bioihbjkbjnl/mcl2 huggingface dataset:
Anesthesia on Optic Nerve Sheath Diameter
Condition: Optic Nerve Sheath Diameter
Study type: Interventional

Summary: 
      Different amounts of anesthetic gas can be used in the obstetric gynecological surgery
      operations to be performed with open method. Researchers aimed to compare the effect of gas
      changes on intraocular nerve diameter by ultrasonography.
    

Detailed description: 
      A total of 80 patients who underwent laparotomic gynecological surgery were divided into two
      groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was
      maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and
      with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15
      minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and
      desflurane, and 10 minutes before the end of the surgery, the patients were switched to high
      flow with 50% oxygen-50% air at 2 L/min.
    

Intervention name(s): The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater
Intervention type(s): Procedure
Intervention description(s): The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Minimal Flow Anesthesia; Optic Nerve Sheath Diameter
A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects
Condition: Pharmacodynamics; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics
      of AZD9977 following Single-Dose administration to healthy male subjects
    

Detailed description: 
      This study will be a phase I study to assess the pharmacodynamics of AZD9977 following
      single-dose administration to healthy male subjects. It is a single-blind (with regards to
      AZD9977 and AZD9977 Placebo), randomized, four-treatment, four-period crossover design, with
      a potential 5th and 6th randomized cross-over treatment period. In this study eplerenone is
      used as a positive control and fludrocortisone will be used as a challenge agent. In addition
      the safety, tolerability and pharmacokinetics will be assessed.
    

Intervention name(s): AZD9977 oral suspension; AZD9977 placebo oral suspension; Fludrocortisone, tablets; Eplerenone, tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AZD9977 oral suspension, single dose; oral suspension, single dose; Loading dose of 0.5 mg and maintenance doses of 0.1 mg every second hour up to a total dose of 1.0 mg per treatment period (may be modified to up to 1.3 mg based on emerging data); 100 mg (2 x 50 mg tablets) single dose, may be modified based on emerging data (will not exceed 500 mg per treatment period)
Intervention MeSH terms: Fludrocortisone; Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pharmacodynamics; AZD9977; Safety; Tolerability; Pharmacokinetics; Eplerenone; Fludrocortisone
Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective
      treatment method of pain associated with pancreatic cancer. The neurolytic injectate is
      usually alcohol 50-100%; however, phenol >5% is also possible to use. Nowadays, there are
      several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed
      tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous
      computed tomography guided technique is the gold standard technique, it has multiple
      drawbacks as availability and cost of imaging modality, exposure to radiation and multiple
      complications.Surgical technique in spite of being easy, cheap but there is a controversy
      about its efficacy. Also there is no head to head comparison between the surgical technique
      and the percutaneous technique.In this study we hypothesized that intraoperative technique
      has the same efficacy of percutaneous celiac block technique with less complication and cost
    

Detailed description: 
      This study aimed to compare the efficacy of the surgical technique versus the per cutaneous
      computed tomographic guided technique of celiac plexus neurolysis for pain management in
      unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with
      VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass
      surgery will receive celiac plexus neurolysis either intraoperative or post operative CT
      guided . All patients will be managed by systemic analgesic if the block not sufficient . In
      this study we will give the patient the analgesic according to WHO recommendation as starting
      by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we
      will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be
      given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND
      ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .
    

Intervention name(s): Intraoperative celiac plexus neurolysis; CT guided celiac plexus neurolysis
Intervention type(s): Procedure; Procedure
Intervention description(s): neurolysis of celiac plexus by intraoperative techniques; Neurolysis of celiac plexus percutaneously by CT guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this booster vaccination study is to evaluate the persistence and immune
      memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT
      (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals'
      Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy
      toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.
    

Detailed description: 
      The study is an extension of the primary vaccination study 711202/001 (MenC-TT-001). It
      comprises 5 groups: 4 parallel groups of toddlers vaccinated in study 711202/001 (group
      vaccinated with Meningitec™ is control group 1) and 1 group of naive subjects (no previous
      vaccination against MenC disease, control group 2). All subjects receive 1/5th dose Mencevax™
      ACWY and a concomitant dose of Infanrix hexa®. 2 blood samples: prior to and 1 month after
      vaccination.
    

Intervention name(s): MenC-TT; Hib-MenC-TT
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus Influenzae type b/Meningococcal (vaccine); Prophylaxis meningococcal serogroup C disease, Hib diseases
Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations
Condition: Bioavailability Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the relative bioavailability of early phase
      and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under
      fasting conditions. The secondary objective of the study is to evaluate the safety of
      hetrombopag olamine in healthy Chinese adult subjects.
    


Intervention name(s): Hetrombopag
Intervention type(s): Drug
Intervention description(s): Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions
Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Coronavirus Pediatric Serological Study
Condition: SARS-CoV2 Infection
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The Coronavirus Pediatric Serological Study's aim is to provide a better insight of
      children's immune response after SARS-CoV-2 infection.

      Serological tests were conducted on blood samples taken 3 to 5 months after the children's
      viral infection.

      The study was performed in collaboration with the Institute of Medical Immunology, were
      antibody levels were measured and immunoglobulin subclasses profiles were studied.
    

Detailed description: 
      The hospital laboratory provided us the list of children under 15 years old tested for
      SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1
      2020 and December 31 2020.

      The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and
      clinical information was collected.

      For each positive child, the family was contacted by phone 3 months after the proven viral
      infection in order to ask permission to take a single blood test.

      Covid19 serologies were performed in the hospital laboratory, and blood samples were then
      sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin
      subclasses were studied.
    

Intervention name(s): Blood sample
Intervention type(s): Diagnostic Test
Intervention description(s): Blood sample taken 3 to 5 months after the infection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children under 15 years old
      
Biospecimen description: 
      Blood samples
    
Keywords: SARS-CoV-2; Immune response; Children
The Effect of Protein on Calcium Absorption and Gastric Acid Production
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      We have established that dietary protein is an important regulator of intestinal calcium
      absorption in humans. However, we do not understand the mechanism by which dietary protein is
      affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether
      dietary protein-induced changes in gastric acid secretion explain the observed changes in
      intestinal calcium absorption.
    

Detailed description: 
      We have established that dietary protein is an important regulator of intestinal calcium
      absorption in humans. However, we do not understand the mechanism by which dietary protein is
      affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether
      dietary protein-induced changes in gastric acid secretion explain the observed changes in
      intestinal calcium absorption. We have compelling in vitro data that amino acids can
      stimulate gastric acid secretion. We have found that this occurs via allosteric activation of
      the calcium sensing receptor expressed on the gastric acid-secreting parietal cells. At a
      fixed concentration of extracellular calcium, addition of L but not D isomers of specific
      amino acids activates the calcium sensing receptor and stimulates parietal cell acid
      production. We hypothesize that dietary protein induced gastric acid production increases
      calcium solubility and bioavailability thereby increasing its absorption. We will test this
      hypothesis in humans by quantifying the impact of dietary protein on intestinal calcium
      absorption in subjects who cannot make gastric acid. We will measure intestinal calcium
      absorption in healthy adults as they consume either a high protein diet with concomitant
      administration of a proton pump inhibiting (PPI) drug or the same high protein diet with a
      placebo instead of a PPI. The order of the 2 interventions will be randomized, and study will
      be double-blind and placebo controlled. If our hypothesis is correct, then intestinal calcium
      absorption will be highest during the high protein diet with placebo, and lowest during the
      drug intervention.
    

Intervention name(s): esomeprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet; Placebo 20 mg twice a day for 9 days
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gastric acid; Dietary protein; Calcium; Intestinal absorption; Calcium sensing receptor
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the
      optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8
      weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid
      [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active
      Crohn's disease.
    


Intervention name(s): Placebo; OPC-6535; OPC-6535
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration of placebo once-daily for 8 weeks; oral administration of OPC-6535 25 mg once-daily for 8 weeks; oral administration of OPC-6535 50 mg once-daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination
Condition: Pelvic Examination,Virtual Reality
Study type: Interventional

Summary: 
      Objective: The study was conducted as a randomized controlled experimental study to examine
      the effect of the video watched with virtual reality glasses during the pelvic examination on
      the level of pain and anxiety perceived by women.

      Materials-Methods: The sample of the study consisted of 128 women (64 experimental, 64
      control group) who applied to the Obstetrics and Gynecology Polyclinics with non-pregnancy
      complaints between November 2021 and February 2022, volunteered to participate in the study
      and were approved by the doctor for pelvic examination. Institutional and ethical committee
      permissions were obtained before starting the study. Descriptive Information Form, State
      Anxiety Scale, Visual Comparison Scale (GDS), Pelvic Examination Experience Evaluation
      Questionnaire, and Questionnaire Evaluating Non-Verbal Responses to Emotional Stressful
      Situations, prepared by the researcher, were used to collect data. In the pre-test to the
      women in the experimental group of the study: Descriptive Information Form, State Anxiety
      Scale, Visual Comparison Scale (for anxiety), then Pelvic examination + Virtual reality
      application (using virtual reality glasses for a minimum of 5 maximum 15 minutes), Emotional
      Stress to be applied by the researcher The Form Evaluating Non-Verbal Responses to the
      Creating Situations, and in the post-test: State Anxiety Scale, Visual Comparison Scale
      (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. In the
      pre-test to the women in the control group of the study: Introductory Information Form, State
      Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination (routine
      service), Form Evaluating Non-Verbal Responses to Emotional Stressing Situations to be
      administered by the Researcher, In the post-test: State Anxiety Scale, Visual Comparison
      Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied.
      Data were evaluated in computer environment and using SPSS 23.0 statistical package program.
      A p value of <.05 for the data was considered statistically significant.
    


Intervention name(s): Virtual reality
Intervention type(s): Device
Intervention description(s): I had the women wear virtual reality glasses and watch the video they wanted for at least 5, maximum 15 minutes during the examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Pelvic Exam; Pain; Anxiety; Virtual Reality
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel
      preparation can be improved for a good colonoscopic examination without missing lesions and
      complications.
    

Detailed description: 
      Objectives:

        1. Primary:

             -  Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with
                Lubiprostone (Arm 2)

             -  Waiting time for colonoscopic procedure and quality of bowel preparation

        2. Secondary:

             -  Quality of bowel preparation without Dietary restriction (Modified bowel
                preparation regime without Fiber diet restrictions)
    

Intervention name(s): Lubiprostone
Intervention type(s): Drug
Intervention description(s): Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Lubiprostone; Bowel preparation regime
Imaging Biomarkers of Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study aims to develop, evaluate and translate highly accelerated imaging sequences (each
      protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical
      3T scanner using novel compression sensing and parallel imaging strategies.The overarching
      objective of the study is to establish a non-invasive imaging biomarker based on the
      development of rapid relaxation mapping with compressed sensing (CS) that will be clinically
      useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients
      with high risk of developing knee osteoarthritis (OA), 30 patients with mild OA and 30
      healthy controls will be accrued.
    

Detailed description: 
      Current noninvasive imaging methods to evaluate knee joints include plain radiographs,
      computed tomography (CT), and clinical morphological magnetic resonance imaging (MRI) of
      joint structures. These techniques can only detect later-stage, macroscopic joint structural
      abnormalities that are irreversible and not amenable to early therapy. This study aims to
      develop highly accelerated imaging sequences for ex-vivo knee OA applications on a standard
      clinical 3T scanner using novel CS and parallel imaging (PI) strategies.
    

Intervention name(s): PRISMA 3T MRI scanner (Siemens Medical Solutions)
Intervention type(s): Device
Intervention description(s): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic