bioihbjkbjnl/mcl2 huggingface dataset:
Inflammation and Brain Function - Pilot Study
Condition: Sickness Behavior
MeSH terms: Inflammation; Illness Behavior
Study type: Interventional

Summary: 
      In this randomized double blind cross-over study 8 healthy persons were injected with 0.8
      ng/kg body weight lipopolysaccharide (LPS) /endotoxin and placebo at two different occasions.
      The aim was to investigate how pain sensitivity and health perception change in response to
      an acute immune activation.
    

Detailed description: 
      Eight healthy participants were included in this randomized and balanced double blind
      cross-over study. They were injected two times, once with the active component and once with
      placebo. Participants were recruited by advertising and screened through questionnaires and a
      health examination by a physician. They were asked not to engage in strenuous physical
      activities, sleep regular hours and refrain from alcohol the day before the experiment. If
      the participants felt ill, e.g. coming down with a cold, they were instructed to call and
      were rescheduled for a later appointment. C-reactive protein (CRP) was assessed to exclude
      participants having an ongoing infection on the experimental day. Pregnancy was also an
      exclusion criteria and a pregnancy test was administered for all female participants on
      arrival. Several pain sensitivity measures were performed baseline and at peak inflammatory
      response 1-2 hours after injection. Subjects filled out questionnaires at baseline, 90
      minutes and 4,5 hours after injection.

      The study and the procedures used in the study are described in detail here:
      https://openarchive.ki.se/xmlui/bitstream/handle/10616/44650/Thesis_Bianka_Karshikoff.pdf?seq
      uence=8&isAllowed=y

      The following papers have been published using data from this study:

      Olsson MJ, Lundstrom JN, Kimball BA, Gordon AR, Karshikoff B, Hosseini N, Sorjonen K, Olgart
      Hoglund C, Solares C, Soop A, Axelsson J & Lekander M. The Scent of Disease: Human Body Odor
      Contains an Early Chemosensory Cue of Sickness. Psychol Sci. 2014 Jan 22.

      Sundelin T, Karshikoff B, Axelsson E, Hoglund CO, Lekander M, Axelsson J. Sick man walking:
      Perception of health status from body motion. Brain Behav Immun. 2015;48:53-6.

      Karshikoff B, Lekander M, Soop A, Lindstedt F, Ingvar M Kosek E, Olgart Höglund C, & Axelsson
      J. Modality and sex differences in pain sensitivity during human endotoxemia. Brain,
      Behavior, and Immunity. 2015 May;46:35-43
    

Intervention name(s): Lipopolysaccharide; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Endotoxin at 0.8 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD); Saline administered intravenously
Other intervention name(s): Endotoxin; LPS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Sickness behavior; Cytokines; Psychoneuroimmunology
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study in patients with advanced solid tumours. Part A will investigate the
      pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment
      compared to patients with normal hepatic function; Part B will allow any patient with mild or
      moderate hepatic impairment or normal hepatic function, who completes Part A, continued
      access to AZD9291 after the PK phase and will provide additional safety data.
    


Intervention name(s): AZD9291 tablet dosing; Pharmacokinetic sampling - AZD9291; Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Part A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od.; Blood sampling to measure AZD9291 pharmacokinetic parameters.; Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550.
Intervention MeSH terms: Osimertinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: oncology, cancer, neoplasm, anticancer drug, pharmacokinetics, area under curve, AZD9291, solid tumour, mild hepatic impairment, moderate hepatic impairment
Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and the best dose of viral therapy in treating
      young patients with solid tumors that have come back or that have not responded to standard
      therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a
      virus called wild-type reovirus. The virus causes cells with this weakness to die, and may
      therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a
      drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving
      wild-type reovirus together with cyclophosphamide may kill more tumor cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of
      REOLYSIN (wild-type reovirus) administered as an intravenous infusion daily for 5 days, every
      28 days to children with relapsed or refractory solid tumors.

      II. To define and describe the toxicities of Reolysin in these patients. III. To define the
      toxicity and tolerability of combining Reolysin with oral cyclophosphamide in these patients.

      IV. To characterize the pharmacokinetics (time course of viral clearance) of Reolysin in
      children with refractory cancer.

      SECONDARY OBJECTIVES:

      I. To define the antitumor activity of Reolysin within the confines of a phase I study.

      II. To evaluate the development of neutralizing antibodies to Reolysin following intravenous
      administration of Reolysin alone and in combination with cyclophosphamide.

      III. To assess the biologic activity of Reolysin.

      OUTLINE: This is a dose-escalation study of wild-type reovirus.

      Patients receive wild-type reovirus intravenously (IV) over 60 minutes once daily (QD) on
      days 1-5. Some patients also receive cyclophosphamide orally (PO) on days 1-21. Treatment
      repeats every 28 days for up to 12 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up periodically for up to 1 year.
    

Intervention name(s): wild-type reovirus; cyclophosphamide; laboratory biomarker analysis; pharmacological study
Intervention type(s): Biological; Drug; Other; Other
Intervention description(s): Given IV; Given PO; Correlative studies; Correlative studies
Other intervention name(s): REOLYSIN; CPM; CTX; Cytoxan; Endoxan; Endoxana; pharmacological studies
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction
Condition: Recent Acute Myocardial Infarction
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Myocardial Infarction; Infarction; Ventricular Remodeling
Study type: Interventional

Summary: 
      Coronary artery disease is a common and serious disease, the leading cause of death
      worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in
      coronary artery disease where it could be involved in the pathophysiology and perhaps
      prognosis. The entanglement of the two pathologies is actually quite well known, in
      particular the consequences of one over the other just beginning to be studied. Understanding
      the pathophysiology through new imaging modalities should improve the management of patients
      to propose new approaches.

      "SAS-IDM" is an interventional and prospective study conducted at the University Hospital of
      Montpellier. Patients will be divided in three groups depending of the results of the
      polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate
      OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the
      group "severe OSA".
    


Intervention name(s): Without Obstructive Sleep Apnea (syndrome); Mild or moderate Obstructive Sleep Apnea (syndrome); Severe Obstructive Sleep Apnea (syndrome); CPAP
Intervention type(s): Other; Other; Other; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Recent acute myocardial infarction; Obstructive sleep apnée (syndrome); Ventricular remodeling; Continuous Positive Airway Pressure
The University of Michigan OWL (Online Wellness and Lifestyle) Study
Condition: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this trial is to pilot test our existing very low carbohydrate diet intervention,
      adapted for young adults.
    

Detailed description: 
      Obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes,
      cancer, sleep apnea, asthma, and depression. While advice from the Centers for Disease
      Control, American Heart Association, and the National Institutes of Health recommend a
      low-fat diet with a focus on whole grains and lean meats, research shows that a very
      low-carbohydrate diet may be more effective at reducing body mass index (BMI). Given the
      disconnect between recommendations and research, higher quality, long term, large trials are
      needed. In preparation for that research, the investigators plan to pilot test a very
      low-carbohydrate diet program, the OWL study (Online Wellness and Lifestyle Study), for 30
      young adults followed over 4 months.
    

Intervention name(s): diet and lifestyle program
Intervention type(s): Behavioral
Intervention description(s): See description of main arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nutrition; Diet, Ketogenic; Diet, Carbohydrate-Restricted
Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether AVONEX (Interferon Beta-1a), when compared
      to placebo, reduces the total dose of IVIg that is administered after Visit 5 and through
      Visit 9 (Week 32, End of Study).
    

Detailed description: 
      Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired peripheral
      neuropathy of unknown origin. The etiology is not well understood but is presumed to be
      immunological. Evidence for this comes from observed similarities to Guillain-Barre syndrome
      and from the favorable response with immunomodulatory treatments.

      CIDP is a peripheral nervous system demyelinating neuropathy that is sometimes a corollary
      disorder to the central nervous system demyelination of multiple sclerosis (MS. The precise
      mechanisms underlying the pathogenesis are uncertain, but a number of those mechanisms
      support a potential role for immunomodulatory treatments such as interferon beta (e.g.,
      Biogen Idec Inc.'s AVONEX).

      The rationale for the use of AVONEX in CIDP derives from observations on the pathogenesis of
      the condition and its similarities to MS, the mechanism of action of AVONEX, clinical trials
      that have been performed in CIDP that support a role for IFN-beta, and the unmet need that
      currently exists because of availability and safety issues with existing therapies.

      This Phase 2b study is a dose-ranging study designed to provide scientific evidence regarding
      the safety and efficacy of AVONEX in CIDP. In addition, the study aims to demonstrate the
      responsiveness and clinical relevance of changes in the MRC sum score and ODSS in CIDP
      patients.
    

Intervention name(s): Interferon Beta-1a
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Inflammatory Demyelinating Polyradiculoneuropathy; CIDP; IVIg; AVONEX
Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the safety and efficacy of the Medtronic
      hybrid closed-loop (HCL) system utilizing the proportional-integral-derivative algorithm with
      insulin feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control
      operating during the day and night.
    

Detailed description: 
      Study participants will be asked to use the CGM and the study insulin pump provided for
      approximately 4 to 5 days prior to initiation of the HCL PID-IFB system in a hotel setting
      for another 4 to 5 days. All participants with diabetes and the parent/ guardian of
      participants < 18 years of age will be asked to stay overnight in a hotel while the HCL
      PID-IFB system is on and to remain close to Stanford University during the day. For
      participants > 18 years of age, designated remote monitors will be asked to receive alerts
      for low/ high glucose levels.

      Enrolled participants will be asked to complete evaluations to describe their user
      experience/ evaluation of the system.Each participant had a companion (parent/ legal guardian
      of participants < 18 years of age, or the designate remote monitor for participants > 18
      years of age) who will consent to monitor the participant and complete an evaluation, but
      will not be considered enrolled in the study.
    

Intervention name(s): Medtronic Hybrid Closed-loop System - Android Platform; Medtronic Hybrid Closed-loop Integrated System
Intervention type(s): Device; Device
Intervention description(s): A continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm using an Android controller.; A fully integrated continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrophysiological Recording for Patients Receiving Deep Brain Stimulation Electrode for Treatment-resistant Obsessive-compulsive Disorder
Condition: Obsessive-compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      The purpose of this project is to study live recordings from neuronal population of the human
      nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes for the
      treatment-resistant obsessive compulsive disorder (OCD). The central aim of this project is
      to determine if intra-operative electrophysiological data can confirm that the electrode is
      located in the nucleus accumbens. This confirmation could allow the placement of the DBS
      electrodes with a higher degree of precision. An additional aim of this project will be to
      study the activity of the neuronal population of the nucleus accumbens while a subject is
      presented with a task involving an unexpected reward.

      The investigators central hypothesis is that unexpected reward will be associated with
      increase firing and synchrony in the neuronal population. This will translate into recordable
      increase activity in the investigators region of interest and therefore confirm the proper
      placement of the electrode.

      This study enrolled 2 subjects, with 1 subject completing the protocol showing the
      feasibility of the experiment. There were electrophysiological variations with the task
      presented but no conclusion could be drawn given the small sample size.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects in this study are suffering from treatment-resistant OCD
      
Keywords: treatment resistant obsessive-compulsive disorder
The Sunrise SpO2 and Pulse Rate Accuracy Validation Study
Condition: Validation Study
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor
      2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by
      comparison to SaO2 values determined from arterial blood sample specimen analyzed by a
      CO-oximeter. Testing is conducted under normal office environment conditions. It is expected
      that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the
      required specification of ARMS of 3.5% or less allowed for reflectance technology in
      non-motion conditions for the range of 70-100% SaO2.

      A secondary goal is to evaluate the pulse rate performance simultaneously collected over the
      SpO2 range covered.
    

Detailed description: 
      Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable
      plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation
      stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial
      blood samples will be collected for each plateau, while keeping at least 20 seconds in
      between each sample and at least 30 seconds once the plateau has been reached. The blood will
      be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen
      saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected
      electronically simultaneously to blood drawn from the indwelling catheter. Data will be
      collected under non-motion conditions. The pulse rate will be simultaneously collected over
      the SpO2 range covered. The reference method for the computation of pulse rate accuracy will
      be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data
      analysis results will provide documentation showing SpO2 and pulse rate accuracy performance
      of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference
      CO-Oximetry and to ECG heart rate, respectively.
    

Intervention name(s): Pulse oximeter validation population
Intervention type(s): Device
Intervention description(s): Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      60 patients involved were divided into two matched groups; Group A: 30 patients were treated
      with conventional fenestration laminectomy and discectomy and Group B: 30 patients were
      treated with microdiscectomy. The age of the patients involved in this study ranged from 19
      years old to 46 years old
    

Detailed description: 
      60 patients involved were divided into two matched groups; Group A: 30 patients were treated
      with conventional fenestration laminectomy and discectomy and Group B: 30 patients were
      treated with microdiscectomy. The age of the patients involved in this study ranged from 19
      years old to 46 years old. All the patient was suffering from symptomatic lumbar disc
      herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients
      to prove clinically, the symptomatic lumbar disc herniation which was present in all
      patients.
    

Intervention name(s): Microdiscectomy
Intervention type(s): Procedure
Other intervention name(s): Open discectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbar disc herniation , Open Discectomy, Micrdiscectomy
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Condition: Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport
      used in the treatment of upper limb spasticity (altered skeletal muscle performance) in
      children with cerebral palsy (CP).
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Intervention description(s): Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment