bioihbjkbjnl/mcl2 huggingface dataset:
Changes of Endothelial Function Before and After DSA in Patients With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators
      hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In
      this study, the investigators will select 200 diabetic patients who have a DSA for diabetic
      foot screening. Also, the investigators will select 100 healthy subjects as controls. The
      endothelial function will be determined by high resolution ultrasound before and after DSA.
      The investigators will observe the changes of endothelial function after DSA assay.
    


Intervention name(s): DSA assay
Intervention type(s): Other
Intervention description(s): All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We will select 200 patients with diabetes. DSA will be taken for this group. Endothelial
        function will be measured before and after DSA. In the meantime, 100 healthy subjects will
        be selected as controls.
      
Keywords: diabetic foot; digital subtraction angiography; endothelial function; Patients with diabetes; Age 40 to 70 years old; Endothelial function are determined
Facilitated Referral for Children Screening Positive for Mental Illness
Condition: Mental Disorders; Mentally Ill Persons; Emergency Medicine
MeSH terms: Emergencies; Mental Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      The purpose of this study is to find out how prevalent unidentified Mental Health issues are
      in the pediatric population that visits the Emergency Department in an urban city.
    

Detailed description: 
      The purpose of this research study is to find out how many children in the Emergency Room
      have emotional issues and how many of them go unnoticed. In particular the study looks at how
      well a questionnaire for children and teenagers, the DISC Predictive Scales, Version IV
      (DPS-IV) works and what is the best way to ask the questions. In addition, for children aged
      9-17 this study will look at families' readiness to seek care when a problem is indicated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergency Department patients ages 6-18 who present without any history of mental health
        issues.
      
Keywords: Mental Disorders; Mentally Ill Persons; Emergency Medicine; Emergency Department; Screening
Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039)
Condition: Dyslipidemia
MeSH terms: Hepatic Insufficiency; Liver Failure; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.
    


Intervention name(s): anacetrapib
Intervention type(s): Drug
Intervention description(s): single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Intervention MeSH terms: Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Insufficiency
The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the
      treatment of children with cerebral palsy.
    

Detailed description: 
      The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia)
      or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the
      treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to
      spasticity.

      The efficacy and safety are evaluated for 12weeks through 3 follow up visits.
    

Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Intervention description(s): 1 time, gastrocnemius muscles injection, dose of 4U/kg body weight in patients with hemiplegia, dose of 6U/kg body weight in patients with diplegia, Maximum dosage 200U
Other intervention name(s): Neuronox®, Siax®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexamethasone for Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators want to test the efficacy of these anesthetic antiemetic measures
      collectively with or without ondansetron or dexamethasone, in the prevention of postoperative
      nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.
    

Detailed description: 
      More than half of the patients undergoing laparoscopic cholecystectomy will have
      postoperative nausea and vomiting (PONV). PONV is related to surgical, anesthetic and patient
      factors.

      We want to test the efficacy of these anesthetic antiemetic measures collectively with or
      without ondansetron or dexamethasone, in the prevention of PONV in patients undergoing
      laparoscopic cholecystectomy.

      Three groups to be studied : (Group O) will receive 4 mg ondansetron, (Group D) will receive
      8 mg dexamethasone and (Group P) will receive normal saline .
    

Intervention name(s): Dexamethasone; Ondansetron; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 mg, Intravenous; 4 mg, intravenously; 2 ml, intravenously
Intervention MeSH terms: Dexamethasone; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Postoperative Nausea and Vomiting; Ondansetron; Dexamethasone
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Condition: Liver Diseases; Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional

Summary: 
      Early screening and monitoring of chronic liver diseases in hepatology practice has become
      crucial. To achieve this goal, hepatology clinics need simple and available tools at the
      point-of-care to perform disease severity assessment. The objective of this study is to
      assess the performance of a new non-invasive ultrasound-based system for the assessment of
      liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness
      (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis
      extent).
    

Detailed description: 
      The study will enroll adult patients with known chronic liver disease, and referred to a
      hepatology outpatient visit for liver fibrosis assessment.

