bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the
      Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from
      Prevnar 13™ to V114 during the four-dose PCV immunization schedule.
    


Intervention name(s): Prevnar 13™; V114; RotaTeq™; Pentacel™; RECOMBIVAX HB™; HIBERIX™; M-M-R™ II; VARIVAX™
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.; V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.; RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.; Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.; RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.; HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.; M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.; VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other intervention name(s): VAXNEUVANCE™; V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.; Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.; V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.; Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.; V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.; V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Endothelial Dysfunction
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to investigate the role of endothelial dysfunction in chronic
      obstructive pulmonary disease.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in
      developed countries. Acute exacerbations and cardiovascular diseases are the major causes of
      morbidity and mortality in COPD patients. According to the frequency of exacerbations,
      phenotype "frequent exacerbator" is defined and characterised with severe clinical course and
      was recognised as an increased risk for cardiovascular mortality. Recent studies considered
      that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial
      dysfunction is a suspected link between increased cardiovascular mortality and systemic
      inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow
      mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the
      presence of endothelial dysfunction in COPD patients, as well as the deterioration of
      endothelial function during exacerbations of COPD. This study will, for the first time,
      systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD
      patients with simultaneous assessment of endothelial function flow mediated dilatation index
      (FMD index) and plasma markers.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with COPD, smokers and former smokers recruited in an ambulatory basis.
      
Biospecimen description: 
      plasma
    
Keywords: Chronic obstructive pulmonary disease; frequent exacerbator; endothelial dysfunction; Flow mediated dilatation; Systemic inflammation
Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      In this project the investigators will be using non-invasive brain stimulation on people with
      multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be
      recruited. One group will perform strength testing with and without the brain stimulation.
      The second group of participants will perform a fatigue task, pulling against a wire at a low
      level of force, with and without the brain stimulation. This type of brain stimulation has
      been shown to transiently improve strength and fatigue measures in other populations, e.g.
      aged, Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is
      the investigator's hope that the increases in performance seen in other patient groups will
      also occur in people with multiple sclerosis. Future investigations will look to apply the
      non-invasive brain stimulation technique during physical rehabilitation to improve short and
      long term outcomes related to physical function.
    


Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.
Other intervention name(s): The Travel Model v2.0 Advanced tDCS Kit; The Brian Simulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Faster Aspart on Insulin-pump Treated T1DM Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Observational retrospective study about effectiveness and safety of insulin Faster Aspart on
      continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM)
      patients in routine clinical practice.
    

Detailed description: 
      Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster
      Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus
      (T1DM) patients in routine clinical practice.

      All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).

      Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are
      presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon
      signed-rank test were used for the analysis of differences. Comparisons between proportions
      were analyzed using a chi-squared test. A P value < 0.05 was considered statistically
      significant.

      The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic
      Committee. All participants provided written informed consent.
    

Intervention name(s): Insulin Faster Aspart; Insulin pump
Intervention type(s): Drug; Device
Intervention description(s): Currently receiving Faster Aspart during 3 or more months.; Currently receiving CSII therapy during 6 or more months.
Other intervention name(s): Fiasp; Medtronic 640G; Medtronic 670G; T Slim X2; Accucheck Insight
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our
        consults were eligible.
      
Keywords: insulin pump; Faster aspart; insulin; glycemic variability
Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      The current study is designed to assess the impact of an enriched oral nutritional shake
      (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove
      a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a
      segment of intestine is the standard of care for invasive bladder cancer. This operation has
      a high complication rate and several studies have shown that this may be directly related to
      poor nutrition.

      The investigators believe that patients who consume an enriched nutritional shake before and
      after surgery will improve their nutrition status and experience fewer complications, shorter
      length of stay and less readmissions compared to those who do not.

      Patients who are scheduled to undergo elective radical cystectomy will be eligible for
      enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group
      will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery
      and the other will be offered a daily over-the-counter multivitamin for the same period of
      time. The investigators will follow both groups for up to 30 days after their surgery and
      compare clinical outcomes such as: complication rates, length of stay, readmission rates and
      mortality as well as measure serum markers of nutrition status and assess changes in body
      composition.
    


