bioihbjkbjnl/mcl2 huggingface dataset:
Electrical Stimulation in Patients With Unipolar Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive
      Disorder. The primary objective is to assess the safety and tolerability of eTNS (external
      trigeminal nerve stimulation) of the V1 branch of the trigeminal nerve as an adjunctive
      treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).
    


Intervention name(s): Stimulation of the trigeminal nerve (active stimulation); Placebo stimulation of the trigeminal nerve (placebo)
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks. the duration of the open label trial will be more 24 weeks.; Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.
Other intervention name(s): Electrical Stimulation; Sham Eletrical Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Electrodes, Implanted; Electric Stimulation Therapy
Vitamin D Level and Emergence Delirium in Children
Condition: Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Observational [Patient Registry]

Summary: 
      In our study, we aimed to evaluate the relationship between vitamin D levels and
      postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy.
    

Detailed description: 
      Patients are assigned to one of two groups. Serum 25(OH)D level will be determined as <12
      ng/ml group 1, group 2 with ≥12 ng/ml. ASA I-II children aged 2-10 years who will undergo
      adenoidectomy and/or tonsillectomy surgery under general anesthesia will be included in the
      study. In the operating room, the patient will monitored using electrocardiography, pulse
      oximetry, noninvasive blood pressure measurements, capnography. Under anesthesia, blood
      samples were taken for serum 25(OH)D levels. After extubation, patients will be taken to the
      recovery room. Delirium will be evaluated using the PAED (Pediatric Anesthesia Emergence
      Delirium) scale at 10-minute intervals in the recovery unit. In our study, 25(OH)D level was
      measured.
    

Intervention name(s): PAED
Intervention type(s): Diagnostic Test
Intervention description(s): Delirium positive or negative
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This was a prospective, single-center, double-blind, randomized study. The primary outcome
        was the presence or absence of presenting delirium with or without vitamin d deficiency.

        Secondary outcomes, postoperative additional need analgesia. Children aged 2-10 years, ASA
        (American Society of Anesthesiologists) physical I or II scheduled for tonsillectomy were
        eligible, with or without adenoidectomy.
A Study of Adavosertib as Treatment for Uterine Serous Carcinoma
Condition: Uterine Serous Carcinoma
MeSH terms: Carcinoma; Cystadenocarcinoma, Serous
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2b study aims to evaluate the efficacy and safety of adavosertib, an inhibitor of
      the tyrosine kinase WEE1, in subjects with recurrent or persistent uterine serous carcinoma
      (USC) who have previously received at least 1 prior platinum-based chemotherapy regimen for
      the management of USC.
    

Detailed description: 
      This Phase 2b, open-label, single-arm, multi-center study will assess the efficacy and safety
      of adavosertib in eligible subjects with histologically confirmed recurrent or persistent
      USC, evidence of measurable disease as per Response Evaluation Criteria in Solid
      Tumors.(RECIST) v1.1, and who have received at least 1 prior platinum-based chemotherapy
      regimen for the management of USC. Subjects with carcinosarcomas are not eligible.
    

Intervention name(s): Adavosertib
Intervention type(s): Drug
Intervention description(s): The subjects will receive oral adavosertib 300 mg, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
Other intervention name(s): AZD1775
Intervention MeSH terms: Adavosertib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adavosertib; Phase 2b; open-label; single-arm
High-activity Natural Killer Immunotherapy for Small Metastases of Nasopharyngeal Cancer
Condition: Metastatic Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of high-activity natural killer
      immunotherapy to small metastases of nasopharyngeal cancer.
    

Detailed description: 
      By enrolling patients with small metastases of nasopharyngeal cancer adapted to enrolled
      criteria, this study will document for the first time the safety and the short and long term
      efficacy of high-activity natural killer cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): High-activity natural killer
Intervention type(s): Biological
Intervention description(s): Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Nasopharyngeal Cancer; High-activity natural killer
Study of COR388 HCl in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human
      trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.
    


Intervention name(s): COR388; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as oral capsule; Administered as oral capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution
      volume (VT), after phenelzine treatment and if so to what extent.
    

Detailed description: 
      Subjects will receive a PET and MRI scan before and after treatment with phenelzine.
    

Intervention name(s): phenelzine treatment
Intervention type(s): Other
Intervention description(s): Subjects will have a PET and MRI scan before and after treatment with phenelzine.
Intervention MeSH terms: Phenelzine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Positron Emission Tomography (PET); MAO-B
Cayenne Pepper Cataplasm - Effect Study
Condition: Back Pain; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since
      1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal
      cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as
      natural medications to treat painful or aching areas in the case of acute or chronic back
      pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC)
      application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used
      to treat musculoskeletal conditions of pain especially of the low back.

      Therefore, the aim of the present study was to test effects of a series of ten applications
      of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature,
      skin sensory functions, pain threshold, and proprioception. Placebo control condition (0%
      cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application
      of a CPC will have significant effects on the measured parameters.

      40 subjects will be randomized into Treatment/control group.
    


Intervention name(s): Cayenne Pepper Cataplasm; Placebo Cataplasm
Intervention type(s): Other; Other
Intervention description(s): Poultice of Kaolin, Cayenne Peppfer (5%) and Water; Poultice of Kaolin and Water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
At-Home Gait Assessment
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The goal of this study is to validate an MS Gait Remote Capture and Analysis (MS-GRCA) system
      based on wearable shoe-based motion sensors for home-based and repeatable gait assessments.
    

Detailed description: 
      This is a single-site observational longitudinal study to validate an MS Gait Remote Capture
      and Analysis system for home-based and repeatable gait assessments. The investigators will
      recruit 30 participants who will have an in-person baseline visit (informed consent, standard
      gait assessment, sensor-based gait assessment, self-reported questionnaires), followed by
      three remote visits (sensor-based gait assessment, SUS questionnaire [last remote visit
      only]).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults (ages 18-70) diagnosed with MS, any subtypes (Relapsing Remitting, Primary
        Progressive, or Secondary Progressive MS).
      
Keywords: Gait Analysis; telehealth; sensor-based gait analysis; home-based
Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked
      pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.
    


Intervention name(s): PF-06372865 (65mg); PF-06372865 (15mg); Pregabalin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single oral dose (65 mg); single oral dose (15mg); single oral dose (300mg); matching oral placebo
Intervention MeSH terms: Pregabalin; PF-06372865
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pain; evoked pain; healthy volunteer; pharmacodynamics
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate
      (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of
      age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days
      at minimum and eligibility for inclusion in this study will be assessed. Following the
      observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week
      double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2
      weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse
      events (AEs), will be evaluated. A 30-day follow-up visit will take place after the
      completion (or discontinuation) of the 2-week treatment period, to confirm presence or
      absence of serious adverse events (SAEs) and trial procedure-related AEs.
    


Intervention name(s): Mometasone furoate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug is MFNS (50 μg spray device) and the dose will be:
5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks; MF Placebo nasal spray and administration will be as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks
Other intervention name(s): Nasonex
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Multivariate MRI Maps of Body Awareness
Condition: Attention
Study type: Observational

Summary: 
      Meditation skills, or paying attention to internal mental states, are thought to improve
      people's health. This study is developing a new brain measure of meditation skills, called
      the EMBODY Task, using functional magnetic resonance imaging (fMRI). The investigators are
      testing whether pattern recognition methods can be applied to fMRI data to identify mental
      states during meditation, including attention to the body and to thoughts. This task is being
      developed in meditation practitioners and non-meditators. The goal is to understand what
      people are paying attention to during meditation using brain data. The investigators
      hypothesize that pattern recognition technology will be able to identify different mental
      states that occur during meditation.
    

Detailed description: 
      The investigators are developing a new functional magnetic resonance imaging (fMRI) task (the
      EMBODY Task) to measure mental states during meditation using pattern recognition or machine
      learning technology. This task is being piloted and validated in 20 meditators and 20 control
      participants, in two waves of pilot testing. Meditators will have practiced meditation for at
      least the 5 years, at least 90 minutes weekly. Control participants will have little to no
      meditation experience and will be age- and gender-matched to each meditator. All participants
      will be MRI-compatible, healthy with no health conditions that affect breathing, have no
      current psychiatric disorder, and not be taking psychotropic medications.

      In the EMBODY Task, participants will be instructed to pay attention to areas of the body,
      their thoughts, sounds in the scanner, and to stop paying attention, in short intervals
      (16-45s). They will also meditate on their breath for 10 minutes. The investigators will
      determine whether pattern recognition technology can distinguish 5 mental states, and whether
      these brain patterns can be used to identify mental states during meditation. The
      investigators hypothesize that all 5 mental states will be distinguished by pattern
      recognition in the meditators, and potentially in the controls. Investigators also
      hypothesize that meditators should pay attention to their breath longer during meditation
      compared to controls.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study is designed for healthy adults, some of whom have extended meditation practice
        (at least 5 years), and some who have little or no meditation experience.
      
Keywords: attention; interoception; meditation; mind wandering
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in
      patients with Diabetic Foot Ulcer, compared to placebo therapy.
    

Detailed description: 
      Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional,
      Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center
      Study
    

Intervention name(s): ALLO-ASC-DFU; Vehicle sheet
Intervention type(s): Biological; Procedure
Intervention description(s): Application of ALLO-ASC-DFU sheet to diabetic foot ulcer; Application of Vehicle sheet to diabetic foot ulcer
Other intervention name(s): Hydrogel sheet containing allogenic mesenchymal stem cells; Hydrogel sheet without Allogenic mesenchymal stem cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pilot and Feasibility Study of Mobile-Based Asthma Action Plans
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and
      University of Arkansas for Medical Sciences Center for Distance Health will collaborate to
      develop a mobile-based Asthma Action Plan application to improve asthma self-management
      skills specifically targeting adolescents. The investigators hypothesize that an interactive,
      mobile-based asthma action plan will be a feasible means of reinforcing long-term asthma
      management guidelines as well as delivering acute management instructions to adolescents with
      asthma.
    

Detailed description: 
      A written Asthma Action Plan from a healthcare provider is one of the key features of asthma
      self-management recommended by the National Asthma Education and Prevention Program asthma
      guidelines; guidelines-based asthma care has not yet fully translated to the community
      despite the fact that National Asthma Education and Prevention Program released the first set
      of national guidelines nearly 2 decades ago. Previous reports have proven that patients with
      an Asthma Action Plan have better outcomes including fewer acute healthcare utilization
      visits, fewer days missed from school, and improved symptoms scores compared to patients
      without an Asthma Action Plan. Recently, mobile-based phone applications and music file (MPEG
      layer 3)(MP3) players have been utilized in the management of chronic diseases such as asthma
      and diabetes to provide medication reminders and to provide alternatives to paper dairies for
      logging symptoms or other health-related data such as peak flow readings or blood glucose
      readings. We propose to design an application that will fully meet the recommended
      individualized Asthma Action Plan treatment plan as recommended by national guidelines and
      will also provide participants with medication reminders, education tips, and data
      logging/tracking capabilities.
    

Intervention name(s): Mobile-based Asthma Action Plan
Intervention type(s): Other
Intervention description(s): The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth "rotating" message will be sent twice weekly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Mobile based applications; Asthma action plan; Self Efficacy
Iontophoresis With Potassium Iodide and Thyroid Function
Condition: Thyroid Dysfunction
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      The aim of the study: To assess the influence of iontophoresis treatment with 2% potassium
      iodide on the level of thyroid hormones (TSH, FT3, FT4) The study group: conducting 10
      iontophoresis treatments with Potassium iodide; The control group: conducting 10 placebo
      treatments with iontophoresis with destilled water; Intervention: 10 iontophoresis treatments
      with 2% potassium iodide in healthy individuals.

      Test the level of thyroid hormones before and after the 10 iontophoresis treatments; The
      study allows to assess the influence of iodine on the function of thuroid gland.
    


Intervention name(s): Iontophoresis with 2% potassium iodide
Intervention type(s): Procedure
Intervention description(s): 10 iontophoresis treatments with 2% potassium iodide on the area of thyroid gland; electrodes with tin foil (Amperage:2mA, duration: 30min)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Iontophoresis; potassium iodine; thyroid