bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      It is an open-label dose-escalating study in sequential cohorts to assess safety and
      pharmacokinetics of GNR-038.
    

Detailed description: 
      Hereditary angioedema (HAE) is a rare potentially life-threatening genetically determined
      disease associated with a deficiency or impairment of C1 esterase inhibitor (C1 inhibitor)
      functional activity. Main clinical manifestations of HAE are recurrent mucous membranes edema
      and localization of the derma deep layers. Attack persist from several hours to several days
      and disappear without a trace in most cases, without additional therapy.

      The prevalence of the disease in the world is from 1:10 000 to 1: 150 000. The
      plasma/recombinant C1 inhibitor use to compensate for its deficiency or insufficient
      functional activity in patients with HAE is recommended both for severe and for long-term and
      short-term (before surgical interventions and dental manipulations) prophylaxis.

      GNR-038 is a recombinant C1 inhibitor (rhC1-inh), which is a complete structural and
      functional analogue of the plasma C1 inhibitor.
    

Intervention name(s): GNR-038, 25 МЕ/kg; GNR-038, 50 МЕ/kg; GNR-038, 100 МЕ/kg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 25 МЕ/kg once per study; 50 МЕ/kg once per study; 100 МЕ/kg once per study
Other intervention name(s): rC1inh, 25 МЕ/kg; rC1inh, 50 МЕ/kg; rC1inh, 100 МЕ/kg
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential dose-increase cohorts in healthy volunteers
Masking: None (Open Label)
Primary purpose: Other
Keywords: Angioedema; Angioedemas, Hereditary; Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Genetic Diseases, Inborn; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs
Effects of Inspiratory Muscle Training on Breathing Pattern in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Muscle Weakness Conditions
MeSH terms: Muscle Weakness; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The improvement in inspiratory muscle function might result in beneficial changes in
      breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory
      muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing
      pattern during an incremental cycle exercise.
    


Intervention name(s): Inspiratory muscle training
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes
Condition: Bladder Cancer
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of stroke volume variation (SVV)
      guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.
    

Detailed description: 
      The purpose of this study is to investigate the effect of stroke volume variation(SVV) guided
      fluid therapy on the blood loss and postoperative outcomes in radical cystectomy. Patients
      were randomized to fluid management to maintain <10% SVV (group A), or to undergo fluid
      management during radical cystectomy to maintain SVV 10-20% (group B). Intraoperative blood
      loss and hemodynamic parameters, perioperative laboratory data, and postoperative
      complications were compared between two groups.
    

Intervention name(s): crystalloid; colloid; mannitol; lasix
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Group A (SVV <10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy; Group A (SVV <10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is > 20%; Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%; Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%
Other intervention name(s): Hartmann's solution; volulyte
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: stroke volume variation; radical cystectomy; blood loss; postoperative complications
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if treatment with SAGE-217 reduces depressive
      symptoms in females with severe postpartum depression (PPD) as compared to placebo.
    

Detailed description: 
      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-217 oral capsules.; SAGE-217 matched-placebo oral capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAGE-217; Postpartum depression
Effect of V0251 in Acute Vertigo
Condition: Acute Vertigo
MeSH terms: Vertigo; Dizziness
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
    


Intervention name(s): V0251; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Photoplethysmography Detects Changes in Vascular Tone
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Observational

Summary: 
      Changes in the vascular tone of anesthetized patients is common and cause hemodynamic
      problems. The monitoring of such changes in vascular resistance using simple and non-invasive
      tools is lacking. The present study was designed to determine if photoplethysmography can
      detect changes in the systemic vascular resistance using Doppler as the reference method.
    

Detailed description: 
      This is a prospective and observational study designed to test the reliability of
      photoplethysmography to diagnose changes in the vascular resistance during anesthesia. The
      investigators will studied 50 mechanically ventilated patients undergoing general anesthesia.
      Photoplethysmography will be continuously recorded in the right thumb during anesthesia.
      Duplex color and power Doppler will measure flow in the radial artery of the right hand.The
      contour analysis of both, photoplethysmogram and radial artery flow will be analyzed,
      correlated and compared using the Bland-Altman plot.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing general anesthesia
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will
      receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2
      (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
    


Intervention name(s): Sotrovimab (Gen1); Sotrovimab (Gen2); Sotrovimab (Gen2)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material; Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection; Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion
Intervention MeSH terms: Sotrovimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; coronavirus; coronavirus disease 2019; COVID-19
A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Observational

Summary: 
      The purpose of this study is to conduct full psychometric testing of the Early Arthritis for
      Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations
    

Detailed description: 
      This is a multicentre, observational, descriptive estimate of the proportion of participants
      with psoriatic arthritis among psoriasis participants attending dermatology clinics selected
      for this study. In addition, this study will involve full psychometric assessment of the
      Early psoriatic screening questionnaire (EARP) questionnaire with the aim of identifying and
      appropriately referring participants to a rheumatologist for review if their EARP score is 3
      or greater at Screening (i.e. >= 3 at Visit 1).
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): This is an obervational study
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with psoriatic arthritis among psoriasis participants attending dermatology
        clinics.
      
Keywords: Psoriatic arthritis
Plyometric Training for Elderly Women
Condition: Healthy
Study type: Interventional

Summary: 
      Introduction: the physiological aging process induces several structural changes in the
      musculoskeletal system. These, in turn, result in functional changes that are reflected in
      the senescent dependency, determining the reduction in their quality of life. Power training
      has been identified as ideal to mitigate the effects of aging. However, there are indications
      that an intervention based on the potentiation of the stretch-shortening cycle action is a
      better choice.
    

Detailed description: 
      Study hypotheses: the participants of the proposed intervention will increase their bone
      mineral density, muscle volume, functional capacity and will show some improvement in their
      gait, as well as in their quality of life. Purposes: the main objective of this study was to
      propose a training model based in the potentiation of the stretch-shortening cycle action and
      assess its effects on selected parameters of musculoskeletal morphology, functional capacity
      and quality of life of elderly women.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Plyometric training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: power training; plyometric training; functional capacity
An Evaluation of the Spectra Optia CMNC Collection Procedure
Condition: Healthy Apheresis Donors; Mononuclear (MNC) Cell Donors
Study type: Interventional

Summary: 
      The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate
      the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared
      to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject
      safety will be evaluated beginning with mobilization, throughout the collection procedure and
      for the day following the last collection.
    

Detailed description: 
      This is a prospective, randomized, cross-over, multi-center study to evaluate the performance
      of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra
      system's MNC Procedure in mobilized healthy donors.

      Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects.
      Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE
      Spectra MNC collection procedure first, followed by the opposite on the following day.

      Study participation will be up to 14 days: a 7-day screening period, four days for
      mobilization, one day for the first MNC collection with additional dose of mobilization, one
      day for the second MNC collection, and safety follow-up the following day.

      Subject safety will be evaluated beginning with mobilization, throughout the collection
      procedure and for the day following the second collection.
    

Intervention name(s): Spectra Optia CMNC; COBE Spectra MNC; Granulocyte-colony stimulating factor (G-CSF)
Intervention type(s): Device; Device; Drug
Intervention description(s): The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.; It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.; Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.
Other intervention name(s): Spectra Optia Apheresis System CMNC collection procedure; COBE Spectra Apheresis System MNC collection procedure; Mobilization Procedure
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: MNCs; Mononuclear Cells; Apheresis; Spectra Optia
Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:
Condition: Low-level Laser Acupuncture in Patients With Total Knee Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Total knee arthroplasty is a common and effective surgical procedure for patients with
      end-stage knee osteoarthritis, and wound pain is still a problem for many of the patients.
    

Detailed description: 
      Therefore, the purpose of this study was to apply low level laser therapy Measured variables
      included postoperative pain intensity, patient-controlled analgesia requirements, side
      effects caused by morphine, knee stiffness and wound pain in the daily activities of patients
      undergoing total knee arthroplasty. Data were collected between April 2018 and January 2019.
      Eighty-two knee osteoarthritis patients receiving total knee arthroplasty were recruited from
      one hospital and randomly, equally assigned to the laser acupuncture or control group. The LA
      group received the low-level laser therapy with 3 joules at each acupuncture point at Hour 2,
      Hour 6, Hour 10, Hour 24, Hour 48, and Hour 72 after surgery; whereas the control group
      received the same manner except for joule.
    

Intervention name(s): low-level laser; Sham laser
Intervention type(s): Device; Device
Intervention description(s): low level laser emission on specific acupuncture points; Sham laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acupuncture points, low-level laser, postoperative pain, total knee arthroplasty
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of
      Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with
      community-acquired pneumonia (CAP).
    

Detailed description: 
      Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and
      developed countries. In the choice of antibacterial agents used to treat CAP,
      fluoroquinolones have received considerable attention because of their wide spectrum of
      bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a
      selective bacterial topoisomerase inhibitor.

      This study will Evaluate the clinical efficacy, microbiological efficacy and safety of
      Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with
      community-acquired pneumonia.

      Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous
      IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
    

Intervention name(s): Nemonoxacin 500 mg; Nemonoxacin 650 mg; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV Infusion, once daily for 7~14 days; IV Infusion, once daily for 7~14 days; IV Infusion, once daily for 7~14 days
Intervention MeSH terms: Moxifloxacin; Nemonoxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moxifloxacin
Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Urinary Incontinence
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Urinary Incontinence; Enuresis; Sclerosis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic
      floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple
      Sclerosis
    

Detailed description: 
      Subjects of the study should conduct a specific training in pelvic floor exercises. They were
      randomly assigned into 2 groups: Group A only received written instructions for exercises to
      be performed at home; Group B received written instructions and, in addition, exercises were
      performed in a 30 minutes weekly session with a physiotherapist guiding them
    

Intervention name(s): Pelvic floor exercises guided by a physiotherapist; Non guided pelvic floor exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home); Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic floor muscle exercise; Supervision; Physiotherapy
Inflammatory Response in Aortic Valve Replacement
Condition: Inflammation; Systemic Inflammatory Response Syndrome; Thoracic Surgery; Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Inflammation; Systemic Inflammatory Response Syndrome
Study type: Observational

Summary: 
      The study investigates inflammatory and antiinflammatory response in patients with severe
      aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement)
      or interventional cardiology treatment (transcatheter aortic valve implantation using the
      transfemoral access route or the transapical access route).
    

Detailed description: 
      Background

      Surgical and interventional therapy for aortic valve stenosis exposes the patients to a
      immune reaction, which is different depending on the type of the treatment. In this study,
      the investigators would like to better understand the inflammatory and antiinflammatory
      response in this patient population by monitoring the perioperative cytokine response
      (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma
      factors (CD62L) involved in inflammatory processes.

      Objective

      Characterisation of inflammatory and antiinflammatory response in patients receiving aortic
      valve prosthesis selected for different treatment options.

      Methods

      Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours
      postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10,
      CRP, TNF, soluble CD62L.
    

Intervention name(s): Whole blood analysis
Intervention type(s): Other
Intervention description(s): In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with severe aortic valve stenosis selected for surgical aortic valve replacement
        or transcatheter aortic valve implantation.
      
Biospecimen description: 
      whole blood analysis
Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor
Condition: Acute Cardiac Event; Acute Cardiac Failure; Acute Cardiac Pulmonary Edema
MeSH terms: Pulmonary Edema; Heart Diseases; Cardiovascular Diseases; Heart Failure
Study type: Observational

Summary: 
      A prospective observational study in patients admitted with an acute cardiac disease, in
      which the PPG-based device will be attached to them on admission, for frequent monitoring of
      their vitals during hospitalization and interventional procedures. in parallel to
      currently-used and approved devices. Data will be crossed with gathered clinical and
      laboratory data, to study the device's ability to detect acute hemodynamic and respiratory
      changes during hospitalization, and gathering workflow information from the nursing staff.
    


Intervention name(s): Non-invasive Monitoring
Intervention type(s): Device
Intervention description(s): Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        200 men and women admitted to the cardiac ICU with acute caridac event.
      
Keywords: Acute Catdiac Events; Remote Patient Monitoring