bioihbjkbjnl/mcl2 huggingface dataset:
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Condition: Cryptogenic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO)
      closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical
      treatment in the prevention of recurrent embolic stroke.
    

Detailed description: 
      The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the
      non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke
      due to presumed paradoxical embolism within the last 270 days.
    

Intervention name(s): AMPLATZER PFO Occluder; Standard of Care - Medical Management
Intervention type(s): Device; Other
Intervention description(s): patent foramen ovale closure device; Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: AMPLATZER PFO Occluder
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cryptogenic; Stroke; PFO; Patent foramen ovale; AMPLATZER; Occluder
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
Condition: Hypertrophic
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Neodyne has developed an investigational dressing for post-operative incision care. Neodyne
      is conducting this research to study whether the investigational dressing, called the Neodyne
      Dressing, can minimize scar formation in a simple manner.
    

Detailed description: 
      It is proposed to study a dressing designed to reduce the appearance of scars after scar
      revision surgery. It is expected that by managing the incision site after primary closure but
      during the longer term healing phase, scar formation may be minimized.
    

Intervention name(s): embrace device
Intervention type(s): Device
Intervention description(s): Adhesive bandage/dressing intended to minimize scar formation.
Other intervention name(s): Neodyne dressing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: scar; incision; wound healing; scarring; scar revision
Psychomotor Performance of Preterm Infants
Condition: Psychomotor Development Impaired
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The first part involved 120 children in grades II and III of elementary schools. From this
      group, children were qualified for the second part of the study - 35 randomly selected
      children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). EUROFIT
      tests, Vienna Tests and postural stability tests were carried out in both groups.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        180 healthy school children
      
Keywords: Preterm Birth; Preterm Infant; Motor abilities; Eurofit; Vienna test; Postural stability
First-in-Human Single and Multiple Dose of EB8018
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety profile of single and multiple doses of
      EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and
      multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018
      on the healthy male gut microbiome.
    

Detailed description: 
      Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging
      evidence suggests that the microbiome plays an important role in triggering an abnormal
      mucosal immune response in patients with Crohn's Disease. Independent studies have
      demonstrated an imbalance of the microbiome with a significant increase of E coli with
      invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to
      the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently
      trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral
      small molecule that is designed to block FimH thereby preventing the entry of AIEC into the
      gut wall thereby disarming the bacteria without disrupting the gut microbiome.
    

Intervention name(s): Single Ascending Doses of EB8018; Single Ascending Doses of placebo; Multiple Ascending Doses of EB8018; Multiple Ascending Doses of placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Plethysmography Opto-electronic and Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Objective: To assess the influence of nebulization with bronchodilators carried by the heliox
      coupled to PEP in the distribution of compartimental lung volumes in asmathic adults and to
      correlate with pulmonary function data. Methods: A controlled randomized trial involving 27
      patients divided into four groups: heliox + PEP, oxygen + PEP, heliox and oxygen. After the
      initial evaluation, it was placing 89 reflective markers attached to the surface of the trunk
      and images acquired by optoelectronic plethysmography (OEP) of six cameras. Three slow vital
      capacity maneuvers and quiet breathing regarded as phase control. After the control phase,
      all patients underwent nebulization with a distribution noninvasive system, semi-closed using
      10 drops of Fenoterol Bromide and 20 drops of Ipratropium.
    


Intervention name(s): Oxygen; Heliox; PEEP
Intervention type(s): Other; Other; Other
Intervention description(s): For inhalation of oxygen, we used a noninvasive delivery system, semi - closed (Figure 3) consisting of a non-toxic face mask with two unidirectional valves - inspiratory and expiratory branch - connected to the
nebulizer (Airlife Misty Neb, Baxter; Valencia, CA, USA). In the inspiratory branch, a reservoir bag (Hudson RCI, USA) with capacity of 2.5 L was connected, in order to avoid dilution of the gas. This skin was fixed to the patient's face to prevent leakage and to maintain adequate pressurization and improved patient compliance to the PEEP. The nebulizer was fed by a flow of 8 l / min of oxygen.; For inhalation of heliox, we used a noninvasive delivery system, semi - closed consisting of a non-toxic face mask with two unidirectional valves - inspiratory and expiratory branch - connected to the
nebulizer (Airlife Misty Neb, Baxter; Valencia, CA, USA). In the inspiratory branch, a reservoir bag (Hudson RCI, USA) with capacity of 2.5 L was connected, in order to avoid dilution of the gas. This skin was fixed to the patient's face to prevent leakage and to maintain adequate pressurization and improved patient compliance to the PEEP. The nebulizer was fed by a 11 l / min of heliox for the heliox group in accordance with a protocol of Hess et al.; PEEP supplied was 10 cm H2O through valve (Vital Signs,Totowa, USA) attached to the expiratory branch.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Acupuncture Functional Magnetic Resonance Imaging (fMRI) Study on Chronic Pain: Response Reliability and Dose Effect
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional

Summary: 
      In this proposal, we plan to dynamically investigate brain response to verum acupuncture (of
      two different "doses") and placebo acupuncture, using a paradigm that approximates clinical
      acupuncture practice across multiple treatment sessions in knee osteoarthritis (OA) patients.
      This proposal aims to: 1) characterize session-to-session brain responses to verum / sham
      acupuncture treatment (reliability of response) for OA patients, and 2) investigate how
      different "doses" of acupuncture influence brain response and acupuncture efficacy (impact of
      dose). The findings of this project will deepen our biological understanding on why and how
      acupuncture can treat chronic pain and what happens in the brain during the multiple-session
      acupuncture treatment.
    


Intervention name(s): acupuncture
Intervention type(s): Device
Intervention description(s): patient will receive high dose, low dose or sham acupuncture treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: acupuncture; osteoarthritis; fMRI
Comparison of Two Daily Disposable Lenses
Condition: Refractive Ametropia; Myopia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study was to compare the clinical performance of the new DAILIES®
      AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily
      disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).
    

Detailed description: 
      Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.
    

Intervention name(s): DACP FreshTech contact lenses; DACP contact lenses
Intervention type(s): Device; Device
Intervention description(s): Nelfilcon A soft contact lenses with a modified lens design; Nelfilcon A soft contact lenses
Other intervention name(s): DAILIES® AquaComfort PLUS® FreshTech; DAILIES® AquaComfort PLUS®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: eye strain; eye fatigue
A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of this study are to evaluate the safety and tolerability of multiple ascending
      doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma
      and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to
      healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of
      PF-04455242 on serum prolactin concentration will be explored.
    


Intervention name(s): PF-04455242; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3, 6, and 23 mg capsules administered orally Q6 hours for 7 days of dosing.; Placebo administered orally Q6 hours for 7 days of dosing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: An investigator and subject blinded (sponsor open); multiple dose; dose escalation design with PF 04455242 and matching placebo.
Airway Clearance System (K031876) Phase IV Device Efficacy
Condition: Cystic Fibrosis, Pulmonary
MeSH terms: Cystic Fibrosis; Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis
      (mild, moderate or severe). The study is completely voluntary and is designed to measure
      participants use and the effectiveness of the device within the 510K indication of: airway
      clearance therapy when external manipulation of the thorax. The trial period shall be 21 days
      and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well
      as completion of semi-weekly participant survey.
    

Detailed description: 
      Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or
      severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876),
      Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance
      therapy when external manipulation of the thorax is the physician's choice of treatment.
      Indications for this form of therapy are described by the American Association for
      Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (
      I ) (1991). According to AARC guidelines, specific indications for external manipulation of
      the thorax include evidence or a suggestion of retained secretions, evidence that the patient
      is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus
      plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for
      external manipulation of the thorax to promote airway clearance or improve bronchial drainage
      for purposes of collecting mucus for diagnostic evaluation.
    

Intervention name(s): Electro Flo Percussor, Model 5000
Intervention type(s): Device
Intervention description(s): FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        18 to 55 years of age, male or female.non-smokers
      
Keywords: airway clearance system; cystic fibrosis; lung secretion clearance
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
Condition: Progesterone; Fertilization in Vitro; Infertility; Pregnancy
MeSH terms: Infertility
Study type: Observational

Summary: 
      At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program
      should fresh embryo transfer (ET) be cancelled?
    

Detailed description: 
      There is still an ongoing debate on the effect of subtle increased P-hCG concentration on
      pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG
      seems to exist. It is accepted that high P advances endometrium, leading to asynchrony
      between the implanting embryo and the endometrium, and resulting in implantation failure. A
      freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been
      proposed.
    

Intervention name(s): Progesterone
Intervention type(s): Other
Intervention description(s): Progesterone level
Intervention MeSH terms: Progesterone
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing IVF-ICSI ad fresh embryo transfer
Potato Consumption and Risk of Mortality
Condition: Morality
Study type: Observational

Summary: 
      Although previous studies have linked fried potato consumption with the incidence of
      mortality in the US population, the association between potato consumption and mortality in
      the Chinese population remains unknown.
    

Detailed description: 
      This study investigated the association of potato, fried potato, unfried potato, and sweet
      potato consumption with the incidence of mortality in the China Health and Nutrition Survey
      (CHNS).We analyzed the CHNS data and the participants (n = 14,116) over 20 years old were
      followed for up to 22 years. The participants were initially free of cancer, myocardial
      infarction, apoplexy, and pregnancy. Potato consumption was assessed using validated
      semi-quantitative food questionnaires (FFQ) in interviews. In each wave of interviews, the
      participants' situations such as alive, dead, or dying was listed and the death months were
      recorded. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated using Cox
      proportional hazard models with adjustment of potential confounders.In the CHNS cohort, total
      potato, fried potato, unfried potato, and sweet potato consumption were all strongly
      associated with a reduction in all-cause mortality in both Chinese women and men.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Of the 14,116 participants, 6,493 male and 7,623 female were enrolled, ranging from 20 to
        93 years old. People who consumed the potatoes, sweet potatoes, stir-fried potatoes, and
        non stir-fried potatoes accounted for 57.52%, 14.6%,51.53%, and 54.82%, respectively.
      
Keywords: potato consumption; CHNS; mortality; fried potato; sweet potato
Pregabalin as Treatment for Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed protocol is an 8 week open label outpatient pilot trial of the safety and
      efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary
      objective of the study is to determine the efficacy of pregabalin in promoting alcohol
      abstinence among individuals with an alcohol use disorder.
    

Detailed description: 
      The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of
      pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for
      the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve
      pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in
      an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in
      outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to
      determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with
      an alcohol use disorder.
    

Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): pregabalin up to 600 mg/day
Other intervention name(s): lyrica
Intervention MeSH terms: Pregabalin
Intervention model: Single Group Assignment
Intervention model description: open label pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol use disorder; alcohol abuse; treatment; lyrica
The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia
Condition: Endotoxemia; Inflammation; Multi Organ Dysfunction Syndrome; Sepsis
MeSH terms: Endotoxemia; Inflammation
Study type: Interventional

Summary: 
      The human body knows a biphasic immunological reaction to sepsis. First, the pro-inflammatory
      reaction takes place, marked by the release of pro-inflammatory cytokines like TNF-α, as a
      reaction to the bacterial toxins. Secondly, the counter regulatory anti-inflammatory reaction
      arises. This phase is acting as negative feedback on the inflammation by inhibition of the
      pro-inflammatory cytokines. This is called "immunoparalysis", a pronounced immunosuppressive
      state, which renders patients vulnerable to opportunistic infections. Most of the septic
      patients survive the initial pro-inflammatory phase, but die during this second
      stage.Research in the past has shown that immunostimulatory therapy with GM-CSF or IFN-γ has
      promising effects on the pro-inflammatory reaction during immunoparalysis ex vivo. Both drugs
      are known for their immunostimulatory effects. Recent pilot studies have showed in septic
      patients, that long-lasting monocyte deactivation in sepsis ex vivo can be reversed by these
      two immunostimulants. However, the mechanism and extent of immunoparalysis recovery may be
      different between the two compounds. Previously it has been shown that human endotoxemia
      (induced by LPS), leads to marked immunosuppression in healthy individuals, characterized by
      a transient refractory state to a subsequent LPS challenge (endotoxin tolerance).
      Consequently, human endotoxemia can serve as a standardized, controlled model for
      sepsis-induced immunoparalysis. Until now, all studies have focused on the ex vivo tolerance.
      However, we have recently proved, that the ex vivo condition is not completely representative
      for the in vivo situation. Ex vivo, leukocyte tolerance to LPS resolves within one day, while
      the in vivo immunoparalysis persists for two weeks. In this project, we will investigate the
      effects of both GM-CSF and IFN-γ in a parallel double-blind placebo controlled randomized
      manner on the immunoparalysis following human endotoxemia, both in-vitro and in vivo. As a
      result, we hope to get more insight in the pathophysiology of sepsis-induced immunoparalysis
      and thereby develop new immunostimulatory therapies that improve patient outcome
    


Intervention name(s): GM-CSF; IFN-Y; E.coli endotoxin
Intervention type(s): Drug; Drug; Other
Intervention description(s): GM-CSF (4microgram/kg/day subcutaneously) on days 2, 4 and 6.; IFN-Y (100 microgram/day, subcutaneously) on days 2, 4 and 6.; 2 ng/kg E.coli reference endotoxin 11:H 10:K negative intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endotoxin; Inflammation; Sepsis; GM-CSF; IFN-y
Human Genomic Population Structure and Phenotype-genotype Variation in ADME Genes in Four Populations
Condition: Healthy
Study type: Interventional

Summary: 
      Physicians know that their patients can react differently to the same medical treatment: for
      some of them, the drug will prove inefficient, whereas for others it might provoke
      side-effects, sometimes rather serious. Such differences in response to drug intake are due
      to several factors, of which molecular variations in specific genes, named " ADME "
      (Absorption, Distribution, Metabolism, Excretion). This project aims at investigating the
      evolutionary mechanisms responsible for the diversity of ADME genes in human populations.
      Because of their role at the interface between the organism and its chemical environment,
      ADME genes are likely targets of recent selective pressures linked to changes in the
      environments in which humans evolved, such as changes in dietary habits for instance.

      The aim of this project is to study the diversity of ADME genes and of their expression in
      five populations located along a latitudinal axis that extends from East Africa to Central
      Europe, passing through the Arabian Peninsula and the Mediterranean area, so as to take into
      account environmental factors that might have influenced the evolution of this diversity.
      This project is thus intended to evidence the evolutionary mechanisms that shaped genomic
      regions that are functionally important from the clinical and epidemiological point of view.
      Moreover, it will allow us to extend the knowledge of human molecular diversity and its
      evolution to a key-region of the peopling history of our species.
    


Intervention name(s): Phenotyping; Genotyping
Intervention type(s): Drug; Genetic
Intervention description(s): finger-tip blood drop : enzymatic activities assessed by specific single point concentration ratios after oral intake of the Geneva micrococktail made of : CYP1A2: paraxanthine/caffeine CYP2B6: 4-hydroxybupropion/bupropion CYP2C9: 4-hydroxyflurbiprofen/flurbiprofen CYP2C19: 5-hydroxyomeprazole/omeprazole CYP2D6: dextrorphan/dextromethorphan CYP3A4: 1-hydroxymidazolam/midazolam; DNA sampling from a saliva sample
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers