bioihbjkbjnl/mcl2 huggingface dataset:
Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
Condition: FESD; Rehabilitation; Spinal Cord Injuries; Complete Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      20 patients were recruited by two hospitals (AOUP and AOUC) in Italy from January 2015 to
      January 2018. The participants have been addressed to two different groups: the ones
      recruited by the AOUP were submitted to an experimental protocol of rehabilitation with FES
      Cycling, the ones recruited by the AOUC were submitted to a standard protocol of manual
      mobilization.

      The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20
      cm) from the superior margin of the patella, while the secondary outcomes were the muscle
      tone evaluated with Modified Ashworth Scale (MAS) and the sensation of pain registered with
      International Spinal Cord Injury - Pain Basic Data Set (ISCI-P).

      From these outcomes the Quality Adjusted Life Years (QALYs) was obtained. The costs of the
      two treatments were calculated through a consultation process with the Competent Offices of
      the two hospitals. The QALYs and the costs were used to calculate the Incremental
      Cost-Effectiveness Ratio (ICER) in order to verify the cost-effectiveness ratio of the two
      treatments.
    


Intervention name(s): FES-C; Standard Treatment
Intervention type(s): Device; Other
Intervention description(s): The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.; The participants were submitted to 20 sessions of standard rehabilitation for lower limbs with manual mobilization, three/five times per week. Each session lasted about 30'.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether an investigational malaria vaccine is safe
      and induces an immune response against malaria when tested in adults living in the United
      States.
    

Detailed description: 
      The study begins with the US phase in which 26 volunteers aged 18 to 50 years will be
      enrolled to receive an investigational malaria vaccine. The vaccine is made of a malaria
      protein FMP010 mixed in the adjuvant AS01B. Since this vaccine has not yet been in humans,
      first, 5 volunteers will get a small (10 µg) dose of FMP010 in AS01B. If it is safe, then 20
      volunteers will get 50 µg FMP010 in AS01B. Vaccinations are given IM in the deltoid of the
      non-dominant arm, every month for 3 months. After each vaccination, the subjects will follow
      up at clinical trials for evaluation of any adverse events. There will be blood draws to
      assess safety of the vaccine as well as the level of immune response generated to the
      vaccine.

      Upon receipt of preliminary safety results, the Kenya phase begins in which 30 volunteers who
      are randomized to receive either 50 µg FMP010 in AS01B (20) or the rabies vaccine (10).
      Vaccination and is on the same schedule as in the US phase and follow-up is for 112 days.
    

Intervention name(s): Plasmodium falciparum Malaria Protein 010 (FMP010)
Intervention type(s): Biological
Intervention description(s): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Vaccine; MSP-1 (merozoite surface protein-1); Phase 1
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145
      mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective
      is to characterize the pharmacokinetic profile of fenofibric acid when administered as a
      single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this
      regimen will also be evaluated.
    

Detailed description: 
      Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The
      primary objective of this study is to evaluate the bioequivalence of fenofibric acid and
      fenofibrate under fasting conditions. Additionally, the safety and tolerability of the study
      treatments will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old,
      male and female volunteers will be randomly assigned in a crossover fashion to receive each
      of two dosing regimens, fenofibric acid (Fibricor™) and fenofibrate (Tricor®) in sequence
      with a 7 day washout period between dosing periods. On the morning of Day 1, after an
      overnight fast of at least 10 hours, subjects will receive either a single oral dose of the
      test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference
      formulation, fenofibrate (1 x 145 mg tablet). After a 7 day washout period, on the morning of
      Day 8 after an overnight fast, subjects will receive the alternate regimen. Fasting will
      continue for 4 hours after each dose. Blood samples will be drawn from all participants
      before dosing and for 72 hours post dose at times sufficient to adequately define the
      pharmacokinetics of fenofibric acid and fenofibrate. Subjects will be monitored throughout
      their participation for adverse reactions to the study drug and/or procedures. Seated blood
      pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose.
      All adverse experiences, whether elicited by query, spontaneously reported, or observed by
      clinic staff, will be documented in the subject's case report form.
    

Intervention name(s): Fenofibric Acid (Fibricor™) 105 mg Tablet; Fenofibrate (Tricor®) 145 mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours; 1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours
Other intervention name(s): (Fibricor™); (Tricor®)
Intervention MeSH terms: Fenofibrate; Fenofibric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; pharmacokinetics; therapeutic equivalency; fasting; procetofen; fenofibric acid
Morphological and Functional Evaluation of Irvine-Gass Syndrome
Condition: Irvine Gass Syndrome
MeSH terms: Macular Edema; Syndrome
Study type: Observational

Summary: 
      Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome

      Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery
      will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance,
      contrast sensitivity and microperimetry in a fixed time schedule
    


Intervention name(s): if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection
Intervention type(s): Behavioral
Intervention description(s): if prescribed: Ultracortenol/ Acular eye drops 3-4 times a day, if prescribed: singular intravitreal triamcinolone injection
Intervention MeSH terms: Triamcinolone; Ophthalmic Solutions; Levobunolol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 patients suffering on CME secondary to cataract surgery
      
Keywords: Irvine Gass syndrome; multimodal imaging; SD-OCT; CME secondary to cataract surgery; in vivo correlation of morphology and function
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate
      in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA
      with or without oral corticosteroids and additional asthma controllers.
    


Intervention name(s): Benralizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab subcutaneously on study week 0 until study week 52 inclusive.; Placebo subcutaneously on study week 0 until study week 52 inclusive.
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of JNJ-64232025 following
      single ascending intravenous (IV) study intervention administrations and a single
      subcutaneous (SC) intervention administration in healthy participants.
    


Intervention name(s): JNJ-64232025 IV; JNJ-64232025 SC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-64232025 will be administered as IV infusion.; JNJ-64232025 will be administered as SC injection.; Matching placebo will be administered as IV infusion or SC injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 2 Study of Vapendavir in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Condition: Asthma
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo.
      The objectives are to obtain safety and efficacy data in moderate to severe asthmatic
      patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human
      Rhinovirus infection.
    

Detailed description: 
      This is a multicenter trial to be conducted at approximately 60 sites among 6-8 northern
      hemisphere countries in North America and Central Europe. Sufficient patients will be
      randomized in order to recruit 150 subjects who are laboratory confirmed for human rhinovirus
      (HRV) infection. Depending on HRV PCR positivity rates, it is expected that randomization of
      250-480 subjects will be required to achieve this number of subjects with HRV infection.

      Appropriate asthma subjects will be screened up to 180 days prior to presentation at the
      study site with symptoms of presumed HRV infection for potential study inclusion on Study Day
      1. The study drug treatment period has a duration of 7 days, beginning on Study Day 1.
      Follow-up study visits to the clinic occur on Study Days 3, 5, 7, 14, 21, and 28 with a
      telephonic final safety follow-up visit conducted on Study Day 35. Thus, depending on the
      duration of the screening period, a subject's duration of participation can be estimated to
      last from approximately 37 days up to 215 days.
    

Intervention name(s): Vapendavir; Vapendavir; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vapendavir 264 mg twice daily; Vapendavir 528 mg twice daily; Placebo twice daily
Other intervention name(s): BTA798; BTA798
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symptomatic Human Rhinovirus Infection; Moderate to Severe Asthma; Antiviral; Cold; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
The Effects of Light on Glucose Metabolism
Condition: Diabetes Mellitus, Type 2; Glucose Intolerance; Prediabetic State
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      This study evaluates the effect of bright light on postprandial blood glucose metabolism in
      obese subjects with impaired fasting glucose and/or impaired glucose tolerance.
    

Detailed description: 
      Light has a major influence on the biological clock and several studies suggest that bright
      light during the day and dim light in the evening are beneficial for the circadian timing
      system. Nowadays, large parts of the population spend 90% of their time indoors and are
      thereby exposed to artificial lighting instead of daylight. The artificial light levels are
      relatively low during the day and continue relatively late in the evening. The lack of a
      clear natural light-dark cycle could results in delayed timing of the biological clock
      relative to the behaviour. Optimizing the lighting conditions under controlled laboratory
      settings might lead to better alignment of the biological clock, which in turn could improve
      metabolic parameters such as glucose control.
    

Intervention name(s): Exposure to bright light during the day; Exposure to dim light during the day
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.; Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Circadian Rhythm
Hemodynamic Effect of Topical Anesthesia During Induction in Patients Undergoing Cardiac Surgery
Condition: Coronary Artery Disease; Valvular Heart Disease; Arrythmia
MeSH terms: Coronary Artery Disease; Heart Diseases; Heart Valve Diseases
Study type: Interventional

Summary: 
      Patients scheduled for cardiac surgery are fragile. Hemodynamic fluctuation might be
      associated with adverse outcomes. Therefore, it is essential to keep hemodynamics stable
      during and after the induction period. Previous studies have shown that topical anesthesia
      can provide excellent superior supraglottic and subglottic local anesthetic effects and can
      significantly reduce the dosage of intravenous anesthetics. Therefore, we designed this study
      to explore whether the combination of topical anesthesia and intravenous anesthetics could
      decrease the stress response of endotracheal intubation and keep hemodynamics stable during
      and after the induction period.
    

Detailed description: 
      Patients scheduled for cardiac surgery are often accompanied by cardiac insufficiency.
      Hemodynamic fluctuation might lead to disastrous events. Therefore, it is essential to keep
      hemodynamics stable during and after the induction period. The routine anesthesia induction
      strategy for cardiac surgery is to decrease stress response during endotracheal intubation by
      using large doses of opioids. However, high doses of opioids often leads to persistent and
      recurrent hypotension in patients from the anesthesia induction period to the beginning of
      the surgery. Previous studies have shown that topical anesthesia can provide excellent
      superior supraglottic and subglottic local anesthetic effects and can significantly reduce
      the dosage of intravenous anesthetics. Therefore, we designed this study to explore whether
      the combination of topical anesthesia and intravenous anesthetics could decrease the stress
      response of endotracheal intubation and keep hemodynamics stable during and after the
      induction period.
    

Intervention name(s): The combined topical anesthesia induction group; The routine induction group
Intervention type(s): Procedure; Procedure
Intervention description(s): Inhalation of aerosolized surface anesthesia with 10 ml 2% lidocaine would be administered with an atomizer for 15 minutes prior to intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia with 3ml 2% lidocaine.; Inhalation of 10 ml 0.9% normal saline would be administered with an atomizer for 15 minutes prior to intravenous anesthesia. After the intravenous induction, 3ml 0.9% normal saline would be administered into subglottic airway with a catheter.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Topical anesthesia; Atomization inhalation; Cardiac surgery; Hemodynamics; Endotracheal intubation
A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia
Condition: Severe Aplastic Anemia (SAA)
MeSH terms: Anemia; Anemia, Aplastic
Study type: Observational

Summary: 
      Background:

      - This research is being done to describe the types of bacteria found in the mouths of
      patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the
      immune system or with stem cell transplant. People with SAA who receive these treatments are
      more likely to get infections. Studies show that there might be a link between the bacteria
      in your mouth and those bacteria that can cause infections. The bacteria found in the mouths
      of patients with SAA will be described.

      Objectives:

      - To understand the changes in mouth bacteria that are related to treatment and to describe
      the oral bacterial environment.

      Eligibility:

        -  Adults at least 18 years of age who are going to be treated for SAA.

        -  Healthy volunteers at least 18 years of age.

      Design:

        -  Participants will answer questions about their medical history and dental care. Their
           mouths will be examined.

        -  Participants with SAA will be tested during treatment for their disease, over the course
           of 1 year. All participants with SAA will be tested at 3 scheduled appointments. Any
           participants who require a breathing tube will receive additional tests.

        -  Healthy volunteers will be tested during 1 visit.

        -  Participants will give two samples each time. A saliva sample will be taken with a
           disposable padded tool. Skin cells will be collected from the tongue with a small
           plastic brush.
    

Detailed description: 
      The mouth is a complex biological ecosystem normally containing over 700 different species of
      bacteria. Some of these bacteria live in an exopolysacchride matrix biofilm and occupy
      specific niches in this complex oral environment. Understanding the oral environment and the
      microbiota that inhabit it will assist in determining their impact on health and disease.
      There are several studies in critically ill patients demonstrating changes in oral bacteria
      related to acute illness. Identification of respiratory pathogens in the mouth has led
      researchers to hypothesize that a relationship exists between the oral cavity and pulmonary
      infections. This descriptive study will characterize the oral microbiota of patients who have
      severe aplastic anemia (SAA). Patients will be followed for 1 year after treatment for
      development of respiratory symptoms that require intubation. A difference in the oral
      microbiome will be identified in specimens collected before and after treatment.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: Oral Microbiome; Next Generation Sequencing
Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis
Condition: Ischemic Stroke, Acute; Stent Stenosis; Thrombosis
MeSH terms: Stroke; Ischemic Stroke; Thrombosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Intravenous (IV) recombinant tissue plasminogen activator is the standard of care for
      patients with acute ischemic stroke (AIS) who present to the hospital within 4.5 hours of
      symptom onset. However, IV thrombolysis, even bridging thrombolysis (combining intravenous
      thrombolysis and mechanical thrombectomy) has limited efficacy among patients who had
      occlusive lesions associated with highgrade arterial stenosis requiring revascularization to
      improve neurological deficits. The investigators evaluated whether rescue stenting results in
      good outcomes among patients after the failure of intravenous thrombolysis and bridging
      thrombolysis.
    

Detailed description: 
      Stroke is the second most common cause of death worldwide, with an annual mortality rate of
      approximately 5.5 million. Depending on the timing of presentation, intravenous (IV)
      administration of recombinant tissue plasminogen activator can be an effective treatment, but
      is most effective when used between 3 and 4.5 hours of symptom onset. Bridging thrombolysis,
      which describes the combination of IV thrombolysis and mechanical thrombectomy, can lead to
      long-term functional independence after 90 days with higher recanalization success rates than
      IV thrombolysis alone without increased risk. The HERMES meta-analysis of fve trials (MR
      CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) indicated the potential benefits of
      mechanical thrombectomy (MT) in case of proximal circulation occlusions. The recanalization
      failure rate of this treatment, defined as a modified Thrombolysis in Cerebral Ischemia
      (mTICI) score of 2a or worse, remained high, ranging from 13% to 29%, and most patients
      experienced poor clinical outcomes. Permanent stent placement has been suggested as a
      potential approach for achieving successful recanalization, which is the goal of endovascular
      therapy in the early management of acute ischemic stroke (AIS). However, the risk of
      intracranial hemorrhage associated with the combined use of IV thrombolysis and a loading
      dose of dual antiplatelet therapy (DAPT) increases when rescue stenting is applied. The
      investigators hypothesize that stent deployment might serve as a feasible treatment for large
      artery occlusion after the failure of intravenous thrombolysis and bridging thrombolysis.
    

Intervention name(s): Rescue stenting
Intervention type(s): Procedure
Intervention description(s): Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RES
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic stroke; Rescue stenting; Intravenous thrombolysis; Dual antiplatelet therapy