bioihbjkbjnl/mcl2 huggingface dataset:
Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Condition: Onychomycosis, Toe
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal
      infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial
      identification test after administration of itraconazole (ICZ) capsule, to identify the
      change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the
      relationship between the change of SCIO score and mycological cure rate and clinical
      improvement.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multicenter (when
      more than one hospital or medical school team work on a medical research study) study of ICZ
      in participants with onychomycosis. The present study consists of 2 periods: Screening period
      (up to Week minus 2) and Treatment period (up to Week 49). The ICZ will be administered in 3
      cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100
      milligram (mg) each, orally, twice daily, continuously for 1 week. Total duration of
      treatment will be of 49 weeks. Efficacy will primarily be evaluated by percentage of
      participants showing 10 percent or higher response in SCIO Score. Participants' safety will
      be monitored throughout the study.
    

Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention description(s): Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.
Other intervention name(s): Sporanox
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis, Toe; Itraconazole; Sporanox
Challenge Study of an ETEC Vaccine
Condition: Enteritis; Escherichia Coli, Enterotoxigenic
MeSH terms: Escherichia coli Infections; Enteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E.
      coli (ETEC)-caused diarrhea.
    

Detailed description: 
      The purpose of the study is to establish preliminary efficacy of dscCfaE administered with
      LTR192G by intradermal (ID) immunization in prevention of disease caused by a challenge with
      a CFA/I expressing ETEC strain (H10407).
    

Intervention name(s): LTR192G with dscCfaE; No Intervention
Intervention type(s): Biological; Other
Intervention description(s): Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G); Controls only receive challenge
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with
      chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS).

      Secondary Objectives:

        -  To compare the effects of SAR292833 with placebo on the change of neuropathic pain
           symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI);

        -  To evaluate the effects of SAR292833 in comparison to placebo on the change in pain
           intensity of mechanical allodynia;

        -  To investigate the safety and tolerability of SAR292833 in comparison to placebo;

        -  To investigate the pharmacokinetics (PK) and the relationships between main efficacy
           parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in
           patients with chronic peripheral neuropathic pain.
    

Detailed description: 
      Total study duration (from screening to last follow-up visit) is 9 weeks that includes a 3
      week follow-up period.
    

Intervention name(s): SAR292833; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form:capsule
Route of administration: oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
Condition: Major Trauma; Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      The occurrence of sepsis in trauma patients is a very serious complication. Identifying
      trauma patients at high risk of sepsis was not revealed in the latest surviving sepsis
      campaign in 2016. Several biomarkers have been proposed for early prediction of sepsis in
      trauma patients as leukocyte anti sedimentation rate (LAR) and the proinflammatory cytokine
      monocyte chemo attractant protein-1 (MCP-1). Sepsis prophylaxis before occurrence of
      multi-organ failure still represents a major challenge. Vitamin D and probiotics have
      antimicrobial, anti-inflammatory and gut microbiota immune modulatory properties.Little is
      known about the effect of vitamin D and probiotics co-supplementation on the inflammatory
      response in trauma patients at high risk of sepsis.

      Another promising strategy is the use of vitamin C in addition to thiamine. Trauma is
      associated with increased oxidative stress and vitamin C deficiency. High dose vitamin C is
      required to restore oxidant-antioxidant balance. Vitamin C and thiamine have shown promising
      results in treatment of sepsis. Vitamin C possesses anti-inflammatory, endothelial protective
      and anti-microbial effects. Thiamine is the precursor of thiamine pyrophosphate (TPP), a key
      enzyme in Krebs cycle.
    

Detailed description: 
      This study will investigate effect of vitamin D and probiotics versus Vitamin C and thiamine
      on inflammatory response (represented by change in MCP-1 level), Sequential Organ Failure
      Assessment (SOFA) Score and Acute Physiology and Chronic Health Evaluation II (APACHE II) in
      trauma patients at high risk of sepsis. Secondary goal is to assess if the predictive ability
      of MCP-1 plus LAR to determine high risk of sepsis in major trauma intensive care patients
      and if there is correlation between LAR and MCP-1.
    

Intervention name(s): oral lactobacillus probiotics plus intramuscular cholecalciferol; intravenous vitamin C plus thiamine
Intervention type(s): Drug; Drug
Intervention description(s): According to leukocyte anti- sedimentation rate (LAR) result on day 1 patients will be classified into high risk for sepsis patients (LAR < 15 %) and low risk for sepsis patients (LAR ≥ 15%) High risk sepsis patients will be randomly allocated into one of the 3 groups (sealed opaque envelops) to vitamin D plus probiotics intervention group (HR-DP) group. to vitamin C plus vitamin B intervention group (HR-CB) group. to control group (HR-C) group that does not receive any supplement; starting from day 1 in a dose of 1 gm vitamin C and 200 mg thiamine intravenous 4 times at 12-hour intervals for 48 hours
Intervention MeSH terms: Cholecalciferol; Vitamin D; Thiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fabry : National Initiative of Screening
Condition: Ischemic Stroke Hospitalized
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease
      allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of
      life threatening manifestations such as an ischemic stroke.

      The purpose of the study is to determinate the prevalence of Fabry disease in a population of
      male patients hospitalized for an ischemic stroke.

      This study, with a screening of Fabry disease, allows the patients to make a precise
      diagnosis of their ischemic stroke and to facilitate the screening of the other members at
      the facility.
    


Intervention name(s): Blood sample
Intervention type(s): Procedure
Intervention description(s): Ischemic stroke hospitalized
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fabry disease, Screening, Ischemic stroke
Heparin and Protamine Titration in Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
Condition: Cardiopulmonary Bypass
Study type: Interventional

Summary: 
      During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate
      level of anticoagulation is accomplished. To achieve this, the patient is administered
      heparin. After completion of the surgery, protamine is given to reverse the anticoagulant
      action of heparin. In this prospective clinical study the researchers will investigate the
      impact of the two different methods to calculate the required dosage of heparin and
      protamine; the individualized calculation computed by the Hemostasis Management System Plus
      (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators
      hypothesize that the aforementioned methods result in different dosages and will elaborate on
      their impact on postoperative bleeding.
    


Intervention name(s): Hemostasis Management System Plus; Activated Coagulation Timer System Plus
Intervention type(s): Device; Device
Intervention description(s): Hemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood.; The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: anticoagulation; cardiopulmonary bypass
Ambroxol in Disease Modification in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and pharmacodynamics of ambroxol in
      participants with Parkinson Disease. Participants will administer ambroxol at five dose
      levels and will undergo clinical assessments, lumbar punctures, venepuncture, biomarker blood
      analysis and cognitive assessment throughout the course of the study.
    

Detailed description: 
      The AiM-PD study will recruit 20 patients (10 GBA-positive & 10 GBA-negative status)
      diagnosed with Parkinson disease (PD). Each patient will self-administer the study drug,
      ambroxol (60 mg per tablet) at 5 intra-dose escalations over the course of 6 months, as shown
      below:

        1. Day 1-7: 60 mg three times a day

        2. Day 8-14: 120 mg three times a day

        3. Day 15-21: 180 mg three times a day

        4. Day 22-28: 300 mg three times a day

        5. Day 29-186: 420 mg three times a day

      The study drug is licensed in the EU as an over-the-counter drug to treat respiratory
      conditions by reducing mucus production. Previous studies have shown that ambroxol can
      penetrate the brain in rodent and non-human primate models, and may have an effect in slowing
      PD. The results also indicate individuals who express the GBA mutation (increased risk of PD)
      are able to reduce the growth of cells that cause PD by stimulating an enzyme called
      glucocerebrosidase.

      The study will collect cerebrospinal fluid, blood, and urine samples before, during and after
      the drug has been taken over a 6 month period. In these samples the Investigators will
      measure ambroxol drug levels, assess whether the glucocerebrosidase enzyme has been
      stimulated and the levels of other substances thought to be associated with the development
      of PD and confirm whether the study drug has penetrated the cerebrospinal fluid and CNS. The
      study will administer clinical and cognitive assessments to determine if there is any
      improvement in patient's PD symptoms. If the study proves ambroxol penetrates the CNS and
      replicates our current findings in the laboratory, the Investigators shall move on to a much
      larger drug trial to test whether the study drug may be able to slow the progression of PD.
    

Intervention name(s): Ambroxol
Intervention type(s): Drug
Intervention description(s): Details outlines in the intervention description.
Other intervention name(s): Brand name: Ambrosan
Intervention MeSH terms: Ambroxol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare employment support with behavioral skills training to employment
      support alone in schizophrenia patients taking either risperidone or olanzapine to determine
      which is more effective in helping the patients maintain a job.
    

Detailed description: 
      Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty
      concentrating, and hallucinations. Individuals with schizophrenia often experience reduced
      emotional, social, and occupational functioning. Data indicate that antipsychotic drug
      treatment and occupational training and support may be effective in helping people with
      schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs;
      participants in this study will be taking either risperidone or olanzapine for the duration
      of the study. This study will provide schizophrenia patients with employment support alone or
      with behavioral skills training to determine which combination is more effective in helping
      patients obtain and maintain a job.

      At study entry, participants will undergo a clinical and diagnostic evaluation to determine
      the severity of their schizophrenia. Participants will be tapered off their regular
      medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly
      assigned to receive either risperidone or olanzapine. Participants will then be assigned an
      Individual Placement and Support (IPS) specialist to assist them in finding a job. After
      participants secure a job, they will be randomly assigned to receive IPS either alone or with
      the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or
      olanzapine treatment will continue during this 2-year period. Participants will have clinic
      visits at study entry and Months 7, 12, and 24. At each visit, participants will complete
      questionnaires and will be interviewed about their schizophrenia symptoms and occupational
      functioning.
    

Intervention name(s): Individual Placement and Support (Supported Employment); Social Skills Training; Olanzapine; Risperidone
Intervention type(s): Behavioral; Behavioral; Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antipsychotic Agents; Employment
Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis
Condition: Cystic Fibrosis; Healthy
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion
      regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol
      on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in
      CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC
      chloride.
    


Intervention name(s): Albuterol; Placebo saline
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer; nebulized 3mL normal saline) using a Power Neb2 nebulizer
Intervention MeSH terms: Albuterol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exhaled breath condensate; diffusion capacity of the lungs for carbon monoxide and nitric oxide; albuterol; peripheral oxygen saturation; ion regulation
Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The Chinese patients with chronic hepatitis C have a different genetic background, which had
      been demonstrated to significantly influence their responses to pegylated interferon and
      ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6
      infection were treated with pegylated interferon and ribavirin. Their response was compared
      amongst different genotypes.
    


Intervention name(s): 48-weeks course; Ribavirin; Peginterferon alfa2a; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks; patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks; patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks; patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peginterferon alfa-2a; ribavirin
Staccato Prochlorperazine Thorough QT/QTc
Condition: Cardiotoxicity
MeSH terms: Cardiotoxicity
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval
      duration) at 2 dose levels compared to placebo in healthy volunteers.
    

Detailed description: 
      The planned study is a single dose, double-blind, double-dummy, active and placebo
      controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels
      of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral
      moxifloxacin), and placebo.
    

Intervention name(s): Inhaled placebo; Oral placebo; Inhaled prochlorperazine 5 mg; Inhaled prochlorperazine 10 mg; Oral moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato placebo (0 mg); Oral placebo (identical to 400 mg moxifloxacin); Staccato prochlorperazine 5 mg, single dose; Inhaled prochlorperazine 10 mg, single dose; Oral moxifloxacin 400 mg, si/ngle dose
Other intervention name(s): ADASUVE; ADASUVE
Intervention MeSH terms: Moxifloxacin; Prochlorperazine; Loxapine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Female and male subjects in approximately equal numbers were randomly assigned (1:1:1:1) to receive the 4 treatment sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inhaled prochlorperazine, Thorough Qt/QTc,
Microaspiration in Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common
      in patients with IPF.

      Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for
      microaspiration in patients with IPF.

      Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and
      inflammation are markers of microaspiration in IPF.

      Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary
      function.

      Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e.
      unscheduled clinic visit, emergency room visit, or hospitalization).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with IPF
      
Biospecimen description: 
      This is a prospective cohort study of patients with IPF. Subjects will undergo (1) an
      assessment of the presence or absence of microaspiration (via bronchoscopy and BAL pepsin
      level), (2) measurement of biomarkers of microaspiration (via esophageal function studies,
      laboratory tests, pulmonary function, chest imaging, and survey), and (3) longitudinal
      follow-up to document disease progression (via pulmonary function and survey).
Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The study is a single center, open-label, single arm, prospective pre-market study designed
      to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of
      atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal
      atrial fibrillation.
    

Detailed description: 
      Subjects with documented symptomatic, recurrent, PAF refractory to at least one beta blocker,
      calcium channel blocker or Class I or Class III anti-arrhythmic drug, who meet all
      inclusion/exclusion criteria and are deemed appropriate candidates for catheter ablation will
      undergo PV ablation with the VAS. Pre-procedural CT scan or MRI will be obtained to assess LA
      and PV anatomy and size. PV ablation will be performed utilizing the VAS (see procedure
      description below). Acute post-ablation confirmation of PV electrical isolation will be
      evaluated via standard mapping techniques.
    

Intervention name(s): VytronUS Ablation System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ablation; ultrasound; automation; catheter