bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the
      efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the
      progression of IPF in these participants.
    

Detailed description: 
      The study has been amended in February 2016 to further allow for the enrollment of a subgroup
      of participants (N=60) who will be allowed to receive treatment with approved IPF therapy
      with pirfenidone or with nintedanib as concomitant therapy.

      These additional participants will be stratified by background therapy, randomized to
      pamrevlumab or placebo, and followed up for 24 weeks. The main objective of the study remains
      safety. Pharmacokinetic (PK) samples to assess drug concentrations will also be collected.

      This sub-study portion only applies to a select United States centers.

      Enrollment for the main study was completed on 29 June 2016. Enrollment for the sub-study was
      completed on 16 December 2016.
    

Intervention name(s): Pamrevlumab; Placebo; Sub-Study: Pirfenidone; Sub-Study: Nintedanib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Solution for infusion; Solution for infusion; Pirfenidone concomitant therapy will not be provided by the Sponsor.; Nintedanib concomitant therapy will not be provided by the Sponsor.
Other intervention name(s): Fully human recombinant immunoglobulin G (IgG), kappa monoclonal anti-body.; FG-3019; Esbeiet; Ofev
Intervention MeSH terms: Pirfenidone; Nintedanib; Immunoglobulins; Antibodies; Immunoglobulin G; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idiopathic Pulmonary Fibrosis; IPF; Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Lung Fibrosis
A Comparison of Different Ventilation Strategies in Infants Using the PLMA™
Condition: Ventilation
Study type: Interventional

Summary: 
      The purpose of this research study is to compare difference between breathing by oneself or
      with the partial help from an anesthesia machine in infants under general anesthesia.

      Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated
      (improved breathing) with the help of the breathing machine versus breathing on their own.
    

Detailed description: 
      The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and
      allows the patient to breathe in and out adequately under general anesthesia (GA). The
      ProSeal™ laryngeal mask airway (PLMA™) is a specialized type of LMA with a design that
      permits the delivery of higher pressures to help the patient breathe in and out (ventilate)
      and also contains a channel to suction the stomach.

      Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation
      consists of the infants breathing on their own through a PLMA™. Pressure support ventilation
      allows the patient to breathe on their own with additional help from the anesthesia machine.
      Pressure control ventilation allows the patient to breathe with the help of an anesthesia
      machine.

      An infant undergoing surgery requires a deep level of general anesthesia which negatively
      affects their ability to ventilate. Thus, infants may not breathe in oxygen and carbon
      dioxide out adequately at this level of anesthesia and it may be beneficial to provide some
      level of support to enhance carbon dioxide exchange and to avoid hypoventilation.

      This study will attempt to determine whether pressure support ventilation improves
      ventilation in infants undergoing outpatient surgery.
    

Intervention name(s): Spontaneous ventilation; Pressure support ventilation; Pressure control ventilation
Intervention type(s): Other; Device; Device
Intervention description(s): The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.; The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.; The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Proseal™ LMA; infants; ventilation; general anesthesia; outpatient surgery
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield
      Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple
      sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP
      and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS)
      relapse, slowing disability progression, and reducing new MS lesion formation in this study
      population.
    

Detailed description: 
      This study will provide participants who complete Study 205MS202 (NCT00870740) with the
      option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy
      and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in
      participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100
      participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a
      selected subset of sites which will run concurrently during the main study, and will evaluate
      the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by
      autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible
      participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune
      response to vaccination,
    

Intervention name(s): BIIB019 (Daclizumab); trivalent seasonal influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Administered as specified in the treatment arm.; All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
Other intervention name(s): Daclizumab High Yield Process; DAC HYP
Intervention MeSH terms: Daclizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS; Multiple Sclerosis
The Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride
Condition: Hyperglycaemia (Diabetic); Healthy Volunteers
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of
      globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated
      the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin
      hydrochloride (SY-004).
    

Detailed description: 
      Glucokinase is a characteristic hexokinase isoenzyme in hepatocytes that catalyzes the first
      step in glucose metabolism. In addition to its role in glucose metabolism, glucokinase is
      expressed in pancreatic islet beta cells where it acts as a "glucose sensor" for insulin
      release. Activation of glucokinase increases the glucose sensitivity of insulin secretion,
      effectively lowering the glucose threshold for insulin secretion. Because of its potential to
      enhance insulin secretion and affect hepatic glucose metabolism, is being investigated for
      use as a treatment for hyperglycaemia,glubalagliatin( the active ingredient in SY-004
      capsule) is being investigated for use as a treatment for T2DM patients. This is a phase 1
      randomized,double-blind,placebo-controlled study with single oral dose of SY-004 administered
      to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and
      pharmacodynamics of SY-004.
    

Intervention name(s): globalagliatin hydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally administration, single dose; orally administration, single dose
Other intervention name(s): SY-004 capsule
Intervention MeSH terms: Globalagliatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: T2DM; Diabetes; GKA
Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent
      a demanding challenge for clinicians. It has classically been claimed that using higher
      dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation
      and increase the chances of success. However, scientific evidence supporting this view is
      scanty and costs are inevitably much higher. In this study, the investigators hypothesized
      that similar chances of pregnancy may be achieved with a mild stimulation using exclusively
      Clomiphene citrate (CC).
    


Intervention name(s): Clomifene Citrate; GnRH analog and recombinant human FSH
Intervention type(s): Drug; Drug
Intervention description(s): 3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle; daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.
Other intervention name(s): clomid; decapeptyl; Gonal-F
Intervention MeSH terms: Triptorelin Pamoate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian reserve; ovarian stimulation; clomifene citrate; high doses Follicle Stimulating Hormone (FSH)
Predicted Level of General Anaesthesia in Hip Fracture Surgery
Condition: Hip Fracture Surgery
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if prediction of general anaesthesia level by the
      Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip
      fracture surgery.
    


Intervention name(s): General anesthesia managed by the Smartpilot® View; General anesthesia managed without the Smartpilot® View
Intervention type(s): Device; Device
Intervention description(s): General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.; General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Smartpilot View; Hip fracture surgery; Depth of anaesthesia; Intraoperative hypotension; Quality of anaesthesia
Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
Condition: Depression; Treatment
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This is a sham-controlled, randomized trial for patients with MDD to identify the effects of
      TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
    

Detailed description: 
      This is a sham-controlled, randomized trial for patients with MDD to identify the effects of
      TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG),
      peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and
      neurotransmissions) in MDD patients.
    

Intervention name(s): TBS; Sham
Intervention type(s): Device; Device
Intervention description(s): Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS); The sham-TBS coil produced a similar sound without a magnetic pulse.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; transcranial magnetic stimulation; theta-burst stimulation
Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy
Condition: Ebola; HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Ebola and HIV are found predominately in the same regions of the world and countries in
      sub-Saharan Africa are most affected by both diseases. For Ebola, no approved therapies
      exist. However, new investigational drugs are being evaluated to understand if they are
      effective against the Ebola virus. Remdesivir is an anti-Ebola investigational drug for the
      treatment of Ebola. Little is known about how the blood levels of remdesivir relate to how
      effective it is in patients with HIV taking antiretroviral therapy. This study will explore
      how commonly utilized ART (tenofovir/lamivudine and atazanavir/ritonavir) affect the drug
      levels of remdesivir.
    

Detailed description: 
      The study is designed as an open-label, randomized, fixed sequence, single intravenous dosing
      study to assess the effects of antiretrovirals on remdesivir pharmacokinetics.

      The selection of healthy volunteers, as opposed to patients with HIV, avoids the greatest
      possible extent confounding factors, such as enzyme or transporter activity alteration in
      inflammatory states, concomitant medications potentially impacting drug disposition and other
      factors which are commonly present in a population of patients and cannot be easily
      eliminated.

      Objectives:

      Primary objective

        1. To assess the safety and tolerability of single intravenous doses of remdesivir in adult
           healthy volunteers

        2. To evaluate the intracellular pharmacokinetics of single dose intravenous remdesivir
           with or without co-administration of oral fixed-dose combination tenofovir/lamivudine
           with patients serving as their own controls

      Secondary objectives

        1. To evaluate the difference in plasma and intracellular pharmacokinetics of intravenous
           remdesivir among healthy volunteers receiving tenofovir/lamivudine versus healthy
           volunteers receiving tenofovir/lamivudine plus atazanavir/ritonavir tablets.

        2. To generate a population pharmacokinetic model to describe inter-individual variability
           in intracellular pharmacokinetics of remdesivir

      Exploratory objectives

      1. To describe polymorphic variants of relevant kinases that activate TFV and explore
      possible consequences on remdesivir PK.
    

Intervention name(s): Remdesivir
Intervention type(s): Drug
Intervention description(s): Remdesivir (GS-5734) is a nucleoside analogue with in vitro activity against filoviruses EBOV, SUDV, BDBV and MARV, in addition to arenaviruses and coronaviruses
Other intervention name(s): GS-5734
Intervention MeSH terms: Remdesivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ebola; HIV; Pharmacokinetics; Remdesivir; Drug Interactions
Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients
Condition: House Dust Mite Allergy
MeSH terms: Dust Mite Allergy
Study type: Interventional
Phase: Phase 2

Summary: 
      hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The
      purpose of this study is to assess the safety and clinical tolerability of subcutaneous
      immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic
      rhinoconjunctivitis compared to placebo.
    


Intervention name(s): Placebo solution; hdmASIT+TM
Intervention type(s): Biological; Biological
Intervention description(s): 15 injections over 7 weeks; 15 injections over 7 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of High Flow Nasal During Exercise in COPD Patients
Condition: COPD Exacerbation
Study type: Interventional

Summary: 
      Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of
      chronic obstructive pulmonary disease (COPD). However, its implementation is challenging
      particularly as regard exercise training. High flow ventilation in reducing work of breathing
      and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute
      effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients
    


Intervention name(s): High Flow nasal cannula
Intervention type(s): Device
Intervention description(s): High intensity Constant Work-Rate exercise test with High Flow Nasal Cannula in COPD patients involved in a Pulmonary Rehabilitation Program after an exacerbation (< 7 days after hospital discharge). High Flow nasal will be administered through nasal cannula using the Airvo2 (Fisher&Paykel)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Exercise; High Flow Nasal; Muscle Oxygenation; Pulmonary Rehabilitation
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
Condition: Scoliosis; Spinal Cord Injury
MeSH terms: Scoliosis; Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17
      spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs.
      The LTS improved significantly the functional scoliotic spinal alignment in the frontal and
      sagittal planes regardless of the severity of scoliosis.
    

Detailed description: 
      SCI patients often develop progressive scoliosis due to loss of muscular support to maintain
      good sitting posture. Special seating with LTS has been widely used in clinical practice to
      improve their sitting postures. However, little is known as to how this can affect the
      scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk
      supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI)
      individuals with scoliosis.

      Ten male and seven female SCI subjects with scoliosis sat on an experimental chair with and
      without LTS while radiographs of the spine in the anteroposterior and lateral directions were
      taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital
      radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete
      image of the spine was obtained from separate x-ray images of the upper and lower trunk due
      to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices
      based on the anteroposterior radiographic images and the angles of the thoracic and lumber
      spine based on lateral were calculated.
    

Intervention name(s): Lateral trunk support of wheelchair seating
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scoliosis; Spinal Cord Injury; Lateral Trunk Support; Radiography
A Study in the Treatment of Osteoarthritis Knee Pain
Condition: Osteoarthritis Knee Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an
      effect on pain levels.
    


Intervention name(s): Placebo; LY545694 49 mg; LY545694 105 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LY545694 placebo BID po for 5 weeks; LY545694 49 mg BID po for 5 weeks.; LY545694 105 mg BID po for 5 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Tetrahydrocannabinol on Ocular Hemodynamics in Healthy Subjects
Condition: Retinal Blood Flow
Study type: Interventional

Summary: 
      Glaucoma is among the leading causes for irreversible blindness worldwide. While lowering
      intraocular pressure (IOP) remains the mainstay of therapy, there are still some patients who
      progress despite wellcontrolled IOP. There is evidence from several studies that ocular blood
      flow and its regulation is impaired in patients with glaucoma. Tetrahydrocannabinol (THC) has
      been used in the treatment for glaucoma in some countries for several years due to its IOP
      lowering effect. In addition, there is also evidence that THC features neuroprotective
      effects and improves ocular hemodynamics. Dronabinol is a synthetic THC that is legally
      available in several European countries. It has the advantage that exact dosing of THC is
      possible in contrast to previously applied administration forms such as smoking. Due to its
      legal status in the past, data about the effect of THC on ocular blood flow and its
      regulation are sparse. This holds true for basic research in healthy subjects as well as in
      patients with glaucoma.The aim of the present study therefore is to investigate whether
      single administration of THC alters optic nerve head (ONH) blood flow in healthy subjects. In
      addition, other parameters for ocular blood flow will be measured, in particular retinal
      blood flow, retinal oxygen saturation and retinal neurovascular coupling. The study will be
      conducted in a randomized, double-masked, placebocontrolled, two-way cross-over design.
      Subjects will receive 5mg dronabinol on one study day. This dose is the recommended starting
      dose for some indications in clinical practice. Other studies investigating retinal
      hemodynamics or IOP after administration of THC also have used similar or slightly higher
      doses.
    


Intervention name(s): Dronabinol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Capsules containing 5 mg Dronabinol; capsules identical in appearance to dronabinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic