bioihbjkbjnl/mcl2 huggingface dataset:
Sharing History Through Active Reminiscence and Photo-imagery (SHARP) Pilot Program
Condition: Cognitive Change
Study type: Interventional
Phase: Early Phase 1

Summary: 
      SHARP is a neighborhood-based and technology-supported approach to brain health for older
      Black adults that integrates walking and image-prompted social reminiscence to maintain or
      improve brain health.
    

Detailed description: 
      The SHARP study tests the feasibility, usability, and cultural relevance of an android
      application-supported walking study for brain health among older Black adults. The SHARP
      walking application enables the seamless integration of the brain-healthy behaviors of
      walking, social engagement, and reminiscence. Methods: Over the course of 24 weeks in the
      rapidly gentrifying historically Black neighborhoods of Portland, Oregon, triads aim to
      complete three 1-mile walks per week. The SHARP application is preprogrammed with 72 themed,
      1-mile routes, accessible via a group tablet device. At three points along each route,
      GPS-triggered "Memory Markers" (historical images of local Black culture) appear on the
      walking application, serving as prompts for conversational reminiscence as triads walk.
      Walking reminiscence sessions are recorded for inclusion into a digital oral history archive.
    

Intervention name(s): Sharing History through Active Reminiscence and Photo-imagery (SHARP)
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention to increase physical and social activity. In triads, participants walk 1-mile neighborhood routes three times per week and engage in image-based conversational reminiscence.
Other intervention name(s): SHARP
Intervention model: Single Group Assignment
Intervention model description: 21 individuals without cognitive impairment engage in the study intervention over 24 weeks
Primary purpose: Prevention
Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Condition: Malignant Melanoma; Angiosarcoma
MeSH terms: Melanoma; Hemangiosarcoma
Study type: Interventional

Summary: 
      Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with
      BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate
      treatment dose will be determined.
    


Intervention name(s): CICS-1 (investigational device),SPM-011(investigational drug)
Intervention type(s): Other
Intervention description(s): Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BNCT; Boron Neutron Capture Therapy; Borofalan; Melanoma; Angiosacronoma; skin cancer
Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.
Condition: HIV; Lipodystrophy
MeSH terms: Lipodystrophy; Metabolic Diseases; Dysbiosis
Study type: Observational

Summary: 
      This study plans to learn more about immune responses in intestinal (gut) tissue in people
      with human immunodeficiency virus (HIV) infection. This study will determine whether change
      in the composition of gut bacteria in HIV infected individuals is related to a high
      prevalence of chronic gut inflammation and metabolic disease. The investigators will also
      investigate immune-modulatory properties of specific bacteria that correlate with disease
      both by characterizing which functional genes are selected for in their genomes and by
      stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This
      work will establish whether gain/loss of bacterial drivers/suppressors of information in the
      gut contributes to metabolic disease in HIV-infected individuals.
    

Detailed description: 
      This is a prospective cohort and cross-sectional case-control study. Study participation will
      last up to 2 months and 93 participants will be enrolled. Participants will be evaluated for
      lipodystrophy, asked to complete food & gastrointestinal symptoms questionnaires and provide
      stool samples. A subset of participants will be asked to have a flexible sigmoidoscopy
      (mucosal biopsy).

      Cohort A will consist of 93 participants:

      Cohort A1: ART (Antiretroviral therapy) -treated HIV-infected individuals with lipodystrophy
      (n=35) Cohort A2: ART-treated HIV-infected individuals without lipodystrophy (n=18) Cohort
      A3: HIV-1 infected individuals naïve to ART (n=20) Cohort A4: HIV-1 seronegative individuals
      who are at a high risk for infection (n=20)

      Cohort B will be a selected subset of subjects from Cohort A:

      Cohort B1: ART-treated HIV-infected individuals with HIV-associated dysbiosis (n=10) Cohort
      B2: ART-treated HIV-infected individuals without HIV-associated dysbiosis (n=10)
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV positive and HIV negative subjects (with and without lipodystrophy) between 18 and 65
        years old.
      
Biospecimen description: 
      Blood and rectosigmoid biopsy tissue will be collected.
    
Keywords: Gut microbiota composition
Experimental Study to Validate the Modified Glucose Disposal Test
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects
      and those with type 2 diabetes mellitus
    


Intervention name(s): Insulin, glucose and staple isotopes
Intervention type(s): Procedure
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
Condition: Infants; Difficult Airway
Study type: Interventional

Summary: 
      Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study.
      Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins,
      trisomy 21, or similar congenital malformations. Patients with American Society of
      Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital
      heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy
      with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by
      a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
      Randomization (1:1) will be based on computer-generated codes with random block sizes and
      stratified by hospital; allocation will be concealed and provided to clinicians via a secure
      web site that will be accessed shortly before induction of anesthesia.
    


