bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
    

Detailed description: 
      This is a 2-part study. Part 1 of the study will compare the PK of ACP-196 in participants
      with mild hepatic insufficiency (a score of 5 to 6, on the Child-Pugh scale) and moderate
      hepatic insufficiency (a score of 7 to 9, on the Child-Pugh scale) to healthy (mean) matched
      control participants for age and weight. Part 2 of the study, if it is conducted, will
      compare the PK of ACP-196 in participants with severe hepatic insufficiency (a score of 10 to
      15 on the Child-Pugh scale) to the healthy control participants from Part 1. In Part 1, 6
      participants with mild hepatic insufficiency, 6 participants with moderate hepatic, and 6
      healthy control participants matched to the hepatic insufficiency groups according to mean
      age and mean weight will be enrolled. In Part 2, if conducted, 6 participants with severe
      hepatic insufficiency will be enrolled. The control group of Part 1 will be used for Part 2
      PK comparison. Participants will be screened within 28 days before the dose. Participants
      will be contacted approximately 14 days after the last dose of study drug administration to
      determine if any adverse event has occurred since the last dose of study drug.
    

Intervention name(s): ACP-196
Intervention type(s): Drug
Intervention description(s): All study participants will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study.
Other intervention name(s): Acalabrutinib
Intervention MeSH terms: Acalabrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACP-196; Healthy participants; Mild hepatic impairment; Moderate hepatic impairment; Severe hepatic impairment; Pharmacokinetics; PK; Safety
Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Low-intensity extracorporeal shock wave therapy (Li-ESWT) has shown promise as a novel
      treatment for erectile dysfunction (ED), though the the mechanism of action and optimal
      protocol for administration has not been well-established. The aim of this study is to assess
      for subjective and objective improvements in erectile function following treatment with
      Li-ESWT.
    

Detailed description: 
      Eligible patients will be enrolled as outlined below. Prior to initiation of Li-ESWT
      treatments, patients will complete validated questionnaires to assess erectile function. In
      addition, patients will undergo induction of artificial erection in clinic with assessment of
      penile blood flow using penile Doppler. Intracavernosal pressure measurements will be
      obtained. A corporal aspirate will be drawn and examined for levels of neuronal nitric oxide
      synthase, endothelial nitric oxide synthase, brain-derived neurotropic factor and vascular
      endothelial growth factor. Patients will then receive twice-weekly Li-ESWT treatments of
      0.2mJ/mm^2 over 3 treatment sites along the dorsal penile shaft, 1500 shocks per treatment
      (500 shocks per treatment site), for a total of 3000 shocks per week, for 6 weeks of
      treatment (totally 18,000 shocks). Following Li-ESWT treatments, patients will complete the
      same validated questionnaires, penile Doppler studies, corporal aspirates and measurement of
      intracavernosal pressures immediately following the final Li-ESWT treatment, 4-6 weeks
      following completion of treatment, and again at 3 and 6 months following completion of
      treatment.
    

Intervention name(s): Low-Intensity Extracorporeal Shock Wave Therapy
Intervention type(s): Device
Intervention description(s): Twice-weekly treatments for 6 weeks, of 0.2mL/mm^2 administered for 500 shocks per treatment site, for a total of 3000 shocks per week.
Other intervention name(s): Storz Duolith SD-1 t-top >>ultra<< device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Low intensity shock wave therapy
Cost of Illness Associated With Influenza in the UK
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The objective of this study is to describe the burden associated with influenza in the UK,
      from both primary and secondary care perspectives, and to stratify the burden by the annual
      degree of mismatch between predicted and actual virus strains.
    

Detailed description: 
      This is a retrospective, cross sectional, exploratory, observational study using database
      analysis and therefore there is no patient or user group involvement.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Data of patients diagnosed with acute respiratory illness is extracted from General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Health Protection Agency (HPA), Office of National Statistics (ONS), and National Health Service (NHS) Reference Costs, during the period January 21st 2001 and March 31st 2009 inclusive.
All analyses of primary care data (GPRD) and separately for secondary care (HES) data will be repeated for all eligible patients, and the subset of patients with a linkage to additional data (HES, ONS). All analysis including secondary care data will be restricted to the subset of patients with linked HES data. Estimates of average burden per patient and total burden in the UK will be performed. Burden is defined as both resource use and cost. Annual incidence and burden will be calculated.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients coded within the relevant database (GPRD and HES) as having acute respiratory
        events that could be related to an infection between 2001 and 2009.
      
Keywords: Illness; Influenza; Cost; UK
Urokinase Like Plasminogen Activator Levels in Patients Undergoing Bronchoscopy
Condition: Hemoptysis
MeSH terms: Hemoptysis
Study type: Observational

Summary: 
      Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an
      immunocompromised state. The etiology of this remains uncertain. The investigators suspect
      that individuals with malignancy have abnormalities involving certain factors that influence
      the coagulation pathway.

      The investigators plan to measure these factors prior to and after bronchoscopy.
    

Detailed description: 
      This is a prospective observational study looking at some coagulation factors in individuals
      with lung cancer. We are looking at BAL and plasma. We would like to see if there is a
      difference in the levels and if this is the reason behind the higher incidence of hemoptysis
      in patients with lung cancer.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from the VAMC in Oklahoma city
      
Keywords: hemoptysis
Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial
Condition: Neovascular Age-related Macular Degeneration; Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Excessive vascular endothelial growth factor (VEGF) plays a key part in promoting
      neovascularization and edema in neovascular (wet) age-related macular degeneration (nAMD).
      VEGF inhibitors (anti-VEGF), including ranibizumab (LUCENTIS®, Genentech) and aflibercept
      (EYLEA®, Regeneron), have been shown to be safe and effective for treating nAMD and have
      demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via
      intravitreal injection and can be a significant burden to the patients. RGX-314 is a
      recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a
      soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein
      following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment
      burden of currently available therapies while maintaining vision with a favorable
      benefit:risk profile.
    

Detailed description: 
      This Phase I/IIa, open-label, multiple-cohort, dose-escalation study was designed to evaluate
      the safety and tolerability of RGX-314 gene therapy in subjects with previously treated nAMD.
      Five doses were studied in approximately 42 subjects. Subjects who met the
      inclusion/exclusion criteria and had an anatomic response to an initial anti-VEGF injection
      received a single dose of RGX-314 administered by subretinal delivery. RGX-314 uses an AAV8
      vector that contains a gene that encodes for a monoclonal antibody fragment which binds to
      and neutralizes VEGF activity. Safety was the primary focus for the initial 24 weeks after
      RGX-314 administration (primary study period). Following completion of the primary study
      period, subjects continued to be assessed until 104 weeks following treatment with RGX-314.
    

Intervention name(s): RGX-314
Intervention type(s): Genetic
Intervention description(s): RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: dose escalation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nAMD; wet AMD; gene therapy
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
Condition: OSA; Rocuronium; Neuromuscular Blockade; Hypoxic Ventilatory Response; CPAP
MeSH terms: Sleep Apnea, Obstructive; Hypoxia
Study type: Interventional

Summary: 
      This study describe the effect of partial neuromuscular blockade of rocuronium on the acute
      hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.
    


Intervention name(s): Rocuronium
Intervention type(s): Drug
Intervention description(s): Partial neuromuscular blockade with rocuronium with a TOF 0.70
Other intervention name(s): CPAP
Intervention MeSH terms: Rocuronium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours
Condition: Unresectable Solid Tumor; Metastatic Solid Tumor; Locally Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in
      Patients with Locally Advanced Unresectable/Metastatic Solid Tumours to determine the safety
      and tolerability of RC118, including the maximum tolerated dose (MTD)/maximum administered
      dose (MAD), and to define the recommended Phase II dose (RP2D).
    

Detailed description: 
      This is an open-label, Phase 1, FIH, study consisting of dose-escalation (Part A) and dose
      confirmation (Part B) in Australia. This trial is to evaluate the safety, tolerability
      (MTD/MAD), PK, immunogenicity of RC118, and further determine the RP2D. In addition, the
      preliminary anti-tumour efficacy of RC118 as single agent will be assessed.
    

Intervention name(s): RC118 for injection
Intervention type(s): Drug
Intervention description(s): RC118 will be administered intravenously (IV) on Day 1 of every 14-day cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of a single
      subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with
      varying degrees of renal function, including subjects requiring hemodialysis.
    

Detailed description: 
      This adaptive design, non-randomized, open-label, staggered parallel group study evaluates
      the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in
      subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage
      1, a single dose of albiglutide will be administered to subjects with normal renal function
      and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition
      to subjects with normal renal function and moderate renal impairment, Stage 2 of the study
      will also include cohorts of subjects requiring hemodialysis, subjects with severe renal
      impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.
    

Intervention name(s): albiglutide
Intervention type(s): Biological
Intervention description(s): single dose of subcutaneously injected albiglutide
Intervention MeSH terms: rGLP-1 protein
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: albiglutide; hemodialysis; pharmacokinetics; renal
Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
Condition: Chronic Pain; Diabetic Neuropathies; Diabetes Mellitus
MeSH terms: Diabetic Neuropathies; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in
      patients when compared to placebo (a tablet that does not contain active product) and when
      compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will
      be undertaken to find out if the patient's general health and well-being improves under trial
      treatment.

      The concentrations of cebranopadol in the blood will be investigated to get a better
      understanding of how it is absorbed from the gut, distributed and broken down in the body,
      and eliminated from the body.
    


Intervention name(s): Cebranopadol 100 µg; Cebranopadol 300 µg; Cebranopadol 600 µg; Pregabalin; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.; Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.; Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.; Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.; Placebo will be matched to pregabalin and cebranopadol.
Other intervention name(s): Lyrica®
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Painful Diabetic Peripheral Neuropathy
Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Condition: Chemotherapy Induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety
      compared to daily G-CSF in chemotherapy-induced neutropenia.
    

Detailed description: 
      Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily
      G-CSF(up to 10 days). This study is conducted for 1 cycles of chemotherapy.
    

Intervention name(s): PEG-G-CSF; G-CSF
Intervention type(s): Drug; Drug
Intervention description(s): Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle; Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 1 cycle
Other intervention name(s): DA-3031; Leucostim®
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEG-G-CSF
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea
      fiber supplementation on gut community structure and features of host biological state
      (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual
      diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat
      (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to
      consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet,
      subjects will supplement their diet with pea fiber for a total of 21 days; the energy
      contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs
      during this time. After completing the pea fiber supplementation phase of the study subjects
      will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and
      blood will be sampled periodically throughout.
    


Intervention name(s): Low fiber diet; Pea Fiber Bar; Low fiber diet
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49); Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35; Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Biomarkers in Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Depression is a leading cause of disability worldwide, affecting nearly 16% of the general
      population. Its physiopathology remains unclear. Based on gene-environment studies and
      epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE)
      results from the convergence of multiple factors including biological factors such as
      multi-genic vulnerability, hormonal and immunological variations as well as environmental
      factors. As a consequence, mRNA could define a biological signature of the MDE.
    


Intervention name(s): blood prelevement; psychometric data collection
Intervention type(s): Other; Other
Intervention description(s): blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
Other intervention name(s): psychometric data collection wil be done ( hamilton scale and clinical exam)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Major depression
Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare manualised physical exercise conducted in groups to
      manualised cognitive-behavioral therapy conducted in groups as treatment for panic disorder
      with or without agoraphobia.
    


Intervention name(s): Physical exercise; Cognitive-behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks; Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Panic disorder; Physical exercise; Cognitive-behavioral therapy; Manualized
New Measures for Tracheobronchial Anatomy
Condition: Thoracic CT-scan; Right Upper Lobe Anatomy; Right Sided Double Lumen Endobronchial Tube
Study type: Observational

Summary: 
      The right-sided double lumen endobronchial tube (R-DLT) is seldom. The principal cause of
      reticence for using the R-DLT are the difficult positioning of its lateral orifice in front
      of the origin of the right upper lobe (RUL) and the variability of the length of the right
      main stem bronchus (RMSB). Both the angle between the right upper lobe (RUL) bronchus origin
      and the RMSB and the length of the RMSB can be measured with high resolution CT-scan. These
      measures can be useful in clinical practice as they help to determine when a R-DLT should not
      be used or used with caution when facing a large variation of the angle of the RUL or a
      proximal implantation of a RUL bronchus .
    

Detailed description: 
      Since the introduction in the early '80s of the disposable double-lumen endobronchial tube
      (DLT), combined with the use of fiberoptic bronchoscopy (FOB) to confirm its positioning,
      some controversies have aroused; the main concern being the use of the right-sided
      double-lumen endobronchial tube (R-DLT). Alongside this persistent controversy, the anatomy
      of the right tracheo-bronchial tree seems to be the principal cause of reticence for using
      the R-DLT. Compared to the left main stem bronchus, this anatomy is relatively complex and
      can be divided in two issues: 1) the variable length of the right main-stem bronchus (RMSB)
      and consequently, the variable level of insertion of the right upper lobe (RUL) bronchus on
      the lateral part of the RMSB and 2) the alignment of the lateral orifice of the R-DLT in
      regard of the RUL bronchus origin. A as part of an extensive study of the tracheo-bronchial
      tree anatomy with high resolution CT-scan, we had the opportunity to measure differently the
      length of the main stem right bronchus and the angulation between the RUL bronchus origin and
      the lateral aspect of the right side main stem bronchus.
    

Intervention name(s): Measurement of the length of the right main stem bronchus; Measurement of the right upper lobe bronchus antero-posterior angulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Measurement of the length of the right main stem bronchus on CT-Scan; Measurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Evaluation of radiological consecutives thoracic CT-Scan reconstruction in a tertiary
        university hearth and lung institute. Patients had CT- scan for diagnosis or follow-up
        purposes