bioihbjkbjnl/mcl2 huggingface dataset:
Representation and Medication Use in Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      According to the International League of Associations for Rheumatology classification,
      Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown
      cause and with onset before 16 years of age, characterized by joint inflammation lasting for
      6 or more weeks. Few studies exist regarding the care experience of children affected by this
      rheumatic condition. On the other hand, methotrexate and biologics constitute the primary
      treatment for children with JIA. As with adults undergoing the same treatment, adherence is
      critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if
      adherence promotion in pediatric chronic conditions has been the subject of recommendations
      with regard to care management, the investigators lack information to understand the grounds
      for adherence specifically in JIA. In order to understand and decipher the parent-child
      adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the
      relational approach between children and their caregivers as well as unrestricted drug
      adherence involves researching and understanding how appropriation of the disease and
      treatment could be achieved.
    


Intervention name(s): Interviews with parents of children with juvenile idiopathic arthritis; Interviews with children with juvenile idiopathic arthritis; Interviews with Physicians
Intervention type(s): Other; Other; Other
Intervention description(s): Interviews with parents of children with juvenile idiopathic arthritis; Interviews with children with juvenile idiopathic arthritis; Interviews with Physicians
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children with JIA and their parents
      
Keywords: Role of parents, children and physician; Qualitative; Interview; Juvenile idiopathic arthritis; Adherence; mechanisms of adherence in juvenile idiopathic arthritis
Strategies to Enhance New CGM Use in Early Childhood (SENCE)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the efficacy and safety of CGM alone and
      CGM combined with a family behavioral intervention with a control group using home blood
      glucose monitoring (BGM) alone.
    

Detailed description: 
      Although prior studies have not demonstrated that continuous glucose monitoring (CGM) use
      results in improved glycemic control in children <8 years of age, many of the barriers to CGM
      efficacy in this age group may have been due to problems in the wearability and accuracy of
      prior generation devices, as well as to the setting of glycemic targets aimed primarily at
      preventing hypoglycemia at all costs. There may also be behavioral barriers to consistent and
      effective CGM use in this age range. The goal of this study is to assess the impact of CGM
      alone and CGM combined with a family behavioral intervention focused on supporting CGM use on
      glycemic control in very young children with T1D compared with usual care without CGM.
    

Intervention name(s): CGM + Family Behavioral Intervention; Standard CGM
Intervention type(s): Behavioral; Device
Intervention description(s): use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence; use of CGM alone to assess CGM adherence
Other intervention name(s): FBI
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition
      and functioning of stable schizophrenia participants treated with antipsychotics.
    


Intervention name(s): Basmisanil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.; Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety of PDT-Photofrin® Prior to Lung Surgery
Condition: Lung Cancer; Lung Cancer Metastatic
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is being conducted to assess the safety of PDT in subjects with
      peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will
      involve up to 10 sites in USA. Participation will last 4 months.
    

Detailed description: 
      Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have
      the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic
      technologies (such as navigational bronchoscopy) have been shown to enable physicians to
      safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new
      technology may now potentially offer bronchoscopic therapeutic interventions, such as
      photodynamic therapy, to tumors that were previously unreachable due to their peripheral
      anatomic location.

      Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is
      activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits
      no heat. This technique works to allow the medical doctor to specifically target and destroy
      abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation
      of the drug is done by lightning the abnormal area using a fiber optic device (very fine
      fiber [like a fishing line] that permits light transmission) inserted into a flexible tube
      with a light, called bronchoscope for the lung. The light activates the porfimer sodium
      concentrated in the abnormal tissue, leading to its destruction.

      The purpose of this study is to assess the safety of using photodynamic therapy prior to
      surgical resection of tumors located in the periphery of the lung.
    

Intervention name(s): Porfimer Sodium; Fiber optic
Intervention type(s): Drug; Device
Intervention description(s): Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.; After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Other intervention name(s): Photofrin
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lung cancer; lung carcinoma; lung metastases
Electroretinogram in Autistic Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Observational

Summary: 
      This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG)
      b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).
    

Detailed description: 
      Autism Spectrum Disorder (ASD) is a neurodevelopmental condition which becomes apparent as
      children grow. Children with ASD are slow to develop language and have problems interacting
      socially with others. It is not clear why ASD occurs, but there is some evidence that the
      signals that tell the brain how to grow are altered which causes the brain to develop and
      function differently in people with ASD. Eyes develop from the same embryonic tissue as the
      brain. This means that the retina, which is the light sensitive layer at the back of the eye,
      shares the same signals as the brain. Investigators can listen to retinal signals outside the
      eye and the retina can, in this way, act as an accessible part of the brain.

      The investigators will detect retinal signals as electrical messages. Sensors placed near the
      eye pick up the electrical changes in the retina each time a light flashes. This
      non-invasive, routine clinical test is called an electroretinogram, (ERG). The investigators
      have carried out a study that showed differences in the ERGs recorded from adults with ASD
      compared to control participants.

      The main aim of this project is find out how common ERG differences are in children with ASD
      compared to controls. If it is common, investigators could use the ERG to make an earlier
      diagnosis of ASD and help families sooner. It could help investigators better understand the
      way the ASD brain signals and give investigators a way of measuring if therapies work.
    

Intervention name(s): electroretinogram (ERG)
Intervention type(s): Diagnostic Test
Intervention description(s): an ERG is a measure of the eyes response to a flash of light
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        individuals diagnosed with ASD and typically developing controls
      
Keywords: electroretinogram
Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
Condition: Skin Ulcers; Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell; Skin Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate
      in terms of healing rate in patients with refractory sickle cell ulcers.

      II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion
      or inhibition of wound healing in these patients.

      III. Determine whether the regimen used in this study is appropriate for testing in pivotal
      trials.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of
      two treatment arms. Arm I: Patients receive arginine butyrate IV over 6-9 hours at night 5
      days a week for 12 weeks, plus concurrent standard local therapy consisting of cleaning,
      saline irrigation, and dressing changes as prescribed by each patient's physician. Patients
      who experience progressive healing receive arginine butyrate 3-4 times a week. Arginine
      butyrate treatment may be discontinued and reinstated following a single 2 week medical
      complication.

      Arm II: Patients receive standard local therapy alone for 12 weeks. Patients randomized to
      arm II may cross over to receive arginine butyrate if no or less than 25% healing is observed
      after 12 weeks.

      Patients whose ulcers have closed by at least 15% per cycle may receive 2 additional 8-week
      cycles of arginine butyrate therapy and are followed for 2 months after healing is completed.
    

Intervention name(s): Arginine Butyrate; Standard local care dressing
Intervention type(s): Drug; Other
Intervention description(s): To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.; To heal leg ulcers.
Intervention MeSH terms: Arginine butyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dermatologic disorders; genetic diseases and dysmorphic syndromes; hematologic disorders; rare disease; sickle cell anemia; skin ulcers; thalassemia major
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is done to compare how faster aspart is taken up, broken down and removed from the
      body between different age groups (children [6-11 years], adolescents [12-17 years] and
      adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster
      aspart will also be investigated after consuming a meal replacement drink. The effects of
      faster aspart will be compared to the effects of NovoRapid®.
    


Intervention name(s): Faster aspart; Insulin aspart (NovoRapid®)
Intervention type(s): Drug; Drug
Intervention description(s): An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.; An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
Intervention MeSH terms: Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin
Condition: Alveolar Bone Grafting
Study type: Interventional

Summary: 
      This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary
      grafting. This grafting is done from the patient's chin using a computer-guided stent that is
      customized for each patient, and the cleft volume is analysed at first to estimate the needed
      amount of bone to be harvested.
    


Intervention name(s): Platelet-rich fibrin
Intervention type(s): Procedure
Intervention description(s): Addition of platelet-rich fibrin into the cleft site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section
Condition: Cesarean Section
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This prospective double-blind placebo-controlled randomized clinical trial will be conducted
      at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women
      candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of
      misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of
      misoprostol.
    


Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): mesotac; Placebo tablet identical to the misoprostol tablet but without the active ingredient
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cesarean section; Misoprostol; sublingual; uterotonics
ONO-7746 Study in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in
      healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and
      pharmacodynamic profiles of ONO-7746.
    


Intervention name(s): ONO-7746; ONO-7746
Intervention type(s): Drug; Drug
Intervention description(s): 5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day; 5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-7746; Healthy adult subjects
Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents
Condition: Asthma in Children
Study type: Interventional
Phase: Phase 4

Summary: 
      Exercise induced asthma (EIA) is common in adolescents. (Fluticasone furoate (FF)/Vilanterol
      (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was
      to investigate the short and long-term effects of FF/VI on EIA in adolescents. Adolescent
      asthmatics were referred for evaluation of EIA. Patients with a positive exercise challenge
      test, were allocated to a single administration of salbutamol and 22 to FF/VI in a double
      blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI
      for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.
    

Detailed description: 
      Exercise induced asthma (EIA) is common in adolescents. Relvar® (Fluticasone furoate
      (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours.
      Our objective was to investigate the short and long-term effects of FF/VI on EIA in
      adolescents. Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation
      of EIA. 44 patients had a positive exercise challenge test (ECT), 22 (22/44) were allocated
      to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double
      blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI
      for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose.
    

Intervention name(s): Fluticasone furoate (FF)/Vilanterol (VI); Salbutamol
Intervention type(s): Drug; Drug
Intervention description(s): Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints; Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints.
Other intervention name(s): Relvar®; Salbutrim
Intervention MeSH terms: Fluticasone; Xhance; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First phase: Randomized, double blind, double dummy. Second phase: open label
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Trial of a Behavioral Treatment for Epilepsy
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to see if a behavioral program which includes a
      relaxation technique and lifestyle changes can improve seizure control and well-being in
      epilepsy patients.
    

Detailed description: 
      The behavioral treatment approach studied aims to help epilepsy patients discover which
      circumstances and behaviors trigger their seizures. The most common seizure precipitants are
      irregularities of sleep, sensory triggers such as flashing lights and emotional stress.
      Patients will learn how to avoid seizure precipitants and how to stop seizures in their first
      beginnings. Study participants will continue their prior medications.
    

Intervention name(s): Andrews/Reiter behavioral treatment for epilepsy
Intervention type(s): Behavioral
Intervention description(s): The behavioral intervention in this study uses lifestyle counseling to avoid triggers for seizures and strategies to stop beginning seizures. Participants are taught to practice meditative relaxation exercises.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavior Therapy; Relaxation Techniques
MRL in the Upper Extremity
Condition: Lymphedema of Upper Limb
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      Objective: The aim of this study is to examine the feasibility and applicability of the MRL
      protocol for the upper extremity in Maastricht University Medical Center, and to examine the
      differences of the lymphatic system between lymphedema patients and healthy volunteers.

      Study design: An explorative study of an MRL protocol for the upper extremity in Maastricht
      University Medical Center+.

      Study population: There are two study groups. The first group (n=10) consists of patients
      with secondary lymphedema in the upper extremity. The second group (n=10) consists of healthy
      volunteers.

      Intervention (if applicable):

      All participants will undergo an MRL examination with the same protocol, developed in a
      previous 'proof of principle' study, in the Maastricht University Medical Center+.

      After localizer scans, a T2-weighted sequence is used. Then a T1-weighted sequence will be
      made before the injection of contrast. After the injection of the contrast agent a
      T1-weighted sequences of the upper and lower arm are performed alternately.

      Main study parameters/endpoints:

      The primary outcome is to determine the feasibility and applicability of the MRL protocol by
      evaluating the images of the upper extremity in patients with secondary lymphedema and
      healthy subjects.

      The secondary outcome is to assess the value of MRL in staging lymphedema.
    


Intervention name(s): Magnetic Resonance Lymphography
Intervention type(s): Diagnostic Test
Intervention description(s): Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Bioequivalence Study of Favir 200 mg Film Tablet Kocak Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose of Reference product containing 200 mg favipiravir and a single dose of Test
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at
      room temperature, in each period under fasting conditions with current pandemic precautions.
    

Detailed description: 
      Favipiravir is a drug with a mechanism of action different from that of the existing
      influenza antiviral drugs and effective against all types and sub-types of human influenza A,
      B and C viruses in vitro, showing anti-viral activity against various influenza virus strains
      including avian and swine viruses. Favipiravir also has shown anti-viral activity even
      against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The
      mechanism of action of favipiravir is the selective inhibition of RNA polymerase by
      favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to
      antiviral activity.
    

Intervention name(s): FAVIR 200 MG FT; AVIGAN 200 mg FT
Intervention type(s): Drug; Drug
Intervention description(s): FAVICOVIR containing 200 mg favipiravir manufactured by Kocak, Turkey.; AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan
Other intervention name(s): Test; Reference
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: COVID-19; COVID-19 drug treatment; Favipiravir; Novagenix; Farmagen