bioihbjkbjnl/mcl2 huggingface dataset:
Cohort Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma
Condition: Asthma; Allergies
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine if a simple blood test can help in disease
      management, particularly asthma. This will be researched by looking at certain features of
      the blood and to compare asthmatics without allergies to those that have allergy-induced
      asthma.
    

Detailed description: 
      A total of 20 participants (men or women) between the ages of 18-50 years with asthma will be
      enrolled. Participants will remain on their usual asthma treatments as prescribed by their
      usual asthma care provider. Current asthma treatments and any changes will be recorded at
      baseline and each subsequent visit. The primary outcome measures are correlation of
      microvesicle patterns with atopic state and variation from baseline with episodes of poor
      asthma control. Secondary outcomes include correlations between microvesicle patterns and
      spirometry, eNO levels, and glucorcorticoid sensitivity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Biospecimen description: 
      blood, nasal lavage (optional)
    
Keywords: blood test; asthma; skin test
A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose
      study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy
      subjects.
    


Intervention name(s): GS-6615; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GS-6615 tablet(s) administered orally once daily; Placebo tablet(s) to match GS-6615 administered orally once daily
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ischemic Heart Disease; Heart Disease
Communication Skills Training and Competency Assessment for Pulmonary and Critical Care Medicine Fellows
Condition: Communication
Study type: Interventional

Summary: 
      Study to determine if pulmonary/critical care fellows will demonstrate increased competency
      in the behavioral skills necessary to facilitate family meetings focused on discussions of
      goals of care in the ICU from pre- to post-communication skills training.
    

Detailed description: 
      The investigators hypothesize that pulmonary/critical care fellows will demonstrate increased
      competency in the behavioral skills necessary to facilitate family meetings focused on
      discussions of goals of care in the ICU from pre- to post-communication skills training.
    

Intervention name(s): First year program; Control comparison
Intervention type(s): Behavioral; Other
Intervention description(s): Information on group that underwent new educational program; Information from group that did not undergo new first year program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Communication skills
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Condition: Foramen Ovale, Patent; Heart Catheterization; Heart Septal Defects, Atrial
MeSH terms: Foramen Ovale, Patent; Heart Septal Defects; Heart Septal Defects, Atrial
Study type: Interventional

Summary: 
      The foramen ovale is an opening in the interatrial septum. It results from an incomplete
      coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis
      of the interatrial septum is a clinical finding and is defined as a patent foramen ovale
      (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted
      in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a
      material with superelastic properties, which, in its relaxed state, has the form of a double
      umbrella. This is a single-center, non-comparative, prospective interventional clinical
      investigation involving 1 center in Germany to assess the effectiveness, safety and
      practicability of implantation of the Nit-Occlud PFO® Closure Device.
    


Intervention name(s): Nit-Occlud® PFO
Intervention type(s): Device
Intervention description(s): Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PFO; Patent Foramen Ovale
Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the antitumor effect and safety of clinical
      effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1
      based chemotherapy for advanced gastric cancer.
    


Intervention name(s): DC-CIK; S-1; Cisplatin
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.; The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.; Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.
Intervention MeSH terms: Cisplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; S-1; DC-CIK; T cell
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
Condition: Influenza (Pandemic)
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well the vaccine is tolerated at sites where
      administrations are given, any effects it may have on subjects' wellbeing and whether it can
      produce antibody responses in the body that may protect against the subjects catching a
      pandemic strain of flu
    

Detailed description: 
      Pandemic influenza occurs when a strain of influenza to which the human population has not
      been exposed develops the ability to infect man and spread from person to person. Some
      pandemics can have very severe health impacts and be widespread. This study will evaluate
      PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as
      a potential alternative to other vaccine technologies. This study represents the first study
      with this vaccine and will provisionally assess its safety and immunogenicity (ability to
      generate an immune response) at four different dose combinations. The vaccine will be given
      as a prime-boost regimen with vaccination on Days 0 and 28
    

Intervention name(s): pPML7789 with and without pPJV2012 administered by PMED
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is for a randomized clinical trial (RCT) to determine if the combined use of interferon
      beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent
      used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).
    

Detailed description: 
      This is a multicenter, double blind, randomized trial examining combination therapy versus
      single agent therapy with three-year follow-up on the last patient randomized. All patients
      will remain on therapy until the last patient completes the study. All patients will then be
      transitioned, based on the findings, to open label of combination with continued follow-up or
      some recommendation about single agent therapy. While the study design benefits from having
      two arms of single agent therapy to examine the important question of whether there are
      differences between the single agents, the primary interest is in combination therapy.
      Therefore, a two-group combination versus single agent concept was used - splitting the
      population into single agent and combination therapy equally. The single agent arm is divided
      into two groups, IFN and GA providing for 3 treatment arms: IFN intramuscularly (IM) and GA
      subcutaneously (SC) (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA
      SC and placebo IM (25% of the patients).
    

Intervention name(s): Interferon beta 1-a; glatiramer acetate; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).; The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).; an inactive substance
Other intervention name(s): IFN; GA
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Clinical trial; treatment trial; autoimmune disease; Relapsing Remitting; MS Treatment; interferon beta-1a; glatiramer acetate
Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to obtain information about the safety and tolerability of BIIF
      1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose
      (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic
      data.
    


Intervention name(s): BIIF 1149 BS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is
      designed to perform a personalized clinical trial by first analyzing the expression of tumor
      associated antigens in patients with newly diagnosed glioblastoma and then immunizing the
      patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will
      be monitored. Safety and efficacy will be observed in the study.
    

Detailed description: 
      This is an open label, single-arm, single-institution, Phase I study designed to investigate
      the safety and efficacy of personalized cellular tumor vaccine for patients with newly
      diagnosed glioblastoma (GBM). Newly diagnosed GBM patients will undergo tumor resection. The
      tumors will be analyzed for the expression of a panel of glioma-associated antigens and
      immune-related genes. Post surgical treatment will be 6 weeks standard chemotherapy with
      temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day
      window. Patients will undergo leukapheresis either after surgery or after concurrent
      radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA
      will be generated and used to pulse in vitro generated DCs. The patients will be immunized
      i.d. and i.v. biweekly with DC cellular vaccines. Safety and efficacy will be monitored. The
      primary objective is to assess the safety of the personalized cellular vaccines. The
      secondary objective is to assess the specific T cell response to immunized vaccines. In
      addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria,
      progression-free survival and overall survival.
    

Intervention name(s): Personalized cellular vaccine
Intervention type(s): Biological
Intervention description(s): Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.
Other intervention name(s): Tumor antigen pulsed DC vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma; DC vaccine; tumor antigen; personalized vaccine
Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil
Condition: Hypertension, Pulmonary; Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor,
      on treprostinil pharmacokinetics.
    

Detailed description: 
      This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on
      treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR in healthy
      volunteers.
    

Intervention name(s): Treprostinil diethanolamine; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth immediately following breakfast before and after repeated daily dosing with esomeprazole.; Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.
Other intervention name(s): UT-15C; UT-15C SR; Oral treprostinil; Nexium
Intervention MeSH terms: Treprostinil; Esomeprazole
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, Pulmonary; Treprostinil; Pharmacokinetics; Treprostinil Diethanolamine; Pulmonary Arterial Hypertension; Esomeprazole
MRgFUS in the Treatment of Osteoarthritic Knee Pain
Condition: Osteo Arthritis Knee; Osteoarthritis; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of
      magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused
      by knee osteoarthritis (OA)
    

Detailed description: 
      Osteoarthritis (OA) is a common, disabling, and costly disease, and the knee is one of the
      most affected joints. The predominant symptom is pain. Effective and lasting non-invasive
      treatment approaches are missing. MR-guided focused ultrasound surgery (MRgFUS) is a new
      minimally invasive technique which may represent a valid solution providing several
      advantages. The primary aim of this work will be to assess the efficacy of MRgFUS in the
      treatment of pain caused by knee OA in 80 patients candidate for arthroplasty in a
      prospective, randomized, double-blinded, placebo-controlled clinical trial. Different
      parameters related to pain, quality of life, function, and imaging will be collected and
      analyzed in a 12-month follow-up. The secondary aims will be focused on a) the evaluation of
      the effects on the joint organ and changes of biological features in response to MRgFUS, and
      b) the impact of selective ablation of nociceptors on OA pain, based on the analysis of
      resected joint tissues.
    

Intervention name(s): MRgFUS Treatment; Placebo
Intervention type(s): Device; Other
Intervention description(s): Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound; Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind placebo-controlled randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee; MRgFUS; ExAblate; Pain; High-Intensity Focused Ultrasound Ablation
Midazolam Drug-Drug Interaction Study With Lurasidone HCl
Condition: Schizophrenia Patients
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.
    

Detailed description: 
      lurasidone 120 mg, midazolam 5 mg

      To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone
      vs. when administered with a single-dose of lurasidone 120 mg.

      To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone
      vs. when administered after steady state dosing with lurasidone 120 mg.
    

Intervention name(s): Lurasidone HCl
Intervention type(s): Drug
Intervention description(s): Day1: 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day6: 120 mg lurasidone (three 40 mg tablets) + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day 7-12: 120 mg lurasidone (three 40 mg tablets) 120 mg lurasidone (three 40 mg tablets) on Day 13 + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup)
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: DDI study between Midazolam and Lurasidone HCl; Male and Female
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Condition: Post-operative Pain; Total Shoulder Arthroplasty; Osteoarthritis of the Shoulder; Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a single-center, prospective, randomized controlled cross-sectional study
      comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine
      with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty.
      Primary endpoint will be total opioid consumption in the first three post-operative days.
    


Intervention name(s): Liposomal Bupivicaine 1.3%; Bupivacaine 0.5%
Intervention type(s): Drug; Drug
Intervention description(s): 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block; 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Other intervention name(s): epinephrine; dexamethasone preservative-free
Intervention MeSH terms: Dexamethasone; Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, prospective, randomized controlled cross-sectional study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial Plexus; Liposomal Bupivacaine; Dexamethasone; Interscalene; Bupivacaine; Shoulder Arthroplasty; Regional anesthesia; Exparel
CMR in Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 2; Heart Disease
MeSH terms: Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM),
      with or without known cardiovascular disease, will be recruited from the diabetes outpatient
      clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic
      resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.

      This study project sets out to answer the following hypotheses:

        1. Patients with T2DM have an increased risk of developing diastolic dysfunction. Using
           CMR, the investigators wish to measure left ventricle peak filling rate and passive
           atrial emptying fraction as a measure of cardiac diastolic function. The investigators
           hypothesize that classic T2DM markers such as levels of urinary albumin excretion,
           retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM
           duration, etc. are associated with pathological findings by CMR.

        2. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by
           gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk
           factors mentioned above, are associated with left ventricle myocardial hypoperfusion as
           determined by gadolinium contrast CMR.
    


Intervention name(s): Cardiac Magnetic Resonance Imaging (CMR); Echocardiography; Bood samples
Intervention type(s): Other; Other; Other
Intervention description(s): An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping.; Standard measurements and strain.; HbA1c, Glucose, Hgb, Creatinin, Sodium, Potassium, Total cholesterol, LDL cholesterol, HDL cholesterol, Free fatty acids, ALAT, Urinary albumin, NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        300 T2DM patients, with or without known cardiovascular disease, will be recruited from the
        diabetes outpatient clinic, Slagelse Hospital.

        The patients will be divided into groups depending on their diabetes complication status.
        Individual groups of patients with fx. +/- retinopathy, +/- autonomous neuropathy, +/-
        hypertension, normo-/mikro-/makroalbuminuria will be compared.
      
Biospecimen description: 
      EDTA-plasma Heparin-plasma Serum urine
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the safety and tolerability of AZD0328
      following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum
      tolerated dose.
    


Intervention name(s): AZD0328; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.; Administered orally as a solution once per day on day 1, and then day 3 through to day 14.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Safety; tolerability; AZD0328