Intervention name(s): laryngoscopy with oxygen; laryngoscopy without oxygen
Intervention type(s): Other; Other
Intervention description(s): Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.; Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: infants with cleft palate; Pierre Robin; Treacher Collins; trisomy 21
Fingolimod -Response According to Coping - Evaluation
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, open-label, multi-center phase IV study to assess response to
      fingolimod initiation according to coping profile in adult patients with highly active
      relapsing remitting multiple sclerosis in France.
    


Intervention name(s): fingolimod
Intervention type(s): Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Fingolimod; Coping; Anxiety; France; Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9); Active
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
Condition: Norovirus; Healthy Participants
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to collect serum samples to evaluate serologic assays and to
      establish proficiency panels for serologic assays used for assessment of post vaccination
      immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent
      virus-like particle (VLP) vaccine.
    

Detailed description: 
      The vaccine being tested in this study is called Norovirus GI.1/GII.4 bivalent Virus-Like
      Particle Vaccine (NoV Vaccine). The purpose of this study is to collect serum samples to
      evaluate serologic assays and to establish proficiency panels for serologic assays used for
      assessment of post vaccination immune response after intramuscular (IM) vaccination with the
      NoV vaccine. The validation and proficiency testing of the immunogenicity assays is required
      to support the NoV Vaccine development program. This study also looked at side effects in
      people who were administered a single dose of the NoV vaccine.

      The study enrolled 50 patients. All participants received one dose of the NoV vaccine via
      intramuscular injection.

      Participants were asked to record any symptoms that may be related to the vaccine or the
      injection site in a diary card for 7 days after receiving the vaccination.

      This single-centre trial was conducted in the United States. The overall time to participate
      in this study was 183 days. Participants made 4 visits to the clinic, and were contacted by
      telephone 183 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): NoV GI.1/GII.4 Bivalent VLP Vaccine
Intervention type(s): Biological
Intervention description(s): Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Influence of Hesperidin and Vitamin C on Uric Acid Concentration
Condition: Higher Uric Acid Concentrations (>5,5 mg/dl); Healthy
Study type: Interventional

Summary: 
      Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric
      acid concentrations.
    

Detailed description: 
      Duration of the study is 9 weeks. 1) a washout week, 2) two intervention weeks, 3) four weeks
      washout period, 4) two intervention weeks.

      The study is conducted under free living conditions. During washout weeks consumption of
      orange juice or citrus fruits or vitamin C containing supplements is restricted.

      During intervention weeks 200 mL of study drink is consumed daily. And participants are asked
      to maintain their normal physical activity and habitual diet. Additional citrus or vitamin C
      containing beverages are not allowed.

      At the beginning and the end of each intervention phase uric acid, insulin sensitivity, blood
      pressure, pulse wave velocity and bioavailability of hesperidin are assessed.
    

Intervention name(s): Control; Hesperidin; Vitamin C; Hesperidin + Vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): study drink (two weeks); study drink + Hesperidin 600 mg (two weeks); study drink + Vitamin C 250 mg (two weeks); study drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks)
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: hesperidin; vitamin C; uric acid concentration
Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy and safety of remote ischemic
      conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
    

Detailed description: 
      In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours
      from onset are included. The experimental group receive basic treatment and remote ischemic
      conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control
      group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times
      within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to
      evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous
      thrombolysis in treating acute ischemic stroke.
    

Intervention name(s): remote ischemic conditioning; sham remote ischemic conditioning
Intervention type(s): Device; Device
Intervention description(s): Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.; Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Condition: Glioblastoma; Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and
      temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall
      survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal
      growth factor receptor (EGFR) amplification.

      In addition, there is a Phase 1, open-label, multicenter sub-study to assess the
      pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed
      EGFR-amplified GBM who have mild or moderate hepatic impairment.
    


Intervention name(s): Temozolomide; Depatuxizumab mafodotin; Radiation; Placebo for ABT-414
Intervention type(s): Drug; Drug; Radiation; Drug
Intervention description(s): Oral Capsule; Intravenous (IV) Infusion; IV Infusion (IV)
Other intervention name(s): ABT-414
Intervention MeSH terms: Temozolomide; ABT-414
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Newly Diagnosed Glioblastoma; Epithelial Growth Factor Receptor (EGFR); Temozolomide; ABT-414; Radiology Therapy Oncology Group; Antibody Drug Conjugate; Brain Tumor; Brain Tumor Group; EGFRvIII; EGFR Amplified; First Line Therapy; Brain Cancer
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Condition: G6PD Deficiency
MeSH terms: Glucosephosphate Dehydrogenase Deficiency
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD
      G6PD Analyzer in measuring G6PD activity when used by trained health care workers.
    

