bioihbjkbjnl/mcl2 huggingface dataset:
Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Cardiac output monitoring is mandatory in most surgical and critical care patients. Many
      techniques to assess cardiac output are invasive and/or have many limitations,
      contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal
      is an interesting option due to the simplicity and non-invasive nature of its calculation.

      The present study was designed to compare the cardiac output measurement using a capnodynamic
      formula versus the reference thermodilution method.
    

Detailed description: 
      This is a prospective and observational study designed to test the accuracy and precision of
      the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients.
      We will study 30 patients undergoing cardiovascular by pass in which an invasive
      trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.

      A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along
      the surgery. Analysis of precision will be done at the begining of the protocol and during
      stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and
      regression analysis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac surgical ASA II-III patients.
      
Keywords: carbon dioxide; cardiac output; ventilation; thermodilution
Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
Condition: B-cell Non Hodgkin's Lymphoma
MeSH terms: Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the
      Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in
      Previously Untreated Subjects With CD20+ DLBCL
    


Intervention name(s): HLX01; Rituximab; CHOP
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were
      destroyed by chemotherapy used to kill tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell
      transplantation in treating patients who have stage IV breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation
           after an immunoablative conditioning regimen to induce a state of mixed host/donor
           chimerism in patients with metastatic breast cancer.

        -  Determine the ability of this treatment regimen to induce an allogeneic
           graft-versus-tumor response in these patients.

        -  Determine the feasibility of giving other approved therapies to these patients at the
           first sign of disease progression in order to stabilize or produce a minimal or partial
           response.

      OUTLINE: Patients receive chemotherapy comprising fludarabine IV over 30 minutes and
      cyclophosphamide IV over 1 hour on days 1-4. Patients receive filgrastim (G-CSF) SC daily
      beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days
      for a maximum of 2 courses.

      Patients receive a transplantation preparative regimen comprising fludarabine IV over 30
      minutes and cyclophosphamide IV over 2 hours on days -6 to -3 (beginning on day 22 of
      immune-depleting chemotherapy) followed by allogeneic peripheral blood stem cell
      transplantation IV on day 0. Patients receive G-CSF SC daily beginning on day 0 and
      continuing until blood counts recover, plus cyclosporine IV over 1-2 hours every 12 hours on
      days -1 to 14 and then orally until day 40.

      Patients with persistent malignant disease and less than grade II acute graft-versus-host
      disease receive donor lymphocytes IV on days 42, 70, and 98.

      Patients are followed twice weekly until day 100, and then at 6, 9, 12, 18, and 24 months.

      PROJECTED ACCRUAL: A maximum of 70 patients will be accrued for this study within 24 months.
    

Intervention name(s): filgrastim; therapeutic allogeneic lymphocytes; cyclophosphamide; cyclosporine; fludarabine phosphate; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Cyclosporins
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; male breast cancer
Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy
Condition: Myotonic Dystrophy 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Tideglusib is safe and efficacious in the
      treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy.
      The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.
    


Intervention name(s): Tideglusib
Intervention type(s): Drug
Intervention description(s): Tideglusib for oral suspension,
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability profile of tramadol
      hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported
      by currently available toxicology and clinical data (200 mg to 600 mg per day).
    

Detailed description: 
      This is a randomized (study drug assigned by chance), sequential-cohort (time lagged),
      double-blind (neither the participant or the study doctor will know the name of the assigned
      treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of
      3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl
      in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially
      assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in
      each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl
      or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind
      treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day
      safety review period before the next ascending dose of study drug is administered to the next
      group. Participants in each group will be confined to the study center for a total of 5 days,
      the total duration of each subject's participation will be up to 33 days, including the
      screening phase. The total duration of the study (completion of all 3 treatment cohorts) will
      be up-to-approximately 2 months.
    

Intervention name(s): Tramadol HCl, 50 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50-mg overencapsulated tablet for oral administration; Size-matching capsules containing an appropriate inactive excipient
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Pain; Tramadol hydrochloride; Tramadol HCl; Analgesic; QT prolongation; RWJ-26898-002
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules,
      USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules
      130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals
      Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed condition.
    

