bioihbjkbjnl/mcl2 huggingface dataset:
Methylphenidate Effect on Humphrey Visual Fields
Condition: Visual Field Tests
Study type: Interventional

Summary: 
      Study will include adults with abnormal visual fields. Half of them will be given either
      methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as
      controls. All Subjects will also have a complete eye examination, a short questionnaire and a
      questionnaire to screen for attention deficit disorder. The investigators will compare the
      visual field results between the 2 tests.
    

Detailed description: 
      Healthy adults with abnormal visual fields will be offered to participate Subjects will have
      a complete ophthalmic examination including dilated fundus examination.

      Subjects with clear explanation for a visual field defect (e.g. optic neuropathy or retinal
      disorder) will be excluded from the study the subjects will be randomly assigned to the study
      group and control group using a 1:1 allocation.

      Subjects in the study group will be provided with a single tablet of methylphenidate 10 mg to
      be taken orally 2 hours before repeating their visual field test.

      The control group will not receive any placebo Both groups will repeat their visual fields.
      Both groups will fill out a short questionnaire to evaluate their experience in the second
      visual field test.

      The study group will also fill out a screening questionnaire to rule out previously
      undiagnosed attention deficit disorder.

      Two experienced ophthalmologists will separately interpret the visual fields results and
      compare the first and second visual fields of each subject, while being blinded to which
      group he was in.

      Subjects will be provided with their test results and the ophthalmologist interpretation.
    

Intervention name(s): methylphenidate; guidance
Intervention type(s): Drug; Other
Intervention description(s): a single dose of methylphenidate 10 mg to be taken orally in the morning; subjects will be given an explanation and advice about how to perform well in visual field testing
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Humphrey visual fields; methylphenidate; attention deficit disorder; MoCa questionnaire
Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients
Condition: Enteral Nutrition; Postoperative Period; Digestive System Neoplasms
MeSH terms: Digestive System Neoplasms; Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after
      abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after
      abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy
      delivered by oral feeding or patients are discharged from hospital. The primary and secondary
      outcomes will be collected.
    

Detailed description: 
      Patients after abdominal surgery will receive enteral nutrition for 2 days, if she/he can
      tolerate 30% of goal-dose EN, then she/he will be randomized to Gradual or immediate
      Goal-dose EN group at day 3. Patients in Gradual Goal-dose EN group will receive increased
      calories gradually by EN and will reach the 80% of target energy by EN at day 8 while
      patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3
      after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy
      delivered by oral feeding or patients are discharged from hospital, whichever arrives first.
      The primary and secondary outcomes will be collected.
    

Intervention name(s): Enteral nutrition
Intervention type(s): Other
Intervention description(s): Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both of the two group will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enteral Nutrition; Digestive System Neoplasms; Randomized Controlled Trial; Clinical Outcomes
Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional
      filling material (compomer) to restore decayed deciduous teeth in children
    

Detailed description: 
      A tooth decay in deciduous teeth has to be restored with proper filling material. ACTIVA™
      BioACTIVE is a new filling material which has the ability to release and recharge fluoride in
      the oral cavity which is important for preventing further tooth decay. In this study we will
      compare this new filling material with Compomer (the traditional control filling material) by
      restoring decayed deciduous molars with one of the mentioned filling materials.

      Both filling materials have no reported adverse effect and used regularly in the dental
      practice.

      The treatment procedure is performed in healthy children from both genders with decayed
      deciduous molars aged between 5 to 10 years by one operator in the dental chair under local
      anesthesia in the department of pediatric dentistry and special care, Ghent University
      hospital, Ghent, Belgium.

      At least 35 teeth is needed to demonstrate an effect. Each material is placed randomly based
      on randomization done by the computer. Each participant will receive both types of
      treatments, one type on each side of the mouth.

      The participants will come back each six months to check the success of each treatment group
      by two trained dentists other than the operator. and to check whether the control group
      performs similar, better or worse than the control group.

      The duration of treatment procedure of both treatment groups is recorded and compared to
      check if one filling material takes less time than the other to placed in the oral cavity.
    

Intervention name(s): ACTIVA™ BioACTIVE; Compomer
Intervention type(s): Drug; Drug
Intervention description(s): Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth; Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
Other intervention name(s): ACTIVA; Dyract
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Experimental prospective double blinded split-mouth randomized controlled trial .
Each patient receive both types of treatment in the oral cavity, one type of the treatment on each side.
The patients act as their control
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Class II; Primary molar; Restorative material; Bioactive material; Compomer; Activa bioactive; Ryge criteria
Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response
Condition: Healthy
Study type: Interventional

Summary: 
      Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and
      insulinemic responses compare to a trans free palm margarine (TFPM).
    

Detailed description: 
      The objective of this study was to investigate whether IE-fat blends behave differently on
      postprandial serum lipid, insulin, C-peptide and glucose concentration compare to TFPM. A
      randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and
      conducted on 10 males and 10 females adults. During postprandial challenge day, each subject
      received an a test muffin incorporated with test margarine. Blood samples were collected at
      half-hourly intervals until 4 hr by using cannulation technique.
    

Intervention name(s): Trans free palm margarine; Interesterified Palm based margarine; IE Soybean oil-based margarine
Intervention type(s): Other; Other; Other
Intervention description(s): A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.; A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.; A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Condition: Lower Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if two sustained released formulations of
      carisoprodol are more effective than placebo.
    

Detailed description: 
      Methodology:

      This was a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study
      in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study
      consisted of a baseline screening (Study Day 1), during which subjects were evaluated for
      inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through
      Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the
      following double-blind treatments: sustained release(SR) carisoprodol 500-mg
      tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo.

      Subjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained
      symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind
      extension period at the discretion of the Investigator. Subjects were contacted by telephone
      for a safety follow-up 7 days after the last dose of study medication.

      A pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood
      samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment
      period, if applicable.
    

Intervention name(s): Carisoprodol SR; Carisoprodol SR; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 700 mg twice daily; 500 mg twice daily; Placebo tablet
Other intervention name(s): sustained release(SR); sustained release(SR) tablet; no other name
Intervention MeSH terms: Carisoprodol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Condition: Electromyography; EMG: Myopathy; EMG Syndrome; Pelvic Pain; Pelvic Floor Disorders; Pelvic Pain Syndrome; ElectroPhys: Myopathy
MeSH terms: Muscular Diseases; Pelvic Floor Disorders; Beckwith-Wiedemann Syndrome; Syndrome; Pelvic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Chronic pelvic pain (CPP) is a common presenting complaint affecting approximately 15-40 % of
      women aged 18-50 in western countries and 5-43% of women in most developing countries. It is
      debilitating and has a large socio- economic impact, with a 45%reduction in work
      productivity, and a 15% increase in absence from work in women with the condition. Botulinum
      neurotoxin type A (BoNTA) has been suggested to improve pain in muscle spasm, its role in CPP
      secondary to pelvic floor spasm has gained increasing interest. However, clinicians do not
      have a diagnosis tool to evaluate the CPP and the BoNTA treatment results.

      Design and develop an efficient and simple tool for the diagnosis and detection of pelvic
      floor muscle (PFM) dysfunction based on superficial electromyography (EMG) and perform 25 EMG
      registrations sessions in healthy patients and 25 EMG sessions in patients diagnoses with PFM
      that will be treated with BoNTA to and study the EMG signal before and after BoNTA
      administration.
    


Intervention name(s): Clostridium botulinum type A (BoNTA)
Intervention type(s): Drug
Intervention description(s): Powder and solution for solution for injection Specify total dose: 80 U
Route of administration:
Other intervention name(s): BoNTA; Clostridium botulinum type A
Intervention MeSH terms: incobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BoNTA; Electromyography; EMG; Pelvic Pain; Pelvic Pain Syndrome
Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers
Condition: Obesity; Weight Loss; Overweight and Obesity
MeSH terms: Obesity; Overweight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity is a direct result of food-intake in excess of body energy expenditure. Thus,
      induction of increased energy expenditure via the activation of thermogenesis at targeted
      anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel
      compound, in treating obesity by activating thermogenesis in subcutaneous fat.
    

Detailed description: 
      Obesity is a direct result of food-intake in excess of body energy expenditure. Therefore, a
      feasible approach to combat obesity is via energy-consuming activities, such as physical
      exercise. Unfortunately, our modern society is moving in the other direction, spending more
      time in immobilized positions, at work and at home. An alternative strategy for the induction
      of increased energy expenditure is via the activation of thermogenic cells that utilize fat
      to produce heat.RZL-012 is a novel molecule that enables de-novo generation of thermogenic
      tissue at favorable anatomical sites. As a result, the extra fat accumulated in obese persons
      will be turned into heat. This is a double blind, randomized, placebo controlled, dose
      escalation Phase 2a clinical trial for the evaluation of safety, efficacy and
      thermogenesis-induction of RZL-012 in overweight and obese volunteers. This trial aims to
      study the ability of RZL-012 in treating obesity via the induction of thermogenic foci in
      subcutaneous fat.
    

