following discharge criteria are met: plasma radioactivity levels below the limit of
      quantitation for 2 consecutive collections and ≥ 90% mass balance recovery, or ≤ 1% of the
      total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive
      24-hour periods in which both are collected. If discharge criteria are not met by Day 8,
      subjects will remain in the CRU up to Day 12.
    

Intervention name(s): Saroglitazar magnesium
Intervention type(s): Drug
Intervention description(s): On Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium
Other intervention name(s): not any
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies
Condition: Mitochondrial Myopathies; Healthy Controls
MeSH terms: Muscular Diseases; Mitochondrial Myopathies
Study type: Observational

Summary: 
      The purpose of this study is to develop simple diagnostic screeningtests and investigate
      potential biomarkers for identifying patients with abnormalities of mitochondrial function,
      which also can be used as outcome measures in future clinical trials. The study will
      investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore
      investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with
      mitochondrial myopathy.
    


Intervention name(s): Diagnostic screenings tests
Intervention type(s): Diagnostic Test
Intervention description(s): Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Genetically verified primary Mitochondrial disorder with myopathy.
Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic
      response and satiety in subjects with type 2 diabetes mellitus under intensive insulin
      therapy.
    


Intervention name(s): Low glycemic index; High glycemic index
Intervention type(s): Other; Other
Intervention description(s): Subjects intake a low glycemic index breakfast; Subjects intake a high glycemic index breakfast
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Glycemia; Satiety; Insulin; Breakfast; Low glycemic index; High glycemic index
Salivary Proteome and Sensitivity to Bitterness
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to establish whether the protein composition of healthy males contribute to
      their sensitivity to the bitterness of caffeine.
    


Intervention name(s): caffeine
Intervention type(s): Other
Intervention MeSH terms: Caffeine
Primary purpose: Basic Science
Keywords: sensitivity to caffeine
Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and
      co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.
    

Detailed description: 
      An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After
      the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg
      and Rosuvastatin 10 mg in Healthy Volunteers
    

Intervention name(s): HCP1201 750/10mg; Metformin SR 750mg; Rosuvastatin 10mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.; Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.; Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
Other intervention name(s): Glucophage SR 750 mg; Crestor 10mg
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc.
      This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion,
      efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess
      the long-term efficacy and safety of multiple doses of CT-P13.
    


Intervention name(s): Infliximab
Intervention type(s): Biological
Intervention description(s): CT-P13(3mg/kg) administered as a 2-hour IV infusion per dose co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose (dose and route must be maintained from Study CT-P13 3.1 and be maintained from the beginning to the end of the extension study) and folic acid(≥5mg/week, oral dose)
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RA; Biosimilar
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this randomized double-blinded study is to determine whether transition to
      propofol for 3 min at the end of sevoﬂurane anaesthesia reduces the incidence of EA in
      children undergoing genito-urinary paediatric surgeries.
    


Intervention name(s): Propofol; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR; Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Condition: Major Depressive Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Depressive Disorder; Depression; Depressive Disorder, Major; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol
      consumption.
    

Detailed description: 
      The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for
      major depressive disorder and alcohol use disorder in an open-label trial.
    

Intervention name(s): Ketamine + Naltrexone
Intervention type(s): Drug
Intervention description(s): Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).
Intervention MeSH terms: Naltrexone; Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketamine; Naltrexone; Depression; Alcohol
Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      This was a retrospective cohort study to assess the treatment history, demographic
      characteristics, clinical characteristics, and early treatment patterns of patients who
      received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.
    

Detailed description: 
      This was a retrospective cohort study of patients with wet AMD who received brolucizumab.
      Evidence was generated from the IRIS registry to describe patient treatment histories,
      demographic and clinical characteristics, and early treatment patterns.

      Setting and study population:

      IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who
      initiated brolucizumab were analyzed.

      Identification period of the index date: The patients fulfilling the selection criteria
      identified during the period from 10/08/2019 to 03/31/2020.

      Index date: Defined as the date of the earliest brolucizumab injection.

      Study Period: The period from 10/08/2018 to 03/31/2020.

      Pre-index period: The period 12 months prior to the index date.

      Post-index period: The period 4 months after the index date (not a required selection
      criterion; only for the assessment of select endpoints in a subgroup of patients).
    

Intervention name(s): Brolucizumab
Intervention type(s): Drug
Intervention description(s): Participants received brolucizumab injection during the index period
Other intervention name(s): BEOVU®
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with wet AMD who initiated brolucizumab were analyzed in this study
      
Keywords: AMD,; brolucizumab,; anti-VEGF switchers,; treatment-naive
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
Condition: Emergence Agitation; Remimazolam; Sevoflurane; Pediatric Ophthalmic Surgery; Anesthesia, General
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for
      induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines
      drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and
      also has the advantages of acting quickly, short half-life, no injection pain, slight
      respiratory depression, independent of liver and kidney metabolism, long-term infusion
      without accumulation, and has a specific antagonist: flumazenil. This study aims to
      investigate whether Remimazolam reduces the incidence of emergence agitation in children
      after ophthalmic surgery, compared to sevoflurane (RCT).
    


Intervention name(s): Remimazolam; Sevoflurane; Fentanyl; Cisatracurium Besylate; Remifentanil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Anesthesia was induced with Remimazolam 0.4-0.8 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h until the end of surgery.; Anesthesia was induced with 8 % Sevoflorane by sevoflurane volatilization tank until the loss of consciousness (LoC), followed by 2 %-3 % Sevoflorane until the end of surgery.; Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.; Anesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate during the operation.; After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
Intervention MeSH terms: Fentanyl; Remifentanil; Sevoflurane; Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a RCTs.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anesthesia, General; Pediatric ophthalmic surgery; Emergence Agitation; Remimazolam; Sevoflurane
Pioglitazone and Quetiapine XR Pharmacogenetic Study
Condition: Bipolar Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing
      pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted
      at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome
      comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20).
      Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar
      depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the
      respective IRB protocols for more information.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 310 subjects between the ages of 18 and 70 will be targeted for enrollment. We
        anticipate a low enrollment rate of 200 from the targeted 310 participants. Eligible
        participants will be diagnosed with DSM-IV bipolar disorder (type I, II, or not otherwise
        specified) or DSM-IV major depressive disorder, as determined by extensive clinical
        interview and the Mini-International Neuropsychiatric Interview-Plus (MINI-Plus).
        Participants will be approached for enrollment if they are currently enrolled in one of
        four studies: IRB protocol numbers 10-06-19, 12-07-29, 07-07-20, and 07-08-24. Please see
        these protocols for additional study specific information.