bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      PART1 Participants in Part 1 (Run-in-Phase) of study will receive tocilizumab (TCZ)
      (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2
      weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during
      Part 1 may be eligible to move into Part 2 of the study.

      PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics,
      pharmacodynamics and immunogenicity of tocilizumab in reduced dose frequency in participants
      with adequately controlled systemic juvenile idiopathic arthritis who have experienced a
      laboratory abnormality on twice weekly tocilizumab dosing, that has since resolved.
      Participants will receive tocilizumab 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After
      5 consecutive infusions, participants who experience an event of neutropenia,
      thrombocytopenia or liver enzyme abnormality will move to every 4 weeks tocilizumab
      administration. Anticipated time on study treatment is 52 weeks.
    


Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): Participants will receive tocilizumab IV infusions of 12 mg/kg (for participants < 30 kg) or 8 mg/kg (for participants >/=30 kg) Q2W/Q3W/Q4W.
Other intervention name(s): RoActemra/Actemra
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is aim to evaluate the immunogenicity and safety with two groups of participants
      who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2
      and B) or an active comparator (licensed influenza vaccine
    

Detailed description: 
      This is a phase II/III, non-inferiority double-blinded, randomized, controlled trial of
      immunogenicity and safety with two groups of participants who will received a seasonal
      trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator
      (licensed influenza vaccine).

      A total of about 945 healthy Thai male and female adult volunteers 18 through 49 years of
      age; 630 participants will be randomized to receive the GPO Tri Fluvac and 315 will receive
      an active comparator (a 2:1 ratio) (inclusion of ~7% lost to follow-up).

      Safety will be assessed for all participants through Day 90 after vaccination. Immunogenicity
      will be assessed in serum samples obtained at baseline and 21 days after vaccination in a
      subset of at least 586 individuals randomized to study vaccine and 293 active comparator
      vaccine recipients.
    

Intervention name(s): GPO Tri Fluvac vaccine; Licensed influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.; The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: non-inferiority double-blinded, randomized, controlled trial
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: GPO Tri Fluvac Vaccine; Tri Fluvac vaccine
Local Anesthetics New Formulations: From Development to Clinical Tests
Condition: Local Anesthetic Effectiveness
Study type: Interventional
Phase: Phase 1

Summary: 
      This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a
      previously reported liposome-encapsulated mepivacaine formulations.
    


Intervention name(s): mepivacaine
Intervention type(s): Drug
Intervention description(s): One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.
Intervention MeSH terms: Mepivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized comparison of standard induction treatment with daunorubicin for 3 days and
      Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of
      maintenance treatment with IL2
    

Detailed description: 
      Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d
      IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm
      3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g /
      m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to
      initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd
      treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5
      million IU / m² x 5 d / month in SC for 12 months) or no treatment.
    

Intervention name(s): chemotherapy (Aracytine + Daunorubicin); chemotherapy (Aracytine + Daunorubicin); chemotherapy (Aracytine + Daunorubicin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3; Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3; Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Intervention MeSH terms: Cytarabine; Daunorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myeloid Leukemia in adults; Newly-diagnosed untreated AML; Patient aged 50 to 70 years
Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
Condition: Dyspareunia; Perineal Tear; Sutured Laceration
MeSH terms: Dyspareunia; Lacerations
Study type: Interventional

Summary: 
      To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to
      poliglecaprone 25 using a validated sexual function questionnaire.

      To assess maternal satisfaction with the laceration repair and suture material.

      To assess overall perineal pain using a visual analog scale.

      To assess the rate of wound breakdown and the need for suture removal.
    

Detailed description: 
      This randomized controlled trial will be conducted and VCU medical center comparing 2 types
      of suture: rapidly absorbing polyglactin 910 (Vicryl Rapide) and poliglecaprone 25 (Monocryl)
      for first and second-degree lacerations requiring suture repair. Patients will be enrolled in
      the study immediately after vaginal delivery if a laceration occurs spontaneously. Patients
      will be randomized to one of the 2 sutures after enrollment.

      Randomization will be obtained via computer generation in consecutively numbered, opaque
      sealed envelopes with the name of one of the suture materials. The envelope will be opened at
      the time of repair of perineal laceration once inclusion criteria have been met by the
      physician or midwife performing the laceration repair. Repair with the chosen suture will be
      performed using the continuous suture technique using a 3-0 suture, which is current standard
      practice. Patients will not be informed of the type of suture used, although the type of
      suture will be recorded in the patient's electronic medical record. Various maternal and
      fetal characteristics will be recorded including maternal age, gravity and parity,
      gestational age at delivery, birth weight, mode of vaginal delivery (spontaneous or
      operative).

