bioihbjkbjnl/mcl2 huggingface dataset:
MLN8237 to Treat Children With Relapsed/Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Excluding CNS; Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed
      for cell growth.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to
      see how well it works in treating young patients with relapsed or refractory solid tumors
    

Detailed description: 
      1.1 Primary Aims 1.1.1 To estimate the maximum tolerated dose (MTD) and recommended Phase II
      dose of MLN8237 administered orally once daily for 7 days every 21 days to children with
      refractory solid tumors. 1.1.2 To estimate the maximum tolerated dose (MTD) and recommended
      Phase II dose of MLN8237 administered orally twice daily for 7 days every 21 days to children
      with refractory solid tumors. 1.1.3 To define and describe the toxicities of MLN8237
      administered on this schedule.

      1.1.4 To characterize the pharmacokinetics of MLN8237 in children with refractory cancer.

      1.2 Secondary Aims 1.2.1 To preliminarily define the antitumor activity of MLN8237 within the
      confines of a Phase I study. 1.2.2 To obtain initial Phase II efficacy data on the anti-tumor
      activity of MLN8237 in children with relapsed-refractory neuroblastoma using the once daily
      dosing schedule. 1.2.3 To explore the relationship between polymorphic variations in the
      UDPglucuronyltransferase gene UGT1A1 and exposure to MLN8237.

      1.2.4 To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and
      Val57Ile) thought to potentially influence tumorigenesis. 1.2.5 To preliminarily examine the
      relationsh
    

Intervention name(s): MLN8237
Intervention type(s): Drug
Other intervention name(s): Alisertib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children
Condition: Elevated Blood Lead Levels
Study type: Interventional

Summary: 
      The study is a parallel, randomized, double-blind, placebo controlled clinical trial will
      evaluate the effect of Lactobacillus plantarum DSM 33464 on reduction of Blood lead levels
      and general well-being of children.
    


Intervention name(s): Lactobacillus plantarum DSM 33464; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 sachet SmartGuard® per day for 12 weeks; 1 sachet of placebo per day for 12 weeks
Other intervention name(s): SmartGuard®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Multidisciplinary Education in Lung Cancer Patients Who Receiving Chemotherapy Treatment
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to compare the fatigue in lung cancer patients receiving
      chemotherapy treatment, between the education programme in self-care a multidisciplinary with
      the group who received standard care.
    

Detailed description: 
      Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer
      chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home
      exercise program, 30 minutes of physical education. Teaching and demonstration exercises of
      the muscles to breath and conservation of energy during exercise and record the
      exercise/walking diary, the nutritional education nutrition counseling, psychiatric
      assessment,self-care prevention of depression.
    

Intervention name(s): multidisciplinary education programme; standard education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.; standard education before and after chemotherapy
Other intervention name(s): multidisciplinary self care education programm; standard education before and after chemotherapy
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fatigue Lung Cancer Patients
      
Keywords: Lung cancer; Chemotherapy; Multidisciplinary self care programme; Fatigue
Comparative Results of Maxillary Deficiency Treatment by Tongue Plate and Facemask in Growing Patients
Condition: Maxillary Deficiency
MeSH terms: Micrognathism
Study type: Interventional
Phase: Phase 3

Summary: 
      A new appliance will be used to transfer the tongue force during its physiological activity
      to advance the nasomaxillary complex; this method will be compared with the traditional
      method which uses a Facemask appliance.
    

Detailed description: 
      The above method will be compared with traditional one which uses the Facemask in combination
      with an intra-oral appliance.
    

Intervention name(s): Tongue plate; Facemask
Intervention type(s): Other; Other
Intervention description(s): A functional appliance use for maxillary protraction.It has two adams clasp and two C clasp to retained the appliance and long palatal plate in the canine area which cages the tongue and transfer the force of the tongue during physiological activity to the upper arch. It has posterior bite plate and middle screw for maxillary expansion.It should be used all the time except meal time and brushing the teeth,the acrylic appliance makes specifically for the patient.; An extraoral appliance use for treatment of maxillary deficiency in growing patients.It takes anchorage from chin and forehead, it has removable intraoral appliance with hooks for elastics that exerted a force of 300 gr.It should be used 14 hours a day.
Other intervention name(s): tongue appliance; Reverse pull headgear
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Tongue plate; Facemask; class III maxillary deficiency; orthodontic angle class three
Intranasal Oxytocin and Learning in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to determine the safety and therapeutic potential of
      intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when
      paired with a computer game intervention that is designed to enhance face perception skills.
    

Detailed description: 
      Recognizing faces is critical to social functioning, and can be improved for individuals with
      ASD by using intervention software in the form of appropriately designed computer games. The
      effects of this type of social intervention may be amplified with the concurrent use of
      oxytocin. Furthermore, these learning effects may impact social skills in general and
      translate to the level of the individual's everyday social behavior. Thus, the objective of
      this study is to determine the safety and therapeutic potential of intranasal oxytocin in
      children and adolescents with ASD when paired with a computer game intervention that is
      designed to enhance face perception skills.
    

Intervention name(s): Intranasal Oxytocin (Trade name: Syntocinon)
Intervention type(s): Drug
Intervention description(s): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders; Oxytocin; Clinical Trial; Computer-based Intervention; Social Perception; Social Motivation; Social Cognition
A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy
Condition: Locally Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced
      stage III non-small cell lung cancer. However, the optimal combination remains unclear. The
      aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and
      22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy
      (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5
      fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate.
      Secondary objectives are toxicity, time to progression, and overall survival.
    

Detailed description: 
      Lung cancer is the most common malignancy among men in most countries and constitutes the
      leading cause of cancer death worldwide. Non-small cell histology represents roughly 80% of
      lung cancer cases comprising one third of patients with stage III, locally-advanced disease
      at diagnosis. Some stage IIIA cancers are considered resectable but many stage IIIA (with
      bulky N2) and stage IIIB (T4 any N M0, any T N3M0) cancers are considered unsuitable for
      surgery. However, some authors have shown that surgery after chemoradiotherapy (CHRT) is
      beneficial for at least progression-free survival (PFS). Since the 90s, CHRT has become the
      cornerstone of inoperable locally advanced non-small cell lung cancer (NSCLC). A
      meta-analysis of 52 randomized studies showed a survival improvement of 3% at 2 years and 2%
      at 5 years for patients treated with CHRT versus radiotherapy alone [6]. Concomitant
      chemoradiation was demonstrated to be better than sequential administration in terms of
      overall survival (OS) in 3 out of 4 randomized studies with esophagitis as the dose-limiting
      toxicity. Nevertheless, the median survival was around 16 months and improvement is needed.
      To better control micrometastatic disease and reduce distant relapses, one possibility is to
      increase radiosensitization with higher doses of chemotherapy.The aim of this phase II study
      is to evaluate the anti-tumoral activity of a weekly docetaxel-cisplatin combination
      administered concurrently with radiotherapy after 2 induction cycles with the same drugs.
    

Intervention name(s): Docetaxel; concomitant radiotherapy; Cisplatin
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): Induction chemotherapy; Pulmonary and mediastinal radiotherapy; Induction chemotherapy
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Intervention model description: This was a prospective, open-label, multicentric, phase II study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concurrent 3-D chemoradiotherapy,Docetaxel,Cisplatin,Chemotherapy ·
Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c)
      interval more than placebo
    


Intervention name(s): BI 10773 (low); Moxifloxacin; BI 10773 Placebo; BI 10773 (high)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single oral dose; single oral dose; 2 times single dose; single oral dose
Intervention MeSH terms: Empagliflozin; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Study type: Observational

Summary: 
      This study will evaluate long-term safety of etanercept with or without other DMARDs in
      children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared
      to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or
      without other DMARDs.
    


Intervention name(s): Enbrel®
Intervention type(s): Drug
Intervention description(s): Etanercept alone, etanercept plus methotrexate or other DMARDs
Intervention MeSH terms: Etanercept
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects age 2 to < or = 18 years of age with polyarticular course or systemic
        JRA who have recently started and are currently receiving: etanercept alone or in
        combination with methotrexate or other DMARDs; methotrexate alone or in combination with
        other DMARDs.The population includes pediatric subjects who completed Immunex protocol
        016.0028 and selected other Immunex protocols will be eligible for this study once they
        change to marketed etanercept.
      
Keywords: JRA; Registry
In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.
Condition: Discolored Teeth
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      To evaluate the efficacy, safety and impact on quality of life related to oral health of home
      and office tooth whitening techniques in young individuals.
    

Detailed description: 
      The aim of this study is to evaluate the efficacy, safety and impact on quality of life
      related to oral health of tooth whitening techniques in young individuals. It will be a
      randomized, parallel and single blind. Participants are divided into three groups (n = 30)
      according to bleaching technique to be performed (G1 = Office / hydrogen peroxide 6%; G2 =
      Office / hydrogen peroxide 15%; G3 = Home / carbamide peroxide 10%). The color of the teeth
      will be evaluated in seven different times, using the color scale Vita Master Classic 3D and
      spectrophotometer Vita Easy Shade Advance. IGM (1986) - the presence of tooth sensitivity by
      visual analogue scale and gingival security through modified gingival index will be
      evaluated. The impact of bleaching quality of life will be assessed using the Brazilian
      version of the oral impact on daily performance (OIDP). The instrument will be applied in
      interview form at two different times at baseline (T0) and thirty days after the first
      evaluation (T4). Statistical analysis include descriptive analysis and testing to compare the
      two bleaching techniques as the color change, sensitivity, gum irritation and impact on
      quality of life.
    

Intervention name(s): hydrogen peroxide 6%; hydrogen peroxide 15%; Carbamide Peroxide 10%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application; Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application; Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days
Other intervention name(s): Group 1 - HP 6%; Group 2 - HP 15%; Group 3 - CP 10%
Intervention MeSH terms: Hydrogen Peroxide; Carbamide Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: carbamide peroxide; Hydrogen peroxide; Quality of life
Association With Spinal Needle-puncture Pain and Menstrual Phase
Condition: Pain
Study type: Observational

Summary: 
      This prospective observational study aimed to evaluate the relationship between menstrual
      phase cycles and spinal needle-puncture pain during spinal anesthesia in female patients of
      reproductive age.
    

Detailed description: 
      Before the spinal anesthesia procedure, the anxiety and depression levels of the patients
      will be evaluated with the 14-scale 'hospital anxiety and depression scale.' The spinal
      anesthesia procedure will be performed by the anesthesiologist responsible for the patient.
      At the end of the spinal anesthesia procedure, a researcher with no knowledge of the
      patient's menstrual phase information will ask rate the spinal needle-puncture pain felt
      during spinal anesthesia with a numerical rating scale (NRS), which is graded from 1 to 10
      (0: no pain, 10: very severe pain).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        80 female patients who are of reproductive age and have had a regular menstrual cycle for
        at least six months
Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients
Condition: Diabetes; Healthy
Study type: Interventional

Summary: 
      Several studies have shown that in diabetic patients, the glycemic profile was disturbed
      after intra-articular injection of corticosteroids. Little is known about the impact of
      epidural injection in such patients. The goal of this study was double, at first comparing
      the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate
      methylprednisolone either intra-articular or epidural, secondly to compare the amount of
      systemic diffusion of the drug the after both procedures.
    


Intervention name(s): intra-articular infiltration; epidural infiltration
Intervention type(s): Drug; Drug
Intervention description(s): intra articular infiltration; epidural infiltration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: methylprednisolone; intra articular infiltration; glycemia; epidural infiltration; diabetes
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical pharmacology study to characterize the biotransformation and excretion of
      [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single
      oral dose of [14C]CC-90001 in healthy male subjects. Approximately 8 subjects will be
      enrolled into the study with a goal of 6 subjects being eligible for analysis.
    


Intervention name(s): [14C]CC-90001
Intervention type(s): Drug
Intervention description(s): Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mass balance; Males; Healthy volunteers; CC-90001; [14C]CC-90001
The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      In 2016, a meta-analysis showed that DNA-based risk reporting alone does not facilitate
      behavior change. However, there have been several studies showing that tailoring care plans
      related to diet may help with adherence to a tailored diet plan.

      Risk prediction report displays both Polygenic Risk Score (PRS) and modifiable (non-genetic)
      risk factors. Overtime, the investigators aim to combine both PRS and modifiable risk factors
      to have a localized and stronger prediction model for the local population. The risk
      prediction report is designed to tailor care plans for patients by their physicians or care
      planner.

      Focus groups allow deeper discussions in themes important to guide design of the report. This
      method has been used in previous similar studies, such as one by Cutting et al to understand
      physicians' preference in integrating genetic reports into daily practice. Studies also have
      shown that local adoption of personalized medicine and care is hindered by limited
      infrastructure of information management and awareness, despite personalized medicine being
      widely adopted in healthcare systems in developing countries.
    


Intervention name(s): Focus Group Discussion
Intervention type(s): Other
Intervention description(s): Each focus group will consist up to five participants in every session, two sessions each for both low and high risk group. Every FGD sessions will last for 1 to 2 hours and be conducted in Indonesian, and will be recorded. Both groups will be asked the following questions: 1) What is your opinion regarding the clarity of information in the dummy breast cancer risk prediction report?; 2) What is your opinion regarding the completeness of information in the dummy breast cancer risk prediction report?; and 3) What is your impression regarding the results presented in the dummy breast cancer risk prediction report?.
Intervention model: Single Group Assignment
Intervention model description: Focus Group Discussion
Masking: None (Open Label)
Primary purpose: Other
Keywords: Breast Cancer
Semi-barbed Suture for Pulmonary Small Nodules Localization
Condition: Suture; Nodule, Solitary Pulmonary; Video-Assisted Thoracoscopic Surgery
MeSH terms: Solitary Pulmonary Nodule
Study type: Interventional

Summary: 
      Hookwire and microcoil are currently the most widely used localization instruments. Although
      their success rate is relatively high in preoperative localization attempts, they may lead to
      consequences that negatively affect patient outcomes, such as pain because of the metal's
      hardness, localization failure due to wire detachment, and the presence of permanent traces
      of metal and foreign bodies .

      To overcome these disadvantages, we designed an absorbable semi-barbed suture to localize
      small intrapulmonary nodules (patent number: ZL201821444387.X).

      The results of the previous animal experiments were satisfactory, and it is now necessary to
      recruit 10 patients for clinical trials.
    


Intervention name(s): absorbable semi-barbed suture
Intervention type(s): Device
Intervention description(s): Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People
Condition: General Mental Health and Well-Being
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting
      positive mental health through emotional self-awareness in adolescents. Participants will be
      recruited from second-level schools in Ireland. Schools will be randomly assigned to the
      intervention or control condition. Participants in the intervention condition will use
      CopeSmart for a four week period. Those in the control condition will not use any mental
      health app.
    


Intervention name(s): CopeSmart
Intervention type(s): Device
Intervention description(s): Participants will use the CopeSmart app at least once per day for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Emotional Self-Awareness; Positive Coping; Help-Seeking