Detailed description: 
      This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal
      of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent
      study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick
      capillary blood.

      G6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin
      concentration must be measured.

      Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor
      point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a
      HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples.

      Another venous blood sample will be sent to a clinical laboratory improvement amendments
      (CLIA)-certified laboratory for reference testing by the gold standard assays:

        -  G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay

        -  hemoglobin measurement by a hematology analyzer

      Individuals identified as G6PD deficient with the reference test will be notified of their
      results by the clinic and referred to their physician for follow-up.
    

Intervention name(s): SD Biosensor G6PD Analyzer; Pointe Scientific Test Kit; HemoCue System
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in the US and is considered an investigational product.; The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.; The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: G6PD deficiency
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
Condition: Upper Respiratory Infection; Acute Otitis Media
MeSH terms: Respiratory Tract Infections; Otitis Media
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of oral administration of probiotic
      Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.
    


Intervention name(s): Lactobacillus rhamnosus GG
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
Condition: Non-Muscle Invasive Bladder Cancer (NMIBC)
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of
      APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is
      administered alone and concurrently with BCG.
    

Detailed description: 
      Six eligible participants will be administered with APL-1202 one week prior to the first BCG
      instillation, during the six-week course of BCG instillation, and additional five weeks, for
      a total of 12 weeks of dosing. Safety assessment will be performed during the entire 13 week
      study duration. Plasma and urine samples will be collected from each participant at prior to
      first and fifth BCG instillations for PK analysis.
    

Intervention name(s): APL-1202
Intervention type(s): Drug
Intervention description(s): To assess the safety and pharmacokinetics of APL-1202 alone and in combination with Bacillus Calmette Guerin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Cancer (NMIBC); Oral Antineoplastic Agent
Diabetic Kidney Alarm (DKA) Study
Condition: Type 1 Diabetes Mellitus; Diabetic Ketoacidosis
MeSH terms: Diabetes Mellitus, Type 1; Ketosis; Diabetic Ketoacidosis
Study type: Observational

Summary: 
      The overarching goals of this study are to determine whether tubular dysfunction (elevated
      urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1
      [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL] and matrix metallopeptidase 9
      [MMP9]) exist in diabetic ketoacidosis (age 3-18), whether it is reversible and whether it is
      related to uricosuria and copeptin. The investigators propose to study a cohort of youth
      (ages 3-18, n=40) with T1D who have serum and urine collection at DKA diagnosis and 3-month
      follow-up.
    

Detailed description: 
      Every year over 86,000 children (0-14 years) worldwide are diagnosed with type 1 diabetes
      (T1D) translating to a lifetime of exposure and risk for early death from cardiovascular
      disease (CVD) and diabetic kidney disease (DKD). DKD, which manifests in children and
      adolescents, remains the leading cause of renal failure and dialysis in the Western world
      (4). While diabetic glomerulopathy has received significant attention from researchers,
      determinants of tubular injury in diabetes are less well examined. Compared to glomerular
      injury, tubular injury is known to associate better with renal function. The majority of
      youth diagnosed with T1D in the US present with diabetic ketoacidosis (DKA), a condition
      associated with risks factors for tubular injury including dehydration, metabolic acidosis
      and acute glycemia. It is unknown whether DKA is associated with tubular injury. The
      investigators published the first report showing that youth with established T1D have more
      acidic urine and higher fractional excretion of uric acid (FeUA) than their non-diabetic
      peers, which may predispose to UUA-mediated tubulopathy. Furthermore, T1D is associated with
      vasopressin overactivity, and the investigators reported strong relationships between serum
      copeptin, a reliable surrogate marker for vasopressin, and DKD in T1D. The overarching goals
      of this study are to determine whether tubular dysfunction (elevated urine sodium,
      bicarbonate and amino acids) and injury (elevated KIM-1, NGAL and MMP9) exist in DKA, whether
      it is reversible and whether it is related to uricosuria and copeptin. The investigators
      propose to study a cohort of youth (ages 3-18, n=40) with T1D who have serum and urine
      collection at DKA diagnosis and 3-month follow-up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants (3-18 years) with T1D presenting with DKA will be recruited from the Emergency
        Department (ED) at Children's Hospital Colorado.
      
Biospecimen description: 
      Serum and urine collection at 0-8h and 12-24h after starting IV insulin, and at 3 month
      follow-up.