Intervention name(s): Ensure Plus®; Multivitamin
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Ensure®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: radical cystectomy; urinary diversion; nutrition; oral supplementation; enteral nutrition
DAAOI-1 Treatment for Treatment-resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      Pharmacotherapy for schizophrenia has limitations such as residual positive and negative
      symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia
      (particularly clozapine-resistant) is still a difficult clinical issue at present. According
      to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have
      therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing
      agents.

      The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant
      treatment for clozapine-resistant refractory schizophrenia patients in a randomized,
      double-blind, placebo - controlled trial.
    

Detailed description: 
      Pharmacotherapy for schizophrenia has limitations such as residual positive and negative
      symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia
      (particularly clozapine-resistant) is still a difficult clinical issue at present. Among
      schizophrenia patients, around 20-25%are treatment-resistant. According to the
      N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were
      studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids (D-serine,
      D-alanine), and sarcosine (a glycine transporter I inhibitor), revealed beneficial but
      limited efficacy for positive and negative symptoms. The investigators recently started to
      study the potential of DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor which can elevate
      synaptic concentration of D-amino acids.

      The aims of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant
      treatment for clozapine-resistant refractory schizophrenia patients in a randomized,
      double-blind, placebo - controlled trial.
    

Intervention name(s): DAAOI-1; DAAOI-1; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DAAOI-1 1g; DAAOI-1 2g; starch pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; NMDA; DAAOI; Clozapine resistant schizophrenia
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the First Time in Human Study for GSK2256294 and will evaluate the safety,
      tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses
      of GSK2256294 administered to healthy male volunteers (Cohort 1) and otherwise healthy adult
      male moderately obese smokers (Cohorts 2 to 4). Cohorts 1 and 2 will enrol 12 subjects each
      and each subject will take part in four study periods. All subjects will receive placebo
      regimen and three dosing regimens of GSK2256294 in a specified sequence (planned doses 2 mg,
      6 mg and 18 mg in Cohort 1 and 15 mg, 40 mg and 100 mg in Cohort 2). Each study period will
      be followed by a Wash-out period of 7 to 14 days in Cohort 1 and up to 4 weeks in Cohort 2.
      During each study period subjects will be in-house from Day -1 until the 48 hours post dose
      assessments have been completed. Subjects will return to the unit as out-patients for
      remaining post-dose assessments. Subjects will then be followed for 7 to 14 days in Cohort 1
      and up to 3 to 4 weeks in Cohort 2. Total duration of the study for Cohort 1 will be 98 days
      and for Cohort 2 it will be up to 144 days. Cohort 3 and 4 will each recruit 15 subjects. For
      Cohorts 3 and 4, each subject will take part in one treatment period of 18 days (Day-1 to Day
      17) with dosing from Day 1 to Day 14. Subjects will then be followed for 7 to 14 days. Total
      duration of the study for Cohort 3 and Cohort 4 will be 67 days. Dose selection for Cohorts 3
      and 4 will be based on the safety, PK profile and enzyme inhibition obtained in Cohorts 1 and
      2. This study will also evaluate the evidence for a functional effect of soluble Epoxide
      Hydrolase (sEH) in a forearm blood flow (FBF) model.
    


Intervention name(s): GSK2256294; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2256294 capsules will be administered as once daily as single dose 2 mg, 6 mg, 15 mg in Cohort 1 and 15 mg, 40 mg, 100 mg in Cohort 2. GSK2256294 capsules will be administered once or twice daily (cohorts 3 and 4) at the dose determined from the data from Cohort 1 and 2. GSK2256294 capsules will be available in 1, 5, 25 mg dose strength.; Matching placebo will be administered once daily (cohorts 1 and 2); and once or twice daily (cohorts 3 and 4).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; forearm blood flow; soluble Epoxide Hydrolase inhibitor
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Condition: Anemia of Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to see if a blood transfusion changes how fast blood flows to the
      intestines of a premature baby. Blood flow is measured by an ultrasound test. The
      investigators also look to see if the blood flow to the intestines depends on whether the
      baby feeds or doesn't feed during the blood transfusion.
    

