bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases; Irritable Bowel Syndrome
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel
      and/or the colon leading to recurrent diarrhea and abdominal pain.

      Irritable Bowel Syndrome with diarrhea (IBS-D) is characterized by abdominal pain or
      discomfort, gas, loose and frequent stools.

      Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic
      relief when orally supplemented in patients suffering from various colonic diseases. The
      investigator proposes to investigate the effect of a microencapsulated form of sodium
      butyrate on the fecal microbiota of patients with IBD and IBS-D.
    

Detailed description: 
      The IBDMicro is an interventional, randomized, double-blind, placebo-controlled study. A
      novel oral formulation of butyrate contained in a lipophilic microcapsule, that provides
      extensive capacity for intestinal diffusion and facilitates slow release of the active
      ingredient will be used ("Butyrose" produced by SILA SRL, Italy). A proof-of-concept study
      has been already published in this context, and preliminary data showed that butyrate
      administration was able to change the gut microbiota of patients with IBD and IBS-D after 12
      weeks of treatment, in association with the changes of intestinal inflammation indexes (fecal
      calprotectin). In keeping, investigators will assess the microbiota before and after the
      butyrate administration. Also, clinical data will be collected by using validated
      disease-specific questionnaires (Rome IV and clinical indexes for IBD). Quality of life will
      be also recorded. The analysis of intestinal microbiota will be carried out by collecting a
      fecal sample and analyzed with metagenomics techniques.
    

Intervention name(s): Butyrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 cps/die 300 mg/cps; 3 cps/die 300 mg/cps
Other intervention name(s): Butyrose; starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IBD; Microbiota; Butyrate; IBS
A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety
      and pharmacokinetic characteristics of CKD-337 in healthy male volunteers
    

Detailed description: 
      This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to
      compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.

      Subjects will receive either a single oral dose of the test formulation(CKD-337) or a oral
      dose of the reference formulation(Atorvastatin Calcium Trihydrate+Fenofibrate).

      Each treatment period was separated by a washout period of at least 7 days.
    

Intervention name(s): Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate); Test drug(CKD-337)
Intervention type(s): Drug; Drug
Intervention description(s): Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet); CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)
Intervention MeSH terms: Atorvastatin; Fenofibrate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether exercise training leads to changes in the
      blood that are produced by exercised muscles and if these changes produce new hormones that
      affect the body's regulation of sugar and body weight.
    


Intervention name(s): Exercise Intervention
Intervention type(s): Other
Intervention description(s): 10 Week aerobic exercise training
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of
      moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with
      normal hepatic function.
    

Detailed description: 
      This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of
      hepatic impairment on the PK of glasdegib after administration of a single oral 100 mg dose.
      Subjects with moderate or severe hepatic impairment will be enrolled, followed by healthy
      subjects with normal hepatic function who serve as matched controls.
    

Intervention name(s): Glasdegib 100 mg single oral dose
Intervention type(s): Drug
Intervention description(s): A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glasdegib; PF-04449913; Pharmacokinetics; Hepatic Impairment
Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to determine the dose-related safety, immunogenicity, and
      protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy
      adults.
    

Detailed description: 
      All currently licensed influenza vaccines in the United States are produced in embryonated
      hen's eggs. There are several well-recognized disadvantages to the use of eggs as the
      substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could
      be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is
      usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process
      that can be time consuming, is not always successful, and can select receptor variants that
      may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken
      flocks, and that might be an important issue in a pandemic due to an avian influenza virus
      strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore,
      development of alternative substrates for influenza vaccine production has been identified as
      a high-priority objective.

      One potential alternative method for production of influenza vaccine is expression of the
      influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids
      dependence on eggs and is very efficient because of the high levels of protein expression
      under the control of the baculovirus polyhedrin promoter.
    

Intervention name(s): Influenza Vaccine, recombinant Hemagglutinin
Intervention type(s): Biological
Intervention description(s): 0.5mL dose for IM injection
Other intervention name(s): FluBlok; rHA; rHA0; recombinant hemagglutinin
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza
Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
Condition: Constipation; Post-Op Complication
MeSH terms: Constipation; Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic
      assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The
      experimental group will take a pre-operative course of polyethylene glycol daily for seven
      days prior to procedure date. The control group will not be given any intervention
      preoperatively. All patients will take polyethylene glycol postoperatively.
    

Detailed description: 
      In order to assess bowel characteristics and assess for pre-existing constipation a
      standardized questionnaire will be distributed to all patients prior to surgery at their
      pre-operative visit. The patients in the experimental group will have follow up via phone
      call, 3-4 days prior to surgery to assess for medication compliance or any side
      effects/complications. Patients will record if they are taking their Miralax as prescribed
      daily. They will also record their bowel movements and pain levels during evacuation. Prior
      to surgery, in the pre-operative area, medication compliance will be assessed once again.
      Post operatively all patients will take polyethylene glycol for seven days, once a day. They
      will maintain a bowel diary, which will record bowel movements, stool type and pain with
      evacuation. The primary objective is to determine if the preoperative use of polyethylene
      glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary
      outcomes include pain with first bowel movement, stool consistency and daily pain levels.
    

Intervention name(s): Polyethylene Glycol Powder
Intervention type(s): Drug
Intervention description(s): Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose and DDI Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for
      14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919
      co-administration at low and high doses on the PK of atorvastatin in a single cohort.
    


Intervention name(s): Placebo; PF-06835919; atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets administered once or twice daily, with food, in Part A.; Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.; In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: nonalcoholic steatohepatitis
Learning Lab for Diagnostic Fidelity
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Diagnostic error and delay remain a leading cause of preventable harm and death in the United
      States. Using a learning laboratory structure, researchers will implement mixed-methods
      research approaches to identify the systemic weaknesses that contribute to diagnostic error
      and delay in the hospital setting. The knowledge gained from research innovative will allow
      researchers to design, develop, implement, and refined a suite of human-centered tools that
      can be deployed to reduce the risk of diagnostic error and delay in both community and
      academic hospital settings.
    

Detailed description: 
      Despite the recognition that diagnostic errors an delays are a major contributor to
      preventable deaths in the USA, little progress has been made to reduce mortality outcomes
      from this known killer. An effective strategy leading to meaningful reduction in diagnostic
      error and delay rates has not made its way into practice. This proposal is unique and novel
      and combines mixed-methods research approaches with systems engineering research approaches
      to understand the interplay of the multiple factors contributing to diagnostic error and
      delay. The knowledge gained from this holistic approach will then be used within the learning
      laboratory to inform the design, development, evaluation, and refinement of the solutions to
      diagnostic error and delay. "Control Tower" will be the staging ground for the in situ
      learning laboratory and will be built on top of a well-established clinical informatics
      infrastructure and hospital environment open to innovation and practice change.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. All patients at risk of diagnostic error will be eligible for the study.

          2. We will include both sexes and all genders and all minority populations as they
             present with the risk of diagnostic error in the hospitals.

        Given the nature of the study, which focuses on patients with or at risk of diagnostic
        error, outreach efforts to underrepresented populations or individuals would not be
        possible.
      
Keywords: Critical Illness; Patient Safety; Delivery of Health Care; Electronic Health Records
Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)
Condition: Ultrasound; Oral Mucosa; Gingival Recession; Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss; Gingival Recession
Study type: Observational

Summary: 
      The overall purpose of this study is to establish an ultrasound technique to aid in oral and
      dental examination of soft and hard tissues. Ultrasound is currently not used in Dentistry
      and associated oral examinations and its usefulness for clinical practice will be explored.
      This study will investigate the use of ultrasonic imaging for planning and placing dental
      implants, as well as evaluate the use of ultrasonic imaging for monitoring marginal bone loss
      around dental implants.
    

Detailed description: 
      This study will involve two different groups of subjects: Patients scheduled for a dental
      implant procedure, and patients scheduled for a revision surgery after developing infection
      after implant surgery.

      Twenty subjects examining only specific aim one is funded and will be studied. If future
      funding is granted and additional 30 subjects for aim one and 40 for aim two will be studied
      Subjects in both groups will receive an ultrasound examination of the oral cavity prior to
      their clinically-scheduled dental surgery. Subjects in group 1 also may receive a CBCT scan
      if not previously clinically-ordered.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects 18 years of age and older who will be scheduled to have an implant surgery from
        premolar to premolar with bilateral adjacent teeth present will be recruited.
Glucose Variability
Condition: Glucose Variability
Study type: Observational

Summary: 
      A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected
      prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital,
      typically up to 1 week after deliver) will be conducted. These women are of any age and all
      ethnic backgrounds delivering at St. Mary's Health Center.
    

Detailed description: 
      Maternal glucose control is considered to be a major determinant of neonatal outcome in
      pregnancies complicated by diabetes. Studies have examined the link between neonatal
      mortality and morbidity using specific mean preprandial or postprandial plasma glucose
      levels, however, have not taken into account the daily wide excursions that occur in maternal
      glucose levels. Limited data are available on glucose variability (GV) in pregnancy and
      affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose
      variability between two data points, a morning fasting blood glucose and an afternoon blood
      glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c),
      which has been considered the "gold standard" for diabetes control since the Diabetes Control
      and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through
      review of data, we propose to examine other methods of evaluating daily maternal glucose
      variations to determine the correlation to maternal and neonatal outcomes.

      The objective of this study is to determine the effect of glucose variability and/ or other
      elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that
      glucose variability will be a stronger indicator of neonatal outcome than A1c or any single
      given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or
      the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We
      hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more
      maternal and fetal co morbidities.
    

Intervention name(s): lab results
Intervention type(s): Other
Intervention description(s): Comparison of lab results
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women with diabetes in pregnancy of any age, any ethnic background
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of etanercept with usual
      disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe
      rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
    


Intervention name(s): Etanercept , Methotrexate; Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Intervention type(s): Drug; Drug
Intervention description(s): Etanercept: 25 mg twice weekly over 16 weeks, SC
Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO; Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Etanercept; Methotrexate; Leflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the present pilot randomized controlled trial is to compare the effects of the
      following: 1)-panettone enriched with arabinoxylans (p-rich), 2)-panettone not enriched
      (p-standard) on blood glucose and insulin values, and appetite scores in 10 healthy
      volunteers.
    

Detailed description: 
      This is a crossover, randomized double-blind trial. A product enriched with arabinoxylan
      extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic
      index) was developed to assess the impact on metabolic responses and satiety when compared to
      the standard product (p-standard) .

      Ten Caucasian non-smoker healthy adult volunteers were enrolled starting from January 2023.

      Participants were randomized to receive either the p-rich or p-standard. The order of
      administration of each product was randomized using a computer-generated sequence. The day of
      each test, fasting individuals underwent a blood sample collection, and weight and height
      measurements. Then, participants consumed 100 grams of the product within 20 minutes, while
      sitting. Blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the
      consumption of each food.
    

Intervention name(s): Enriched panettone; Panettone standard
Intervention type(s): Other; Other
Intervention description(s): Volunteers consumed 100 grams of panettone enriched with fiber (JAX Plus® (Heallo srl, Milano, Italy), a soluble fiber with Arabinoxylans from wheat and barley; Volunteers consumed 100 grams of panettone standard
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: crossover randomized double-blind trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Arabinoxylan; fiber-enriched product; glycemia; insulin; appetite
Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook
Condition: Cholecystolithiasis
MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones
Study type: Interventional

Summary: 
      Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting
      at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another
      option. The aim is to test the hypothesis that with ultrasonic dissection technique a better
      same day discharge and a shorter operative time can be achieved.
    

Detailed description: 
      After initiation of general anesthesia patients are randomized either to conventional or
      ultrasonic dissection group. The patients and recovery room personnel are blinded to the
      operative technique used.
    

Intervention name(s): dissection of gallbladder in laparoscopic cholecystectomy; dissection of gallbladder in laparoscopic cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot; laparoscopic cholecystectomy with ultrasonic scissors starting from fundus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparoscopic cholecystectomy