bioihbjkbjnl/mcl2 huggingface dataset:
Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
Condition: Acute Upper Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Observational

Summary: 
      Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of
      Fuganlin Oral Liquid in children with acute upper respiratory infection
    

Detailed description: 
      Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;

      High-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;

      Treatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.

      Research purpose:

        1. Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated
           indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .

        2. Explore the relationship between elevated white blood cells and efficacy, age and
           efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with
           acute respiratory infection.

        3. Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.

        4. Provide data to support the clinical medicine guidelines and labels amendment of
           Fuganlin oral Liquid.
    

Intervention name(s): Low-dose of Fuganlin Oral Liquid; High-dose of Fuganlin Oral Liquid
Intervention type(s): Drug; Drug
Intervention description(s): less than 1 years old: 5mL each time and three times a day
1~3 years old: 10mL each time and three times a day
4~6 years old: 10mL each time and four times a day
7~12 years old: 10mL each time and five times a day; less than 1 years old: 10mL each time and three times a day
1~3 years old: 20mL each time and three times a day
4~6 years old: 20mL each time and four times a day
7~12 years old: 20mL each time and five times a day
Other intervention name(s): No other names; No other names
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 1 to 12 years old with acute upper respiratory infection
      
Keywords: acute upper respiratory infection
Prognostic Factors of Patients With ADHF
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      To explore the prognostic indicators for patients with ADHF
    

Detailed description: 
      According to ESC Guidelines for the diagnosis of acute heart failure 2008, patients with ADHF
      were diagnosed, and their medical history, laboratory examination and treatment plan were
      retrospectively analyzed, and the patients were followed up for 1 year. The 1-year outcomes
      of patients were analyzed to explore the prognostic indicators for patients with ADHF
    

Intervention name(s): elevated monocyte count
Intervention type(s): Other
Intervention description(s): The monocyte count at admission was higher than 0.445×10*9 cells/L
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        ADHF patient diagnosed in the department of cardiovascular medicine in the first affiliated
        hospital of chongqing medical university
      
Keywords: monocyte count; heart failure; acute decompensated heart failure; all-cause death
Mindfulness Therapy in Inflammatory Bowel Disease
Condition: Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual
      control group in patients with bowel disease. Design: randomized controlled trial. Setting:
      Outpatient setting. Population: patients who attended bimonthly check up.
    

Detailed description: 
      Background: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a
      relapsing disease course. Managing the relapsing nature of the disease causes daily stress
      for IBD patients. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based
      psychological program designed to help manage depressive and stress symptoms.

      Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-as usual
      control group in patients with bowel disease.

      Outcome measures: quality of life, inflammatory and stress markers. Design: randomized
      controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly
      check up.
    

Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): Mindfulness-based therapy has been used effectively to treat a variety of physical and psychological disorders, including depression, anxiety, and chronic pain. Recently, several lines of research have explored the potential for mindfulness-therapy in treating somatization disorders, including fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome. Mindfulness-based therapies (MBT) are a clinical application involving the key element of nonjudgmental acceptance of physical pain or psychological distress, thereby reducing the tendency to ruminate over and catastrophise these experiences.
In the present study, we propose a mindfulness intervention of 12 months, with sessions either personalized or online.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mindfulness; quality of life; Bowel Disease
Effect of Extra-curricular Sports Activities After School on Primary School Children's Academic Performance
Condition: Extra-curricular Sports
Study type: Interventional

Summary: 
      The process of urbanization and the rapid development of information technology have greatly
      reduced the space and time available for children's outdoor activities. In this study, we
      expect to study the effects of the addition of physical education classes after school on the
      academic performance, mental health, physical fitness, and myopia among primary school
      children.
    

Detailed description: 
      Urbanization has led to a shrinking of the space suitable for residential activities and a
      dramatic change in the behavioural patterns, which is particularly evident in children. The
      spread and development of information technology has reduced children's time for physical
      activity. Previous studies have found that physical activity is essential for the growth and
      development of adolescents, preventing and reducing obesity, slowing the development of
      myopia, and is closely linked to mental health. However, parents in China are concerned that
      increased outdoor activity will reduce the amount of time spent studying and affect academic
      performance. Currently, there is a lack of strong evidence on the impact of physical activity
      on academic performance. In this study, we propose to provide after-school physical education
      classes for students in primary schools in a rapidly urbanizing area, and assess the effects
      of the intervention on children's academic performance, physical fitness, myopia, and mental
      health to provide evidence for the development of educational programs and arrangements for
      after-school activities.
    

Intervention name(s): Extra-curricular sports
Intervention type(s): Behavioral
Intervention description(s): The group follows the schedule of school teaching programme. Extra-curricular sports classes will be organized and provided in this group of schools in the afternoon after school until 6 p.m. (Monday to Friday).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open,non-inferiority cluster randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: academic performance; physical activity
To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)
Condition: Cornea
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the precision and agreement of the study device, a
      specular microscope, in comparison to a currently commercially available specular microscope
      in establishing substantial equivalence of the two devices in clinical use for diagnostic
      purposes of the human cornea.
    

Detailed description: 
      The observational clinical investigation is intended to measure agreement between two
      diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000
      specular microscope and the control device is the NonCon Robo Pachy (F&A) (CellChek XL)
      specular microscope. Both instruments measure corneal endothelial cell layer parameters
      including cell density, coefficient of variation, percent hexagonality, and central
      thickness.

      The primary variable is the measurement of agreement between the two instruments for the four
      parameters described. The secondary variables include repeatability (intra-investigator) and
      reproducibility both inter-investigator, and inter-instrument.

      Additionally, measurements of agreement will be made on the EM-3000 using automated analysis
      with and without touch-up.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Intervention is observational to two different diagnostic devices for which comparative readings of the corneal endothelium are being measured; the test device- the EM-3000 Specular Microscope against the Konan Robo-pachy F&A Specular Microscope.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study plan calls for 75 subjects divided into three sub-groups, young healthy (18-50
        yrs), older healthy (51-80 yrs), and pathologic adults (29-80 years).
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and
      Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight
      rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted
      subjects with moderate and severe hepatic impairment.
    

Detailed description: 
      A maximum of 24 subjects will be studied at multiple sites in the Unites States. Eight
      subjects with normal hepatic function and 8 subjects with moderate hepatic impairment will be
      enrolled on Cohort 1 and an additional 8 subjects with severe hepatic impairment may be
      enrolled in Cohort 2. The severity of hepatic impairment will be assessed according to the
      Child-Pugh-Turcotte (CPT) score1 (see Table 4-2). Because CMX001 is highly protein-bound, to
      avoid confounding the PK assessment of hepatic impairment versus hypoalbuminemia, only
      patients with serum albumin levels >3 g/dL will be enrolled in this study.

      Potential subjects will be screened to assess their eligibility to enter the study within 28
      days prior to Check-in.

      Subjects who have met inclusion and exclusion criteria will check in to the clinic on Day -1
      and receive a single oral dose of CMX001 (2 mg/kg of ideal body weight rounded to the closest
      20 mg) on Day 1. The study design schematic is presented in Table 4-3. Subjects will be
      discharged from the clinic on Day 2 (if stable in the opinion of the Investigator), return
      for outpatient visits on Days 3 through 6 for safety assessments and PK sampling, and return
      for an End of Study Visit on Day 14 ± 2 for safety assessments. Subjects may be confined to
      the clinic during the period of Day -1 to Day 6 at the discretion of the Investigator, after
      discussion with the Medical Monitor.
    

Intervention name(s): CMX001
Intervention type(s): Drug
Intervention description(s): single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg
Other intervention name(s): Brincidofovir; BCV
Intervention MeSH terms: Brincidofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hepatic impairment
Pedometers for Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized
      during pregnancy, develop diabetes within 5 years after delivery. Although intensive
      interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is
      unknown if such strategies would be effective in women with GDM. Women with recent GDM, even
      though no longer pregnant, face significant barriers to lifestyle modification, including
      caregiving responsibilities and low perception of risk. Web-based programs can reinforce
      physical activity through visual feedback of pedometer output, tailored messaging, education,
      and on-line communities. Such a program is currently available for adults with chronic
      disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus
      group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to
      women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based
      pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot
      and feasibility study of the program. The intervention will last 12 weeks.
    


Intervention name(s): Stepping Up to Health
Intervention type(s): Behavioral
Intervention description(s): Internet-mediated pedometer-based intervention with gradually increasing goals and feedback on step counts. Also includes educational content targeted at women who have had gestational diabetes about exercise, diet & nutrition and prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GDM; gestational diabetes; pregnancy; diabetes; walking; exercise; pedometer; online
Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
Condition: Type 1 Diabetes; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study is to clarify the current diabetic status, including development
      of complications, in a nationwide cohort of type 1 diabetics, who were last examined together
      in a large study in 1995. These youngsters were originally participating in a nationwide
      study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to
      establish risk factors for developing diabetic retinopathy. The investigators will have
      emphasis on retinal vessel geometry and the possibilities for early detection of reversible
      retinal changes, and prediction of other vascular complications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study includes a cohort of type 1 diabetic patients, who originally were identified in
        21 paediatric departments and studied in 1986. This group initially consisted of 1033
        children and was estimated to involve around 80 percent of all Danish type 1 diabetic
        patients below the age of 18. In 1995 further examinations were performed on the cohort;
        this time 339 chose to participate.

        In this study we will invite the participants from 1995 who also participated in the eye
        examinations, n=324, to participate in yet another follow-up examination.
      
Biospecimen description: 
      buffy coat, whole blood, urine
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
      therapy in treating patients who have head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent
      radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high
      risk of recurrence following curative resection. II. Determine the efficacy of this regimen
      in these patients. III. Determine the survival of these patients treated with this regimen.

      OUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days
      1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is
      administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years,
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18 months.
    

Intervention name(s): cisplatin; fluorouracil; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Fluorouracil
Primary purpose: Treatment
Keywords: stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage I squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx
Effect of tACS Stimulation on Alpha Oscillations
Condition: Healthy
Study type: Interventional

Summary: 
      Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated
      to enhance alpha oscillations in healthy participants by applying weak electrical currents to
      the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced
      frontal alpha oscillations, EEG recordings, and other physiological and biological measures.
    


Intervention name(s): XCSITE100 Stimulator tACS; XCSITE100 Stimulator Sham
Intervention type(s): Device; Device
Intervention description(s): Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.; The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
Other intervention name(s): tACS; Sham tACS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will receive sham stimulation or 10 Hz tACS stimulation at two separate sessions. The order will be randomized (ie, half the participants will receive sham stimulation at the first session and 10 Hz tACS stimulation at the second session, and the other half will receive 10 Hz tACS stimulation at the first session and sham stimulation at the second session).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
Condition: Postoperative Pain Management; Total Knee Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of
      intrathecal morphine for patients after total knee arthroplasty.
    

Detailed description: 
      A single-dose spinal anesthesia combining with morphine for total knee arthroplasty (TKA) is
      a simple, economical anesthetic technique commonly used in our hospital. Still some patients
      could not get effective postoperative pain control. Pregabalin, an anticonvulsant, has been
      shown to reduce acute pain after molar extraction, laparoscopic cholecystectomy, and reduce
      postoperative morphine requirement after total hip arthroplasty, and celecoxib, a selective
      cyclo-oxygenase (COX) - 2 inhibitor, with perioperative prescription is successfully reduces
      pain score and opioid consumption after TKA under spinal anesthesia alone. However, no
      clinical study has yet investigated whether preoperative single-dose of pregabalin, celecoxib
      or in combination compared to placebo can improve analgesic efficacy of intrathecal morphine
      after TKA. The primary objective of this study was to evaluate whether these medications
      could reduce pain scores at rest / when movement and morphine requirement after TKA under
      spinal anesthesia with intrathecal morphine. Secondary outcome assessed include adverse
      effects, anxiety score and patients' satisfaction score.
    

Intervention name(s): Pregabalin; Celecoxib; Pregabalin with celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral single-dose of pregabalin (150 mg) and placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.; Oral single-dose of celecoxib (400 mg) and placebo(C)1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.; Oral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.; Oral single dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg
Other intervention name(s): Pregabalin: Lyrica; Celecoxib: Celebrex; Pregabalin: Lyrica; Celecoxib: Celebrex; Placebo: sugar capsule
Intervention MeSH terms: Celecoxib; Pregabalin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregabalin; Celecoxib; Intrathecal morphine; Total knee arthroplasty