bioihbjkbjnl/mcl2 huggingface dataset:
Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy
Condition: Adenoma, Bile Duct
MeSH terms: Adenoma; Adenoma, Bile Duct
Study type: Interventional

Summary: 
      The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency
      ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia
      or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.
    

Detailed description: 
      Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct,
      after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic
      problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant
      morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of
      dysplastic lesions, including radio-frequency could be an interesting alternative to reduce
      the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a
      technique of local tissue destruction in use in many applications, percutaneously or
      intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for
      the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been
      developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies
      have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These
      two studies have confirmed the feasibility of the technique, with few side effects and
      probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment.
    

Intervention name(s): Habib™ EndoHBP
Intervention type(s): Device
Intervention description(s): During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live
      Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral
      immune response of the above vaccine after intranasal application by using HAI test, micro
      neutralization assays.
    

Detailed description: 
      Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2
      groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will
      received vaccine vaccine strain and 3 who will received placebo.

      Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100
      placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
    

Intervention name(s): Vaccine A/17/CA/2009/38 (H1N1); Placebo:Stabilizer
Intervention type(s): Biological; Other
Intervention description(s): Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1); 5% sucrose
Other intervention name(s): GPO Flu Vaccine-01
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: FLU; H1N1; GPO; PLAIV
The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
Condition: Fever; Reduction in Temperature
MeSH terms: Fever
Study type: Interventional

Summary: 
      A randomized clinical trial to check the antipyretic efficacy of oral and intravenous
      paracetamol and intramuscular diclofenac sodium in patients presenting with fever to
      emergency department.
    


Intervention name(s): Oral paracetamol; Intravenous paracetamol; Intramuscular diclofenac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): after giving medicine temperature is checked every 30 minutes for 2 hours; after giving medicine temperature is checked every 30 minutes for 2 hours; after giving medicine temperature is checked every 30 minutes for 2 hours
Intervention MeSH terms: Acetaminophen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antipyretics; oral paracetamol; intravenous paracetamol; intramuscular diclofenac; emergency department
The Effects of Cannabidiol and ∆-9-THC in Humans
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists
      of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the
      interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.
    


Intervention name(s): Cannabidiol; Delta-9-THC; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active Cannabidiol 5mg.; Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".; Placebo (about a quarter spoon of alcohol with no CBD).; Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis; Marijuana; Cannabidiol; CBD; THC; Psychotic Disorders
Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer
Condition: Cervical Cancers
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and
      response rates with the weekly cisplatin based chemoradiation in the treatment of
      locoregionally advanced cervical cancers.
    

Detailed description: 
      This study is to compare the compliance, toxicity, response and survival rate between
      concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in
      patients with advanced cervical cancer. Patients with primary untreated invasive squamous
      cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA
      were enrolled. Patients with histologically proven locoregionally advanced cervical cancer
      will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly
      cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin
      75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary
      endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.
    

Intervention name(s): radiation; weekly cisplatin; tri-weekly cisplatin
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): radiation with cisplatin 40mg/m2, 6 cycles, every week; weekly cisplatin 40mg/m2, 6 cycles; cisplatin 75mg/m2, 3cycles, every 3 weeks
Other intervention name(s): Cisplatin; Cisplatin
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Neoplasm; chemoradiation; compliance; toxicity
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple dose
      administration of gefapixant (MK-7264) in participants with moderate to severe obstructive
      sleep apnea (OSA). The primary hypothesis is that multiple dose administration of gefapixant
      (MK-7264) in participants with moderate to severe OSA reduces the Apnea Hypopnea Index (AHI)
      relative to placebo.
    


Intervention name(s): Gefapixant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In Periods 1 and 2 (7 days each) participants receive 4 tablets (180 mg) of gefapixant (MK-7264) QHS.; In Periods 1 and 2 (7 days each) participants receive 4 tablets of placebo QHS.
Other intervention name(s): MK-7264
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Muscle in Obesity: Imaging, Function and microRNA
Condition: Muscle Function
MeSH terms: Obesity
Study type: Observational

Summary: 
      Growing evidence suggests that dynapenic abdominal obesity is associated with a greater risk
      of falls, functional disability and hospitalisation compared to those with dynapenia, obesity
      or neither phenotype. Understanding the pathogenesis underlying this phenotype has the
      potential to inform potential treatment strategies.

      MicroRNAs can act as messengers at the cellular level to promote or block processes for
      muscle growth and repair, amongst other things. There is evidence that ageing changes
      microRNA levels in the muscle and that these changes may result in reduced muscle quality and
      quantity. However, it is not known whether being obese can change microRNA levels in muscle
      and how this relates to physical performance.

      The aim of this study is to investigate the effect of dynapenic abdominal obesity on microRNA
      levels in serum and muscle quality and quantity in the legs of older women.

      This is an observational, cross-sectional study. The investigators will recruit 4 groups of
      older women: normal weight, normal weight with dynapenia, obese and obese with dynapenia. The
      investigators will measure the microRNA levels in serum. The investigators will measure the
      quantity and fat content of muscle in the legs using magnetic resonance imaging. Muscle
      strength, fatigue and balance will be measured using gait (walking) analysis, balance tests,
      and a machine designed to measure leg strength and fatigue.

      The investigators will measure and compare microRNA levels between groups. The investigators
      will use databases and computer programmes to look at all of the microRNAs which are
      different between groups and see how they affect the muscle. The investigators will compare
      muscle strength, size and fatigue between groups. The investigators will explore
      relationships of muscle quantity and quality measures with microRNA changes in the muscle.
      This approach will allow the investigators to understand how obesity affects the microRNA
      profile of muscle and whether this translates into impairment of function and mobility.
    


Intervention name(s): observational study
Intervention type(s): Other
Intervention description(s): observational study
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy Caucasian Women Recruited from around South Yorkshire and Merseyside, UK
      
Biospecimen description: 
      Serum
    
Keywords: obesity; sarcopenia; dynapenia; microRNA
Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic obstructive pulmonary disease (COPD) is one of the commonest respiratory diseases.
      During the early stage of COPD, patients only have mild respiratory symptoms or signs which
      may lead to under-diagnosis of the disease. Patients may show poor response to treatment at
      later stages of the disease, associated with higher mortality and incidence of
      re-hospitalization and disability causing burden for both the families and the society.

      So far, there is no large-scale clinical trial on long-term intervention with tiotropium
      bromide (Spiriva) in patients with early stages of COPD (i.e. GOLD Stage I-II COPD or
      asymptomatic COPD). It would be of great significance for COPD prevention and treatment if
      the investigators could prove that tiotropium decreases the lung function decline and
      reverses disease progression in patients with early-stage COPD.

      The investigators objective is to evaluate the efficacy of long-term intervention with
      tiotropium in early stage (FEV1 ≥50% predicted) COPD (difference of trough FEV1, number of
      exacerbations, time to first exacerbation, quality of life, etc) and relevant
      pharmacoeconomic endpoints.
    


Intervention name(s): Tiotropium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months; placebo, once daily, inhaled by HandiHaler
Other intervention name(s): Spiriva
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease; COPD; COPD exacerbation; treatment; tiotropium; anticholinergic; acute exacerbation of COPD (AECOPD)
Effect of Strength Versus Endurance Training on Muscle Damage in Gym Athletes on Caffeine Supplementation.
Condition: Muscle Damage
Study type: Interventional

Summary: 
      Dietary supplements to enhance exercise and athletic performance come in a variety of forms,
      including tablets, capsules, liquids, powders, and bars. Many of these products contain
      numerous ingredients in varied combinations and amounts. Among the more common ingredients
      are amino acids, protein, creatine, and caffeine
    

Detailed description: 
      Caffeine is a popular nutritional supplement among gym athletes. It is frequently used as an
      ergogenic aid to improve physical performance, delay fatigue, and increase muscle power. This
      research aims to evaluate the effectiveness of caffeine through the blood sample test (Serum
      CK, LDH levels, AST levels) on muscle damage of gym athletes who are performing aerobic and
      strength training. This study would help understand the effects of strength training and
      endurance training on muscle damage in gym athletes who are consuming caffeine and to check
      the serum enzymes level of both groups who are on strength training and those who are on
      endurance level training, therefore, this study would help determine which athletes should be
      careful while consuming caffeine for a particular exercise regimen
    

Intervention name(s): Strength Training with Caffeine; Endurance Training with Caffeine
Intervention type(s): Other; Other
Intervention description(s): The intervention protocol consists of 5 types of strength training exercises. The following exercises will be performed for the strength training group:
bench press (3 sets of 10 reps)
biceps curl (3 sets of 10 reps)
triceps pushdown (3 sets of 10 reps)
leg press (3 sets of 10 reps)
leg extension (3 sets of 10 reps)
Strength training would be performed in 3 sets of 10 repetitions with 2 minutes of rest between each exercise. This protocol will be performed in a 30-40-minute session. 10-15 minutes of light warm-up activities will be performed before the start of each exercise session. The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions.; The intervention protocol consists of 3 types of endurance training exercises. The following exercises will be performed by this group:
Cycling (15 min)
Running (20 min)
Rowing (10 min)
The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Crossover Trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Caffeine; Creatine Kinase; Endurance Training; Fitness Centers; Skeletal Muscle; Strength Training
Endothelial Function in Hispanic Children/Adolescents at Risk for Type 2 Diabetes
Condition: Obesity; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      Type 2 diabetes is now more frequent in children/adolescents, especially in those from
      minority populations, including Hispanic Americans (HA). Diabetes and the pre-diabetes state
      markedly increase the risk of cardiovascular disease. Endothelial dysfunction is seen in the
      earliest stages of atherogenesis, which ultimately leads to cardiovascular disease. The main
      aim of this study is to evaluate the endothelial function in HA children/adolescents who are
      at risk for developing type 2 diabetes (obese children/adolescents from the Hispanic
      population).

      The investigators' hypothesis is that endothelial dysfunction is present in this population
      and that it is associated with metabolic abnormalities linked to the insulin resistance
      syndrome. The investigators will study 2 groups of 15 individuals each, age 10-18 years.
      Group 1 will consist of obese (body mass index greater than 85th percentile for age and sex)
      Hispanic American children/adolescents and group 2 will consist of healthy, non-overweight
      (body mass index between the 25th and 50 th percentile for age and sex) Hispanic American
      children/adolescents.

      The study will be carried out at the Joslin Diabetes Center. During the first day,
      participants will have a medical history and full physical examination, a standard OGTT and
      measurement of blood cell count, plasma glucose, insulin, lipids, HbA1c, BUN, creatinine,
      electrolytes, estradiol, testosterone, free fatty acids, CRP, endothelial markers, urinary
      microalbumin and hCG, if appropriate. An OGTT will be performed in order to rule out IGT or
      Diabetes. Estimations of insulin secretion and insulin sensitivity will be assessed using the
      homeostasis model assessment (HOMA). In the second day, the body composition and the brachial
      artery vasodilatory response to hyperemia will be assessed. Those found with diabetes will be
      tested for GAD-65 and IA2.

      The investigators' hypothesis is that Hispanic American children/adolescents at risk for type
      2 diabetes have impaired endothelial function and vascular reactivity that are associated
      with the degree of insulin resistance and its metabolic abnormalities.
    

Detailed description: 
      Information as above
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Hispanic children/adolescents
      
Biospecimen description: 
      plasma samples
    
Keywords: Type 2 diabetes, Endothelium, children/adolescents
Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure
Condition: Myopia; Hyperopia; Presbyopia; Refractive Error
MeSH terms: Myopia; Presbyopia; Refractive Errors; Hyperopia
Study type: Interventional
Phase: Phase 3

Summary: 
      By using a new software two consecutive laser treatments have been combined to correct the
      distance vision and to provide a near vision component in addition to the first treatment.

      This study will help us to answer 2 questions:

        1. How accurately this combined technique corrects distance and near vision

        2. Whether the correction is adequate to remove the complete need for supplementary near
           spectacles
    

Detailed description: 
      LASIK is a surgical technique where the cornea is reshaped using a laser to provide visual
      correction. Typically, this procedure will only correct your long distance vision requiring
      the use of supplementary spectacles for reading and near vision.

      The Technolas 217z Excimer Laser used to deliver the treatment is approved for use in the
      European Community for both treatment versions to correct separately the near vision and the
      distance vision for cases which need one or the other correction.

      By using a new software two consecutive treatments have been combined to correct the distance
      vision and to provide a near vision component in addition to the first treatment.

      This study will help us to answer 2 questions:

        1. How accurately this combined technique corrects distance and near vision

        2. Whether the correction is adequate to remove the complete need for supplementary near
           spectacles
    

Intervention name(s): Supracor
Intervention type(s): Procedure
Intervention description(s): All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components.
The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases.
In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.
Other intervention name(s): Myopia; Hyperopia; Presbyopia; PresbyLASIK; LASIK
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PresbyLASIK; Presbyopia; LASIK; Supracor; refractive; Myopia; Hyperopia
Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being
      conducted at Stanford University Medical Center and the University of Colorado Barbara Davis
      Center. It is paid for by the Juvenile Diabetes Research Foundation.

      The purpose of doing this research study is to understand the best way to stop an insulin
      infusion pump from delivering insulin to prevent a subject from having hypoglycemia.
      Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to
      evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor
      communicating wirelessly with a bedside computer running an algorithm that temporarily
      suspends insulin delivery when hypoglycemia is predicted in a home setting.
    

Detailed description: 
      After the run-in phase, there is a 21-night trial in which each night is randomly assigned
      2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention
      night) or inactive (control night).

      Three predictive algorithm versions were studied sequentially during the study.
    

Intervention name(s): Predictive Low Glucose Suspend Algorithm ON; Predictive Low Glucose Suspend Algorithm OFF
Intervention type(s): Device; Device
Intervention description(s): The algorithm uses a Kalman filter-based model to predict whether the sensor glucose level will fall below 80 mg/dL within a given time period and suspends the insulin pump if this event is predicted.
Other intervention name(s): Intervention Night; Control Night
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment