bioihbjkbjnl/mcl2 huggingface dataset:
Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW
Condition: Adenomatous Polyposis Coli
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Study type: Interventional
Phase: Phase 1

Summary: 
      There is a need for better visualization of polyps during surveillance endoscopy in patients
      with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch
      Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma
      associated biomarkers is a promising technique to accommodate this need. The biomarker
      Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus
      normal tissue and has proven to be a valid target for molecular imaging. The University
      Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting
      humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the
      fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is
      administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma
      visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform
      (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the
      determination of the optimal tracer dose.
    


Intervention name(s): Bevacizumab-IRDye800CW; Near infrared fluorescence endoscopy platform
Intervention type(s): Drug; Device
Intervention description(s): Intravenous administration of a 4.5 mg, 10 mg or 25 mg of Bevacizumab-IRDye800CW 3 days prior to the fluorescence endoscopy procedure.; A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope, which is used for the surveillance endoscopy procedure.
Other intervention name(s): Beva-800CW; Bevacizumab-800CW; Avastin-800CW (Roche)
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Optical imaging; Fluorescence endoscopy; Near infrared fluorescence; Familial Adenomatous Polyposis; IRDye800CW; Vascular Endothelial Growth Factor A; Gastrointestinal endoscopy
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
Condition: Latent Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised
      placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape
      Town Metropolitan Municipality, Western Cape Province, Republic of South Africa.

      The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg
      (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent
      tuberculosis infection (LTBI) in Cape Town primary schoolchildren.

      Statistical analysis will be performed on an intention-to-treat basis to compare acquisition
      of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis
      will be logistic regression with presence/absence of LTBI at follow-up as the outcome,
      adjusted for a random effect of school of attendance.
    


Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3); Weekly oral placebo softgel capsule
Other intervention name(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Reliability of Function Tests for People With Back Pain.
Condition: Low Back Pain; Adult
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Back pain is often accompanied by changes in function. The performance of individuals with
      their backs on their wills may become more functional. It is believed that the test will
      present good to excellent reliability in individuals with chronic back pain. From this, it
      can be used in the clinic to verify the functional capacity of these individuals.
    

Detailed description: 
      This study will be performed to verify the reliability of the functional tests for
      individuals with back pain. A study in which individuals with back pain will be assessed on
      the first day and after the interval of seven days. They should perform the 6-minute walk
      test and answer some questionnaires such as the Roland Morris - disability questionnaire, the
      IPAQ - physical activity level questionnaire and Numeric Rating Scale, after the tests will
      be performed Timed 10-Meter Walk Test and 30 Second Sit to Stand Test. To avoid a random
      error, a minimum sample size of 30 participants is required. For statistical analysis,
      Shapiro-Wilk test will be used for data normalization and the reliability between
      measurements will be calculated through do Intraclass Correlation Coefficients, standard
      error of measurement and Minimal Detectable Change. There were no studies in the literature
      and recorded in the Clinical Trials that evaluated the reliability of these tests for
      individuals with chronic low back pain.
    

Intervention name(s): 6-minute walk test; 10 meters walk test; 30 Second Sit to Stand Test
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): First day: Participants undertook 6-minute walk test. There was a 30-minute interval between the first and second test, when the patient was asked to rest. During the resting period, they respond a pain intensity, functional capacity and physical activity level questionnaire.
Second day: the participants repeated the test and questionnaires.; First day: After the second 6-minute walk test the participants perform the 10-meter walk test, the test must be performed three times with a 30-second interval, at the end the average test velocity.
Second day: the participants repeated the test.; At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Musculoskeletal disease; Stress test; Reproducibility; Gait Speed
Attention Bias Modification Treatment for Children With Social Anxiety
Condition: Social Phobia
MeSH terms: Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      Children with social anxiety will be randomly assigned to either Attention Bias Modification
      Treatment (ABMT) designed to direct attention away from threat or a placebo control condition
      not designed to change attention patterns. Outcome measures will be depression and social
      anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of social
      phobia disorder and symptom counts derived from structured clinical interviews with children
      and their parents.

      We expect to see significant reduction in social anxiety symptoms in the Attention Bias
      Modification Treatment (ABMT) group relative to the placebo control group.
    


Intervention name(s): Attention Bias Modification Treatment (ABMT); Attention Control Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral: Attention Bias Modification Treatment (ABMT) Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.; Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: attention bias modification treatment; cognitive bias modification; attention training; social anxiety
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients
Condition: Heart Assist Device
Study type: Observational

Summary: 
      10 patients with chronic heart failure receiving daptomycin therapy after implantation of a
      left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids
      (mediastinal and pleural drainage systems) and in blood samples.
    


Intervention name(s): Daptomycin
Intervention type(s): Drug
Intervention description(s): standard care
Intervention MeSH terms: Daptomycin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients after heart assist device implantation with wound drainage receiving daptomycin
        therapy
Effect of Aromatherapy on Pain, Anxiety and Sleep Quality in Burn Patients
Condition: Aromatherapy
Study type: Interventional

Summary: 
      This study, which was designed as a randomized placebo-controlled experimental study, was
      conducted to determine the effect of inhalation aromatherapy with lavender essential oil on
      pain, anxiety and sleep quality in burn patients.
    

Detailed description: 
      After 5 patients were included in the sample size of the study, intervention and control
      groups, power analysis was performed using the G*Power Software (3.1.9.2) program. With a
      margin of error of 5%, an effect size of 0.15, and a power of 95%, the sample group size was
      calculated as 54 patients. Considering that data loss might be 10% on average in the study,
      it was decided to recruit 60 patients. Participants were randomized according to patient
      rooms. There are a total of 11 rooms and 16 beds in the burn unit, 5 double and 6 single. 11
      rooms are numbered sequentially according to their location in the corridor.

      In the intervention group, seven drops of lavender essential oil were dripped onto a 5x5
      gauze pad in the morning and evening, for 20 minutes, 10 cm away from the nose, and sniffed.

      In the placebo control group, seven drops of saline/sterile water were dripped onto a 5x5
      gauze pad in the morning and evening, and they were put to sniff for 20 minutes, 10 cm away
      from the nose. Green food coloring was added (one drop of food coloring to 5 ml of
      sterile/saline water) to make sterile/saline water similar to lavender oil. Data were
      collected using Individual Data Collection Form, Spielberg State Anxiety Scale, Visual Analog
      Scale, Richard Campbell Sleep Scale before and after five days of morning and evening
      aromatherapy application.
    

Intervention name(s): steril/salin water; Lavender essential oil
Intervention type(s): Other; Other
Intervention description(s): Five days seven drops of saline/sterile water were dripped onto a 5x5 gauze pad in the morning and evening, and they were put to sniff for 20 minutes, 10 cm away from the nose. Green food coloring was added (one drop of food coloring to 5 ml of sterile/saline water) to make sterile/saline water similar to lavender oil.; Five days seven drops of lavender essential oil were dripped onto a 5x5 gauze pad in the morning and evening, for 20 minutes, 10 cm away from the nose, and sniffed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: burn; Anxiety; lavender aromatherapy; nursing; pain; sleep quality
Alternate-Day Buprenorphine Administration. Phase I - 3
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if two times a subject's daily maintenance dose
      will hold for 48 hours without changes in agonist and antagonist effects.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Improvement of Accommodation With Anti-Oxidant Supplementation in Visual Display Terminal Users
Condition: Ocular Accommodation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the antioxidant supplementation effect on
      accommodation among visual display terminal (VDT) users.
    


Intervention name(s): CDR2
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Accommodation; visual display terminal (VDT); antioxidant
Interactions Between Fibre and Polyphenols on Colonic Phenolic Acid Production and Biomarkers of Health ( 6 Weeks)
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators have studied the acute interactions of polyphenols and NDC in a single meal
      in a human study containing tomatoes, lovage & onions, with and without inulin. The
      investigators now wish to study the longer-term interactions of these foods over 6 weeks as
      well as their impact on biomarkers of human health, the gut microbiome, human proteome and
      markers of risk of chronic disease. This may allow better targeted evaluation of foods which
      influence health through the gut microbiome.
    

Detailed description: 
      Polyphenol rich plant foods have been associated with several health benefits but their
      bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in
      the small intestine and enter the colon where the colonic microbiota metabolise them to
      release a range of phenolic acids, which are now thought to be the main bioactive components
      related to the reduction in disease risk. Very little is known about the impact of other
      constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

      Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols
      but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty
      acids. It is likely that there are key interactions in the colonic bacterial metabolism of
      NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in
      onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive
      phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic
      health.
    

Intervention name(s): Tomato, onion and lovage soup (TOL); TOL soup with inulin
Intervention type(s): Other; Other
Intervention description(s): Soup; Soup
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: self-reported healthy adults; age 40-70; BMI > 25
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study
      in steroid refractory Lupus Nephritis patients.
    


Intervention name(s): tacrolimus
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tacrolimus; FK506; lupus nephritis
A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how much warfarin gets into the blood stream and how
      long it takes the body to get rid of it when given both with and without lanabecestat.
      Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
      when given with lanabecestat by measuring international normalized ratio (INR). INR measures
      the time it takes for blood to clot and compares it to an average. Information about any side
      effects that may occur will also be collected. The study will last about 5 weeks from the
      first dose to follow-up for each participant.
    


Intervention name(s): Lanabecestat; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3314814; AZD3293
Intervention MeSH terms: Warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Of PF-04447943 When Administered With Donepezil To Healthy Volunteer Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before
      and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels
      of both PF-04447943 and donepezil.
    

Detailed description: 
      Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of
      donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and
      donepezil.
    

Intervention name(s): PF-04447943 25 mg; Placebo PF
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3); Placebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: healthy volunteer; pharmacokinetic; safety
Impact of a Childhood Obesity Intervention for African American Families
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session
      childhood obesity intervention for African American families among children aged 5-12 years.
      We hypothesize that children participating in the program will experience a reduction in BMI.
    


Intervention name(s): Active and Healthy Families
Intervention type(s): Behavioral
Intervention description(s): A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schools; Pediatrics; Obesity; Overweight; Intervention Studies; African Americans; Family; Body mass index
Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing
Condition: Epithelial Defect After Phototherapeutic Keratectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK).
      Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has
      numerous serious complications, especially glaucoma. Loteprednol, a new generation of
      corticosteroid has less potency than dexamethasone and was proposed to has less side effect
      regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to
      compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after
      PRK and risk of glaucoma.
    


Intervention name(s): Dexamethasone; Loteprednol etabonate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Loteprednol Etabonate; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Caffeine and Cocaine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being done to find out if medicines that affect a neurotransmitter (chemical
      messenger) in the brain called adenosine improve behavioral problems that are related to drug
      abuse. Another purpose of the study is to find out how genes related to adenosine change how
      people respond to these medicines. More information about how these medicines change
      behaviors may be helpful to come up with new treatments for drug abuse.
    

Detailed description: 
      Specific Aims:

      Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration
      in cocaine-dependent subjects, using laboratory measures of impulse control, drug
      discrimination (with d-amphetamine as the training dose), and subjective effects.

      Hypotheses related to Aim 1:

        1. Subjects will show decreases in impulsivity (delay to reward and response inhibition)
           after acute oral doses of caffeine compared to placebo.

        2. Subjects will show some stimulant-like subjective effects following acute oral doses of
           caffeine, but not the euphoric effects that would predict abuse potential.
    

Intervention name(s): Caffeine 150 MG; Placebo; Amphetamine; Caffeine 300 MG
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion; Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion; Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion; Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Other intervention name(s): Vivarin; Vivarin
Intervention MeSH terms: Caffeine; Amphetamine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: substance abuse; cocaine; caffeine; impulsivity