bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
Condition: Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks
      treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in
      mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and
      an angiotensin converting enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) under
      standardized diet conditions.

      Secondary Objectives:

        -  To compare the renal and cardiovascular PD effects of an 8 weeks treatment with
           sotagliflozin QD to an 8 weeks treatment to empagliflozin QD in mild or moderate
           hypertensive T2DM patients on a stable treatment regimen with metformin and an ACE
           inhibitor or ARB.

        -  To evaluate the safety and tolerability of an 8 weeks QD treatment with sotagliflozin or
           empagliflozin in mild to moderate hypertensive T2DM patients on a stable treatment with
           metformin and an ACE inhibitor or ARB.

        -  To evaluate the pharmacokinetic (PK) profile of sotagliflozin in steady state
           conditions.
    

Detailed description: 
      The total study duration per patient is 70-105 days (for patients without drug washout/switch
      period), and up to 175 days (for patients with drug washout/switch period), including 2-30
      days of screening, 5 days of run-in period, 56 days of treatment period, and a 7-14 days of
      follow-up period.
    

Intervention name(s): Sotagliflozin (SAR439954); Placebo; Empagliflozin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral
Other intervention name(s): Jardiance®
Intervention MeSH terms: Empagliflozin; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
Condition: Healthy; Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora
      incarnata L. in an acute stressful situation
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study
      information and an informed consent form are handed out. After study inclusion on Visit 2,
      participants are assigned to one of two groups at random and receive the test products
      (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of
      questionnaires regarding wellbeing and the Trier Social Stress Test.
    

Intervention name(s): Passiflora incarnata; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 x 1 tablet per day for 3 days; 3 x 1 ablet per day for 3 days
Other intervention name(s): Pascoflair 425mg coated tablets
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pascoflair; tsst; passiflora incarnata; non smoking male; and female volunteers
Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients
Condition: Spinocerebellar Ataxias; Tai Chi
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional

Summary: 
      Spinocerebellar atrophy is the most common autosomal dominant inherited ataxia. There are
      over thirty subtypes, which characterize neurologic features differently. They all have
      obvious substantial cerebellar atrophies in image, and unstable gait、ataxia. In general a
      prevalence of about three cases per 100 000 people is assumed, but this may be an
      underestimate. Progressive neurologic degeneration, in about 10-20 years, will leads to
      disability or wheelchair-dependent. Accompanying with fatigue, downhill course of the disease
      often made patients depressive and hopeless. The recent review of researches concludes no
      effective therapy for the disease. The purpose of the investigator's study is to explore the
      Tai-chi exercise effect for spinocerebellar ataxia.
    


Intervention name(s): Tai chi; conventional medicine
Intervention type(s): Behavioral; Drug
Intervention description(s): participants were required to receive hospital-based Tai chi training at least once a month, and home-based Tai chi exercise at least three times a week over the next 9 months; participants without Tai chi training still received routine conventional medicine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of Modified Valsalva Maneuver on Filling Degree of Internal Jugular Vein
Condition: the Filling of Jugular Vein Before Anesthesia With and Without Valsalva Maneuver
Study type: Observational

Summary: 
      To explore the effect of modified valsalva maneuver on the filling degree of right internal
      jugular vein.

      Method: The anteroposterior diameter and left-right diameter of right internal jugular vein
      in thirty adult gynecology patients were recorded during normal respiration and modified
      valsalva maneuver respectively.

      Investigators hypothesis that modified valsalva maneuver would enchance the filling degree of
      right internal jugular vein.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        female genecology patients, age 18-60 years old; weight 45-70 kg; body mass index (BMI)>20
        kg/m2 and <30 kg/m2; American Society of Anesthesiologists (ASA) grade I-II.

        The exclusion criteria were as follows: a history of chronic throat disease; upper
        respiratory tract infection within two weeks before surgery; and history of mental illness
        or communication barriers.
      
Keywords: modified valsalva maneuver, internal jugular vein
Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes
Condition: GERD
Study type: Interventional

Summary: 
      Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal
      reflux disease (GERD); however, it can be followed by recurrent symptoms or complications
      that may affect patient satisfaction. Intraoperative endomanometric evaluation of
      esophagogastric competence and pressure, combined with LNF in patients with large sliding
      hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.This is a
      retrospective, multicenter, comparative study. Baseline characteristics, initial reflux
      symptoms, preoperative and postoperative antacid medication use, postoperative complications
      (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from
      a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative
      side-effects, and satisfaction with surgery. Quantitative data were compared between the
      studied groups using the independent t-test or Mann-Whitney U test for normally and
      non-normally distributed numerical variables, respectively
    

Detailed description: 
      Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal
      reflux disease (GERD); however, it can be followed by recurrent symptoms or complications
      that may affect patient satisfaction. Intraoperative endomanometric evaluation of
      esophagogastric competence and pressure, combined with LNF in patients with large sliding
      hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.

      Study design: This is a retrospective, multicenter, comparative study. Baseline
      characteristics, initial reflux symptoms, preoperative and postoperative antacid medication
      use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and
      satisfaction were collected from a prospective database. Outcomes measures were recurrent
      reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data
      were compared between the studied groups using the independent t-test or Mann-Whitney U test
      for normally and non-normally distributed numerical variables, respectively.

      This study contributes to the mounting evidence for the effectiveness of endomanometric use
      during LNF. Intraoperative HRM and Endoscope were feasible in all patients and demonstrated
      that the clinical outcomes for endomanometric NF were favorable from an effectiveness and
      safety standpoint.
    

Intervention name(s): endomanometric guided LNF; laparoscopic Nissen fundoplication alone
Intervention type(s): Procedure; Procedure
Intervention description(s): use of endomanometry during LNF; laparoscopic Nissen fundoplication alone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The survival of the refractory CRC is dismal and therapy options are limited ，the researchers
      aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in
      refractory MSS metastatic colorectal cancer in a real-world setting.
    

Detailed description: 
      The invesgators conducted a retrospective single arm, single-center study in which patients
      with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after
      progressed at least two lines of standard chemotherapy with or without targeted drugs such as
      bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June
      2022. Eligible patients were aged 18 years or older and had histologically or cytologically
      confirmed adenocarcinoma of the colon or rectum; with patients who have at least one
      non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors
      (RECIST version 1.1).The primary endpoint was overall survival (OS).
    

Intervention name(s): Fruquintinib combined with anti-PD-1 antibodies
Intervention type(s): Drug
Intervention description(s): Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).
Other intervention name(s): programmed cell death protein 1; immune checkpoint inhibitor
Intervention MeSH terms: Immune Checkpoint Inhibitors; Antibodies
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Refractory MSS Metastatic Colorectal Cancer
      
Keywords: Fruquintinib; PD-1; pMMR/MSS
The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients
Condition: Healthy; Ileostomy
Study type: Interventional

Summary: 
      A controlled dietary intervention study will be carried out based on the stable isotope
      method the investigators have developed to quantify both the absorption of beta-carotene and
      its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will
      consume 2 capsules/day, 7 days/week with each capsule containing 100-mg [13C10] beta-carotene
      and 100-mg [13C10] retinyl palmitate. For two weeks they will consume a diet with high levels
      of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet
      with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount
      of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is
      that the absorption of beta-carotene in oil in comparison with the absorption of
      beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to
      measure the influence of the food matrix of vegetables and fruits on the absorption of
      beta-carotene in ileostomy patients on a western diet.
    


Intervention name(s): absorption and conversion of beta-carotene in human gastrointestinal (GI) tract
Intervention type(s): Behavioral
Intervention MeSH terms: Beta Carotene; Carotenoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin A; beta Carotene; diet; nutrition; nutritional requirements
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
Condition: Influenza Disease
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted
      Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza
      Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to <
      72 Months of Age.
    


Intervention name(s): Trivalent split influenza vaccine (TIV); MF59-adjuvanted trivalent influenza vaccine (aTIV); Licensed comparator trivalent split influenza vaccine (comparator TIV)
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Agriflu; Fluad; Fluzone
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Adjuvanted Trivalent Subunit Influenza Vaccine; vaccine; influenza; adjuvant; MF-59; pediatric
Neurobiological and Cognitive Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children
Condition: Cognitive Change; Behavior
Study type: Interventional
Phase: Phase 3

Summary: 
      The demand for magnetic resonance imaging (MRI) in pediatric patients is increasing due to
      its use in medical diagnosis and surveillance. Pediatric patients often require general
      anesthesia (GA) for MRI due to the need for prolonged immobility during the scanning process
      to obtain high quality images. Two widely used anesthetic techniques for pediatric MRIs are
      volatile-based anesthesia using sevoflurane and total intravenous anesthesia (TIVA) using
      propofol. Concerns have been raised regarding the potential neurotoxic effects of anesthetics
      on the developing brain. Within the animal literature, there is emerging evidence to suggest
      that both sevoflurane and propofol may cause inflammation, impacting brain cell survival and
      connections, thereby contributing to possible cognitive dysfunction. However, given the
      challenges in extrapolating the animal data to humans, and the relatively limited human
      cohort studies examining the long-term effects of anesthesia exposure, there is inadequate
      information available to make informed clinical decisions regarding the choice of optimal
      anesthetic agents for MRI in children. Therefore, this study will uniquely examine the
      mechanisms of two widely used anesthetics and their short and long-term impact on
      developmental outcomes in healthy children.
    


Intervention name(s): Propofol; Sevoflurane; Ametop; Ondansetron
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol); The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol); Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction.; Each patient will receive the antiemetic ondansetron 0.1mg/kg IV.
Intervention MeSH terms: Ondansetron; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection
Condition: Anesthesia, Dental
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Local anesthetic administration step is mandatory step for controlling pain before dental
      procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel
      patch form and Benzocaine 20% topical gel in reducing pain during injection of local
      anesthesia in children receiving dental treatment.
    

Detailed description: 
      A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental
      treatment in the same arch participated in this study. They were healthy children rated 3 or
      4 according to Frankl behavioral rating scale. They were selected from the clinic of
      Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.

      A randomized split mouth design was done in which each child received both tested topical
      anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel
      application was randomly used at the first or second visits. Pain or discomfort was evaluated
      during injection using sound, eye, motor (SEM) scale, and after injection using faces pain
      scale- revised (FPS-R).
    

Intervention name(s): Topicale GelPatch (Benzocaine 18%); Benzocaine oral gel 20%
Intervention type(s): Drug; Drug
Intervention description(s): Intervention group; control group
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth randomized clinical trial.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: benzocaine; Topical; oral patch; pain; dental anesthesia; children
Optimal Fluid Resuscitation for Trauma Patients
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to determine if the overall fluid requirements for the first 24
      hours after admission will be reduced with Hextend versus a standard of care crystalloid
      resuscitation fluid.
    

Detailed description: 
      Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation
      fluid will be either Hextend or crystalloid depending upon attending preference. No tests or
      interventions will be performed for research purposes.

      Data will be collected prospectively from patient medical records and attending clinicians to
      monitor fluid requirements, hemodynamics and outcome.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Trauma Patients
      
Keywords: Trauma Resuscitation
Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects
Condition: Pharmacokinetics; Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, randomised, single dose, 3-way crossover comparative
      (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib
      (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B)
      and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15
      subjects who will receive single oral doses of investigational medicinal product (IMP) across
      3 treatment periods.
    


Intervention name(s): Sorafenib - Period 1; XS005 Sorafenib Capsule A - Period 1; XS005 Sorafenib Tablet A - Period 1; XS005 Sorafenib Capsule A - Period 2; XS005 Sorafenib Tablet A - Period 2; Sorafenib - Period 2; XS005 Sorafenib Tablet A - Period 3; Sorafenib - Period 3; XS005 Sorafenib Capsule A - Period 3
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sorafenib (Nexavar®) Tablet, 200 mg; XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg); XS005 Sorafenib Tablet A, 100 mg; XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg); XS005 Sorafenib Tablet A, 100 mg; Sorafenib (Nexavar®) Tablet, 200 mg; XS005 Sorafenib Tablet A, 100 mg; Sorafenib (Nexavar®) Tablet, 200 mg; XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)
Other intervention name(s): Regimen A (reference); Regimen B; Regimen C; Regimen B; Regimen C; Regimen A (reference); Regimen C; Regimen A (reference); Regimen B
Intervention MeSH terms: Leucovorin; Sorafenib; Fluorouracil; Methotrexate; Carboplatin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study.
Masking: None (Open Label)
Primary purpose: Other
Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)
Condition: Type 2 Diabetes
MeSH terms: Atherosclerosis; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The aim of this study was to investigate whether carotid IMT can predict the presence of more
      advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by
      MDCT and whether MDCT could be useful next step for more aggressive treatment modality in
      Korean type 2 diabetic patients.
    

Detailed description: 
      We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined
      increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave
      velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease
      (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared
      prevalence of large artery stenosis according to carotid IMT group and evaluated whether
      maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive
      coronary angiography in some patients (N=14) and analyzed association for degrees of CAD
      between two angiographic methods.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        type 2 diabetic patients who had multiple cardiovascular risk factors
      
Keywords: Atherosclerosis; Carotid IMT; Multidetector CT; Type 2 diabetes