Intervention name(s): RZL-012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.; Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a consecutive 4 cohort, dose escalation placebo-controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Thermogenesis; Fat reduction
Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation for Colonoscopy Under Anesthesia
Condition: Bowel Preparation
Study type: Observational

Summary: 
      220 patients are allocated randomly to the morning group (am group) or the afternoon group
      (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants have a cluster of elective EGD and colonoscopy under anesthesia.
Cocktail Approach for Cytochrome P450 and P-glycoprotein Activity Assessment Using Dried Blood Spot
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and
      transporters in vivo. It consists of the administration of probe substances metabolised by a
      specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the
      determination of a metabolic ratio or the evaluation of the plasmatic or urinary
      concentrations of the probe substances. The administration of a cocktail containing several
      probe substances allows the simultaneous evaluation of the activity of several cytochromes
      and P-gp in a single test.

      The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs
      for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling
      and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion,
      flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous
      phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.

      The modulation of the activity of cytochromes or P-gp will be evaluated by the administration
      of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin) of the metabolic
      pathways or the P-gp mediated transport.
    


Intervention name(s): Cocktail probe drugs
Intervention type(s): Drug
Other intervention name(s): Oral intake of the cocktail probe drugs :; bupropion 25 mg; flurbiprofen 25 mg; omeprazole 5 mg; dextromethorphan 5 mg; midazolam 1 mg; fexofenadine 25mg; Caffeine (a cup of coffee)
Intervention MeSH terms: Fexofenadine; Flurbiprofen; Midazolam; Dextromethorphan; Caffeine; Bupropion; Omeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Choline Uptake Study
Condition: Choline Uptake; Kinetics
Study type: Interventional

Summary: 
      The study is a randomised, cross-over, double blind, controlled trial in which study
      participants will visit the research facility on two occasions under fasting conditions with
      a washout period of one week. During each visit, study subjects will receive a test shake
      with phospholipid-bound choline or a control shake with choline added as a salt and DHA added
      separately. The two shakes will be given in randomised order and blood will be collected via
      a catheter before and up-to 6 hours after choline consumption. All study participants will
      receive a standardised evening meal prior to each study day and asked not to drink alcohol or
      perform heavy exercise the day before each study day. Study subjects are also asked to avoid
      choline rich products the day before each test day. Study participants are offered a meal
      after the test day.
    

Detailed description: 
      Choline is water-soluble vitamin-like essential nutrient. It is made in small amounts by the
      liver, but humans need to receive choline through the diet or by supplementation for proper
      health. Pregnancy and lactation are times when demand for choline is especially high. Infant
      formula not made from cow's milk is therefore supplemented with choline. Choline is therefore
      widely used. It is normally added to food products as a salt. However, if choline is present
      in a natural form, bound to phospholipids, it may be more efficiently absorbed.
      Docosahexaenoic acids (DHA) are also bound to these phospholipids.

      The primary objective is determine choline uptake and bioavailability after consumption of a
      test shake with phospholipid-bound choline (and DHA), and to compare this to a control shake
      with choline added as a salt (and DHA added as an oil). Secondary objective is to compare the
      uptake and bioavailability of DHA after the two shakes.

      The study is a cross-over, double blind, controlled trial in which study participants will
      visit the research facility on two occasions under fasting conditions. Subjects will receive
      two different choline products in randomized order with a washout period of one week. Blood
      will be collected via a catheter before and up-to 6 hours after choline consumption.
    

Intervention name(s): Choline added as a phospholipid; Choline added as a salt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A shake with 3000 mg choline added as a phospholipid; A shake with 3000 mg choline added as a salt
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial was to show equivalence in recovery from neuromuscular block after
      a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after
      continuous infusion of rocuronium, between participants receiving maintenance anesthesia
      using propofol and participants receiving sevoflurane, to investigate the safety and to
      compare the plasma levels of rocuronium in participants after continuous infusion of
      rocuronium and before the administration of sugammadex, under either propofol or sevoflurane
      anesthesia.
    


Intervention name(s): Sugammadex; Rocuronium; Sevoflurane; Propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium; Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium; Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.; Propofol IV administered for induction and maintenance of anesthesia, based on randomization.
Other intervention name(s): Org 25969; MK-8616; Esmeron®; Rocuronium Bromide; Ultane®; Diprivan®
Intervention MeSH terms: Bromides; Propofol; Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment