bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence
      between single-dose liraglutide administered subcutaneously with two different pen-injectors.
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention description(s): Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Condition: Lymphoma, Non Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label, single-arm, phase IIIb study will evaluate the safety of switching from
      intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment
      for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell
      lymphoma (DLBCL) who have already received at least one full dose of rituximab IV.
      Participants with FL will be given 1400 mg rituximab SC during induction therapy (once
      monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400
      mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles.
      Treatment duration is expected to last up to 7 months for participants with DLBCL and up to
      32 months for participants with FL.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): 1400 mg will be injected subcutaneously (SC).
Other intervention name(s): MabThera; Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare Verbal Scores of Children Diagnosed With ASD Who Received Hyperbaric Treatment To Those Who Did Not
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Observational

Summary: 
      A child's ability to effectively communicate with peers, parents, and caregivers impacts
      their level of independence and quality of personal relationships. This retrospective study
      will compare the speech development of participants aged 2 - 17 years that received 40
      sessions of HBOT at 2.0 ATA to those who had not. Both groups will have a verbal assessment
      every six months. There were 32 subjects in the HBO group and 33 subjects in the non-HBO
      group. The statistical analysis will focus on whether Hyperbaric Oxygen Therapy made a
      significant difference in Verbal Behavior Milestones Assessment and Placement Program
      (VB-MAPP) or Assessment of Basic Language and Learning Skills (ABLLS) results.
    

Detailed description: 
      Methods: This was a study designed to retrospectively determine any association between
      hyperbaric oxygen therapy (HBOT) and change in verbal scores in children with autism spectrum
      disorder (ASD). All children aged 2 to 17 years, diagnosed with ASD who completed a verbal
      test every six months (either Verbal Behavior Milestones Assessment and Placement Program or
      the Assessment of Basic Language and Learning Skills), received applied behavioral analysis
      at Oxford Recovery Center (ORC) were screened for inclusion, some of whom had elected to
      receive HBOT (at least 40 sessions for 60 minutes at 2.0 ATA).
    

Intervention name(s): Hyperbaric Oxygen Therapy
Intervention type(s): Device
Intervention description(s): Subjects received 100% medical grade oxygen for 60 minutes at 2.0 ATA for 40 sessions in a hard-sided monoplace hyperbaric chamber
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The medical records were reviewed for children aged 2 - 17 years who were diagnosed by a
        qualified practitioner with autism spectrum disorder (ASD) and treated at the Oxford
        Recovery Center between Jan 2018 and July 2021. Each child who underwent a minimum of 40
        hyperbaric oxygen treatments at 2.0 ATA in a hard sided monoplace chamber, had two
        age-appropriate verbal tests 6 months apart, and received applied behavioral analysis
        during the study period were included in the treatment group. Children who did not undergo
        hyperbaric oxygen therapy, received two age-appropriate verbal tests 6 months apart, and
        received applied behavioral analysis were included in the control group. Any child
        diagnosed with seizure disorder, genetic or mitochondrial mutation were excluded from the
        study cohort.
      
Keywords: Hyperbaric Oxygen Therapy
Different Surgical Techniques for Pterygium Surgery
Condition: Pterygium
MeSH terms: Pterygium
Study type: Observational

Summary: 
      A study to research the post-operative results according to the chosen surgical technique and
      evaluate the refractive changes before and after the excision of pterygium.
    

Detailed description: 
      To analyze the epidemiological profile of patients who were operated of pterygium in Eyes
      Institute of Goiânia, analyze the post-operative results according to the chosen surgical
      technique and evaluate the refractive changes before and after the excision of pterygium.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals who were underwent pterygium surgery
      
Keywords: pterygium surgery; refractive changes; surgical technique
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite
      identification of [14C]TAS-205 following oral single doses.
    


Intervention name(s): TAS-205, [14C]TAS-205
Intervention type(s): Drug
Intervention description(s): single oral administration under fasted conditions on day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy
Condition: Renal Tumor
MeSH terms: Kidney Neoplasms
Study type: Interventional

Summary: 
      The multimodal analgesia for postoperative pain aims for optimal analgesia through additive
      or synergic drug effects. The multimodal analgesia results in the use of smaller doses of
      opioids and lowering opioid-related side effects.

      Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug
      of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia
      after major surgery.

      NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side
      effects.

      In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely
      used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter
      renal function or cause hemorrhagic complications.

      Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous
      acetaminophen) associated with the analgesic effectiveness of nefopam could explain the
      observed synergy of the combination.

      The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and
      analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and
      propacetamol in patients undergoing laparoscopic nephrectomy.
    


Intervention name(s): nefopam-propacetamol combination; propacetamol alone
Intervention type(s): Drug; Drug
Intervention description(s): Patients in both groups will receive intravenous patient-controlled analgesia (PCA) using fentanyl.
In nefopam-propacetamol combination group, patients will receive nefopam(20mg mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.; In propacetamol alone group, patients will receive placebo (normal saline 2 ml mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
Intervention MeSH terms: Acetaminophen; Propacetamol; Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Hypotension is the most common complication of neuraxial anesthesia in obstetric patients and
      its prevalence in cesarean section is about 50-90%. Maternal hypotension causes unpleasant
      symptoms such as nausea, vomiting, loss of consciousness, respiratory depression, and cardiac
      arrest. Hypotension may reduce placental perfusion and result in fetal acidosis and
      neurological injury. Several techniques have been proposed to prevent hypotension.

      The recommended spinal block height to ensure patient comfort for Cesarean delivery is T4-6.
      Clinically, it is desirable that the spread of local anesthetic through the cerebrospinal
      fluid (CSF) achieves a sensory level no higher than the T4 dermatome to avoid extensive
      sympathetic block. It is also important that the spinal block level be no lower than T6 to
      avoid patient discomfort during peritoneal manipulation and uterine exteriorization. The
      effect of injection speed on spread of spinal anesthesia is controversial. Several studies
      have demonstrated more extensive spread with faster injection while others report either
      greater spread with slower injection, or no difference. Slow injection of hyperbaric
      bupivacaine 10 mg over 60 and 120 sec has been shown to reduce the incidence and severity of
      hypotension during Cesarean delivery under spinal anesthesia.
    

Detailed description: 
      Patients admitted to undergo elective c-section under spinal anesthesia will be randomized
      using the sealed envelope technique to Group I who will receive intrathecal injection in a
      slow speed 1ml in 15 sec and group II who will receive 1ml in 5 sec.

      The baseline pulse rate, blood pressure, respiratory rate, and oxygen saturation will be
      recorded intraoperatively. The presence of preoperative hypotension, nausea and vomiting, and
      level of block at 5 and 10 mins post intrathecal injection will be assessed .
    

Intervention name(s): Low speed; High speed
Intervention type(s): Other; Other
Intervention description(s): Speed of intrathecal injection will be 1ml in 15 seconds; speed of intrathecal injection will be 1ml in 5 seconds
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker
Condition: Gastrointestinal Subepithelial Tumors
Study type: Interventional
Phase: Phase 4

Summary: 
      Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump
      inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is
      to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus
      of symptom score, histopathologic findings and inflammatory biomarker.

      A prospective study performed at single hospital enrolled 20 patients who were diagnosed
      clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal
      impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once
      daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after
      treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary
      elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T
      lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be
      accessed.
    


Intervention name(s): Ilaprazole
Intervention type(s): Drug
Intervention description(s): Patients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux, proton pump inhibitors, ilaprazole
Lymphatic Morphology of Fontan Patients
Condition: Lymphatic Abnormality; Plastic Bronchitis; Protein-Losing Enteropathies; Univentricular Heart; Congenital Heart Disease
MeSH terms: Bronchitis; Protein-Losing Enteropathies; Heart Diseases; Heart Defects, Congenital; Univentricular Heart; Lymphatic Abnormalities
Study type: Observational

Summary: 
      The Fontan procedure has revolutionized the treatment of patients born with a congenital
      univentricular heart defect. However, over time, it is associated with severe lymphatic
      complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral
      edema.

      The hypothesis is that patients with a univentricular circulation have a changed morphology
      which may be associated with both the degree of lymphatic complications and their physical
      capacity.

      The morphology will be described using T2-weighted non-contrast MRI.
    

Detailed description: 
      The Fontan procedure has revolutionized the treatment of patients born with a congenital
      univentricular heart defect. However, over time, it is associated with severe lymphatic
      complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral
      edema. It has been proposed that these complications arise due to a elevated central venous
      pressure of the changed circulation.

