bioihbjkbjnl/mcl2 huggingface dataset:
Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients
Condition: Preemptive Peripheral Nerve Block; Pain, Postoperative; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effectiveness of preemptive effect of rectus
      sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in
      laparoscopic cholecystectomy (LLC).

      After induction of general anesthesia, group of patient is decided randomly. In Group pre,
      RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post,
      RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

      Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24
      hours after arrival at the recovery room.
    


Intervention name(s): Ultrasound guided Rectus sheath block; Intercostal nerve block
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus; Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: preemptive analgic effect; Rectus Sheath Block; laparoscopic cholecystectomy
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of a study drug
      called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1
      to less than 4 years. Blood tests will be performed to check how much nasal glucagon gets
      into the bloodstream. Blood sugar will also be measured to understand the effect of the drug
      on blood sugar levels. The study consists of a screening period up to 35 days before dosing,
      1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first
      follow-up call on the day after the nasal glucagon was given and second call about one week
      after nasal glucagon was given. The study will last up to 9 days, not including the screening
      period.
    


Intervention name(s): Glucagon Nasal Powder [Baqsimi]
Intervention type(s): Drug
Intervention description(s): Administered intranasally
Other intervention name(s): LY900018; Baqsimi
Intervention MeSH terms: Glucagon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Severe Hypoglycemia; Nasal Powder; Hypoglycemia Rescue Therapy; Ready to use Glucagon
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in
      patients with Crohn's disease.
    


Intervention name(s): Certolizumab Pegol; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: isotonic sodium chloride solution
Pharmaceutical Form: Solution for injection
Concentration: 1 mL
Route of Administration: Subcutaneous use
Other intervention name(s): CDP870
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease; CDP870; Certolizumab pegol
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral
      rinse
    

Detailed description: 
      Training of new examiners and validation of new clinical site to run 4 day short-term plaque
      studies. All products are commercially available.
    

Intervention name(s): Fluoride; Triclosan, fluoride; Chlorhexidine Gluconate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brush half mouth twice daily for four days.; Brush twice daily; Rinse mouth twice a day
Other intervention name(s): Total toothpaste
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Astaxanthin on Oxidative Stress Indices in Patients With Polycystic Ovary Syndrome
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of
      reproductive age It is hypothesized that ∼20 fold increase in reactive oxygen species (ROS)
      generation in Follicular fluid (FF) and granulosa cells of PCOS women plays an adverse role
      in affecting the IVF success rate. Astaxanthin (3,3'-dihydroxy-β,β'-carotene-4,4'-dione) is a
      nonprovitamin A carotenoid classified as a xanthophyll and is found in high amounts in the
      red pigment of crustacean shells (e.g., crabs, shrimp), salmon, trout, and asteroides. It has
      been demonstrated that astaxanthin displays a wide variety of biological activities,
      including anti-oxidative, anticancer, and anti-inflammatory effects.

      investigators aim to investigate the effect on Astaxanthin administrating on reducing of ROS
      in FF and induction of antioxidant response elements in PCOS women.
    


Intervention name(s): Astaxanthin 8 mg; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): experimental; Matching placebo pill
Other intervention name(s): Algalife, Icelandic Astaxanthin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: PCOS; Astaxanthin; ROS
The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control
Condition: Healthy
Study type: Interventional

Summary: 
      The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse
      Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in
      a double blind study.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): SNRIs
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Physiology of Serotonergic and Adrenergic systems
Inhaled Furosemide for Transient Tachypnea of Newborn
Condition: Respiratory Morbidity
MeSH terms: Tachypnea; Transient Tachypnea of the Newborn
Study type: Interventional

Summary: 
      This is a randomized double blind clinical trial in which newborns with suspected Transient
      tachypnea of the newborn (TTN) will receive either furosemide or normal saline by nebulizer
      every 6 hours for 24 hours.
    


