bioihbjkbjnl/mcl2 huggingface dataset:
Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps
Condition: Colon Polyps
MeSH terms: Polyps; Colonic Polyps
Study type: Observational [Patient Registry]

Summary: 
      A prospective outcomes study in patients referred for endoscopic mucosal resection of complex
      colon polyps.
    

Detailed description: 
      Colon cancer is the third leading cause of cancer-related death in the United States. The
      number of these deaths has significantly decreased due to screening colonoscopies. A
      colonoscopy is a procedure in which a physician examines the rectum and large intestines for
      abnormalities through the use of a specialized camera called an endoscope. Colonoscopies
      decrease the mortality associated with colon cancer through two main ways: by detecting and
      removing pre-cancerous lesions called polyps; and by detecting colon cancer at earlier stage,
      when therapies can still be effective at treating or removing the cancer.

      Most colon polyps are small and can be completely removed during a standard colonoscopy.
      However, there is a growing awareness amongst endoscopists of polyps that are too large or
      inaccessible to be safely removed during a routine colonoscopy. Previously, these lesions
      required surgery for removal of the affected part of the colon. There is a growing body of
      evidence that suggests these more complex colon polyps can be entirely removed endoscopically
      through a procedure called endoscopic mucosal resection (EMR), thereby avoiding costly and
      debilitating surgery. Given that it is a novel procedure, it is only available at specialized
      care centers.

      EMR is a procedure identical to a colonoscopy, with more steps involved in the lifting and
      removal of complex polyps. As many as 80-90% of complex polyps can be successfully removed
      with EMR. However, it has been noted that removal of the polyp in pieces, rather than as a
      whole can result in a 20-30% recurrence rate at the resection site. Any manipulation of the
      polyp prior to EMR may impair the ability to fully remove the lesion. Some factors that have
      previously been suggested to increase the difficulty of EMR include previous dye injections,
      removal attempts, and polyp sampling. However, the true impact of previous manipulations of
      CCPs remains unclear.

      This study aims to be one of the largest prospective, multi-centered studies investigating
      factors that predict the failure of EMR in the removal of complex colon polyps.
    

Intervention name(s): Endoscopic Mucosal Resection
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Formation of a multi-site prospective database of patients refereed for endoscopic mucosal
        resection for a complex colon polyp(s).
      
Keywords: Endoscopic; Mucosal; Resection
Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients
Condition: Asthma; Allergic Rhinitis; Conjunctivitis; Atopic Dermatitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Dermatitis
Study type: Observational [Patient Registry]

Summary: 
      One hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to
      HDM. Questionnaires were administered to document demographic and clinical characteristics.
      Serum IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der
      p 10 was measured by ImmunoCAP.
    

Detailed description: 
      Background: The role of specific IgE (sIgE) against Der p 1and Der p 2 in Chinese patients
      with house dust mite (HDM)allergy has not yet been well investigated.Methods: One hundred
      patients were enrolled, based on sensitization and doctor-diagnosed allergy to HDM.
      Questionnaires were administered to document demographic and clinical characteristics. Serum
      IgE reactivity toDermatophagoides pteronyssinus (Dp) extract, Der p 1, Der p 2 and Der p 10
      was measured by ImmunoCAP.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients were evaluated by a physician face-to-face, using a detailed questionnaire to
        establish the nature and severity of their clinical manifestations. The questionnaire also
        included demographic characteristics, a family history of allergic diseases and any other
        history of allergic disease.
      
Keywords: House dust mite; Der p 1; Der p 2; China
Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate whether there was a drug-drug interaction between BI 10773
      and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773
      and glimepiride were determined when both drugs were given in combination compared to
      multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given
      alone.
    


Intervention name(s): BI 10773; Glimepiride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glimepiride; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for
      treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    


Intervention name(s): Macitentan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Macitentan 10 mg, oral tablet, to be taken once daily.; Matching placebo oral tablet, to be taken once daily.
Other intervention name(s): ACT-064992
Intervention MeSH terms: Macitentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)
Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF)
      on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at
      risk for metabolic syndrome.

      Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and
      postprandial lipemia in individuals at risk for metabolic syndrome.
    

Detailed description: 
      A randomised, double-blind, crossover trial will be undertaken to test the acute effects of
      supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to
      attend during postprandial period and these occasions will be separated by at least one week.
      On the day preceding the postprandial high fat meal challenge, subjects will be asked to
      avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects
      will be provided with a standardised low fat meal (containing < 10 g fat) on the day
      preceding the postprandial study days to consume as their evening meal. They will be asked to
      fast overnight and instructed to avoid eating or drinking anything, except water, after 10
      pm. Fasting blood samples will be collected on the next day and subjects will then consume
      the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood
      samples will be collected at regular intervals for up to 6 hours postprandially.
    

Intervention name(s): Gamma delta TRF; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.; 50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gamma delta TRF; Insulin sensitivity; Postprandial lipaemia; Inflammatory markers; NF-κB
Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations
Condition: Neutropenia; Healthy
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics (relative bioavailability) and
      pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes,
      between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and Neulastim®
      (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.

      In addition to that, a pharmacodynamics comparison will be performed, through change in
      absolute neutrophil count in leukogram performed in the same time of pharmacokinetics
      analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00,
      96:00 and 384:00 hours.
    


Intervention name(s): Pegfilgrastim
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery
Condition: Gastro-Oesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The aim of this trial was to characterise the intra and post operative metabolic, endocrine
      and inflammatory response to laparoscopic fundoplication in children. We are testing the
      hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and
      catabolism and blunting of the endocrine/inflammatory stress response
    


Intervention name(s): Laparoscopic fundoplication; open Nissen fundoplication
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients
Condition: Non-infectious Intermediate, Posterior and Panuveitis
MeSH terms: Panuveitis
Study type: Observational

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of Humira®
      (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis
      patients under a routine treatment practice.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-infectious intermediate, posterior and panuveitis (NIIPPU) patients who had been
        prescribed with Humira® will be registered to the study in accordance with the drug
        approval status as well as the investigator's clinical judgment.
      
Keywords: Non-infectious intermediate, posterior and panuveitis; Post-Marketing Surveillance; Humira®
Effects of Individual Intervention for Men in Focused Deterrence Program
Condition: Violence
Study type: Interventional

Summary: 
      This project will implement and evaluate a community-based intervention to improve individual
      outcomes in violence-related injuries and homicide. Young African American men participating
      in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be
      randomized to receive an additional individual intervention based on the cognitive-behavioral
      Reasoning and Rehabilitation program.
    


Intervention name(s): Individual intervention
Intervention type(s): Behavioral
Intervention description(s): Individual intervention based on a cognitive-behavioral program Reasoning & Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of
      VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic
      impairment and in matched healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-121/TEZ/D-IVA
Intervention type(s): Drug
Intervention description(s): Fixed-dose combination tablets for oral administration.
Other intervention name(s): VX-121/VX-661/VX-561; VX-121/VX-661/CTP-656; VX-121/tezacaftor/deutivacaftor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if people taking lansoprazole two times a day to
      control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium
      just once a day.
    

Detailed description: 
      approximately 20% of patients taking first generation proton pump inhibitors (PPIs) are
      taking more than the standard approved dose. This dosing is required to attain adequate
      control of the gastric and intraesophageal pH in order to affect the desired clinical
      improvement. It is recognized that the b.i.d dosing strategy increases the intragastric pH
      control of <4 from approximately 12 hours to almost 16 hours. The refinement of the S isomer
      of omeprazole (Nexium)has led to a way to more effectively control acid exposure. Comparative
      trials with all the PPIs have shown significantly greater pH control of <4 and head to head
      comparisons as well as a recent crossover study. One study suggests that Nexium dosing
      contains approximately 16.5 hours of a pH control of <4. Conceivably, this duration of pH
      control suggests that b.i.d. dosing of other PPIs might be avoided. Furthermore, it suggests
      that patients currently taking b.i.d. PPIs might be successful candidates for conversion to
      q.d. Nexium. This would provide a considerable cost implication to health care plans and for
      patients who are responsible for paying for their PPI therapy. To date, esomeprazole has not
      been studied in comparison to b.i.d. dosing with other PPIs. There is pharmacologic evidence
      to suggest, however, that it is comparable. In this proposed study, we believe that by
      beginning with patients who were well controlled should make for a cleaner definition and a
      higher likelihood to demonstrate efficacy.
    

Intervention name(s): Antacids
Intervention type(s): Drug
Intervention MeSH terms: Antacids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Reflux; GERD
Tamoxifen Pharmacogenetics and Clinical Effects
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this research is to try to identify which women who take tamoxifen are likely
      to suffer from hot flashes or are more likely to have other side effects or benefits from the
      drug. The researchers will do so by determining whether there are mutations that normally
      occur in human DNA that might influence the way individuals respond to medications.
    

Detailed description: 
      The study will test the following hypotheses.

        1. There is a relationship between genetically distinct metabolic profiles of tamoxifen and
           the frequency and severity of hot flashes in women on chronic tamoxifen therapy.

        2. Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone
           turnover metabolites and bone mineral density, and coagulation factors.

        3. Different genetic profiles of estrogen responsive genes influence the pharmacodynamic
           effects of tamoxifen in cardiovascular system.
    

Intervention name(s): Tamoxifen (pharmacodynamic analysis)
Intervention type(s): Drug
Intervention description(s): Tamoxifen 20mg po daily
Intervention MeSH terms: Tamoxifen
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients included women 18 years or older, non-pregnant or lactating, who were
        recommended tamoxifen for adjuvant treatment or for the prevention of breast cancer from
        the oncology clinics.
      
Biospecimen description: 
      Whole Blood Serum Plasma
    
Keywords: Breast Cancer; Tamoxifen; Prevention
Effect of Using Whey Protein and Creatine Supplements on Muscular Strength in Weight-training Adult Males
Condition: Nutritional Status
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the effect of combined whey protein and creatine
      supplement, as compared with whey protein supplement alone, on change in upper and lower body
      strength.
    


Intervention name(s): Whey protein and creatine supplement; Whey protein only supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Each sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day; Each sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day; Each sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children
Condition: Fiberoptic Intubation in Children
Study type: Interventional

Summary: 
      The goal of this prospective randomized study is to compare the effect of operator experience
      on the ability to use fiberoptic-guided intubation in children less than two years old, with
      and without the use of an air-Q as a conduit. The question the investigators are trying to
      answer is: Does the operator experience make a significant difference in the time for
      successful fiberoptic guided tracheal intubation with and without the use of an air-Q
      intubating laryngeal airway?
    

Detailed description: 
      The aim of this study is to compare the effect of operator experience on the ability to use
      fiberoptic-guided intubation in children less than two years old, with and without the use of
      an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of
      laryngeal view, time for fiberoptic tracheal intubation, and peri-operative complications
      will also be assessed.
    

Intervention name(s): air-Q, followed by fiberoptic intubation; Free-hand Fiberoptic Intubation
Intervention type(s): Device; Device
Intervention description(s): Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed
Other intervention name(s): Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: supraglottic airway; children; tracheal intubation; fiberoptic bronchoscopy
A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usability of the I-Port Injection Port
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a
      new disposable injection port through which prescribed medication is injected subcutaneously
      from a standard syringe or pen. Additional investigation compared subject opinion towards
      using the I-PORT™ device compared to standard injection therapy.
    


Intervention name(s): I-Port(TM) Injection Port
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes
HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an
      effective intervention for lowering blood pressure in early unmedicated hypertensives.
    


Intervention name(s): Mindfulness Based Stress Reduction (MBSR) Therapy
Intervention type(s): Behavioral
Intervention description(s): The objectives of MBSR therapy are to 1) understand their personal response to stress and 2) develop techniques to change the way these patients respond and cope with stress
Other intervention name(s): stress reduction therapy; Jon Kabat-Zinn; mindfulness meditation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Mindfulness Based Stress Reduction (MBSR); Stress Reduction; hypertension; high blood pressure; ambulatory blood pressure monitoring
Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This is a six-month non-interventional prospective study of various controller therapies in
      children with asthma in outpatient clinical practice.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy
        with ICS and LABA who have completed at least one valid CACT assessment after the study
        entry
      
Keywords: Asthma, Asthma in Children