bioihbjkbjnl/mcl2 huggingface dataset:
Early Versus Late Application of STN DBS to PD Patients With Motor Complications
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical
      treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is
      lacking. This study is intended to demonstrate that early, compared with delayed,
      introduction of STN DBS is more beneficial for PD patients who have developed motor
      complications.
    

Detailed description: 
      In this prospective study, 200 PD patients will be recruited for STN DBS over three years,
      including 133 with motor complications existing for more than three years (late complication
      group) and 67 less than three years (early complication group). To make a comparison of
      therapeutic efficacy between the two groups, motor and non-motor symptoms will be assessed
      using specific rating scales and questionnaires.
    

Intervention name(s): Bilateral deep brain stimulation of the subthalamic nucleus
Intervention type(s): Device
Other intervention name(s): Activa PC or RC neurostimulator, Medtronic
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population are PD Patients with motor complications and an intention of receiving
        DBS.
      
Keywords: Parkinson disease; deep brain stimulation; subthalamic nucleus; motor complication; quality of life
Study to Test the Usefulness of Magnetoencephalography (MEG) Imaging of Cognition in Children and Adolescents
Condition: Cognition
Study type: Observational

Summary: 
      The primary objective of this protocol is to test the feasibility and utility of obtaining
      magnetoencephalography (MEG) recordings in healthy children and also in children who have a
      psychiatric or developmental disorder. Secondary objectives are to examine and compare
      typical and atypical motor, sensory, and cognitive functioning as recorded by MEG, and to
      identify subpopulation groups for which MEG may be optimal in order to establish feasibility
      of future hypothesis-driven MEG research.
    

Detailed description: 
      Healthy children and those who have a psychiatric or developmental disorder will undergo MEG
      recording to evaluate whether such children are candidate MEG subjects. Essentially, this
      feasibility study will examine whether children can remain still enough, complete simple
      tasks, and produce neurophysiologically consistent responses that would warrant full size
      studies.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        children and adolescents with or without a psychiatric disorder
      
Keywords: feasibility of MEG in pediatric populations
Digital Support for People With Cognitive Impairment
Condition: Cognitive Impairments; Stroke; Brain Injuries
MeSH terms: Brain Injuries; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Cognitive impairment may cause problems in planning and initiating daily activities, as well
      as remembering to do what is scheduled. This study investigates the effectiveness of an
      interactive web-based mobile reminder calendar, (RemindMe). The calendar sends text messages
      to the user's mobile phone as support in everyday life, for persons with cognitive impairment
      due to neurological injury/diagnoses. The study has a randomized controlled trial design with
      data collection at baseline and at follow-up sessions after two and four months. Data
      collection started in October 2016 and continued until February 2018. RemindMe may give the
      needed support to remind the person and thus increase the ability to perform activities and
      to become independent in everyday life.
    


Intervention name(s): Cognitive support by RemindMe
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Self-Help Devices; Occupational Therapy
A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess
      the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in
      healthy volunteers.
    


Intervention name(s): REGN1033(SAR391786); REGN1033(SAR391786); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration method A; Administration method B; (inactive substance)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
Condition: Narcotic Abuse; Opioid-related Disorders; Analgesia; Chronic Pain
MeSH terms: Chronic Pain; Opioid-Related Disorders; Narcotic-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study
      designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine
      sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid
      users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be
      selected during Part A of the study (Dose Selection Phase). Each subject participated in the
      study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to
      12 nights.
    


Intervention name(s): Placebo; EMBEDA - morphine sulfate/ naltrexone hydrochloride; morphine sulfate CR crushed.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lactose (100 mg) placebo tablets crushed; single dose; EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose; Morphine sulfate controlled release 30 mg tablet crushed
Intervention MeSH terms: Naltrexone; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: abuse liability; abuse potential; morphine; intranasal administration; snorting; opioid abuse; pharmacodynamic; recreational drug use
Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      the current study is to evaluate the efficacy and safety of Montelukast in the treatment of
      patients with non-alcoholic steatohepatitis (NASH).
    

Detailed description: 
      This is a randomized, prospective placebo-controlled study that will be conducted on 44
      patients who fulfill the selection criteria and will be classified randomly into two groups.

      Group 1 (Control group n= 22): Patients will receive Placebo once daily at bedtime.

      Group 2 (Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime.

