bioihbjkbjnl/mcl2 huggingface dataset:
Remifentanil for Smooth Emergence in Elderly Patients
Condition: Drug Usage
Study type: Interventional
Phase: Phase 4

Summary: 
      Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually
      need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was
      to investigate the optimal effect-site concentration of remifentanil for preventing cough
      during emergence in elderly patients under sevoflurane and remifentanil anesthesia.
    


Intervention name(s): Remifentanil; Remifentanil; Sevoflurane
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in elderly patients (65-80 years) .; Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in adult patients (20-60 years) .; Anesthesia was maintained with sevoflurane with 1.5-2.0 vol% in air/50%oxygen mixture, and sevoflurane was adjusted to about 1.0 vol% 10 min before end of surgery.
Other intervention name(s): Ultiva; Ultiva
Intervention MeSH terms: Remifentanil; Sevoflurane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: tracheal extubation; remifentanil
Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet
Condition: Flexible Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficay of functional plantar orthoses on
      flatfoot in children.
    

Detailed description: 
      There's a considerable controversy regarding the effectiveness of plantar orthoses in the
      treatment of flexible flat foot, despite being the most widely used treatment. Several
      studies tried to investigate the correction of the deformity using plantar orthoses, but
      there are few studies with a control group of people, not enough to compare the effectiveness
      of the treatment.

      A randomized, double-blind, parallel design clinical trial was conducted with two study
      groups. The sample consisted of 61 children, aged 3 and 4 years old, who were randomly
      assigned to each study group. One group (intervention group) received treatment with
      functional plantar orthotics, and the other group (control group) received treatment with
      placebo-type plantar orthotics, to use as a reference or comparison. Both groups were
      followed for a one-year period. Before delivering the treatment, all subjects underwent
      dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences
      in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre
      and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed
      as a statistical test.
    

Intervention name(s): Plantar orthoses
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Flatfoot; orthoses; children
Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit
Condition: Body Massage Oil From Snake Fruit; Facial Mask From Snake Fruit; Jelly From Snake Fruit
MeSH terms: Facies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study consisted of three sub-studies including 1) development and evaluation of body
      massage oil from Snake fruit on skin moisture, elasticity, oiliness, and melanin in healthy
      participants 2) development and evaluation of facial mask from Snake fruit on skin moisture,
      elasticity, oiliness, and melanin in healthy participants and 3) development and evaluation
      of ready-to-drink jelly from Snake fruit on controlling blood glucose and endurance time in
      healthy participants.
    

Detailed description: 
      Study 1: senventy-one male and female participants, aged 23.99 ± 5.68 years were randomly
      assigned into 3 groups including 1) control group (n = 23): participants received Thai
      massage without any oil for 1 hour/day, 1 day/week for 12 weeks 2) treatment-1 group (n =
      23): participants received Thai massage with pure coconut oil which is a popular oil used in
      spa for 1 hour/day, 1 day/week for 12 weeks and 3) treatment-2 group (n = 25): participants
      received Thai massage with oil mixed with Snake fruit extract for 1 hour/day, 1 day/week for
      12 weeks.

      Study 2: fifty-nine male and female participants, aged 23.39 ± 4.84 years were randomly
      assigned into 2 groups including 1) control group (n = 29): participants did not receive any
      facial mask for 12 weeks and 2) treatment group (n = 30): participants received home-based
      program facial mask with Snake fruit extract for 30 min/day, 2 days/week for 12 weeks.

      Study 3: this study was divided into 2 sub-stidies. Study 3.1: twenty-five male and female
      participants, aged 22.60 ± 3.33 years were randomly consumed with either control jelly or
      jelly with Snake fruit juice at 3.5 g/kg body weight. All participants were analyzed for
      blood glucose level before consumption and after consumption at 30, 60, 90, and 120 min.
      Study 3.2: twenty-three male and female participants, aged 21.57 ± 1.88 years were randomly
      consumed with either control jelly or jelly with Snake fruit juice at 3.5 g/kg body weight.
      After each consumption, all participants performed leg cycling at intensity 60% of maximal
      oxygen consumption as long as tolerance (time to exhaustion test).
    

Intervention name(s): Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice
Intervention type(s): Other
Intervention description(s): Interventions among the 3 studies were categorized as other.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study 1 and 2 were parallel model, study 3 was crossover model.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational [Patient Registry]

Summary: 
      This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin
      in patients with acute myocardial infarction.
    

Detailed description: 
      Dendritic cells (DCs) are the most potent antigen-presenting cells, with the unique ability
      to initiate a primary immune response to certain antigens by activation of "naive" T cells,
      and are actively related to the process of atherosclerosis. Two DC subsets, myeloid DCs
      (mDCs) and plasmacytoid DCs (pDCs), were identified in humans. In our previous study, the
      investigators found that change of dendritic cells and fractalkine in patients with acute
      myocardial infarction. At the same time, the level of P-selectin increased. In addition, the
      interaction of dendritic cells and P-selectin promotes the progress of atherosclerosis. In
      this study, the investigators want to see whether the balance between mDCs and pDCs is
      altered in patients with acute myocardial infarction. sP-selectin is one of the members of
      the family of proteins, mediate leukocyte adhesion and rolling in vascular endothelial,
      studies have shown that in patients with unstable angina and acute myocardial infarction in
      serum sP-selectin protein increased significantly, showed that sP-selectin associated with
      the activity of coronary heart disease, causing plaque instability.However, there is few
      relevant studies about the relationship of dendritic cells and P-selectin in patients with
      acute myocardial infarction. This study valuates the relationship of dendritic cells and
      P-selectin in patients with acute myocardial infarction
    

Intervention name(s): measurement
Intervention type(s): Other
Intervention description(s): Blood is obtained into ethylene diamine tetraacetic acid（EDTA） tubes from all subjects via antecubital vein puncture to measure the number of dendritic cells(DCs) and the concentration of sP-selectin. The number of dendritic cells(DCs) and the concentration of sP-selectin are measured in all patients with STEMI at 0 and 5-7 days after admission. The number of dendritic cells(DCs) and the only once in control group after admission.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with STEMI.
      
Keywords: dendritic cells; P-selectin
Effects of Whole-Body Vibration on Balance in the Elderly Population
Condition: Distorted; Balance
Study type: Interventional

Summary: 
      The goal of this pilot study is to test whether in the elderly population there are acute
      long-term improvements in both the static and dynamic balance, reaction time and mobility
      with the use of WBV.
    

Detailed description: 
      Exercise therapy plays an important role in health promotion, preservation of physical
      function and in preventing loss of independence among the elderly. They work beside an
      improvement in balance, a positive effect on metabolic and cardiovascular disorders, reducing
      falls, osteoporosis, colon cancer, breast cancer, depression, anxiety, and the general
      well-being. There is preliminary evidence to indicated that balance, and strength can be
      trained in the elderly using whole-body vibration (WBV) therapy. The use of WBV in the
      elderly population has shown to be a simple and effective treatment in the areas of balance
      and mobility. It would be very desirable to investigate these factors further in order to
      provide evidence for the delivery of sustainability of training methods.
    

Intervention name(s): Stochastic resonance whole-body vibration A; Stochastic resonance whole-body vibration b
Intervention type(s): Device; Device
Intervention description(s): over four weeks, three times a week with 5 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.; over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 5 Hz, Noise 4.
Other intervention name(s): Zeptor med ®; Zeptor med ®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: whole-body vibration; stochastic resonance Therapy; static balance; balance, mobility; elderly, reaction time; The focus of the study is effect of SRT on postural balance
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Condition: Vital Sign Evaluation
Study type: Observational

Summary: 
      Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform
      Description This single-arm cohort, open-label, and multi-center study is designed to
      evaluate the accuracy of a web-based application designed for measurements of vital signs
      including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to
      the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).
    


Intervention name(s): Informed Vital Core App
Intervention type(s): Device
Intervention description(s): All subjects assigned to a single arm, pulse rate measurement will be collected, calculated, and displayed on the web based application. A conventional ECG device will also be used to collect and display the heart rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web based application.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will recruit subjects from clinics and hospitals and the general public.
        Enrollment of 85 subjects with an age range of 22-85 years of age with a wide range of skin
        tone categorization per the Fitzpatrick Scale ranging from 1-6.
A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn about the pharmacokinetics, safety and
      tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants.
      CTB+AVP is a study medicine that is being developed to treat people with complicated urinary
      tract infections.

      This study is seeking healthy adult male and female participants, 18-60 years of age, with a
      body weight > 50 kg and a BMI of 17.5 to 30.5 kg/m2.

      Participants in Part-1 of the study will receive increasing single doses of CTB and/or AVP.
      Participants in Part-2 will receive increasing multiple doses of CTB+AVP three times a day
      for 7 days. The study team will monitor how each participant is doing with the study
      treatments via close monitoring in an in-patient setting. Experiences of people receiving
      CTB+AVP will be compared to those of people who do not. This will help determine if CTB+AVP
      is safe and well-tolerated at each dose of the study medicine.

      Participants will take part in this study for a maximum of 12 weeks for Part-1 (up to 4 weeks
      for screening, up to 3 weeks of taking study medicine and up to 5 weeks for safety follow-up
      visit) and for a maximum of 10 weeks for Part-2 (up to 4 weeks for screening, up to 1 week of
      taking study medicine and up to 5 weeks for safety follow-up visit). During the duration of
      the study, blood samples for study medicine levels, and various measures for monitoring
      safety such as blood samples for clinical laboratory measurements, electrocardiograms and
      vital sign measurements will be taken.
    