      Performances will be assessed from correlation coefficients between biomarkers estimated by
      the medical device subject of the research and reference measurements obtained non-invasively
      from other commercially available equipment.

      Repeatability and reproducibility of biomarkers estimations by the medical device subject of
      the research will be assessed from intraclass correlation coefficients.
    

Intervention name(s): Ultrasound liver assessment
Intervention type(s): Device
Intervention description(s): The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Other intervention name(s): Elastography; Ultrasound attenuation; Sound speed
Intervention model: Single Group Assignment
Intervention model description: All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Elastography; Attenuation; Sound speed; Ultrasound
Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
Condition: Submucous Leiomyoma of Uterus
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A prospective randomized study designed to compare the efficacy of transcervical vasopressin
      injection versus vaginal misoprostol in reducing intra -operative blood loss during
      hysteroscopic mymectomy .
    

Detailed description: 
      This was a prospective, randomized, study on forty women with symptomatic submucous myoma
      presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were
      randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and
      (group B) 20patients with vaginal misoprostol is used .
    

Intervention name(s): Misoprostol; Vasopressin
Intervention type(s): Drug; Drug
Intervention description(s): prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy; one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.
Other intervention name(s): Misotac
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to investigate the efficacy, safety and tolerability of
      esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
    

Detailed description: 
      Insomnia is a common complaint or disorder throughout the world. About one third of the
      population in the industrial countries reports difficulty initiating or maintaining sleep,
      resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer
      chronically from their complaints. It has been reported that in patients with chronic
      insomnia lasting longer than six months, 50% had a past or current mental disorder. This
      raises the possibility that treatment of insomnia may reduce the risk for psychological
      conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is
      designed to assess the efficacy and safety of esmirtazapine in patients suffering from
      chronic primary insomnia.
    

Intervention name(s): Esmirtazapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name corn starch), magnesium stearate, and lactose monohydrate.; The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.
Other intervention name(s): ORG 50081
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders
Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy
Condition: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating
      polyneuropathy.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to
      oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at
      least 5 days, patients cross to the alternate therapy for 4 days.
    

Intervention name(s): ,4-diaminopyridine
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: demyelinating neuropathy; neurologic and psychiatric disorders; rare disease
Topical NanoDox® for Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety and clinical efficacy of a novel doxycycline topical
      formulation in subjects with Atopic Dermatitis (AD). The investigators hypothesize that daily
      application of the study drug in AD subjects will reduce severity of the disease, by reducing
      skin driven inflammation and restoring skin barrier function. The investigators will also
      monitor the anti-microbial activity of this product on AD skin, as colonization with Staph
      aureus is typically associated with disease severity.
    

Detailed description: 
      Atopic Dermatitis (AD) is the most common inflammatory skin disease, affecting about 17% of
      children and 6% adults in the USA , . AD is characterized by skin barrier disruption, an
      aberrant adaptive immune response (i.e., Th2 polarized) to environmental allergens,
      susceptibility to cutaneous bacterial infections and intractable itch , . The intense
      pruritus and cutaneous infections contribute to the morbidity of AD and are major drivers of
      the reduced quality-of-life associated with this disease , . In the World Health Organization
      2010 Global Burden of Disease survey, AD has ranked first among common skin diseases . So
      far, AD treatments have targeted inflammation with the widespread use of topical and more
      intermittent use of systemic corticosteroids. In summary, despite its high prevalence,
      effects on quality-of-life and economic burden - there are few effective treatments for AD.

      Doxycycline are tetracycline antibiotics broadly used systemically to treat
      inflammatory-dermatologic conditions. Several studies in human and animal models have shown
      doxycycline have anti-inflammatory and pro-healing properties, mainly by blocking tissue
      proteolytic activity. Doxycycline have been reported to nonselectively inhibit members of the
      metalloproteinases (MMP) superfamily [reviewed in , ]. In addition to this direct inhibitory
      activity, doxycycline indirectly prevents tryptic kallikreins activation by MMPs . Growing
      body of evidence suggests that the tetracycline might also directly downregulate Protease
      Activator receptor (PAR)-2 expression and function, which was also found to play a role in
      induction of local inflammatory mediators . Importantly, the doxycycline antimicrobial
      activity could lead to reduced Staphylococcus infection/colonization in AD skin, a known
      trigger of AD flares
    

Intervention name(s): Nanodox 1% (doxycycline monohydrate hydrogel)
Intervention type(s): Drug
Intervention description(s): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
Intervention MeSH terms: Doxycycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,
      which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets
      for vaccination against lung cancer. In this clinical study, the investigators examine using
      a combination of these three peptides the safety, immunogenicity, and antitumor effect of
      vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced
      non-small cell lung cancer patients whose disease are controlled after any standard
      therapies.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A
      emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.

      The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,
      which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets
      for cancer vaccination against lung cancer. In this phase I/II trial, the investigators
      examine using a combination of these three peptides the safety, immunogenicity, and antitumor
      effect of vaccine treatment for HLA-A*2402-positive advanced non-small cell lung cancer
      patients whose disease are controlled after any standard therapies, but who do not have any
      options for additional standard ones to prevent .future relapse of the disease.
    

Intervention name(s): HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
Intervention type(s): Biological
Intervention description(s): Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether an experimental fluoridated dentifrice is
      effective in the treatment of dental caries
    

Detailed description: 
      Topical fluorides have been proven to be clinically effective in the prevention of dental
      caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by
      decreasing the rate of enamel demineralization and enhancing the rate of enamel
      remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate
      enamel demineralization and remineralization during the caries process. Determination of
      fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of
      fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake
      model will be used to compare the efficacy of experimental dentifrice with a marketed
      dentifrice and placebo dentifrice. Participants wore partial dentures containing two
      partially demineralized enamel specimens for two weeks- 24 hours per day, except when
      brushing (twice daily) with test dentifrice. Following each treatment period, the enamel
      specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy
      technique.
    

Intervention name(s): NaF/ KNO3/isopentane Dentifrice; NaF/KNO3 Dentifrice; NaF Dentifrice; Placebo Dentifrice
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Experimental toothpaste; Experimental toothpaste; Active comparator; Placebo comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: enamel fluoride uptake; erosion; enamel remineralization
ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effectiveness of ULTRACETÂ® (a combination
      analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. AdvilÂ®,
      MotrinÂ® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g.
      CelebrexÂ®).
    

Detailed description: 
      This is a randomized, multicenter, placebo-controlled, double-blind study to evaluate the
      efficacy and safety of ULTRACET® (tramadol 37.5 mg and acetaminophen 325 mg) as add-on
      therapy in rheumatoid arthritis patients taking an NSAID or a COX-2 inhibitor. The patients
      will be randomized into 2 treatment groups: The first group will receive one ULTRACET® tablet
      3 times per day for 7 days. The second group will receive one placebo tablet 3 times per day
      for 7 days. The primary efficacy measurement will be the patients' average daily pain score.
      Safety will be monitored throughout the study. The study hypothesis is that ULTRACET® will be
      well tolerated and the average daily pain relief score for the ULTRACET® treatment group will
      be better than that of placebo group. Patients will take one ULTRACET® tablet or placebo by
      mouth 3 times per day, for 7 days.
    

Intervention name(s): tramadol hydrochloride + acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; NSAID add-on therapy; tramadol; acetaminophen
Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate
      450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg
      extended release tablet under fasting conditions using a single-dose, randomized,
      three-treatment, three-period, six-sequence crossover design.
    


Intervention name(s): Lithium
Intervention type(s): Drug
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In-patient Study in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a placebo-controlled study in both healthy normal subjects and patients with
      Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is
      given for 7 days, and to assess the impact this medication has on various substances in the
      blood. Assessments include repeat blood sampling and monitoring of any side effects.
    


Intervention name(s): exenatide
Intervention type(s): Drug
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; pharmacokinetics; pharmacodynamics