      The treatment duration will be 12 weeks. Patients will be recruited from National Liver
      Institute and Fever, Liver and GIT disease Shebin El-Kom hospital, Egypt. All participants
      will be informed about the nature of the study. The patients will give their informed
      consent.The study will be approved by Research Ethics Committee of faculty of pharmacy -Tanta
      University. Data of all patients will be private and confidential. Any unexpected risk will
      be reported to patients and ethical committee on time
    

Intervention name(s): Placebo; Montelukast
Intervention type(s): Other; Drug
Intervention description(s): Placebo tabled every day; Montelukast 10 mg daily at bed time.
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, prospective placebo controlled study that will be conducted on 44 patients who fulfill the selection criteria and will be classified randomly into two groups.
Group 1 (Control group n= 22): Patients will receive Placebo once daily at bedtime.
Group 2 (Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate
Condition: Obesity; Weight
Study type: Interventional

Summary: 
      A 4 week intake of drug to find a natural substance that may modify energy balance and may
      enhance health in combination with lifestyle changes with possible decrease in body weight.
    

Detailed description: 
      This study is a double-blind, placebo-controlled, single center, randomized, parallel arm
      clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4
      weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.
    

Intervention name(s): Dihydrocapsiate; Dihydrocapsiate; Dihydrocapsiate
Intervention type(s): Other; Other; Other
Intervention description(s): Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo; Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo; Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Other intervention name(s): Natural Substances present in chili pepper; Natural Substances present in chili pepper; Natural Substances present in chili pepper
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: thermogenesis; respiratory quotient; fat oxidation
Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children
Condition: Plasmodium Falciparum
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label randomised controlled clinical trial will compare the safety, tolerability,
      therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine,
      arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with
      uncomplicated falciparum malaria in Kilifi, Kenya. This study will also provide an up to date
      insight on the current presence of antimalarial resistance in this site.

      In addition, all children will be treated with a single low dose of primaquine, dosing is age
      based.

      The investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated
      falciparum malaria in Kilifi County Hospital.
    


Intervention name(s): Arterolane-piperaquine; Arterolane-piperaquine+mefloquine; Artemether-lumefantrine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Arterolane maleate-piperaquine phosphate tablets (37.5 mg/187.5 mg); Arterolane maleate-piperaquine phosphate tablets (37.5 mg/187.5 mg) Mefloquine tablets (250 mg); Artemether-lumefantrine tablets (20 mg/120 mg)
Intervention MeSH terms: Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised 1:1:1 to one of the three treatment arms
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders
Condition: Hypertension; Sleep; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Hypertension
Study type: Observational

Summary: 
      Several epidemiological studies in large cohorts suggest a strong association between sleep
      duration, complaint of insomnia and risk of hypertension.These findings suggest an important
      role of sleep quality in development of hypertension. Principal limitations of these studies
      are the cross-sectional study design, self-report sleep duration and poor measurement of
      blood pressure. The investigators propose to study an insomniac population with complete
      evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement
      of hypertension.
    

Detailed description: 
      Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with
      chronic complain of insomnia. In our study, sleep duration is evaluated by complete
      evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda
      during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep
      evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained
      by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement.

      The primary objective of this epidemiological study is to show an increase risk of
      hypertension when sleep duration is less than 7 hours, with objective measurement of sleep
      duration and hypertension.

      Secondary objectives are to evaluate role of complain of insomnia in the risk of
      hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        adult with chronic complain of insomnia
      
Keywords: hypertension; sleep; insomnia
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an investigator-initiated study whose primary aim is to determine the effectiveness
      of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current
      medications do not completely control those symptoms. Aripiprazole is a medication that has
      been approved by the United States Food and Drug Administration (FDA) for the treatment of
      Schizophrenia.

      A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to
      side effects with aripiprazole. The goal of this research is to identify individuals who
      metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician
      make dosing adjustments and decrease the risk of adverse events.
    

Detailed description: 
      The primary aim of this study is to assess the effectiveness, safety, and tolerability of
      aripiprazole for the treatment of children and adolescents with bipolar disorder. The
      secondary aim of this study is to determine if common polymorphic variations in the CYP 2D6
      gene underlie the inter-individual variability in aripiprazole systemic drug exposure and the
      occurrence of treatment emergent side effects.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): 5-20 mg/day
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child; adolescent
Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that
      involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides
      adequate post-operative pain relieve following the various abdominal surgeries.
      Theoretically, TAP block may replace the need for epidural analgesia after abdominal
      operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by
      (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior
      abdomen.
    

Detailed description: 
      The transversus abdominis plane (TAP) technique, originally described by involves injection
      of local anaesthetic in the plane between the internal oblique and transversus abdominis
      muscle layers, with the aim of anaesthetising the intercostal nerves supplying the abdominal
      wall. Initially, the block used surface landmarks of the triangle of Petit (latissimus dorsi
      posteriorly, external oblique superiorly, iliac crest inferiorly) and a double fascial 'pop'
      (loss of resistance) to guide placement of the local anaesthetic. More recently,
      ultrasonography has been used to guide the delivery of the injectate into the appropriate
      plane, thereby increasing the accuracy of the Technique.

      The duration of the TAB is limited to effect of administered local anesthetics. To prolong
      the block's duration, adjuvant medications were added to LA to magnify the effect of TAP
      block . Opiates such as morphine and tramadol have peripheral and central analgesic effects.
      Opiate receptors are present at the terminals of afferent peripheral nerves; therefore,
      administration of opiates peripherally might provide a significant analgesic effect.
    

Intervention name(s): Bupivacaine 0.25% 20ml on each side Sonar guided TAB; Morphine 10mg; Morphine 15mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bupivacaine 0.25% 20ml on each side Sonar guided TAP block. After careful aspiration injection of 20ml of 0.25% bupivacaine will be performed and hypoechoic layer will be detected on ultrasound then the maneuver will be repeated on the other side; Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.; Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.
Other intervention name(s): BUCAIN Sonar guided; Morphine injection; Morphine injection
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominal surgery, pain, local, transversus abdominus block.
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to provide information regarding the relative effectiveness of
      three different atomoxetine doses in the treatment of Korean children and adolescents with
      Attention-Deficit/Hyperactivity Disorder (ADHD)
    


Intervention name(s): Atomoxetine Hydrochloride; Atomoxetine hydrochloride; Atomoxetine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period; Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period; Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days.
Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days
Other intervention name(s): LY139603; Strattera; LY139603; Strattera; LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are to assess the efficacy, safety, and side effects among doses
      approved by the Food and Drug Administration and higher (not FDA approved) doses of
      olanzapine in patients with schizophrenia or schizoaffective disorder.
    


Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional
Phase: Phase 3

Summary: 
      This prospective randomized double-blind control trial is carrying out in the neonatal unit
      of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with
      the diagnosis of preterm (<33 weeks gestation) VLBW (birth weight <1500g) and fulfilling the
      inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included
      in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia,
      major congenital anomaly and babies who expired due to other neonatal illness were excluded.
      Gestation was assessed from history of last menstrual period and after birth by new Ballard
      scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G
      Osmani Medical College, Sylhet.
    

Detailed description: 
      Background: Necrotizing enterocolitis (NEC) is the most common acquired disease of the
      gastrointestinal tract in preterm very low birth weight infants and associated with increased
      morbidity and mortality. Prophylactic enteral probiotic supplementation may play a role in
      reducing NEC and potentially provide benefits to preterm very low birth weight neonates. The
      objective was to evaluate the efficacy of orally administered probiotics in preventing
      necrotizing enterocolitis (NEC) in preterm very low birth weight (VLBW) infants.

      This prospective, randomized double blind controlled trial is undergoing in 102 preterm
      (28-33 weeks gestation) VLBW (birth weight 1000-1499g) neonates fulfilling the inclusion
      criteria. The study group was fed with probiotics once daily with breast milk from first
      feeding and the control group only breast milk without the addition of probiotics. The
      primary outcome was the development of NEC (stage II and III). NEC is categorized by modified
      Bell's classification.

      Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm
      neonates with very low birth weight. It is also associated with faster achievement of full
      enteral feeding and shorter duration of hospital stay.
    

Intervention name(s): Probiotics; Breast milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU manufactured by TENSALL BIO-TECH CO.LTD.Taiwan, distributed by Century Health Care, Bangladesh); Normal breast milk will be given as part of standard care
Other intervention name(s): TS 6 Probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Necrotizing Enterocolitis; probiotics; very low birth weight