      Pain will be evaluated using a numeric pain scale at their 6 week postpartum visit and at 3
      months postpartum via a telephone interview. At 3 months postpartum they will also be asked
      the following questions - Have you resumed sexual intercourse(yes/no)? How long after
      delivery was it before you resumed intercourse? Did you have pain the first time after
      delivery (yes/no)? Do you have continued dyspareunia (1-10)? Do you have residual perineal
      pain unrelated to intercourse? How satisfied are you with your laceration repair (very
      unsatisfied -1, neutral-3, very satisfied- 5). They will also be administered a 6 question
      validated Female Sexual Function Index.
    

Intervention name(s): Laceration Repair with Polyglactin 910; Laceration Repair with poliglecaprone 25
Intervention type(s): Procedure; Procedure
Intervention description(s): Polyglactin 910 suture for laceration repair; poliglecaprone 25 suture for laceration repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postpartum dyspareunia; Obestric laceration
Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in
      patients with Type2 Diabetes Mellitus treated with Biguanide.
    


Intervention name(s): Miglitol
Intervention type(s): Drug
Intervention MeSH terms: Miglitol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alpa-glucosidase inhibitor,Biguanide
Metabolic Syndrome and Contrast Induced Nephropathy
Condition: Contrast Induced Nephropathy; Metabolic Syndrome
MeSH terms: Kidney Diseases; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Prevention of contrast induced nephropathy after interventional cardiologic procedures
      deserves close interest because of its association with prolonged hospitalization, increased
      cost and increased in hospital and long term mortality rates. An observational prospective
      cohort study was designed to determine whether metabolic syndrome predicts the development of
      contrast induced nephropathy after elective percutaneous coronary intervention.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for elective percutaneous coronary intervention Patients with metabolic
        syndrome
      
Keywords: creatinine; glomerular filtration rate; metabolic syndrome
The Effect of Kinesiotaping on Sprint and Dynamic Balance in Children
Condition: Sports Performance in Children
Study type: Interventional

Summary: 
      The aim of this study is to examine the acute effects of kinesio taping applied to the
      gastrocnemius muscles of children enrolled in soccer school on sprint and dynamic
      balance.Children who meet the required criteria will be randomly placed in the kinesio taping
      and placebo groups by drawing lots. Dynamic balance and sprint abilities of the participants
      were evaluated before and immediately after taping. Y Balance Test will be used to evaluate
      dynamic balance. Measurements were taken in the anterior, posteromedial and posterolateral
      directions of the right and left sides.10 m and 20 m sprint tests will be used to assess
      speed ability. In-group and between-group comparisons will be analyzed using the Statistical
      Package for the Social Sciences program and appropriate tests.
    


Intervention name(s): Kinesiotaping; Placebo Kinesiotaping
Intervention type(s): Other; Other
Intervention description(s): Y strip kinesiotaping will be applied to both the gastrocnemius muscles while keeping the participant's ankle in full dorsiflexion. The tape will start from the plantar surface of the toe and continue proximally. The medial "Y" tail will be applied along the medial border of the gastrocnemius and the lateral "Y" tail along the lateral border of the gastrocnemius, at approximately 20% tension from the resting length. End points will end just below the popliteal crease.; Placebo kinesiotaping, approximately 5x5 cm in size, will be applied to the body of both gastrocnemius muscles without any tension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: soccer; child; sprint; dynamic balance; kinesiotaping
Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale
Condition: Swallowing Disorder; Validation; Pharyngeal Dysphagia
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      Purpose of the study is the validity and reliability of the Turkish version of the Yale
      Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an
      assessment tool for dysphagia patients.
    

Detailed description: 
      The swallow function is a multidirectional process that depends on complex neuro-muscular
      network. The function can be evaluated using instrumental, such as fibreoptic endoscopic
      evaluation of swallowing (FEES), videofluoroscopy, or well structured scales. There are many
      questionnaire and scales for assessment of swallow but very few have been validated. The
      study will assess the construct validity and reliability of the Turkish version of Pharyngeal
      Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Health professionals
      
Keywords: Pharyngeal; residue; swallow; scale; Yale
Efficacy of Pregnenolone in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative
      symptoms and cognitive decline in schizophrenia. After four months the scores on the negative
      symptom scale should be lower and the scores on the cognitive tests should be higher than
      they were at study entry, compared with people who do not take any additional medication.
    

Detailed description: 
      Pregnenolone is a steroid health supplement which is readily available in health food stores.
      We are using it in this study at higher doses than you would normally take as a health
      supplement because preliminary studies have indicated that negative symptoms improve and
      certain aspects of cognition improve at these doses. We do not require you to stop your
      existing treatment in order to enter the study. After four months we will test your symptoms
      and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a
      follow-up study designed to determine the long-term costs and benefits of taking
      pregnenolone.
    

Intervention name(s): placebo pregnenolone; pregnenolone
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sugar pill, taken twice a day; 500mg in tablet form taken orally twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; negative symptoms; cognition
Short Active Lives Survey in Chronic Lung Conditions
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      Short Actives Lives Survey is a common tool used to measure physical activity in the UK
      population. Self-reported measures such as the Short Active Lives Survey can be prone to
      bias. As such, during project evaluations, benefits may be exaggerated due to over-reporting
      of physical activity or downplayed due to underreporting of physical activity. There is also
      a lack of research reporting the typical short-term and long-term changes in physical
      activity (measured by the Short Active Lives Survey) in people with chronic lung conditions
      who are not receiving support to become active (i.e. usual care, control groups).
      Accelerometers are small lightweight activity monitors that can be worn on the waist. These
      monitors are known to provide accurate and reliable objective assessment of physical activity
      in people with lung conditions.

      This research study will recruit a cohort of inactive people with lung conditions and
      determine changes in physical activity measured by both the Short Active Lives Survey and one
      of the most valid accelerometers used in people with lung conditions (Actigraph GT3X). The
      study will also evaluate how these physical activity measures relate to general health
      (health status and health care use) of people with lung conditions over 12 months. This study
      will provide information on the usefulness of using the Short Active Lives Survey in the
      future for measuring physical activity in people with lung conditions.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The eligibility criteria has been designed to be as broad as possible so that findings can
        be generalisable to the wider population of inactive people with lung conditions. The main
        study population will be recruited via convenience sampling at the participant
        identification centres within Lincolnshire Community Health Services, South Lincolnshire
        CCG, South West Lincolnshire CCG, Lincolnshire East CCG, Lincolnshire West CCG and United
        Lincolnshire Hospitals NHS Trust.
      
Keywords: Physical activity; Health Status
Modulatory Effects of Multichannel tDCS During Prolonged Experimental Pain
Condition: Prolonged Pain; Neuroplasticity; Brain Modulation
Study type: Interventional

Summary: 
      Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked
      potentials (SEPs) is often altered in acute and chronic pain.

      Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in
      healthy participants, which significantly inhibits corticomotor excitability in the primary
      motor cortex (M1).

      Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current
      Stimulation (tDCS) administered to brain regions linked to the resting state motor network
      (network-tDCS) could enhance corticomotor excitability in healthy participants compared to
      single site M1-tDCS.

      It remains unknown whether network-tDCS has also the potential to modulate the inhibitory
      effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs
      associated with prolonged pain
    

Detailed description: 
      To date, pain modulation to M1 rs-network tDCS during 8% capsaicin induced pain has not been
      assessed (Mylius, Borckardt and Lefaucheur, 2012). Further, it is unknown how multichannel
      tDCS acts on tonic cutaneous pain for approximately 24 hours.

      The main objective of these projects are to study and characterize quantitatively the effects
      of multichannel tDCS in the development of prolonged pain.

      It is hypothesized that multichannel tDCS of left M1 resting-state network will reduce the
      severity of experimentally prolonged pain over the m. first dorsal interosseous (FDI), will
      increase descending pain control, might possibly increase pain thresholds and simultaneously
      will modulate the peak-to-peak amplitude of SEPs to electrical painful stimulation. Further,
      it is hypothesized that descending pain modulation of M1 tDCS will be related to interference
      with the suppression of cortical excitability
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The current studies have a randomized, parallel, sham-controlled and double-blinded design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children
Condition: Nutrition Disorder, Child
MeSH terms: Nutrition Disorders; Child Nutrition Disorders
Study type: Observational

Summary: 
      This is an acceptability study (including gastrointestinal tolerance, compliance and
      palatability) of a high energy peptide based paediatric oral nutritional supplement for
      children over 12 months of age.

      The acceptability data from a minimum of 15 participants will be collected in order to submit
      an application to the Advisory Committee on Borderline Substances (ACBS).
    

Detailed description: 
      Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based
      oral nutritional supplement drink for the dietary management.

      The ACBS requirement for evaluable data on 15 participants has informed the trial's
      recruitment target; however, we may need to exceed this target if any patients give their
      consent to join the study but then decide not to participate in the study. Participants who
      join the study and begin using the product would count towards the recruitment total and
      their data would be included in a submission to the ACBS whether they complete the 7-day
      study period or not.

      Each potential participant must meet all of the inclusion criteria and not meet any of the
      exclusion criteria.
    

Intervention name(s): acceptability, tolerance and palatability study
Intervention type(s): Dietary Supplement
Intervention description(s): prospective acceptability study
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        paediatric children 1- 10 years
Ministry of Child and Family Development (MCFD) Interpersonal Psychotherapy for Adolescents (IPT-A) Training Project
Condition: Education of Therapists Treating Adolescent Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Evaluating the Effectiveness of Different Interpersonal Psychotherapy for Adolescents (IPT-A)
      Therapist Training Models
    


Intervention name(s): Psychotherapy Training
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Depression; Adolescents; IPT; Knowledge translation; Psychotherapy