Detailed description: 
      This is a 2-part study in healthy male and female adult participants.

      Part-1 is to evaluate safety, tolerability and pharmacokinetics (PK) of 3 planned and 2
      optional doses in 8 participants, in a 5-period sequential single dose design.

      Part-2 is to evaluate safety, tolerability and PK of 1 planned and 2 optional cohorts in 8
      participants each, in a multiple dose sequential design, with 7 days of repeated every 8
      hours (q8h) dosing in each cohort. In addition, 2 optional cohorts in 6 participants each of
      Japanese descent and Chinese descent will also receive multiple doses of CTB+AVP repeated
      every 8 hours (q8h) for 7 days.
    

Intervention name(s): Placebo; PF-07612577; PF-06264006
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; PF-07612577; PF-06264006
Other intervention name(s): Placebo comparator; CTB+AVP; ceftibuten (CTB)
Intervention MeSH terms: Ceftibuten
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study designed to characterize the plasma pharmacokinetic (PK) profile of CORT125134 in
      healthy subjects receiving once-daily oral administration of the current capsule formulation
      of CORT125134 for 14 days.
    

Detailed description: 
      Initially, subjects will be enrolled into 2 cohorts each of 8 subjects (Cohort 1 and Cohort
      2) to receive CORT125134 at 150 mg or 250 mg, respectively. Data from Cohorts 1 and 2 will be
      evaluated to select dose levels for Cohort 3 and optional Cohort 4.

      The secondary objective of the study is to characterize the plasma PK profile of CORT125134
      metabolites in healthy subjects receiving once-daily oral administration of the current
      capsule formulation of CORT125134.
    

Intervention name(s): CORT125134 150 mg; CORT125134 250 mg; CORT125134 dose to be determined
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CORT125134 150 mg (3 X 50 mg current capsule formulation); CORT125134 250 mg (5 X 50 mg current capsule formulation); CORT125134 current capsule formulation, dose to be determined
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Assessment of the Safety and Efficacy of the Dermal Filler "mARG-01-17" in Facial Rejuvenation Therapy
Condition: Facial Rejuvenation
MeSH terms: Facies
Study type: Interventional

Summary: 
      The aim of the clinical investigation is to evaluate the performance of the mARG-01-17 dermal
      filler in the context of its efficacy and safety.
    

Detailed description: 
      The study is an open-label uncontrolled single-center study for the evaluation of the
      Performance (efficacy and safety) of the dermal filler "mARG-01-17" in the facial
      rejuvenation therapy. The design is of a not blinded, not randomized, single group.
    

Intervention name(s): mARG-01-17 (mesohyal AGRIBENONE)
Intervention type(s): Device
Intervention description(s): Dermal Filler
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Environmental Triggers Of Cardiometabolic Disease
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Study type: Observational

Summary: 
      The investigators posit that a multi-national collaborative effort with focused
      investigations in environments with the highest levels of exposure (developing countries such
      as China and India), are likely to provide new and much needed data on the risk posed by
      these variables on an individuals life-time risk for type 2 diabetes and cardiovascular
      complications. The investigators will test this hypothesis through the establishment of a
      network that would lead studies on the links between exposure and adverse Chronic
      cardiometabolic effects and propose doing this in this as part of 3 specific aims.
    

Detailed description: 
      In aim 1, the investigators propose to establish feasibility of such an effort in Beijing,
      China, an effort that will involve implementation of novel exposure assessment methodologies
      simultaneously with the ability to execute key surrogate outcome measures of importance in
      cardiovascular risk with CM diseases. In Aim 2, the association between functional
      cardiovascular risk variables [insulin sensitivity, Blood Pressure, endothelial function] and
      acute and sub-acute variations in personal black carbon and ambient particulate matter 2.5
      levels among 50 individuals with the chronic cardiometabolic syndrome will be investigated.
      In Aim 3, the investigators will examine potential biologic pathways of importance in the
      proposed functional outcomes. Specifically the investigators will determine the association
      between ambient particulate matter 2.5 levels and alterations in adipocytokines/inflammatory
      variables and autonomic nervous system balance.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from clinics affiliated with the Fuwai Hospital, PUMC. The
        participants will be nonsmokers with cardiometabolic disease, that are not taking
        anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that alter
        baseline insulin sensitivity, blood pressure, or endothelial function, daily use of NSAIDS
        is not allowed.
      
Keywords: cardiometabolic disease
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate,
      xinafoate and acetate) in patients with asthma.
    


Intervention name(s): Indacaterol maleate 400 μg; Indacaterol acetate 400 μg; Indacaterol xinafoate 400 μg; Placebo to indacaterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.; Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.; Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.; Placebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler.
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: QAB149; asthma; indacaterol salts (acetate, maleate, and xinafoate); orally inhaled indacaterol salts; persistent asthma