bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic
      trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet
      inhibition in stable patients who recently underwent acute myocardial infarction and were
      treated with percutaneous coronary intervention.
    


Intervention name(s): Ticagrelor 90 mg; Ticagrelor 60 mg
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 90 mg twice daily; Ticagrelor 60 mg daily
Other intervention name(s): Brilique 90 mg; Brilique 60 mg
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet reactivity; ticagrelor; myocardial infarction; pharmacodynamics; antiplatelet therapy
Workplace Based Rehabilitation for Low Back Disorders
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effect of back supports plus education upon
      recovery from a work-related low back disorder. The study tests the hypothesis: the use of
      back supports plus health education is not different from health education alone in promoting
      recovery from a work-related low back disorder in consideration of personal, health, and job
      factors. Significant improvements in physical health, neurogenic symptoms, back pain
      disability, and low back pain were observed over the twelve months of study follow-up. No
      statistically significant difference between the study groups was found with respect to these
      measures.
    

Detailed description: 
      BACKGROUND Low back pain remains a common major source of morbidity and disability. Few
      studies consider the effectiveness of interventions for low back pain while simultaneously
      considering personal, health, and job characteristics.

      METHODS This is a randomized clinical trial in which 433 active employees with low back
      disorders were randomly assigned to one of two study groups: 1) back support plus education
      on back health; or 2) education on back health only. Demographic, health, medical, and job
      factors were recorded. Outcomes were evaluated over a twelve month period and included
      self-reported measures of back pain, back pain disability level, physical health, mental
      health, back pain recurrence and administrative measures.

      RESULTS Significant improvements in physical health, neurogenic symptoms, back pain
      disability, and low back pain were observed over time in both study groups. However, there
      was no significant difference between the study groups with respect to these outcome
      measures. The adjusted hazard ratio of recurrence rate was suggestive of an incremental
      protective effect due to back supports over education alone (adjusted hazard ratio
      [AHR]=0.711, 95% CI 0.50, 1.04, p=.085). There was also a marginal effect of back supports
      and education on decreasing low back pain over time (AHR=0.0015, p=0.091).

      CONCLUSIONS Back supports may have some value in promoting recovery from low back pain, but
      this effect is only observed in individuals who are actively employed in jobs with medium
      risk of low back disorders.
    

Intervention name(s): Back supports
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Other
Keywords: Low back pain; Industrial workers; Recurrent back pain; Back supports; Back health education; Rehabilitation
Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
Condition: Hypertension; Renal Insufficiency
MeSH terms: Renal Insufficiency; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal
      function, endothelial function, blood pressure variability by comparison with
      hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and
      Hypertension.
    


Intervention name(s): Indapamide; Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): Indapamide SR 1.5mg qd; Hydrochlorothiazide 25mg qd
Intervention MeSH terms: Hydrochlorothiazide; Indapamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; renal insufficiency; indapamide; hydrochlorothiazide
SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial
Condition: Healthy; GEN1 Gene Mutation
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1)
      rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol
      and serum low density lipoprotein cholesterol /serum total cholesterol. This study aims to
      confirm and extend this finding by characterizing the effects of cholesterol from egg yolks
      on lipid profiles in healthy young adults with different SREBF1 genetic makeup. 32 SREBF1
      C/G/G minor allele carriers at rs2236513/rs2297508/rs4925119 and 32 SREBF1 AA/CC/AA major
      homozygotes at rs2236513/rs2297508/rs4925119 were enrolled to test their response to egg
      yolks.
    


Intervention name(s): Egg yolks; Macronutrients equivalent control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two egg yolks/day was designed for the study. However, uneven egg sizes during period 1 made the intervention unable to achieve the protocol's recommended cholesterol intake level, and the intervention was modified in period 2 to be 0.8 g egg yolk/day/kg body weight. This dosage was calculated by dividing the 35 g egg yolk with the lightest weight among the volunteers, which was 45 kg. This provides a more consistent cholesterol intake between persons as the egg yolk dosage is standardized for persons with different weights.; The macronutrients equivalent control group was served 42 g egg white cooked with 10 g olive oil, designed to best imitate the energy and macronutrients of 35 g egg yolk (energy 119 kcal, protein 5 g, fat 10 g, carbohydrate 1 g) since the average weight of two large egg yolk was presumed to be 35 g. As an egg yolk dose of 0.8 g egg yolk per kg body weight per day was served during the intervention period 2, the macronutrients equivalent control was likewise adjusted as follow: subjects who weighed less than 55 kg were served 51 g egg white cooked with 12 g olive oil, which is equivalent to 40 g egg yolk; those who weighed from 55 kg to 65 kg were served 61 g egg white cooked with 14 g olive oil, which is equivalent to 48 g egg yolk; and those who weighed more than 65 kg were served 71 g egg white cooked with 17 g olive oil, which is equivalent to 56 g egg yolk.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Keywords: Gene-by-Diet Interaction; Egg Yolk; Sterol Regulatory Element Binding Protein 1 Gene; HDL-C; LDL-C/HDL-C
Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography
Condition: Echocardiography; Pediatrics
Study type: Interventional

Summary: 
      The objective of this study is analyze the influence of TV entertainment in children less
      than 3 years of age during echocardiography in order to achieve a complete and accurate test.