      The hypothesis of the study is that patients with a univentricular circulation have a changed
      morphology which may be associated with both the degree of lymphatic complications and their
      physical capacity.

      The morphology will be described using T2-weighted non-contrast MRI. The main lymphatic
      vessel, the thoracic duct, will be rendered and measured using 3D software, and the lymphatic
      changes characterized by Dr. Yoav Dori (CHOP, Pennsylvania, USA), using a newly published
      grading system. The above will be correlated with the amount of complications experienced by
      the patients, and their physical capacity measured by both IPAQ questionaire and CPX test.

      The study population consists of patients with a Fontan circulation operated at InCor Heart
      Institute, São Paulo, Brasil and Hospital das Clínicas, Ribeirão Preto, Brasil. Exclusion
      criteria were mental illness, genetic syndromes and age <18 years. The patient group will be
      compared with age, gender and weight matched healthy controls.
    

Intervention name(s): Non-contrast MRI; Cardiopulmonary exercise test
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Classification and characterization of the lymphatic vasculature using non-contrast MRI.; Cardiopulmonary exercise test, measurement of VO2 and heart rate.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with a Fontan circulation.
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity
Condition: General Anaesthesia; Muscle Weakness
MeSH terms: Muscle Weakness; Paresis
Study type: Interventional

Summary: 
      Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients.
      Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities.
      A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it
      is currently unclear if that is feasible.

      In this proof-of-concept trial the primary aim is to show that it is possible to induce a
      diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an
      external electromagnetic stimulation of the phrenic nerve in obese patients.
    

Detailed description: 
      During the time of first spontaneous breathing trial 60% of mechanically ventilated patients
      present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic
      dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as
      early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between
      diaphragmatic atrophy and mortality could be established.

      Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a
      possible method to prevent or treat VIDD. A possible modality would be the non-invasive
      electromagnetic stimulation but feasibility has not been established.

      In this proof-of-concept trial the primary aim is to show that it is possible to induce a
      diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an
      external electromagnetic stimulation of the phrenic nerve in obese patients
    

Intervention name(s): Electromagnetic stimulation
Intervention type(s): Device
Intervention description(s): Electromagnetic stimulation of the phrenic nerve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: VIDD; ICUAW; muscle weakness
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions
Condition: Healthy; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker
      Sustainability Solutions pulse oximetry sensors during motion conditions over the range of
      70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is
      to provide supporting documentation for the SpO2 accuracy validation of the reprocessed
      sensors.
    

Detailed description: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive
      pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements
      from a laboratory blood gas analyzer.

      It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse
      oximetry sensors will meet a specification of +/-3% or better in motion conditions for the
      range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then
      at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds
      at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.
      Motion is defined as controlled rubbing or tapping of the subject's fingers in a 2-4 Hz or
      random sine motion with 2-3 cm amplitude.
    

Intervention name(s): STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Intervention type(s): Device
Intervention description(s): Reprocessed noninvasive pulse oximeter sensors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Quetiapine and the Dopaminergic Epigenetic Control
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      BACKGROUND:

      Epigenetic modifications such as DNA-methylation and histone acetylation are known to be
      involved in the pathophysiology of schizophrenia. Aim of the present study is to investigate

        1. whether differences in the methylation pattern of the promoters of dopaminergic genes
           exist between schizophrenic patients and healthy controls and

        2. whether treatment with the second generation antipsychotic quetiapine leads to changes
           in the methylation pattern of those genes in patients suffering from schizophrenia.

      STUDY DESIGN AND METHODS:

      50 male patients and 50 male controls are to be enrolled into the study. Patients will be
      treated with quetiapine for 3 weeks. Blood samples will be drawn before treatment and after
      three weeks to measure DNA-methylation status. Clinical characterisation includes PANSS,
      AIMS, BDI. Healthy probands will not be treated.
    


Intervention name(s): Quetiapine fumarate
Intervention type(s): Drug
Intervention description(s): Dosage and frequency are judged by the study physician. The dosage must not excess 800mg/d.
Other intervention name(s): Seroquel(R)
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Schizophrenia; Dopamine transporter gene; DNA methylation; Epigenetics