bioihbjkbjnl/mcl2 huggingface dataset:
Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel
      syndrome are essential in order to investigate natural disease course and potential treatment
      options aimed at symptom improvement, since biological markers are currently unavailable.
      Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires,
      have considerable limitations. The Experience Sampling Method (ESM), an electronic
      questioning method characterized by random and repeated, momentary assessments in the
      subject's current state and environment, might overcome these limitations. Aim of this study
      is to validate an IBS-specific electronic patient-reported outcome measure, based on the
      Experience Sampling Method-principle, for symptom assessment in IBS.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IBS patients.
      
Keywords: Irritable Bowel Syndrome (IBS); Experience Sampling Method (ESM); Ecological Momentary Assessment (EMA); Abdominal pain
Inter-observer Reproductibility of Visual Estimation of Left Ventricular Ejection Fraction in Critical Care
Condition: Ventricular Failure
Study type: Observational

Summary: 
      Inter-observer reproductibility of visual estimation of left ventricular ejection fraction is
      known to be good in cardiology but has not been studied in ICU. The goal of the study is to
      determine if this reproductibility is good enough.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        practitioners working in intensive care.
Bioequivalence Study of Ibuprofen 200 mg/5 mL Oral Suspension vs. MOMENT 200 mg Coated Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the study is to evaluate the bioequivalence of a new formulation of
      ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated
      tablet, when administered under fasting conditions as single oral dose to healthy male and
      female volunteers, in two consecutive study periods.
    


Intervention name(s): Ibuprofen 200 mg/5 mL oral suspension; MOMENT 200 mg coated tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Ibuprofen 200 mg/5 ml; Moment 200 mg coated tablet; Oral Suspension
Assessment Of Carotid Flow During General Anesthesia
Condition: Anesthesia; Fluid Responsiveness
Study type: Interventional

Summary: 
      Proper identification of patients who would benefit from fluid infusion (fluid
      responsiveness) is one of the most crucial challenges in anaesthesia and critical care.
      Reliability of several invasive measurements used for this purpose for many years have been
      questioned recently. The study will evaluate consistency between carotid artery flow
      derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of
      intraoperative fluid therapy.
    


Intervention name(s): Fluid bolus
Intervention type(s): Diagnostic Test
Intervention description(s): All patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution.
Intervention model: Single Group Assignment
Intervention model description: All patients included in the study will receive 4 ml/kg fluid bolus.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,
Comparison Between 2 Doses of Misoprostol Before Intrauterine Device
Condition: Pain Relief
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the investigators' study was to evaluate whether misoprostol will improve pain
      scores .
    

Detailed description: 
      an intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the intrauterine device insertion tube, and
      removing the tube; and placement of the device in the uterus.
    

Intervention name(s): misoprostol 200; misoprostol 400
Intervention type(s): Drug; Drug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluate the Safety & Assess Local and Systemic PK of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety
      and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to
      healthy HIV-negative women.
    


Intervention name(s): DS003 vaginal tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The trial will be conducted in three cohorts of 12 women each. In each cohort, participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17. In each cohort, therefore, 9 participants will receive DS003 vaginal tablets and 3 participants will receive placebo vaginal tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
Condition: Treatment for Prevention of Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect of erenumab compared to placebo on the change from baseline in the
      number of monthly migraine days in adults with chronic migraine.
    

Detailed description: 
      This study consisted of the following phases: screening, 4-week baseline phase, 12-week
      double-blind treatment, and 12-week follow-up. Participants may have elected to participate
      in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome
      (PRO) assessment substudy.

      Participants who completed the 12-week double-blind treatment phase of Study 20120295 were
      eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered once a month subcutaneously by authorized investigational site study staff.; Administered once a month subcutaneously by authorized investigational site study staff.
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chronic Migraine
Hemi-diaphragmatic Paresis and Erector Spinae Plane Block
Condition: Anesthesia, Regional; Shoulder
MeSH terms: Muscle Weakness; Paresis
Study type: Observational [Patient Registry]

Summary: 
      To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector
      spinae plane (ESP) block
    

Detailed description: 
      The aim of the study is to assess the effect of hemi-diaphragmatic paresis following
      ultrasound-guided erector spinae plane block.
    

Intervention name(s): ESP block
Intervention type(s): Other
Intervention description(s): ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        shoulder surgery
      
Keywords: Regional Anesthesia; Shoulder Surgery; Hemidiaphragmatic Paresis; Erector Spinae Plane Block
Using Artificial Intelligence to Predict Rectal Cancer Outcomes
Condition: Rectal Cancer Stage III
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Investigator retrospective collect cases during 2010-2021 diagnosed as rectal adenocarcinoma
      with high quality CT images. Local advanced rectal cancer cases were labeled as "disease".
      Nor were defined " normal".

      Using artificial intelligence CNN on jupyter notebook with open phyton code to train and
      develop models capable to recognizing local advanced rectal cancer. Modify the phyton code
      for better predict rate and help physician to quickly evaluate disease severity for fresh
      rectal cancer cases.
    

Detailed description: 
      From 2010.10.1~2021.12.31, rectal cancer patients with cT3-4 lesion was included. Collect
      high quality CT images with DICOM files in tumor segment. cT1-2, low rectal lesions, non-CRC
      cases were not included. Non-contrast and artificial defect images were also excluded. CT
      images were labeled as" diseased " when CRM were threatened (<2mm). All images were labeled
      according to judgment of 2 specialist. The data were separated into 2 parts. One for AI model
      training and testing, another for external validation. The training testing dataset was
      achieved by deep learning neural network and evaluating model accuracy performance. Then the
      model was applied into external validation dataset for real-world testing, evaluating
      coherent rate between AI and the Dr. decision. Furthermore, to see the cancer survival
      outcomes according to AI model prediction results.
    

Intervention name(s): As training material for deep learning model.; As materials for external validation for the buildup model.
Intervention type(s): Other; Other
Intervention description(s): Using labeled images as training materials for artificial intelligence to develop object detecting model.; Using the external validation set to evaluate prediction rate and survival outcome.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Rectal cancer diagnosed during 2010.10.1-2022.7.31. clinical T3-4 lesion. with high quality
        CT images with contrast.
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)
      who are taking certain types of antidepressants but continue to have residual depression
      symptoms. The purpose of this study is to help answer the following questions:

        -  How safe is SPD489 for the supplemental treatment of depression and what are the side
           effects that might be related to it?

        -  Can SPD489 help patients with depression who are also taking an antidepressant?

        -  How much SPD489 should be given to patients with depression who are also taking an
           antidepressant?

        -  How does SPD489 compare to placebo in depressed patients who are also taking an
           antidepressant?
    


Intervention name(s): Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg; Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg; Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg; Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg; Antidepressant + Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks; Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks; Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks; Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks; oral, once daily for 8 weeks
Other intervention name(s): Vyvanse; Vyvanse; Vyvanse; Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Analysis of Sex Hormones and Lipoproteins in Young Males
Condition: Cardiovascular Diseases; Atherosclerosis; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis
Study type: Observational

Summary: 
      To analyze the relationship of sex hormones to lipoproteins in young males.
    

Detailed description: 
      BACKGROUND:

      The investigators conducted a secondary analysis of the Sex Hormones and Lipoproteins in
      Adolescent Males Study (HD/HL18281), a 3-year (1984-1987) study of lipids, blood pressure,
      weight, fat patterning, and sex steroid hormones (SSH) in adolescent males. A total of 664
      black and white males, ages 10-15, were enrolled into a study designed as a series of
      repeated data collections over two years within age cohorts. Cross-sectional analyses were
      used to explain differences during adolescence in sex steroid hormones and sex steroid
      hormone-lipid relationships between black and white boys and between boys with and without a
      family history of coronary heart disease.. When the data were originally collected for this
      study, theoretical models of flexible longitudinal analytic techniques had been developed,
      but were not available for computer use. These techniques, now supported by software, allow a
      more powerful and complete analysis of these data.

      DESIGN NARRATIVE:

      The primary aim of these analyses was to explain the contribution of changes in sex steroid
      hormones and fat patterning to changes in plasma concentrations of high (HDL-C) and low
      (LDL-C) density lipoprotein cholesterol, triglycerides (TG), and apolipoproteins (apo) Al,
      All, and B occurring during puberty in males. Sex steroid hormones assayed included estradiol
      (E2) and free testosterone (T). The following hypotheses were tested: (1) increasing free T
      predicts/leads to decreases in HDL-C and increases in LDL-C, apo B, and the LDL-C/HDL-C ratio
      in adolescent males; (2) increasing E2 predicts decreases in apo B, LDL-C and the LDL-C/HDL-
      C ratio, but the resultant effects will vary with adiposity and fat patterning; (3) rapid
      weight gain predicts increased central adiposity, defined as the ratio of truncal skinfolds
      to total skinfolds, and with greater decreases in HDL-C and increases in triglycerides, apo
      B, LDL-C and the LDL- C/HDL-C ratio. Rapid weight gain predicts increased E2, but the
      atherogenic effects of increased central adiposity on lipids are greater than the anti-
      atherogenic effects of E2. These analyses provided a better understanding of metabolic
      factors underlying obesity-hormone-lipoprotein relationships.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Boostrix® Pregnancy Registry
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes,
      including teratogenicity, in females intentionally or unintentionally exposed to Boostrix
      during their pregnancies in the US. The Registry requires voluntary, prospective reporting of
      eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination
      with Boostrix during pregnancy or within 28 days preceding conception, potential confounding
      factors (such as exposure to other medications) and information related to the outcome of the
      pregnancy will be collected prospectively
    

Detailed description: 
      The Registry was originally initiated on 03 May 2005, as part of a program of enhanced
      pharmacovigilance. Following new European Union Pharmacovigilance legislation, pregnancy
      registries are to be considered as post-authorization safety studies (PASS). The ongoing
      Registry will therefore be converted into a PASS study in Q1 2014.

      Exposed pregnancies reported to the Registry before the transition into a PASS (between 03
      May 2005 and Q1 2014), from which data were collected and analyzed prospectively, will also
      be included in the analyses.

      Some pregnancy exposures may be reported after pregnancy outcome has been identified
      (retrospective reports). The Registry will capture retrospective reports, but these reports
      will not be included in the analyses of prospective reports.

      Pregnancy outcome data will be collected using questionnaires within 2 months of the
      estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for
      all live births for whom the contact details of their HCP will be available) to ascertain the
      presence of birth defects not diagnosed before, from Q1 2014 to Q3 2019.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Initial and follow-up data will be collected using questionnaires.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible pregnancies reported by patients and HCPs
      
Keywords: Pregnancy Registry; Boostrix; Women; Cohort; Prospective; Pregnancy outcome; Exploratory
Tanglewood Trail Walking Program in Rural Kentucky 2017
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The Tanglewood Trail Walking Program is a well-established community health initiative that
      encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market
      each Saturday. The study aims to determine if walking to the market with a community health
      coach results in healthier options being selected at the market.
    

Detailed description: 
      In the summer of 2017, community members of Whitesburg, KY were recruited to join the
      Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday,
      participants reported whether or not they walked the 1-mile trail to the farmers market and
      they reported which fruits and vegetables they purchased. The Walking Program was held June -
      Sept 2017. Participants completed questionnaires about fruit and vegetable consumption and
      physical activity. Participants also provided physical and biological measurements.

      Although originally designed to compare data among walkers and non-walkers, the protocol was
      changed due to participant feasibility. Data were analyzed by comparing "low engagers" -
      those who walked to the market fewer than three times during the program - or "high engagers"
      - those who walked three or more times during the program. Data were collected at baseline
      and 3 months.

      The data for years 2019 and 2020 of the Tanglewood to Trail walking program are registered
      separately in ClinicalTrials.gov.
    

Intervention name(s): walking group led by a community organizer
Intervention type(s): Behavioral
Intervention description(s): Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: farmers market; Appalachia; physical activity; fruit and vegetable voucher program
L. Brevis CD2 Strain Persistence in Oral Cavity
Condition: Oral Health
Study type: Interventional

Summary: 
      The aim of this study is to select the optimal conditions for quantification in the oral
      cavity of Lactobacillus brevis CD2, a probiotic strain contained in a commercially available
      dietary supplement and to assess its persistency after oral administration. Different sets of
      primers for L. brevis detection will be tested in real-time PCR reactions to find optimal
      amplification efficiency and target specificity. Primers ability in the identification of L.
      brevis DNA will be assessed in a pilot study conducted on 12 healthy volunteers clinically
      free of oral pathologies. The subjects will take 3 tablets/day for 3 days and one tablet on
      the 4th day. Clinical samples (dorsal surface of tongue, first molar, vestibular fornix and
      saliva) will be collected at baseline (before beginning the trial), at T0 (in the morning
      before the assumption of the last tablet) and 3, 6, and 9 hours after taking the last tablet.
      The quantities of L. brevis DNA will be compared to the total number of bacteria present in
      the samples. The activity of the enzyme arginine deiminase, responsible for oral pH
      homeostasis (particularly abundant in the CD2 strain) will be also assessed in the saliva
      samples before and after treatment, by HPLC measurements.
    


Intervention name(s): L. brevis
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lactobacillus brevis; Oral health; Bacterial adhesion
Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster
      dose to Chinese children at 18-24 months of age.
    


Intervention name(s): PoliorixTM
Intervention type(s): Biological
Intervention description(s): Single dose, intramuscular administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliomyelitis Vaccines; IPV
A Dose Response Study of E6011 in Participants With Rheumatoid Arthritis Inadequately Responding to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group
      comparison study in rheumatoid arthritis participants inadequately responding to
      methotrexate.
    


Intervention name(s): E6011; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous administration; subcutaneous administration
Intervention MeSH terms: Quetmolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: E6011; rheumatoid arthritis