      This is an experimental study in children with suspected congenital or acquired cardiac
      disease. An examination room was prepared with a TV on the ceiling that was positioned in a
      way that would provide unobstructed viewing for children during the echocardiography
      procedure.
    


Intervention name(s): echocardiography; Watching Animated cartoons
Intervention type(s): Procedure; Behavioral
Intervention description(s): TV was connected to display the cartoon video during the echocardiography: the episode number 125 of 'Dora the Explorer': 'Baby Winky Goes Home!' was reproduced during the echocardiography.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Lifestyle Enhancement for ADHD Program
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if physical activity (PA) can increase in
      children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral
      management training (BMT) program.
    

Detailed description: 
      The purpose of this study is to increase physical activity (PA) in children with ADHD using a
      novel, family-based intervention that promotes PA within the context of evidence-based
      behavioral management training (BMT) for parents, enhanced with mobile health (mHealth)
      behavior change strategies. Our first aim is to test the feasibility and acceptability, of an
      8-week, family-based, multi-level intervention (BMT-Health) to promote PA in young children
      with ADHD. Our second aim is to derive an estimate of the effect size of the intervention on
      PA.
    

Intervention name(s): Lifestyle Enhancement for ADHD Program
Intervention type(s): Behavioral
Intervention description(s): The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Other intervention name(s): LEAP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ADHD; Physical Activity; Behavioral Management Training; Mobile Health
Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status
Condition: Forward Head Posture; Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Using computer for long hours is related to higher risk of computer related muscular
      disorders like forward head posture and neck pain. Deep cervical flexor muscles are important
      head-on-neck posture stabilizers thus their training may lead to improvement in forward head
      posture (FHP) and neck pain (NP).
    

Detailed description: 
      In contemporary societies, computer use by children is a necessity and thus highly prevalent.
      Using computer for long hours is related to higher risk of computer-related muscular
      disorders like forward head posture and neck pain. Deep cervical flexor muscles are important
      head-on-neck posture stabilizers thus their training may lead to improvement in forward head
      posture (FHP) and neck pain (NP). Aim of study was to determine if 4 weeks of deep cervical
      flexors training is effective in alleviating neck pain and improving forward head posture in
      adolescent children using computer regularly. A pretest-posttest experimental group design
      was used. Subjects were randomly assigned into control group (receiving postural advice only)
      and experimental group (receiving deep cervical flexor training and postural advice).
      Dependent variables were measured on day 0 (at baseline) and after 4weeks of training. The
      photographic analysis was used for measuring forward head posture, visual analog scale (VAS)
      for neck pain intensity and Neck Disability Index (NDI) for functional disability.
      Experimental group received craniocervical flexion training for 4 weeks and postural advice.
      Control group received only postural advice.
    

Intervention name(s): Craniocervical flexion training
Intervention type(s): Other
Intervention description(s): PBU airbag was clipped together and folded in, fastened, and placed suboccipital. Uninflated pressure sensor was kept below the neck, so that it touched the occiput then inflated to a stable baseline pressure of 20 mmHg to just fill the space below the neck but not to push it into lordosis. Subjects were demonstrated the correct action of the deep cervical flexors that is gentle nodding of head as if saying "yes".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck pain; Forward head posture; Deep cervical flexors
SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with
      partial seizures and are taking up to 3 medications for this medical condition will take part
      in a research study at approximately 85 different locations in the United States.

      The purpose of the study is to evaluate the effectiveness, safety and tolerability of
      consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about
      five months.

      Each patient who qualifies and chooses to participate in the study will receive placebo
      (inactive drug) or gradually increasing doses of lacosamide up to the target dose of
      400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks.

      The study clinic visits will include a medical history and physical exam, electrocardiogram
      (ECG), blood and urine sample collection, and completion of a seizure diary.

      Patients who complete the study may enroll in an extension trial and receive active study
      drug.
    


Intervention name(s): SPM 927
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Epilepsy with partial seizures
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG Compared to Placebo
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially
      Hydrolyzed Guar Gum (PHGG) in Adults With Constipation as Compared to Placebo (Typhoon 2)
    


Intervention name(s): PHGG
Intervention type(s): Dietary Supplement
Intervention description(s): PHGG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of
      multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir
      in healthy volunteers.
    

Detailed description: 
      This is a multiple ascending dose, non-fasting, open label, randomized study.
    

Intervention name(s): ABT-450; ritonavir; Placebo for ABT-450; Placebo for ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsules, QD or BID, 14 days, ascending doses; capsules, QD or BID, 14 days, ascending doses; capsule, QD or BID, 14 days; capsule, QD or BID, 14 days
Other intervention name(s): ABT-538; Norvir; placebo; placebo
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Ascending Doses
Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and
      efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis.
      Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or
      twice daily for 4 weeks.
    


Intervention name(s): ATI-1777 2.0% w/w; ATI-1777 1.0% w/w; ATI-1777 0.5% w/w; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ATI-1777 topical solution 2.0% w/w; ATI-1777 topical solution 1.0% w/w; ATI-1777 topical solution 0.5% w/w; Vehicle topical solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Behavioral Assessment of Operated Preschool Children
Condition: Child Behavior; Anesthesia; Peri-operative Injury
Study type: Observational

Summary: 
      This study will investigate the behavior of preschool children who had undergone general
      surgery during early infancy and will correlate the behavioral outcomes with clinical
      perioperative variables.
    

Detailed description: 
      Several epidemiologic and observational studies found the relation between surgery in
      childhood and neurodevelopmental features in later life. However, these studies are
      criticized for retrospective design, non homogenous population, social confounders, diversity
      of surgical procedures and anesthetic management.

      Monitoring of neurological function has become standard during surgical procedures at risk
      for neuronal injury (e.g. cardiac surgery). There is also some data on possible predictive
      value of certain methods of neuromonitoring (such as cerebral near infrared spectroscopy
      (NIRS)) for neurodevelopmental outcome.

      General neonatal/infant surgery and the whole perioperative period carry the risk of
      significant physiologic disturbances, which may affect cerebral perfusion, oxygenation or
      metabolism. This study is the continuum of prospective observational trial, which
      investigated the value of the neuromonitoring measures in neonates and young infants
      undergoing general surgery. The present study will apply the behavioral assessment of these
      patients who are now between 2 and 5 years of age.
    

Intervention name(s): Questionaire
Intervention type(s): Other
Intervention description(s): Child behavior checklist is a questionaire, designed to evaluate 1.5-5 years old child's behavior. The checklist is filled out by parents/caregivers.
Other intervention name(s): Child behavior checklist
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children, aged 1.5-5 years, who had undergone general abdominal, thoracic, genitourinary
        surgery until 93 days of life in a single University hospital and were given standard
        inhalational general anesthesia with tracheal intubation and measures for neuromonitoring
        such as cerebral NIRS and measurement of brain specific proteins during perioperative
        period was applied.
      
Keywords: preschool child; behavior; anesthesia; surgery
TELAMON P™ Implant/INFUSE® Bone Graft/CD HORIZON® Spinal System Pilot Study
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™
      Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a
      method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in
      patients with symptomatic degenerative disc disease. The safety and effectiveness of the
      implant will be evaluated.
    


Intervention name(s): TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System
Intervention type(s): Device
Intervention description(s): The TELAMON P™/INFUSE™ Bone Graft Implant in conjunction with the CD HORIZON® Spinal System for single level lumbar fusion from L1 to S1
Other intervention name(s): PEEK OPTIMA™ LT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbar degenerative disc disease
Dexpramipexole Japanese PK Study
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK),
      safety, and tolerability of dexpramipexole administered orally to adult Japanese and
      Caucasian healthy subjects.
    

Detailed description: 
      The study is designed to evaluate the influence of ethnic factors on dexpramipexole safety,
      tolerability, and PK. Subjects will be admitted to the clinical unit on Day -1 (the day prior
      to first dosing) and will remain in the clinical unit under observation until discharge. All
      subjects will have a final follow up visit. Whilst resident in the clinic, subjects will
      receive 4 treatments: The first 3 treatments comprise Part A of the study and the final
      treatment group comprises Part B.

      Part A:

      Treatment 1: Dose 1 (reduced) of dexpramipexole; a single dose Treatment 2: Dose 2 (standard)
      dexpramipexole; a single dose Treatment 3: Dose 3 (standard) dexpramipexole; 5 doses
      administered at 12 hour intervals Part B: Dose 4 (standard) dexpramipexole; 5 doses
      administered at 12 hour intervals There will be a minimum washout of 3 days between
      treatments.

      For all subjects, prior to proceeding to the next treatment group, safety and tolerability
      data will be reviewed.

      Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with
      respect to gender and age and if possible BMI.
    

Intervention name(s): Single dose reduced; Single dose standard; Multiple Dose; Multiple Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment 1 (Part A); Treatment 2 (Part A); Treatment 3 (Part A); Part B
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science