Detailed description: 
      Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether
      premature infants should be fed during a blood transfusion. The effects of a blood
      transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia
      are not known.

      We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be
      the same before as after a packed red blood cell (PRBC) transfusion among anemic premature
      infants.

      Sixty anemic infants (25-32 weeks GA, feeding >= 60 cc/kg/day) will undergo pre- and
      post-feed superior mesenteric artery Doppler studies both before and after a blood
      transfusion. Infants will be stratified by current weight into two groups (< 1250 grams and >
      1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during
      the PRBC transfusion. Randomization will be by block design, with block sizes ranging from
      two to six infants. The investigator performing the Doppler studies will remain masked to the
      feeding assignment of the infant.

      The primary outcome for the study is the superior mesenteric artery blood flow velocity
      response to feeding between anemic and non-anemic states among premature infants. Our
      secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in
      these infants. Statistical analysis will include paired and unpaired Student t-tests and
      regression analysis.
    

Intervention name(s): feed during blood transfusion
Intervention type(s): Other
Intervention description(s): babies receiving the intervention are fed during the PRBC transfusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: anemia; prematurity; blood flow velocity; superior mesenteric artery; intestinal blood flow in premature infants
The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure
Condition: Hepatitis
MeSH terms: Hepatitis; Liver Failure; Hepatic Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to improve the survival rate of those patients with acute
      fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system
      by:

        1. Reducing the number of patients who die before a graft is available

        2. Increasing the chances of survival without a liver transplant

        3. Reducing the pre- and post-operative mortality in transplant patients
    

Detailed description: 
      Patients with fulminant or subfulminant hepatitis with either an indication or a relative
      contraindication to a liver transplantation, are randomized to two groups:

        1. A group treated with the conventional medical intensive treatment (including the
           hemodialysis techniques, continuous veno-venous hemofiltration or hemodiafiltration, if
           necessary) and the gold standard surgical treatment (liver transplantation) compared to

        2. A group receiving, in addition to the conventional medical intensive treatment, albumin
           dialysis using the MARS device and the gold standard surgical treatment (liver
           transplantation).
    

Intervention name(s): Molecular Adsorbent Recirculating System (MARS®)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Albumin dialysis; MARS system; Extracorporeal artificial liver support; Fulminant hepatitis; Subfulminant hepatitis; Acute liver failure
Immune Correlates of Cardiac Structure and Function
Condition: Perinatal HIV Infection; Cardiac Fibrosis; Cardiac Inflammation
MeSH terms: Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to determine the occurrence of scarring of the heart (cardiac
      fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus
      (HIV) infection compared to people not infected with HIV. The information learned from this
      research may help the investigator to better understand the link between cardiac fibrosis and
      cardiac dysfunction and inflammation in those with perinatally acquired HIV infection
      compared to the uninfected.

      Participants will have a blood sample, complete a patient questionnaire, and have a Magnetic
      resonance imaging (MRI) and ultrasound of the heart.

      Researchers will review the medical record and past medical history, for information about
      your heart function and overall health. Research samples and data from this study will be
      stored indefinitely and used for other research.

      There are risks to participate in this study and those risks include side effects from the
      contrast agent used for the MRI scan, (such as headache and injection site pain), and risks
      from blood sampling.
    


Intervention name(s): Cardiac MRI
Intervention type(s): Diagnostic Test
Intervention description(s): This study will use Cardiac MRI to identify subclinical cardiac dysfunction.
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Recruitment will be from Adult or Pediatric Infectious Disease (ID) Clinics at DUHS and
        other clinic sites where Duke providers deliver care for HIV.
      
Biospecimen description: 
      blood collected for storage for future proteomic profiling