bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Ependymoma; Nervous System Neoplasms; Central Nervous System 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 drug and combining chemotherapy with radiation therapy may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to
      see how well they work in treating children with localized ependymoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the event free and overall survival of children with incompletely resected
           localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and
           vincristine followed by radiotherapy.

        -  Determine the response rate in these patients to this regimen.

      OUTLINE: This is a multicenter study.

      Patients undergo surgery to remove as much of tumor as possible. Patients with residual
      disease proceed to chemotherapy, while those with no residual disease proceed directly to
      radiotherapy.

      Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8,
      and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3.
      Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses
      proceed to radiotherapy. If residual disease is still present at completion of chemotherapy,
      second look surgery is recommended.

      Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4
      weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second
      look surgery.

      Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4
      months for 2 years, every 6 months for 2 years, and then annually for 5 years.

      PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.
    

Intervention name(s): cyclophosphamide; etoposide; vincristine sulfate; adjuvant therapy; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Etoposide; Vincristine
Primary purpose: Treatment
Keywords: childhood infratentorial ependymoma; childhood supratentorial ependymoma; newly diagnosed childhood ependymoma
Human Chorionic Gonadotropin Stimulation Effects on Steroidogenesis in Men With Klinefelter Syndrome
Condition: Steroidogenesis; Klinefelter Syndrome; Human Chorionic Gonadotropin (hCG) Stimulation
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study design included six visits. During the first visit (visit 0), the subjects
      underwent physical examination(height, weight, body mass index (BMI), arm span, and upper
      segment measurement) and testicular ultrasound (US) for the calculation of testicular volume.
      At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a
      single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of
      five following consecutive days after the hCG injection. A blood sample was taken at each
      visit after an overnight fast
    

Detailed description: 
      Blood samples were centrifuged at 2955 g for 15 min. Sera were transferred into plain
      polypropylene tubes and stored at -20°C until assayed. P, 17OHP, AS, DHEA, and TS were
      determined by LC-MS/MS at the laboratory of the Centre for Applied Biomedical Research of the
      S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
    

Intervention name(s): human chorionic gonadotropin
Intervention type(s): Drug
Intervention description(s): At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU
Other intervention name(s): hCG
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients
Condition: Intensive Care
Study type: Observational

Summary: 
      The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients)
      aims to develop a low-risk monitoring and control device which allows maintaining metabolic
      control in intensive care units. A system will be developed comprising three subsystems: a
      body interface for the delivery of biofluids, biosensors for the determination of glucose
      concentration in these biofluids and an adaptive control algorithm that generates advice and
      thus represents a decision support system with respect to insulin infusion rate to establish
      glycaemic control in critically ill patients. Within a closed loop system, intensified
      insulin treatment will make use of the calculations leading to external regulation of
      glucose.

      It is the aim of this study to evaluate the correlation between arterial blood glucose
      concentrations and interstitial fluid glucose concentrations in post surgery patients in the
      Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on
      microdialysis in subcutaneous adipose tissue and calculated using the ionic reference
      technique.
    

Detailed description: 
      This trial includes a screening visit (V1) and a monitoring visit (V2) and follow-up
      assessment. Visit 1 will be performed before performance of surgery to obtain informed
      consent and to assess patient eligibility. At Visit 2 monitoring visit after surgery)
      arterial blood glucose values will be monitored and subcutaneous sampling of ISF with
      microdialysis for glucose determination will be performed. Visit 2 will last from admittance
      to the ICU for 48 hours. In a follow-up assessment, two weeks after the end of visit 2,
      further clinical relevant data for the two week period after visit 2 will be collected.
    

Intervention name(s): dosing of insulin
Intervention type(s): Drug
Intervention description(s): Dosing od insulin is calculated by a computer based algorithm
Other intervention name(s): Model predictive control
Intervention MeSH terms: Insulin
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with a blood glucose level of more than 120 mg/dl (6.7mM) at admission to the ICU
        after surgery
      
Keywords: glucose, interstitial, intensive care
Mindfulness-based Program for Children With Disruptive Behavior Disorder
Condition: Disruptive Behavior Disorder; Oppositional Defiant Disorder; Attention Deficit and Disruptive Behavior Disorders
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      The present RCT study investigates whether combined mindfulness program for children and
      their parents was beneficial for Italian children, aged 8-12, with disruptive behavior
      diagnosis (DBD). The study tests the program effects on children's behavioral difficulties in
      school and home contexts; children's and parents' mindfulness abilities; children's
      impulsiveness; and parents' stress. The study include a sample of 50 children randomly
      allocate to the intervention or to the control condition (wait-list control sample). Repeated
      measures of children's and parents' and teachers' reported measures will be used.
    


Intervention name(s): Mindfulness-based program
Intervention type(s): Behavioral
Intervention description(s): The program includes 9 mindfulness-based sessions for children and their parents.
Other intervention name(s): Fiore dentro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; ADHD; Oppositional Defiant Disorder
Use of Lidocaine in Endoscopic Submucosal Dissection
Condition: Gastric Neoplasm
MeSH terms: Neoplasms; Stomach Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effects of lidocaine on the total
      administered dose of fentanyl during sedation for endoscopic mucosal resection.

      The secondary purpose of this study is to investigate the effects of lidocaine on pain score
      related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.
    


Intervention name(s): Lidocaine 1%; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation.
Sedation with fentanyl and propofol; Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation.
Sedation with fentanyl and propofol
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction
Condition: Conjunctival Diseases; Pterygium
MeSH terms: Pterygium; Conjunctival Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue.
      The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium
      surgery, could be an alternative therapeutic resource to this process.
    

Detailed description: 
      The latex biomembrane is considered biocompatible and believed to promote neoformation of
      biological tissues. It also induces vascular neoformation and promotes extra cellular
      provisional matrix formation, fundamental steps for any kind of wound healing. In humans, it
      was successfully used in chronic cutaneous ulcer and otologic surgeries. In rabbits' eyes,
      the latex biomembrane was efficient in ocular surface reconstruction with adequate
      conjunctiva functional recovery, compared to bare sclera. To study the latex biomembrane
      action in human ocular surface, it was compared to conjunctival autograft in humans eyes.
      Considering the deficiency of adequate sized groups and the pterygium recurrences criteria
      differences, this study proposes the fibrovascular tissue growing measure like an auxiliary
      method of pos-operative evaluation. The biomembrane of natural latex seems to be efficient in
      ocular surface reconstruction and must be employed in future studies of other ocular
      pathologies. This material revealed to be a new source of therapeutic resort to external eye
      diseases and conjunctival replace in surgeries living bare sclera.
    

Intervention name(s): pterygium surgery
Intervention type(s): Procedure
Intervention description(s): pterygium was removed surgically
Other intervention name(s): pterygium excision; prevention of pterygium recurrence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ocular surface reconstruction; conjunctival healing; pterygium; latex biomembrane; pterygium surgery
A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer
Condition: Unresectable Advanced Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal
      formulation is designed to extend plasma circulation and to increase accumulation in the
      tumor through the enhanced permeability and retention (EPR) effect.

      This study introduces a new concept of combining free and nanoliposomal drugs.
    

Detailed description: 
      This is a dose-finding and therapeutic exploratory phase Ib multi-center, open label study of
      MM-398 plus irinotecan in two different settings:

        -  Group A : patients with unresectable advanced non-colorectal cancer who should receive
           only MM-398 and irinotecan

        -  Group B : patients with unresectable metastatic colorectal cancer who should receive
           MM-398 and irinotecan combined with leucovorin, 5-fluorouracil and bevacizumab.

      These groups will be enrolling in parallel. Pharmacokinetic and biomarker sampling will also
      be performed.

      There are three periods to this study :

      Screening period (up to -28d): patients undergo screening assessments to determine the
      eligibility for the study

      MM-398 treatment period (C1D1 until safety evaluation/progression): patients receive
      treatment every 2 weeks and undergo biopsies and other required assessments. The treatment
      period is divided into a maximum of 3 dose levels

      Follow up period: patients will be followed-up 30 days after their last dose of MM-398 for
      final safety assessments, and every 2 months thereafter for overall survival follow-up
    

Intervention name(s): MM-398; Irinotecan; Leucovorin (LV); 5-fluorouracile (5-FU); bevacizumab; MM-398
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): unresectable Advanced non-colorectal cancer; unresectable metastatic colorectal cancer; unresectable metastatic colorectal cancer; unresectable metastatic colorectal cancer; unresectable metastatic colorectal cancer; unresectable metastatic colorectal cancer
Other intervention name(s): GROUP A; GROUP A; GROUPE B; GROUPE B; GROUPE B; GROUPE B
Intervention MeSH terms: Leucovorin; Bevacizumab; Irinotecan; Camptothecin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; GERCOR; unresectable; MM-398; CPT-11; colorectal; non colorectal
Preventive Therapy of White Spot Lesions Using Different Remineralizing Agents in Children From 3 to 12 Years Old
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      Compare by clinical observation, photographs and fluorescence the efficacy of sodium
      fluoride, silanofluoride and thiefenfluoride in treating white spots.
    

Detailed description: 
      This in vivo study will be a randomized experimental clinical trial to be carried out in the
      Department of Pediatric Dentistry of the International University of Catalonia. Patients
      between the ages of 3 and 12, who attend the dental university clinic of the International
      University of Catalonia, will be part of the study.

      Parents or legal guardians will be informed of the treatment procedure with a patient
      information sheet and informed consent will be given. Once signed, the patient will be
      assigned to one of the 3 study groups.

      Accepting an alpha risk of 5% and with a power of 80% in a bilateral contrast, 15 subjects in
      each group are required to detect a minimum difference of 4 points between two groups,
      assuming that there are 3 groups and a standard deviation of 4.9. a follow- up loss rate of
      10% has been estimated. The total number of children will be 45 by 15 for each group.

      In order to analyze the degree of agreement of one examiner, 15 children will be evaluated
      twice, with a separation of one month.
    

Intervention name(s): FLUORINE VARNISH
Intervention type(s): Other
Intervention description(s): Participants in all groups will receive written oral hygiene and oral prophylaxis instructions. All groups will receive the application of fluorine varnish every 3 months.
The application of fluoride in the three groups will be done as follows:
-Drying of the teeth, placement of the fluorine varnish on the teeth by quadrants. The varnish will be left to dry for a few seconds according to the manufacturer's instructions. Children in all groups will be asked to avoid brushing and flossing for one day after applying fluoride. They will be instructed to avoid hard food and hot drinks for 4 hours. Children and parents will be instructed on how to care for their teeth at home: brush teeth with conventional toothpaste containing 1000 ppm sodium fluoride, for 3 minutes without rinsing.
In the following reviews (3 and 6 months) the effectiveness of the treatments will be evaluated by visual examination, tactile examination, fluorescence and photography.
Other intervention name(s): 3 MONTHS; 6 MONTHS
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
Condition: Breast Cancer; Radiotherapy; Chinese Herbal Medicine
MeSH terms: Breast Neoplasms; Leukopenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Many breast cancer patients will taking Chinese herbal medicine during receiving
      radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula
      (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the
      investigators designed this double blind and controlled trial to evaluate whether TPE-1 have
      the effects for leukopenia and cancer-related fatigue in breast cancer patients with
      radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also
      designed to evaluate the safety when patients taking this formula.
    

Detailed description: 
      TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing
      the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on
      going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the
      same condition.
    

Intervention name(s): Chinese herbal medicine decoction
Intervention type(s): Drug
Intervention description(s): 100 ml /Qd for 6 weeks(42 days)
Other intervention name(s): TPE-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Breast Cancer; Radiotherapy; Chinese herbal medicine; TPE-1; Leukopenia
Brain Training in Children With/At-risk for Attention-Deficit/Hyperactivity Disorder and Executive Function Impairment
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if different forms of child-friendly,
      computer-based puzzles and games ("brain training") targeting executive function (EF) skills
      (i.e., thinking, problem-solving) result in improvements in EF in preschool children with or
      at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. The
      investigators hypothesize that children receiving active "brain training" will show greater
      improvements in EF and related skills immediately after treatment than children receiving
      passive "brain training." The investigators are also interested in whether any improvements
      in EF and related skills occur or are maintained at 3 and 6 months after completion of brain
      training.
    

Detailed description: 
      -  Investigators will talk to you by telephone to determine if your child might be eligible
           for the study.

        -  Children complete two baseline testing sessions to evaluate executive function (EF) and
           related skills

        -  Parents complete a packet of information, including questionnaires about the child's
           behavior, EF, and functional skills.

        -  After completion of the baseline testing, we will inform you of eligibility for the
           "Brain Training" phase.

        -  During "Brain Training" children play online computer games for 25-30 minutes/day (can
           range from 15-45 minutes/day depending on your child's attention, training version
           received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete
           a total of 25 sessions.

        -  Children return for 3 more time points, immediately after the completion of "Brain
           Training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after
           completion of "Brain Training."
    

Intervention name(s): Brain Training (Active); Brain Training (Passive); Brain Training (Active or Passive)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Online computer games targeting attention, EF, and problem-solving; Online computer games targeting attention, EF, and problem solving; Online computer games targeting attention, EF, and problem solving
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; executive function; preschool
Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage
Condition: Pain and Curettage
Study type: Interventional

Summary: 
      Patients frequently experience pain from moderate to severe during gynecologic procedures.
      This study is a prospective, randomized, placebo-controlled trial and aimed to investigate
      the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous
      paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage
      procedure.
    

Detailed description: 
      A total of 144 mutiparous subjects randomly allocated one of six groups. The first group
      (control group) consisted of 22 participants and they did not receive any treatment. The
      second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The
      third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical
      mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth
      group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth
      group consisted of 25 participants receiving diclofenac sodium.
    

Intervention name(s): comparison of pain relievers during curattage; comparison of pain relievers; comparison of pain relievers during curattage; comparison of pain relievers during curattage; comparison of pain relievers during curattage
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Curettage; analgesia; paracetamol; lidocaine; Dexketoprofen trometamol; pethidine; diclofenac.
Comparison of BIS and PIS in Children
Condition: Depth of Anesthesia Monitor
Study type: Observational

Summary: 
      Comparison of bispectral index and patient sedation index during general anesthesia in
      children
    

Detailed description: 
      the values of BIS and PSI of every 1 minute during general anesthesia in children
    

Intervention name(s): depth of anesthesia
Intervention type(s): Device
Intervention description(s): monitoring of depth of anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        general anesthesia