Intervention name(s): Furosemide; Placebo
Intervention type(s): Other; Other
Intervention description(s): Patients will receive nebulised furosemide solution 1 mg/kg; Patients will receive nebulised 0.9% saline
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain
Condition: Chronic Pain; Sternotomy; Remifentanil; Fentanyl
MeSH terms: Chronic Pain; Chest Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the influence of intra-operative use of remifentanil versus
      fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via
      sternotomy. Secondary quantitative sensory testing is performed to determine thermal and
      electrical detection and pain threshold and the difference in pain variability scoring.
      Postoperative pain scores, analgesic use, genetic variances and costs are measured.
    


Intervention name(s): Fentanyl; Remifentanil; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): fentanyl bolus injections on an "as needed" base, NEXT TO the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.; starting with 0.15 ug/IBW(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.; fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
Other intervention name(s): Sublimaze; Ultiva; Sublimaze
Intervention MeSH terms: Fentanyl; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Chronic thoracic pain; Remifentanil; Fentanyl; sternotomy
Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)
Condition: Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
MeSH terms: Schizophrenia; Schizophrenia, Paranoid; Schizophrenia, Disorganized
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate whether asenapine, which is approved by the United States
      Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also
      effective in adolescents with schizophrenia. Participants who qualify for the study will be
      randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily
      [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each
      participant at various times to assess the efficacy and safety of the study treatment. The
      primary objective of the trial is to demonstrate significant superiority of at least one
      asenapine dose to placebo, as measured by the change from baseline of the Positive and
      Negative Syndrome Scale (PANSS) total score at Day 56.
    


Intervention name(s): asenapine 2.5 mg; asenapine 5.0 mg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): asenapine 2.5 mg tablets for sublingual administration; asenapine 5.0 mg tablets for sublingual administration; asenapine-matched placebo tablets for sublingual administration
Other intervention name(s): Saphris®, SCH 900274, Org 5222; Saphris®, SCH 900274, Org 5222
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asenapine; adolescents; schizophrenia; phase IIIb; placebo-controlled
A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor
      functions and quality of life in patients with stroke that was conducted in two centers in
      india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary
      outcome measure was quality of life at 6 weeks.

      Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions
      and quality of life in patients with stroke.
    

Detailed description: 
      Graded Motor Imagery (GMI) is essentially a brain based treatment, targeting the activation
      of different brain regions in a graded manner. GMI is a three stage treatment programme
      comprising of Left Right discrimination training, Explicit Motor imagery and Mirror therapy.

      In this Study, GMI approach is applied on the patients with Stroke to enhance their Upper
      limb motor functions and Quality of life.

      Conventional treatment:

      Patients of group A and group B had received conventional treatment for 6 weeks. Conventional
      treatment consists of Task oriented upper extremity functional exercises. Components of Task
      oriented training include weight bearing, supportive reactions, and reaching, grasping,
      holding and release activities. It was performed five days a week for six weeks of one hour
      duration.

      Graded Motor Imagery:

      Patients of group A had received GMI programme with conventional treatment for 6 weeks. It is
      a three stage process, was performed five days a week for six weeks of one hour duration. It
      comprises of:

        -  Left Right discrimination training (Implicit Motor Imagery) - 2 weeks

        -  Explicit Motor Imagery (Imagined movements) - 2 weeks

        -  Mirror Therapy - 2 weeks
    

Intervention name(s): Recognise [TM]; Mirror Box
Intervention type(s): Device; Device
Intervention description(s): Recognise accurately measures to identify left and right body parts and movements, and to train left/right discrimination as part of a comprehensive GMI rehabilitation process.; A resource used for many pain and disability states of the hands and feet.
Other intervention name(s): Online Recognise software by the NOI group, Australia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Upper extremity, motor imagery, mirror therapy
Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy
Condition: Traumatic Injury
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Traumatic injury is a major public health problem with an immense societal cost. Despite
      improvements in trauma management, patients continue to suffer significant morbidity and
      mortality. Evidence suggests that males and females tolerate severe injury differently with a
      greater protection afforded to females. Determining the mechanisms responsible for these
      sex-based outcome differences after injury, focusing specifically on the early sex-hormone
      environment post-injury, may allow those at highest risk for poor outcome to be predicted and
      promote interventions that can improve outcomes for all injured patients. The goal of this
      study is to determine if the early sex hormone environment soon after injury has effects on
      the intensity of the immune response, resuscitation and blood transfusion requirements, and
      important clinical outcomes including mortality, organ failure and infection, following
      significant injury.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Injured patients requiring ICU admission who arrive within 6 hours of injury
      
Keywords: Sex hormones; Testosterone; Estradiol
Canola Oil Multi-Centre Intervention Trial II
Condition: Cardiovascular Disease; Diabetes; Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objectives of the study are to examine the health benefits of dietary canola oils on body
      composition, specifically on android fat, and weight management. COMIT II will also include
      analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body
      composition. Measurement of endothelial function, inflammatory, adiposity, and insulin
      sensitivity biomarkers will be done to determine the positive health impact of the changes in
      body composition achieved through canola oil consumption.
    

Detailed description: 
      The proposed multi-center clinical trial would engage the same collaborative team that
      successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and
      Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the
      L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec
      City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State
      University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St.
      Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg,
      Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research
      program will proceed as a double blind, randomized crossover study consisting of three
      treatment phases of six weeks, each separated by a 6-week washout period. Participants will
      consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35%
      energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment
      oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical
      "Western diet" fat intake as a control treatment comprised largely of saturated fat with
      substantial levels of omega-6 linoleic acid, common to current North American intakes.
      Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and
      consumed at breakfast and supper. The clinical segment of COMIT II is expected to be
      completed by the mid to end of the second year, with sample analyses to be completed by the
      end of year three.
    

Intervention name(s): Regular Canola Oil; High Oleic Canola Oil; Western Type Diet - Common Dietary Oils
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure
Condition: Mood
Study type: Interventional

Summary: 
      The purpose of this study was to measure potential mood, cognition and blood pressure effects
      of theobromine and caffeine in healthy women
    

Detailed description: 
      Background Previous research has shown that naturally occurring chocolate ingredients
      theobromine and caffeine have positive effects on mood.

      Objectives: To assess mood and cognition in adult subjects after the consumption of capsules
      filled with 1. placebo, 2. theobromine alone, 3. caffeine alone or, 4. theobromine and
      caffeine combined together.

      Study design: Double-blind, placebo-controlled, randomized, cross-over design, with a 1 week
      washout period in between.

      During the 4 weeks intervention period, once a week one of the 4 types of test products were
      consumed with 250ml of water in a randomized order;

        1. placebo capsules

        2. theobromine capsules (700 mg),

        3. caffeine capsules (120 mg),

        4. mix of theobromine (700 mg) and caffeine (120 mg). Twenty-four healthy female subjects
           (and 4 reserve subjects) were recruited for a four week intervention period in total
           with every week a 4 hrs measurement day and one of the interventions.

      Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire),
      cognition (Digit Symbol substitution) Secondary parameters: blood pressure
    

Intervention name(s): theobromine; Caffeine; caffeine + theobromine; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 700 mg theobromine in gelatin capsules given one time only; 120 mg caffeine in capsules given one time only; 120 mg caffeine and 700 mg theobromine in capsules given one time only; cellulose in capsules given one time only
Other intervention name(s): 3,7-dimethylxanthine; 1,3,7-trimethylxanthine; methylxanthines; avicel (cellulose)
Intervention MeSH terms: Theobromine; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cognition; attention; methylxanthine
Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel
      lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy,
      such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the pharmacokinetics profile of nanosomal docetaxel lipid suspension (NDLS) in
      patients with advanced solid tumors.

      SECONDARY OBJECTIVES:

      I. To assess the safety and toxicity of NDLS in patients with advanced solid tumors.

      OUTLINE: Patients are randomized to 1 of 4 treatment arms.

      ARM I: Patients receive lowest dose nanosomal docetaxel lipid suspension intravenously (IV)
      over 1 hour.

      ARM II: Patients receive low dose nanosomal docetaxel lipid suspension IV over 1 hour.

      ARM III: Patients receive high dose nanosomal docetaxel lipid suspension IV over 1 hour.

      ARM IV: Patients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour. In
      all arms, treatment may repeat every 21 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 30 days.
    

Intervention name(s): nanosomal docetaxel lipid suspension; pharmacological study
Intervention type(s): Drug; Other
Intervention description(s): Given IV; Correlative studies
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment