bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators propose a Phase II interventional trial to investigate the role of
      Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature
      infants and further evaluate safety of the use of this probiotic in a population of premature
      infants.
    

Detailed description: 
      Hypothesis Administration of Lactobacillus reuteri to premature infants will improve their
      intestinal motility when compared with infants receiving placebo. Primary Objective Evaluate
      the effects of L. reuteri in the intestinal motility by measuring the gastric emptying rate
      in infants before and after 21 consecutive days of administration of L. reuteri.

      Secondary Objectives 1. Mechanisms of action of L. reuteri - L.reuteri impact in the host
      immune response by determining fecal cytokines, sIgA and calprotectin before and after 21
      days of administration - L.reuteri rate of colonization after its administration.

      2. Efficacy and safety of L. reuteri to premature infants - Clinical beneficial effects
      secondary to the administration of L. reuteri to premature infants. The following clinical
      outcomes will be identified and compared between groups:

        -  Number of gastrointestinal symptoms (regurgitation, vomiting, stasis)

        -  Days to full feeds. Number of days to reach full feeds defined as > 120cc/kg/day) x2
           days or more.

        -  Days on parenteral nutrition

        -  Weight gain defined as the number of days needed to reach 150% of birth weight

        -  Length of hospital stay

        -  Any possible side effects and adverse events secondary to the administration of L.
           reuteri to premature infants.

        -  Incidence of late onset sepsis.

        -  Incidence and severity of necrotizing enterocolitis categorized by Bell's classification

        -  Use of antibiotics (number of days on antibiotics during the hospital stay)

        -  Mortality (at 28 days after birth and at hospital discharge).
    

Intervention name(s): Lactobacillus Reuteri; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preterm; newborns; Gastric; Motility; Mucosal; immunity
Esmolol Pretreatment on Pain During Injection of Propofol
Condition: Pain
Study type: Interventional

Summary: 
      Pain on injection of propofol is a common side effect. The present study was designed to
      investigate the effect of esmolol on pain on propofol injection and to compare it with
      remifentanil and placebo.
    

Detailed description: 
      In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were
      randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg
      (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. Thirty seconds after pretreatment, 25% of
      the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein.
      Ten seconds after propofol had been given at the rate of 0.5 ml/sec pain was assessed on a
      four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
    

Intervention name(s): Normal saline; Esmolol; Remifentanil; propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous injection with normal saline before injection of propofol; intravenous injection with remifentanil 0.5 mg/kg before injection of propofol; intravenous injection with remifentanil 0.35 ug/kg before injection of propofol; intravenous injection after pretreatment
Other intervention name(s): breviblock; ultiva; diprivan
Intervention MeSH terms: Remifentanil; Propofol; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: esmolol; pain; propofol; remifentanil
Physiology of GIP(1-30)NH2 in Humans
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Glucose-dependent insulinotropic polypeptide (GIP) is a gut-derived incretin hormone that
      affects glucose, lipid and bone metabolism. Secretion of GIP into the blood stream from
      enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation
      of glucose stimulated insulin secretion from the pancreas. The objective of this study is to
      investigate the physiology of GIP(1-30)NH2 in humans with insulin secretion as the primary
      endpoint. Furthermore the effects on on plasma/serum levels of glucagon, C-peptide, glucose,
      bone markers (CTX and P1NP) will be measured.
    


Intervention name(s): GIP(1-30)NH2; GIP(1-42); Saline
Intervention type(s): Other; Other; Other
Intervention description(s): Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp; Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp; Intravenous administration of saline during a stepwise glucose clamp
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects
Condition: Ultrasound Strain Measurement
MeSH terms: Sprains and Strains
Study type: Interventional

Summary: 
      In the critical patient, lung ultrasound is routinely performed for acute respiratory
      distress, adult respiratory distress syndrome and for hemodynamic evaluation. Its diagnostic
      performance is superior to that of chest radiography in the context of pleuropulmonary
      parenchymal pathologies. The search for lung sliding is performed to diagnose a pneumothorax
      or to search for the correct placement of the endotracheal intubation tube. However, this
      analysis is qualitative and is sometimes difficult to interpret. At present, there is no
      global evaluation technique at the patient's bed allowing to analyze simultaneously the
      alveolar recruitment, the pulmonary over-distension and the quality of the lung sliding,
      whereas the pulmonary damage is most often heterogeneous. The justification of our research
      project is based on the need to develop and validate a means of global and regional
      quantification of the mechanical and aeration properties of the lung parenchyma by the
      analysis of the acoustic markers of the pleura (pleural strain) by the ultrasound technique
      of speckle tracking. The aim is to establish the normal values of the pleural strain in
      healthy volunteers, in spontaneous ventilation and then in non-invasive mechanical
      ventilation, in order to vary the lung volume.
    


Intervention name(s): Lung Strain
Intervention type(s): Device
Intervention description(s): The main objective of this study is to describe the physiological values of lung strain in healthy volunteers as well as its variations induced by non-invasive positive pressure ventilation and their correlation with tidal volume.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lung strain; speckle tracking; lung stress
Microbiota Restoration Therapy in HIV With Repeated Low-Dose Interventions
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to
      contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with
      nutritional interventions exert limited immunologic effects, but a deep understanding of how
      these interventions could ameliorate gut dysbiosis and influence health among HIV-infected
      individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on
      effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio<1
      will be included and randomized to either repeated low-dose oral fecal microbiota
      transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary
      outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio,
      inflammatory markers, T cell activation and markers of enterocyte barrier function through
      week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the
      V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint
      will be studied by combination of untargeted mass spectrometry and two different and
      complementary separation techniques in bacterial and plasma samples.
    


Intervention name(s): FMT; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Capsules with fecal microbiota from healthy donors; Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; microbiota; inflammation; fecal microbiota restoration
Seasonal Flu Vaccine in Adult Transplant Recipients
Condition: Immunocompromised; Transplanted
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R)
      in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It
      is expected that when administered once the vaccine fulfills all serological efficacy
      criteria required for the elderly population age 60 years and older.
    


Intervention name(s): Fluad 1x
Intervention type(s): Biological
Intervention description(s): 15 µg antigen/strain:
A/California/07/2009 (H1N1) - like strain
A/Perth/16/2009 (H3N2) - like strain
B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans
Condition: Colorectal Carcinoma; Health Status Unknown; Healthy Subject
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This randomized clinical trial studies how well a lay health worker outreach works in
      increasing colorectal cancer screening in Asian Americans. Training community members to
      educate participants about colorectal cancer and its prevention may improve colorectal cancer
      screening rates in Asian Americans.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC)
      screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster
      randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to
      a CRC brochure and nutrition education (control).

      II. Examine the processes through which LHWs communicate with, connect to, and convince
      community members from 3 Asian American cultures of the importance of CRC screening using
      mixed methods.

      OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.

      GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from
      their social network. Participants attend a CRC educational session conducted by an LHW over
      90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4
      reminding them about CRC screening.

      GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from
      their social network. Participants attend a lecture on healthy nutrition for cardiovascular
      health presented by a professional health educator at months 1 and 3. After the first
      meeting, participants receive a brochure on CRC screening. Participants receive phone calls
      from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants
      may attend an optional post-intervention LHW outreach session on CRC screening.

      After completion of the study, patients are followed up at 2 months.
    

Intervention name(s): Educational Intervention; Educational Intervention; Informational Intervention; Survey Administration; Telephone-Based Intervention; Telephone-Based Intervention
Intervention type(s): Other; Other; Other; Other; Behavioral; Behavioral
Intervention description(s): Attend CRC education session; Attend healthy nutrition session; Receive CRC screening brochure; Ancillary studies; Receive telephone reminder about CRC screening; Receive telephone reminder about healthy nutrition
Other intervention name(s): Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving
Condition: Novice Teen Driver Training
Study type: Interventional

Summary: 
      The long-term goal of this research is to increase safe driving among novice teen drivers by
      increasing the quantity, quality and diversity of driving practice while accompanied by an
      adult. In order to achieve the long term goal of the study, the investigators have developed
      a web-based intervention program known as Teen Driving Plan (TDP) intended to support high
      quality driving practice.
    

Detailed description: 
      Motor vehicle crashes remain the number one cause of death among teens in the United States.
      Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than
      adult drivers (ages 25 to 69). Inexperience is a fundamental factor in the high crash rate
      for novice teens. Safe and skilled driving is a complex task that involves behaviors (e.g.,
      skills and actions) that vary and become increasingly challenging with increasing speed,
      unsafe road conditions and other hazards of the driving environment. Because teens are at
      their lowest lifetime risk of crashing when accompanied by an adult, adult-supervised
      practice provides a safe way for teens to gain needed experience under a variety of driving
      conditions. Unfortunately, few teens receive sufficient quantity, quality and diversity of
      adult-supervised practice prior to licensure.

      The objective of the proposed research is to compare how the driving training process and the
      results of that training process differ between a group of young learning permit holders in
      families that have access to TDP (the intervention group) from the training process and the
      results of that process in an otherwise similar group of teens in families with no TDP access
      (the control group). The investigators hypothesize that teens given access to TDP will
      demonstrate greater competence and safety in a standardized on-road driving assessment than
      teens with no TDP access.
    

Intervention name(s): Teen driving plan
Intervention type(s): Behavioral
Intervention description(s): Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Teen driving; Behind the wheel practice driving; Parent supervision
Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of the study is to determine the glycemic index and the insulinemic index of a
      sweetener syrup
    

Detailed description: 
      Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels.
      All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts,
      fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after
      being eaten. Glycemic index is assessed by having one or more people eat a specific amount of
      a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in
      blood sugar levels compared with the levels achieved after they have eaten a control food
      containing the same amount of digestible carbohydrate, such as white bread or glucose. The
      average change in blood sugar levels over a set period of time relative to the levels after
      consumption of the control food, usually white bread or glucose, is the food's glycemic
      index.

      Insulinemic index is measure with the same methodology.
    

Intervention name(s): Experimental sweetener syrup; Classical sweetener syrup; Classical sugar syrup
Intervention type(s): Other; Other; Other
Intervention description(s): 3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber; 1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber; 3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BLOOD GLUCOSE; glycemic index; rates of digestion and absorption of food
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in
      adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only
      subjects who received booster vaccination in the previous clinical study are eligible for
      participation in this study.
    

Detailed description: 
      This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
    

Intervention name(s): Boostrix TM
Intervention type(s): Biological
Intervention description(s): Single booster dose of vaccine
Other intervention name(s): dTpa vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dTpa vaccine; pertussis; Tdap; Boostrix; booster; tetanus; diphtheria
Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes
      mellitus is increasing. Although in early phases the disease might be successfully treated by
      lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication
      a highly motivational system with low inhibition threshold is needed. Therefore, the
      investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks
      is able to improve HbA1c and weight in patients with type 2 diabetes.
    

Detailed description: 
      Patients with type 2 diabetes were recruited via treating physicians or articles in magazines
      and newspapers. Participants were randomized in an intervention and a control group. The
      intervention group was sent the Wii, the balance board and the interactive video game Wii Fit
      Plus and were instructed to use these items 30 minutes each day during the next 12 weeks. The
      control group got the items 12 weeks later. At begin and after 12 weeks of intervention
      participants (and additionally for the control group: after 12 weeks of waiting phase) sent
      their health parameters, which had been measured in the context of the disease management
      program type 2 diabetes as well as questionnaires about physical activity and quality of life
      to the study center.
    

Intervention name(s): interactive videogame Wii Fit Plus; waiting
Intervention type(s): Device; Other
Intervention description(s): Use of the interactive videogame Wii Fit Plus für 12 weeks.; waiting for 12 weeks
Other intervention name(s): Wii Fit Plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus; physical activity; lifestyle change; motivation; patient empowerment
Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors
Condition: Abdominal Neoplasms; Pelvic Neoplasms
MeSH terms: Neoplasms; Abdominal Neoplasms; Pelvic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to
      be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves
      to create pictures, allowing doctors and other medical professionals to "see" inside the
      body.

      Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's
      Research Hospital researchers want to learn the best and safest dose of this ultrasound
      "dye."
    


Intervention name(s): Optison
Intervention type(s): Drug
Intervention description(s): Intervention description:
Based on recommendation by the FDA, we began with a dose of 0.125ml/m^2 and escalated at 0.15 ml/m^2 increments, to 0.275 ml/m^2 and 0.425ml/m^2 and 0.500ml/m^2. We will now continue to escalate the dose of Optison at 0.300ml/m^2 increments to a maximum single dose of 4ml or a total cumulative dose of 8.7 ml as recommended by the manufacturer.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ultrasound; Abdominal tumors; Pelvic tumors