bioihbjkbjnl/mcl2 huggingface dataset:
Linked Color Imaging (LCI) for Colorectal Adenoma Detection
Condition: Colon Adenoma; Colonic Polyp
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that
      differentiates the red color spectrum more effectively than white light imaging thanks to its
      optimal pre-process composition of light spectrum and advanced signal processing. This
      technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo,
      Japan) with new high-performance LED illumination system, enhances the visibility of colonic
      mucosal vessels and might increase the detection rate of colorectal polyps. Data available
      regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and
      limited to back-to back studies.

      This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is
      superior to WL endoscopy in terms of adenoma detection
    

Detailed description: 
      50-75 years-old subjects participating in the regional screening program undergoing their
      first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and
      meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during
      insertion and withdrawal phase of colonoscopy. A randomisation list for each participating
      center was produced by the coordinating center via computer-generated treatment code list.
      Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first
      vs subsequent test) through an online centralised study database.All procedures are performed
      with a high-definition ELUXEO 700 series videocolonscopes with or without magnification
      (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo).

      The primary outcome measure is the ADR, defined as the proportion of participants with at
      least one adenoma (per-patient analysis).
    

Intervention name(s): Linked Color Imaging
Intervention type(s): Device
Intervention description(s): Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: adenoma detection rate; Linked Color Imaging; colonoscopy
Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The purpose of this protocol is:

        1. To quantify the prevalence of adherence to topical mesalamine in patients with UC

        2. To describe the determinants of medication adherence in patients with UC prescribed
           topical mesalamine
    

Detailed description: 
      Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to
      topical mesalamine adherence exist in patients with UC. These factors can be identified using
      qualitative testing in order to develop and design appropriate behavioral interventions to
      reduce non-adherence.

      The investigators will undertake an observational study of medication persistence in 100
      patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using
      12-month pharmacy refill data. The investigators will also employ a qualitative research
      design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10
      patients and Phase II - Focus Groups (2) with 5 patients each.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of this study will be adults with diagnosed Ulcerative Colitis who have been
        prescribed topical mesalamine (Rowasa/Canasa) for treatment of their ulcerative colitis.
      
Keywords: Ulcerative Colitis
Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
Condition: Healthy
Study type: Interventional

Summary: 
      Non-absorbable, fermentable residues in the diet increase intestinal gas production and
      induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however,
      prebiotics, which are also fermented by colonic bacteria have been shown to improve this type
      of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and
      colonic biomass induced by prebiotics.

      Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d)
      for 3 weeks; they will also receive a standard diet during three days. The following outcomes
      will be measured immediately before, at the beginning and at the end of the treatment: a)
      number of gas evacuations during daytime for 2 days on the standard diet, by means of an
      event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal,
      by means of a barostat; c) microbiota composition by fecal analysis.
    


Intervention name(s): Bimuno Galacto-oligo-saccharide
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intestinal gas; Healthy subjects; microbiota; prebiotics
Erythrocyte and Adipocyte G6PD Activity Levels in Obesity
Condition: Diabetes; Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      This study compares the improvement of weight, fasting lipid profile (triglycerides,
      cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in
      levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).
    

Detailed description: 
      Same as brief summary
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients will be morbidly obese and undergo Roux-en-Y Gastric bypass surgery. Both Type
        2 diabetic and non-diabetic patients will be accepted into the study.
      
Biospecimen description: 
      Blood and tissue samples(adipose, omentum and liver biopsies)
The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
Condition: Oxidative Stress; Muscle Strength; Resistance Training; Body Composition; Muscle Damage
Study type: Interventional

Summary: 
      Thirty active male and female athletes will be recruited for the study. Subjects will be
      examined at baseline for VO2max performance. Subjects will then be stratified and randomly
      divided equally (50% - 50%) into an Oceanix (supplemental) or placebo condition such that
      baseline VO2max match. Once randomization, subjects will be baseline tested for multiple
      measures of muscle force capacity, muscle soreness, immune function, and endocrine function.
      Upon completion of baseline testing, subjects will all complete a one-day, cross-training
      course in Tampa, Florida. The training course is known to be extremely vigorous and causes
      significant muscle damage. Subjects will then be retested for muscle function at 24, and 48
      hours following the course. At 24- and 48-hours subjects will be asked to repeat a simulated
      time trial race. In this way, we will measure repeated race performance, recovery from
      intense exercise, muscle damage from exercise, and immune function during multiple races.
    


Intervention name(s): Cross Training Course; Oceanix
Intervention type(s): Other; Dietary Supplement
Intervention description(s): One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.; Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, parallel, randomized, placebo-controlled trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxidative Stress; Muscle Strength; Resistance Training; Antioxidants
Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
Condition: Cesarean Section
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an unblinded randomized controlled trial. Women were randomized to uterine closure
      with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of
      elective cesarean. The primary outcome was closure time of the uterine incision. Also
      measured were blood loss during incision closure and the use of additional hemostatic
      sutures. Informed consent was obtained
    


Intervention name(s): Knotless barbed suture; polyglactin 910
Intervention type(s): Device; Device
Intervention description(s): uterine incision closure; uterine incision closure
Other intervention name(s): Stratafix; Vicryl
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Knotless barbed suture vs conventional suture of uterine incision
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cesarean, incision, suture,
Biomarkers for Noninvasive Assessment of Human Hydration
Condition: Dehydration
MeSH terms: Dehydration
Study type: Observational

Summary: 
      Low levels of dehydration (the loss of body water corresponding to 2% of the body weight),
      deteriorate physical and cognitive performance and may also be linked to a number of chronic
      diseases. The standard test used for the assessment of hydration status is plasma osmolality.
      This blood test is invasive, requires time and laboratory equipment and is not accurate for
      isotonic dehydration. The goal of this project is to determine whether a new molecular
      technology, saliva-based Stress Response Profiling (SRP) biomarkers, could be used for
      non-invasive diagnostics of dehydration.
    

Detailed description: 
      Dehydration, or the loss of body water, is a common health problem during military
      operations, athletic events and illness, particularly in children and the elderly.
      Warfighters frequently become dehydrated when training or fighting in hot and mountainous
      environments because heat and high altitude increase body water losses. The negative
      consequences of dehydration worsen as body water losses increase. Severe dehydration (>10%)
      is a life-threatening emergency that may result in heat illness, seizures, permanent brain
      damage or death. The most common type of dehydration is caused by sweat loss during heavy
      physical labor or exercise (hypertonic dehydration). A different type of dehydration can be
      caused by blood loss, burns, diarrhea, vomiting or diuretic drugs used for example by
      diabetics (isotonic dehydration). Despite the critical importance of proper fluid balance to
      human performance and health, no field-expedient, non-invasive dehydration test is available
      for either form of dehydration. The ultimate goal of this project is to develop a
      field-expedient, non-invasive test for both types of dehydration. The test will be sensitive
      to 2% dehydration, a critical threshold for performance impairment and a statistically valid
      decision point for hydration assessment.

      Design: Fifteen volunteers will be first euhydrated (well-hydrated) and then moderately
      dehydrated (2-4%) using two procedures. First, sweat loss during exercise in the heat without
      fluids (hypertonic dehydration). Second, excessive urination stimulated by a diuretic pill
      called Lasix (isotonic dehydration). SRP biomarkers in saliva samples will be compared to
      changes in body weight, and to known hydration indicators in blood and urine. Results will
      identify the best SRP biomarkers for diagnosing both types of dehydration and compare
      accuracy of the new saliva test to the existing hydration indicators.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Aerobically fit individuals
      
Biospecimen description: 
      Plasma, Serum, Urine, Saliva
    
Keywords: dehydration; plasma; osmolality; saliva; urine; biomarkers; hypertonic; isotonic; hydration
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in
      China.
    

Detailed description: 
      This study is a multi-center, single-arm, open labeling clinical trial, which the objective
      is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in
      China, and investigate the relationship between Apo-E gene type with adverse events of
      donepezil.
    

Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): Eligible patients is treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the patient can reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who cannot endure the 10mg/d titration of 2nd time and then back to 5mg/d or discontinuance of Aricept® should be regarded as to quit the study. There will be a visting at week 0, the end of week 4 and the end of week 20 ,respectively.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Intervention model: Single Group Assignment
Intervention model description: multi-center, single-arm, open labeling clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AD; Donepezil; Safety
Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Condition: Gastrointestinal Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C
      (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid,
      and to assess the toxicity and activity in patients with previously treated colorectal and
      gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a
      maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg
      m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks
    


Intervention name(s): Mitomycin C; 5-FU; Folinic acid
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Folic Acid; Mitomycins; Mitomycin; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the extent of and sources of variation in the
      glycaemic index values of foods measured by different laboratories around the world.
    

Detailed description: 
      The glycaemic index values of 3 different foods provided from a central location will be
      determined in each of 20-30 centers around the world. A standard protocol will be followed,
      but this protocol leaves room for variation in certain details, such as whether subjects are
      allowed to have coffee or tea with the test meals or only water, or the method of analyzing
      blood glucose. Methodologic details, subject demographic information (height, weight, age,
      and ethnicity), results of local calculations and raw data will be sent to a central
      location.
    

Intervention name(s): Test Meal: Reference food (glucose or white bread); Test Meal: Pirate's Booty; Test Meal: Ceaprove wafer; Test Meal: Stretch Island Strawberry Fruit Leather
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycemic index; Nutrition; Carbohydrates; Glycemic responses; Methodology; Healthy human subjects
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a
      new formulation of oritavancin by adjusting infusion time, concentration and
      reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of
      oritavancin
    

Detailed description: 
      Oritavancin has been approved in the United States for the treatment of adult patients with
      acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused
      by susceptible isolates of designated Gram-positive microorganisms. This is a Phase I, single
      center, double-blind, study evaluating the PK and safety of a new formulation of oritavancin
      by adjusting infusion time, concentration and reconstitution/administration solutions, of a
      single 1200 mg intravenous (IV) infusion of oritavancin in healthy adult subjects.
    

Intervention name(s): Oritavancin; Dextrose
Intervention type(s): Drug; Drug
Intervention description(s): IV - Single dose 1200 mg Oritavancin; D5W 5% in Water
Other intervention name(s): Orbactiv; Placebo
Intervention MeSH terms: Oritavancin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Volunteers
Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cellular therapies are rapidly progressing fields and have shown immense promise in the
      treatment of damaged ovarian function. The purpose of this study is to determine safety and
      efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold
      in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of
      HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.
    

Detailed description: 
      The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with
      injectable collagen scaffold transvaginal injection for POF women. The serum of each patient
      was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured
      in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The
      HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral
      ovaries. The outcomes of patients were examined after the injection. The patients are
      monitored for signs of follicle growth and growing follicles are stimulated with exogenous
      hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).
    

Intervention name(s): HUC-MSCs Transplantation; HUC-MSCs with Injectable Collagen Scaffold Transplantation
Intervention type(s): Biological; Biological
Intervention description(s): The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.; The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
Condition: Bacteremia; Bacterial Infection
MeSH terms: Bacterial Infections; Bacteremia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood
      Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.
    

Detailed description: 
      This trial is a prospective, non-randomized study in patients as an adjunctive treatment for
      blood stream infection (BSI) in patients on renal replacement therapy. The heparin surface
      being studied is currently marketed on extracorporeal circuits. It has been shown to absorb
      various types of Gram positive and Gram negative bacteria and to reduce toxins and cytokines
      in in vitro studies using whole blood. For this study, patients on renal replacement therapy
      who develop bacteremia will have the Seraph® 100 Microbind® Affinity Blood Filter included in
      the dialysis circuit for up to 4 hours, on one day, with hourly monitoring. Patients will be
      followed for 14 days post treatment. Patients will be monitored by vital signs and laboratory
      indices on the day of treatment and on post procedure day 1, 2, 3, 4, 5, 6, 7 and 14.
    

Intervention name(s): Seraph 100 Filter
Intervention type(s): Device
Intervention description(s): Treatment of renal replacement therapy patients with bacteremia.
Other intervention name(s): Seraph 100
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
Condition: Triglyceride Metabolism; Cardiovascular Function
Study type: Interventional

Summary: 
      Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after
      an acute or chronic consumption in rodents. In this study, we aimed to investigate the
      effects of an acute consumption of proanthocyanidins before a breakfast meal in humans.
      Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape
      seed proanthocyanidins in humans should be elucidated as well as its activity on vascular
      function.
    

Detailed description: 
      The intervention will consist in the administration of 2 capsules containing the grape seed
      proanthocyanidins extract or 2 empty capsules (placebo) just before breakfast, which will
      consist of 100g of white bread, 75g of salami, 50g of fatty cheese, 125g of yogurt (10% fat),
      25ml of olive oil and water ad libitum. The nutritional composition of this meal is as
      follows: 1.200 Kcal of energy content, 15% of energy from proteins, 22% from carbohydrates
      and 63% from fat (35% saturated fat), and 120mg of cholesterol. Blood samples will be taken
      at point 0.5,1,2,3 and 6 hours after breakfast. Moreover, urine samples will be collected at
      time 0 and 6 hours.
    

Intervention name(s): 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules); 2 empty capsules
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science