Detailed description: 
      The subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids
      and cannabinoids) in urine prior to admission in each period.

      Following an overnight fast of at least 10 hour, a high-fat high calorie breakfast was served
      to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of
      fenofibrate capsules 130 mg of either test or reference formulation was administered during
      each period of the study, along with 240 mL of drinking water at ambient temperature under
      low light condition and under supervision of trained study personnel.

      Blood samples were collected at pre-dose and at 1.000, 2.000, 3.000, 4.000, 4.500, 5.000,
      5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 9.500, 10.000, 11.000, 12.000,
      16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose in each period under low
      light condition. The pre-dose blood samples in each period were collected in duplicate (2 x 5
      mL), within a period of 1.5 hour before dosing. Post-dose samples were generally collected
      within 2 minutes of the scheduled time.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis at screening). Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry were repeated at
      the end of the study.
    

Intervention name(s): fenofibrate; ANTARA® (fenofibrate)
Intervention type(s): Drug; Drug
Intervention description(s): 130mg, Capsules; 130mg, Capsules
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Condition: Eye Diseases
MeSH terms: Eye Diseases; Mydriasis; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy on pupillary dilation between the single
      dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular
      examination.
    

Detailed description: 
      To the best of the authors' knowledge, there have been no clinical trials using an
      appropriate regimen for pupillary dilation up until now. Therefore, the authors were
      interested to find out the most appropriate regimen for complete ocular examination, based on
      the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy.
      The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is
      adequate to complete the job and are conducting this prospective randomized clinical
      controlled trial to prove the hypothesis.
    

Intervention name(s): 1% tropicamide and 10% phenylephrine
Intervention type(s): Drug
Intervention description(s): single dose vs three doses of 1%tropicamide and 10%phenylephrine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tropicamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: single dose; mydriatic drug; pupillary dilation
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
Condition: Schizophrenia; Schizophrenia; Psychosis
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter
      inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely
      psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of
      schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed
      combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) versus
      placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult
      inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are
      to evaluate improvement in disease severity and symptoms, safety and tolerability, and
      pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.
    


Intervention name(s): Xanomeline and Trospium Chloride Capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral xanomeline 50 mg/trospium chloride 20 mg BID (twice a day) for the first 2 days (Days 1 and 2) followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). At Visit 5 (Day 8), dosing was to be titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the subject was continuing to experience adverse events (AEs) from the previous dose of KarXT 100/20 BID. All subjects who were increased to KarXT 125/30 BID, depending on clinical response and tolerability, had the option to return to KarXT 100/20 BID for the remainder of the treatment period.; Placebo Capsules twice a day (BID)
Other intervention name(s): KarXT; PBO
Intervention MeSH terms: Xanomeline; Trospium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
Condition: Transverse Myelitis
MeSH terms: Myelitis; Myelitis, Transverse
Study type: Observational

Summary: 
      ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism
      in patients with severe spinal cord damage from transverse myelitis
    

Detailed description: 
      Transverse myelitis (TM) is a rare inflammatory condition of the spinal cord. It is
      characterised by rapid onset of motor, sensory or autonomic dysfunction causing neurological
      deficit. It has a diverse range of causes; most commonly it is associated with multiple
      sclerosis and neuromyelitis optica also known as Devic's disease or Devic's syndrome, is a
      heterogeneous condition consisting of the simultaneous inflammation and demyelination of the
      optic nerve (optic neuritis) and the spinal cord (myelitis). It affects approximately 1900
      adults and children in the UK annually, with 350 cases per year of unknown cause.

      Outcome in TM is variable; e.g. neuromyelitis optica mortality can be 30% . There is a
      relationship between the severity of neurological symptoms at presentation and the eventual
      outcome. When a patient is ASIA (American spinal injuries association) A or tetraplegic at
      presentation, they are less likely to recover than when ASIA B/C or paraplegic. Approximately
      30% of patients will be ASIA A-C after a TM episode.

      There are several pathological mechanisms which could increase the risk of decreased blood
      supply and further neurological deficit in TM. The ISCoPE study has shown that in traumatic
      spinal cord injury when swelling causes mechanical compression of the cord against the dura
      there is increased intra spinal pressure (ISP).

      The Investigators propose to monitor the ISP and spinal cord metabolites in 10 TM patients
      with MRI evidence of a swollen enlarged spinal cord. There has never been a study looking at
      ISP in TM patients before. The optimum blood pressure in patients with TM is not known.

      The investigators aim to observe a previously unrecognised pathological mechanism of injury
      in TM. In the future this could lead on to novel treatments to improve drug delivery and
      neurological outcome in a condition otherwise associated with a poor outcome.
    

Intervention name(s): Intra spinal pressure monitoring; Intra spinal microdialysis monitoring
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Sub dural pressure monitoring using a FDA approved intracranial pressure monitor; Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients with formal diagnosis of transverse myelitis
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and
      Amlodipine, phase I study in Hypertensive patient was designed.
    


Intervention name(s): SK3530 100mg, Placebo, Amlodipine
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      In this phase I first-in-human clinical trial, healthy volunteers in two different dose
      cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will
      receive a heterologous booster vaccination with a licensed COVID-19 vaccine.

      The aim of the study is to assess the safety and tolerability of the candidate vaccine and to
      characterize its immunogenicity.
    

Detailed description: 
      The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2
      spike protein (S). A total of 30 participants will receive the following vaccine regime:

      15 participants will receive 10^7 infectious units (IU) of MVA-SARS-2-S on days 0 and 28.

      15 participants will receive 10^8 IU of MVA-SARS-2-S on days 0 and 28. Safety and
      immunogenicity data will be collected throughout the study, which concludes at day 168.

      A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine.
      Vaccinees will receive two doses of the Comirnaty vaccine (21 days interval).
    

Intervention name(s): MVA-SARS-2-S vaccinations (days 0 & 28); Comirnaty
Intervention type(s): Biological; Biological
Intervention description(s): Vaccination with MVA-SARS-2-S in two escalating dose regimens; Vaccination with Comirnaty (21 day interval)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MVA; vaccine; SARS-CoV-2; mRNA vaccine; heterologous
the Effect of WBPC on Subacute Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Whole body periodic acceleration (WBPA) is a head-to-toe movement. The function WBPA works as
      adding pulses to the circulation. This motion increases shear stress to the endothelium,
      which stimulates increased release of endothelial-derived nitric oxide (eNO), prostaglandin
      E-2, tissue plasminogen activator (TPA) into the circulation, and these substances are
      cardioprotective and contribute to vasodilatation. The WBPA were not well studied than whole
      body vibration (WBV), a vertical rocking training machine, and most researches focused on
      cardioprotective effects. A study revealed the effect of Moderate-Intensity Exercise and
      Whole-Body Periodic Acceleration on Nitric Oxide release was the same. This instrument is
      quite safe and was applied to patients with varied diseases in previous study. No sound
      contraindication was mentioned till now.

      Our hypothesis is assuming that the circulation of brain could improve after the intervention
      of WBPA, and stroke recovery and cadio-pulmonary function will improve subsequently.
    

Detailed description: 
      So the investigators will recruit subacute stroke patients as our subjects. The patient who
      is booked to our rehabilitation ward for further rehabilitation programs is eligible for our
      study. the investigators will recruit 30 patients, and randomize them to experimental and
      control group. This study is going to be single blinded, which the evaluator is blinded to
      the condition of the subjects. Whether experimental or control groups will received the same
      intensive rehabilitation programs (6 days a week). The experimental group will receive
      additional WBPA treatment. The duration will be 30 minutes a time, and the frequency will be
      5 days a week, and the treating period will be 3 weeks. The evaluator will assess twice,
      before and after the experiment period. The measurements include: muscle power, brunnstrom
      stages, Barthel Index, functional independence measure (FIM), time up and go test, 6 minutes
      walk test, Fugl-Meyer Assessment, berg balance scale, cardio-pulmonary test. In addition, to
      confirm the immediate effect of WBPA over brain circulation, the investigators will choose 6
      patients to received carotid ultrasonography before and immediately after the WBPA treatment.
    

Intervention name(s): WBPC; Without WBPC
Intervention type(s): Device; Device
Intervention description(s): The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks.; Not treat with WBPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment