bioihbjkbjnl/mcl2 huggingface dataset:
Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
Condition: Liver Cancer; Cirrhosis
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy
      is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition
      improved postoperative recovery for cirrhotic patients with liver cancer underwent
      hepatectomy..
    

Detailed description: 
      A new lipid emulsion enriched ω-3 fatty acid was manufactured, and was reported avoid
      hyperinflammatory situations in patients followed major surgery. However, the role of ω-3
      fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver
      cancer is unclear. This study aims to evaluate the safety and efficacy of ω-3 fatty
      acid-based parenteral nutrition for cirrhotic patients with liver cancer followed
      hepatectomy.

      A prospective randomized controlled clinical trial was conducted for cirrhotic patients with
      liver cancer underwent hepatectomy between March 2010 and September 2013 in the investigators
      institution. For postoperative parenteral nutrition, 20% Structolipid and 10% Omegaven were
      applied to the trial group, while only Structolipid to the control group for 5 consecutive
      days postoperatively.
    

Intervention name(s): Omega-3 Fatty Acid-Based Parenteral Nutrition; Structolipid
Intervention type(s): Drug; Drug
Intervention description(s): Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.; Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.
Other intervention name(s): trial; control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: omega-3; Progression; parenteral nutrition
Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      repeat ascending doses of GSK2018682. The study will also provide further evidence of the
      potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute
      Lymphocyte Counts (ALC).
    

Detailed description: 
      The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      repeat ascending doses of GSK2018682. The study will also provide further evidence of the
      potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute
      Lymphocyte Counts (ALC).
    

Intervention name(s): GSK2018682; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pharmacodynamics; Pharmacokinetics
Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer. It may also help doctors predict how patients respond to
      treatment.

      PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with
      advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without
      bevacizumab on clinical trial E-3200.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the CpG island methylation pathway markers that are adverse for survival after
           treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated
           with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

        -  Compare the methylation results to clinicopathologic and molecular findings and
           survival.

      OUTLINE: This is a multicenter study.

      Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are
      examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14,
      and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q
      LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346,
      and D17S250.

      PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.
    

Intervention name(s): DNA methylation analysis; loss of heterozygosity analysis; microsatellite instability analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E3200
      
Keywords: recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage III rectal cancer; stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed crossover study will compare for the first time the quality of 24-hour
      intraocular pressure control with the combination of travoprost and brinzolamide/timolol
      compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently
      controlled with travoprost. This comparison may determine the real efficacy of the two fixed
      combinations when added to the prostaglandin. The design of the proposed study should
      facilitate a better understanding of the role of these medications in glaucoma management.
    


Intervention name(s): Brimonidine/timolol fixed combination drops added to travoprost; Brinzolamide/timolol fixed combination drops added to travoprost
Intervention type(s): Drug; Drug
Intervention description(s): twice daily administration; twice daily dosing
Other intervention name(s): Combigan; Azarga
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Travoprost; Brinzolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: 24-hour IOP control; brinzolamide/timolol; brimonidine/timolol; travoprost
Evaluation of the Effect of Sensory Imagination on Food Portion Size in School-aged Children
Condition: Sensory Imagination
Study type: Interventional

Summary: 
      The objective of this intervention is to evaluate the effect of sensory imagination (i.e.,
      imagining the sensory properties of an object) on the choice of food portion size in
      school-aged children. Previous research showed that it may help children to choose smaller
      portion size. The investigators would like to assess whether this effect can be reproduced
      with two types of food (one with a high energy-density and one with a low energy-density),
      and in older children.
    

Detailed description: 
      School-aged children (8-11 years old) will be included in their usual schools to participate
      in an afternoon snack, organised according to regular arrangements, during two days separated
      by one week. On each day, the participants will receive a choice of three portion sizes of a
      food (small, medium, large), and will be asked to chose one of these portions and to eat it
      for snack. On one day, the high energy-density food will be offered; and on the other day,
      the low energy-density food. This will be counterbalanced across participants. Moreover, two
      groups of children will be constituted: the first group, the control group, will have to
      perform a sensory imagination task about neutral facts. The second group, the "food sensory
      imagination" group, will have to perform a sensory imagination task foods.
    

Intervention name(s): Sensory imagination about foods
Intervention type(s): Behavioral
Intervention description(s): In both groups, children will be presented with pictures of items. In the control group, the pictures will represent landscapes at different seasons. In the experimental group, the pictures will represent a variety of foods. In the experimental group, based on the pictures representing a variety of foods, children will have to perform a food sensory imagination task before choosing the portion size of a food.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of children will be constituted: the first group, the control group, will have to perform a sensory imagination task about neutral facts. The second group, the "food sensory imagination" group, will have to perform a sensory imagination task foods.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: sensory imagination; foods
Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I
Condition: How Occipital tDCS Affects Brain Function in Healthy Adults
Study type: Interventional

Summary: 
      This study will determine whether transcranial direct current stimulation (tDCS) can be used
      alter the amplitude of spontaneous neural activity, and thereby modulate cognitive function
      in healthy adults
    

Detailed description: 
      An emerging neurological tool, called transcranial Direct Current Stimulation (tDCS), has
      recently been shown to safely and effectively enhance cognition in healthy individuals, as
      well as reduce key symptomatology in disorders such as stroke and depression, with only
      negligible side effects. tDCS delivers low-amplitude current to the scalp using small
      electrodes and part of this current passes through the skull and modulates neural activity in
      the underlying brain region. How this tiny amount of electric current acts to improve
      cognitive function and reduce symptoms (e.g., motor impairments in stroke patients with a
      lesion in motor brain areas) is currently unknown, although many investigators across the
      world are now working on this problem. Magnetoencephalography (MEG) offers a unique view of
      neural function, as it can delineate changes in active brain regions with excellent temporal
      resolution (< 1 ms) and high spatial accuracy (2-3 mm). MEG non-invasively measures the
      magnetic fields that emanate from active neocortical cells. The potential of the MEG
      technique to precisely monitor the neural effects of tDCS shows extreme promise, but to date
      the method has been rarely utilized in this area.

      Under this protocol, Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I,
      approximately 124 participants will provide written informed consent, undergo cognitive and
      behavioral testing and a structural MRI during a single visit, and then return several weeks
      later (2-4 weeks) to complete a short tDCS session followed by a MEG recording (i.e., after
      tDCS). Most participants will return for two more visits, each separated by 2-4 weeks, that
      include a tDCS session followed by a MEG recording (i.e., 4 total visits). The three tDCS-MEG
      visits will be identical except that the nature of the stimulation (e.g., location,
      amplitude, direction/polarity) will be different.
    

Intervention name(s): transcranial direct-current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): 20 minutes duration using high-definition system with center-surround configuration
Other intervention name(s): Transcranial electrical stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Full crossover; all participants complete all conditions
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of various degrees of hepatic function on the
      pharmacokinetics and safety of ALKS 5461.
    


Intervention name(s): ALKS 5461
Intervention type(s): Drug
Intervention description(s): Single dose, given orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
Condition: Adolescent Juvenile Idiopathic Arthritis; Yoga Therapy
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The purpose of the study is to better understand the effects of a yoga program on adolescents
      with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a
      yoga therapy based program will decrease pain and improve quality of life in patients with
      JIA.

      This is an 8-week program with home program of online videos.
    

Detailed description: 
      This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The
      classes are led by a pediatric occupational therapist who is also a certified internationally
      accredited yoga therapist (C-IAYT). The initial and final sessions will include an
      Rheumatologist MD evaluation including a physician global assessment and joint damage
      assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds
      Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is
      75 minutes to include a set-sequence of postures including breathing exercises and final
      corpse pose (final relaxation).
    

Intervention name(s): yoga
Intervention type(s): Behavioral
Intervention description(s): 75 minute weekly group yoga classes for 8 weeks. Home program online.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: yoga therapy; JIA; quality of life; pain management
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BI 653048 BS H3PO4 Capsule Assessing Endotoxin-induced Inflammatory Response in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The general aim of the current study was to investigate the safety and tolerability, and
      pharmacodynamics (endotoxin-induced inflammatory response of a single intravenous bolus
      administration of 2 ng/kg body weight Escherichia coli lipopolysaccharide (LPS)) of BI 653048
      BS H3PO4 capsules in healthy male subjects following oral administration of multiple rising
      doses of 25 mg to 200 mg over three days compared to the active comparator prednisolone and
      placebo.

      Pharmacodynamics were assessed by investigating the influence of LPS administration on
      inflammatory parameters. More specifically, it was evaluated whether and to what extent the
      symptoms induced by LPS challenge can be attenuated by ascending BI 653048 BS H3PO4 doses
      using prednisolone as positive control and placebo as negative control. A secondary objective
      was the exploration of pharmacokinetics of BI 653048 BS, the investigation of other
      pharmacodynamic parameters (biomarker) and of the tolerability of LPS.
    


Intervention name(s): BI 653048 BS; Prednisolone low; Prednisolone high; Placebo; sodium chloride infusion; endotoxin escherichia coli (E. coli) lipopolysaccharide (LPS)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization
Condition: Cardiac Conduction and Repolarization
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized
      study, to compare treatment with intravenous custirsen at 640 mg (highest intended
      therapeutic dose) with placebo. The purpose of this study is to assess the effect of
      custirsen treatment on cardiac conduction and repolarization (electrical activity of the
      heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity
      consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The
      moxifloxacin arm is un-blinded but the ECG readings are blinded.
    

Detailed description: 
      The effects of custirsen will be evaluated following administration of a single dose
      following dose-titration period combined with dexamethasone pretreatment. On days -1 and 7,
      subjects will undergo a full ECG assessment for 24 hours. On day 1, randomization and
      assignment to the treatment groups will be performed prior to drug administration. Subjects
      will remain in the study center throughout the treatment period. All subjects will be
      discharged at the end of day 8 procedures, 24 hours after the last dose of custirsen has been
      administered. Subjects in groups 1 and 2 will return for an additional visit on day 9, 10 and
      14 (±2 days) (approximately 7 days after the last study drug administration). Subjects in
      group 3 will not return for a follow-up visits.
    

Intervention name(s): Custirsen; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Custirsen will be administered iv using an infusion pump over a 2-hour period.; Placebo (commercially available normal saline) will be administered iv using an infusion pump over a 2-hour period.; Moxifloxacin (400 mg) will be administered orally with 240 mL of room temperature still water.
Other intervention name(s): custirsen sodium; Normal saline
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Custirsen sodium; TV1011; OGX-011; Thorough QT study; cancer
Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study has been designed to address the significance of early onset of response
      prospectively in patients treated with an atypical antipsychotic.
    


Intervention name(s): olanzapine; risperidone; risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10-20 milligrams (mg), oral, daily, 10 weeks.; 2-6 mg, oral, daily, for 10 weeks.; 2-6 mg, oral, daily, 10 weeks
Other intervention name(s): LY170053; Zyprexa
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against
      reference drug in healthy volunteers.
    


Intervention name(s): Myrin P Forte; Single drug references
Intervention type(s): Drug; Drug
Intervention description(s): Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose; containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; Healthy Volunteers
The Effect of Preoperative Anxiety Level on the Induction Dose of Propofol and Minimum Alveolar Concentration (MAC) Hour of Sevoflurane During Thyroidectomy
Condition: Thyroidectomy
Study type: Observational

Summary: 
      This study is to evaluate the level of anxiety, and to check the correlation of induction
      dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing
      thyroidectomy.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        female patients aged between 20-65 years and scheduled elective thyroidectomy
A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the pharmacokinetics (PK), safety and
      tolerability profile of cebranopadol (GRT6005) in patients with varying degree of renal
      impairment and participants with normal renal function after an oral single dose
      administration.

      This study was a Phase 1, multi-center, non-randomized, open-label, parallel group,
      single-dose study in up to 24 male and female patients with varying degree of renal
      impairment and participants with normal renal function.

      Within 14 days before the administration of cebranopadol the general eligibility of the
      participants for the study was assessed according to the inclusion/exclusion criteria.
      Estimated glomerular filtration rate (eGFR) was determined according to the Modification of
      Diet in Renal Disease (MDRD) equation.

      A treatment period from Day -1 to Day 8 was performed, with participant confinement to the
      study site from Day -1 to Day 6 and an outpatient visit on Day 8. A single dose of
      cebranopadol 200 μg was administered on Day 1. Multiple blood and urine samples were drawn
      for pharmacokinetic evaluations and safety laboratory monitoring. Additional blood samples
      were taken prior investigational medicinal product (IMP) administration to assess serum
      creatinine concentration and protein binding.

      An End-of-Trial Visit was performed at the time, or within 7 days, of the final blood sample
      on Day 8 or at early withdrawal.
    


Intervention name(s): Cebranopadol 200 μg tablet
Intervention type(s): Drug
Intervention description(s): 200 μg cebranopadol film-coated tablet was taken with 240 mL of water under fed conditions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment