bioihbjkbjnl/mcl2 huggingface dataset:
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM)
      on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope
      to learn about how continuous glucose monitoring affects glycemic variables and
      diabetes-related distress.
    

Detailed description: 
      Synopsis of study protocol

      This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on
      CGM (the intervention group) versus those who are not (the control group). The investigators
      will examine group differences over a 6-month period (Phase 1) on two sets of outcomes:
      psychosocial variables and glycemic variables. After the initial comparison of intervention
      to control across the first six months after diagnosis, the investigators will conduct a
      longitudinal follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18
      months. The CGM system used in this study is the Dexcom G5 System with the Share function
      (FDA Approved). An IDE was obtained to use this system in a non-adjunctive manner.
      Participants will complete Phase 1 in six months. Phase 2 includes 3 more assessments
      conducted every six months until participants are two years post-diagnosis.

      Study Procedures

      Participants will be recruited at two centers: Stanford University and the Barbara Davis
      Center for Diabetes, University of Colorado. Participants will be enrolled while inpatient or
      within 1 month of diagnosis. Once identified, study staff will approach potential
      participants to explain the study, determine eligibility, and obtain informed consent. Once
      enrolled in the study, participants will be randomized. Participants will be randomized at a
      2:1 ratio, intervention to control. The investigators will also stratify by age group to
      ensure equal representation of ages across groups. The age groups (in years) are 2-6, 7-11,
      and 12-17. To ensure safety in the youngest group, recruitment of participants in the age 2-6
      years group will not begin until the investigators have at least 2 weeks of non-adjunctive
      CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on
      these 3 participants and if deemed safe by the DSMB, the investigators will start enrolling
      participants in the youngest age group.
    

Intervention name(s): CGM at diagnosis of T1D
Intervention type(s): Device
Intervention description(s): Initiation of non-adjunctive CGM use at diagnosis of T1D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Longitudinal Mixed Study on the Change Track of Sleep Quality in Critically Ill Children
Condition: Critical Illness; Child; Sleep Disorder
MeSH terms: Sleep Wake Disorders; Critical Illness
Study type: Observational

Summary: 
      This research adopts the uniform parallel hybrid research design; The quantitative data and
      qualitative data were collected at the same time, and then the quantitative and qualitative
      data were analyzed respectively. Finally, the two data sets were combined. Comprehensive
      interpretation of the study issues through complementarity and mutual validation of
      quantitative and qualitative data.
    

Detailed description: 
      With the progress and development of medical technology, the mortality rate of critically ill
      children continues to decline. To improve the long-term prognosis of children has become a
      new goal of modern medicine. Sleep disorders in critically ill children are caused by disease
      factors, the complex environment of ICU, and various treatment factors, which have seriously
      affected the patient's rehabilitation and long-term quality of life. Attention should be paid
      to the sleep disorders in critically ill children. At present, the research on sleep
      disorders in critically ill patients in China is mostly focused on adults, and the critically
      ill children are rarely involved, and there is no research related to sleep disorders and
      recovery tracks of critically ill children. This prospective longitudinal mixed study aims to
      describe the change trajectory of sleep disorder and recovery in critically ill children and
      provide suggestions for subsequent clinical workers to formulate reasonable intervention
      measures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        3-12 years chlidren who are conscious in ICU
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Condition: Periodontitis; Diagnose Disease
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of
      inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated
      with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4
      (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in
      patients with periodontitis and healthy subjects
    

Detailed description: 
      20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals
      (control;C) were included in this study. Clinical periodontal parameters were measured.
      Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent
      assay.
    

Intervention name(s): Saliva and serum sampling
Intervention type(s): Other
Intervention description(s): Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes.
Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inflammation resolution; periodontitis; cell apoptosis
Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Condition: Lung Diseases, Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the Aridol (mannitol) challenge test can
      predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will
      undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The
      effect on lung function and quality of life will then be measured and correlated with the
      Aridol test result.
    


Intervention name(s): Dry powder mannitol; Budesonide 400mcg administered via turbuhaler; Ipratropium bromide 80mcg; Salbutamol 400mcg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Budesonide; Mannitol; Bromides; Albuterol; Ipratropium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
ETOILE : A Feasibility Study in Pediatric Patient Education
Condition: Leukemia, Lymphoblastic
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      Feasibility study of a therapeutic education program for the patient and his carers, intended
      for children suffering from acute lymphoblastic leukemia or having received an allograft of
      hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital (
      Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will
      be assessed.
    

Detailed description: 
      This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized,
      mono-centric type. Feasibility is assessed on process criteria (adoption, reach
      implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of
      patients and their caregivers, before, after and at a distance from education. Patients'
      anxiety levels will also be assessed before, after and at a distance from the program. The
      level of health literacy will be assessed at the start of the study.
    

Intervention name(s): ETOILE therapeutic education
Intervention type(s): Behavioral
Intervention description(s): ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: therapeutic education
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of
      single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by
      a continuous subcutaneous infusion in subjects with Parkinson's disease.
    


Intervention name(s): ABBV-951
Intervention type(s): Drug
Intervention description(s): ABBV-951 administered by subcutaneous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study
      designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of
      persistent atrial fibrillation. (CL-AF-002 - EU)

      A prospective, single-arm, multi-center, multi-national non-randomized study designed to
      provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent
      atrial fibrillation. (CL-AF-001 - Canadian)
    

Detailed description: 
      A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study
      designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of
      persistent atrial fibrillation. (CL-AF-002 - EU)

      A prospective, single-arm, multi-center, multi-national non-randomized study designed to
      provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent
      atrial fibrillation. (CL-AF-001 - Canadian)

      The research study was conducted in the EU and Canada. The protocol and the corresponding NCT
      number is as follows:

      NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)

      The above record was combined into one as both protocols are essentially identical (one is
      post market [EU] and the other pre-market [Canada] and one study report will be written that
      encompasses the data/results for both protocols.
    

Intervention name(s): AcQMap System
Intervention type(s): Device
Intervention description(s): 3D imaging and mapping system for cardiac chambers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Randomized Trial of Treatments for Convergence Insufficiency
Condition: Convergence Insufficiency
MeSH terms: Ocular Motility Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled,
      single-masked, clinical trial designed to compare the benefits of two commonly used treatment
      approaches for patients with convergence insufficiency (CI)
    

Detailed description: 
      Considerable controversy exists regarding the best treatment for convergence insufficiency
      (CI), a common condition that often interferes with the ability to perform near work. The two
      most widely used treatments have significant differences in costs and in practitioner
      perceived utility. Pencil push-up therapy (PPT) is a simple, low-cost treatment in which
      patients are prescribed a single procedure to perform at home with only periodic follow-up.
      Office-based vision therapy (OBVT) is a more comprehensive, time-consuming, complex, and
      costly treatment in which patients are scheduled for weekly in-office therapy visits and are
      often prescribed a specific sequence of therapeutic procedures to perform at home. It is
      important to consider whether either, neither, or both treatments are effective.

      The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked-examiner,
      multi-center clinical trial in which patients are randomized to one of these two treatment
      approaches. The primary goal is to answer the following question:

      After 12 weeks of treatment, is one therapy more effective than the other in improving CI
      signs and symptoms? We will test the null hypothesis that there is no difference in the
      distribution of outcomes between the two populations.

      The primary outcome measure will be a classification of each patient as a "success,"
      "improvement," or "failure." This classification will be based on the level of improvement in
      both the signs (near point of convergence and positive fusional vergence) and symptoms of CI.

      Additional questions relate to longer term effects:

        1. Are the patients who were classified as "success" or "improvement" at twelve weeks the
           same at the one-year follow-up for each treatment group?

        2. Are there differences in the distributions of changes in near point of convergence,
           positive fusional vergence, or accommodative amplitudes, between the two treatment
           groups, at twelve weeks and at one-year of follow up?
    

Intervention name(s): Pencil Push-ups; Office-based Vision Therapy; Placebo Office-based Vision Therapy
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: convergence insufficiency, vision therapy, orthoptics
Ibrutinib and Standard Immuno-Chemotherapy in Younger, High-Risk Patients With Diffuse Large B-Cell Lymphoma
Condition: Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate if treatment results obtained with R-CHOEP in young high-risk
      patients with diffuse large B-cell lymphoma can be further improved by the addition of
      ibrutinib to this regimen.
    

Detailed description: 
      Encouraging results have been achieved in younger high-risk patients with newly diagnosed
      diffuse large B-cell lymphoma treated with R-CHOEP. However, more than one fourth of patients
      still relapse or show primary progressive disease. The outcome of such patients is poor, in
      particular if first-line therapy contained rituximab. In order to avoid such detrimental
      situations, we seek to further improve progression-free survival and overall survival by
      combining R-CHOEP with ibrutinib.

      Ibrutinib is a first-in-class, orally administered, potent, small-molecule inhibitor of
      Bruton's tyrosine kinase, a mediator of critical B-cell signaling pathways implicated in the
      pathogenesis of B-cell cancers.
    

Intervention name(s): Ibrutinib Oral Capsule [Imbruvica]; R-CHOEP chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Imbruvica 140 mg hard capsules (Active substance: Ibrutinib); Immunochemotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ibrutinib
Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, multiple ascending dose, parallel-group,
      pharmacokinetic (PK) and pharmacodynamic (PD) study
    

Intervention name(s): BIA 9-1067; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).; once-daily
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients
Condition: Postoperative Confusion; Delirium
MeSH terms: Confusion
Study type: Interventional
Phase: Phase 4

Summary: 
      Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can
      lead to a reduced ability and seriously affect the quality of life of patients, increase
      personal and social burden, POCD may also increase mortality.POCD can occur at any age, but
      the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are
      more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by
      preoperative cognitive function and psychological scales postoperative assessment, the main
      recommendation of the agreed test methods include, Rey auditory verbal test, the connection
      test, digit span test. In this study, preoperative mini-mental state examination (MMSE)
      screening, comprehensive neurological function during hospitalization for memory, attention,
      executive function and exercise capacity test, and telephone follow-up after discharge Scale
      Revised (TICS-M) test.

      Few study showed that dexmedetomidine may improve cognitive function in young patients others
      show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These
      results conflict and it is necessary to carry out large-scale, multi-center, randomized,
      controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or
      not for elderly patients.
    


Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.; 0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
Other intervention name(s): Yisi
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine
Detection of Gut Metabolites in Mother's Milk Following Juice Intake
Condition: Healthy Diet
Study type: Interventional

Summary: 
      The goal of the biological sample collection is to assess the presence of gut metabolites in
      human breast milk (BM) samples obtained prospectively from healthy lactating mothers and
      after consumption of fruit juice.
    


Intervention name(s): Pomegranate Juice
Intervention type(s): Other
Intervention description(s): Collection of Mother's milk before and after juice consumption
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
Condition: Low Mood; Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      A randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of 8
      weeks of supplementation with Bifidobacterium longum 1714® strain on Beck's Depression
      Inventory-II Score in adults who experience low mood.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel group study, designed to
      assess the effectiveness & safety of Bifidobacterium longum 1714® strain in people with low
      mood. The 8-week intervention study will be conducted in 168 adults, aged ≥18 to ≤70 years,
      who experience low mood, and experience mild or moderate depression, according to the Beck's
      Depression Inventory II (Total score 14-28). The study will consist of 4 visits over a 10
      week period commencing with a screening visit. The second visit will be the baseline (start
      of intervention - either active or placebo), followed by third (mid-intervention), fourth
      (end of treatment). Questionnaires will be administered from the first to the fifth visit and
      safety and research bloods will be collected at each visit throughout the trial.
    

Intervention name(s): Bifidobacterium longum 1714® strain; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic capsules containing 5 x 10^9 CFUs, corn-starch and magnesium stearate.; Capsules containing corn-starch and magnesium stearate only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Pain Therapeutic Effects After Benign Mastectomy
Condition: Pain, Postoperative; Mastectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      With the incremental trend of benign breast tumor, the surgical process of mastectomy was
      proceeded too much every day, especially in the Maternal Health Care Hospital, but whether
      the investigators can find another way to relieve the postoperative pain after such an
      operation is still unknown. The investigators hypothesized that the pain from the relatively
      small surgery may not be significant compared to different treatments, even if no drug was
      delivered to them. The investigators are enrolling patients who underwent mastectomy from
      benign breast tumor, and are observing the analgesic effects of different drugs.
    


Intervention name(s): Saline; Opioid; Opioid; NSAID; NSAID; Opioid; Opioid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Saline 5 ml administrated intravenously; Butorphanol tartrate 1 mg i.v.; Butorphanol Tartrate 2 mg i.v.; Flurbiprofen Axetil 50 mg i.v.; Flurbiprofen Axetil 100 mg i.v.; Tramadol Hydrochloride 10 mg i.v.; Tramadol Hydrochloride 20 mg i.v.
Other intervention name(s): Physiological solution; NuoYang; NuoYang; CaiFen; CaiFen; Trama; Trama
Intervention MeSH terms: Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Neoplasms; Non-Steroidal Anti-Inflammatory Agents; Analgesia