bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Condition: Nonallergic Irritant Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study seeks to investigate the effect of intranasal capsaicin treatment in
      patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry
      (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after
      treatment.
    

Detailed description: 
      A study by Lambert et. al. (2012) was able to objectively identify patients with NAIR by
      intranasal capsaicin challenge followed by assessment with optical rhinometry. Studies have
      shown that capsaicin therapy can improve symptoms of patients historically identified with
      NAIR via visual analog scale (VAS) rating of symptoms and symptom surveys; however, there has
      been no study evaluating the capsaicin therapy on patients objectively identified as NAIR
      patients.

      Multiple studies have demonstrated that intranasal capsaicin can improve nasal symptoms of
      NAIR patients. Regarding the usage of capsaicin, there is a product on the market: Sinus
      Buster which has capsaicin as the active ingredient. Numerous research papers have evaluated
      the efficacy and safety of Sinus Buster for the treatment of congestion in non-allergic
      rhinitis patients. However, the diagnosis of NAIR in these previous studies was based
      primarily on history. In addition, the primary outcome in these studies was symptomatic
      without any objective evaluation. The goal of this study will be two-fold: with patients
      objectively identified as NAIR patients via the optical rhinometer, we will re-evaluate the
      therapeutic action of intranasal capsaicin on the management of rhinitic symptoms. We expect
      that the patients will show significant improvement in their symptoms. We will then use
      optical rhinometry as a means to objectively monitor changes in symptoms in NAIR patients. We
      expect that post treatment, patients will no longer have the positive response previously
      seen on intranasal capsaicin challenge before receiving treatment. We hope to be able to
      establish optical rhinometry as an objective measurement of symptom improvement for NAIR
      symptoms, along with the subjective patient surveys.
    

Intervention name(s): Capsaicin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): intranasal capsaicin; 1% ethanol in 9% saline
Intervention MeSH terms: Ethanol; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nonallergic irritant rhinitis; nasal congestion; rhinorrhea
A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.
Condition: Chicken-pox Illness (Varicella Virus Disease); Chickenpox
MeSH terms: Virus Diseases; Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of
      GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.
    

Detailed description: 
      GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to
      minimize as much as possible the use of animal or human-derived products in the production of
      vaccines. The study is intended to provide information on the safety and immunogenicity of
      GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum
      albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a
      two-dose schedule, with the first and second doses given approximately 42 days apart in the
      second year of life.

      The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing
      approximately 100 subjects enrolled in each of the participating countries.

      Rationale for amendment 1: Sites in the UK can perform home visits. For subjects
      participating through home visits, the subject's parent(s) / Legally Acceptable
      Representative(s) [LAR(s)] will be requested to sign a Recruitment/Randomisation agreement to
      provide personal information and to agree to have their child randomised before providing
      written consent to participate in the study (to be provided at the 1st home visit).
    

Intervention name(s): Varilrix HSA-free; Varilrix™
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses will be administered, one at Day 0 and the other at Day 42; 2 doses will be administered, one at Day 0 and the other at Day 42
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; Varicella; Safety; Human serum albumin; Healthy children; 12 to 23 months
Sonoelastography of the Supraspinatus Tendon
Condition: Elasticity Imaging Techniques; Tendinopathy; Rotator Cuff Tendinitis; Musculoskeletal Disease
MeSH terms: Tendinopathy; Musculoskeletal Diseases; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This study aims a determine the responsiveness of sonoelastography in the
      tendinopathy-affected supraspinatus tendon.
    

Detailed description: 
      The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one
      orthopaedic shoulder clinic in Denmark.

      The intervention will consist of an exercise program including lowload exercises with
      elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with
      two control visits at a physiotherapy department at the hospitals.

      Tissue elasticity (measured by sonoelastography) is used as the primary outcome and is
      measured 12 weeks post baseline
    

Intervention name(s): Low Load Exercises
Intervention type(s): Other
Intervention description(s): All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).
The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).
Other intervention name(s): Scapular stabilization; Rotator Cuff; Exercise; Physiotherapy; Posture; Progressive exercise; Strength training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
Condition: Status Epilepticus; Seizures
MeSH terms: Seizures; Status Epilepticus
Study type: Interventional
Phase: Phase 3

Summary: 
      Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening
      and requires rapid termination. Early and effective treatment is essential to prevent the
      morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of
      care for control of SE when administered by intra-venous (IV) route. The investigators intend
      to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of
      administration of lorazepam. In resource poor settings, sometimes trained personnel or
      appropriate equipment for intra-venous cannulation is not available. Alternate routes of
      administration, if shown equivalent to conventional IV route, will be very useful in such
      settings or for out of hospital management of seizures in children.
    


Intervention name(s): Lorazepam; Lorazepam
Intervention type(s): Drug; Drug
Intervention description(s): Intra-nasal 0.1 mg/kg (maximum 4 mg) once; Intra-venous 0.1 mg/kg (maximum 4 mg) once
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: seizures; status epilepticus; lorazepam; intra-nasal
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Condition: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is carried out to see how Caucasian patients with lung cancer which has EGFR
      mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also
      be collected and analysed to confirm that treatment with gefitinib is safe and well
      tolerated.
    

Detailed description: 
      An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and
      Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who
      have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic
      Non-Small Cell Lung Cancer
    

Intervention name(s): Gefitinib
Intervention type(s): Drug
Intervention description(s): 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met
Other intervention name(s): IRESSA™
Intervention MeSH terms: Gefitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gefitinib; EGFR TKI; efficacy; Caucasian patients; EGFR mutation positive advanced NSCLC; safety
HRQoL in the Low MELD Pre-tx Population
Condition: Cirrhosis of the Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a
      single center for those who are pre-liver transplant candidates
    

Detailed description: 
      The liver organ allocation system was significantly revised in 2002, allowing a more
      objective prioritization of liver transplant candidates. The revised Model for End Stage
      Liver Disease (MELD) system is based primarily on laboratory test results. Candidates with
      MELD scores of less than 15 are considered to be low priority for cadaveric liver transplant
      and have limited treatment options. Yet patients with low MELD scores may suffer from an
      array of symptoms associated with liver disease such as fatigue, sleep disturbances, and
      depression - all of which erode health-related quality of life (HRQoL). No previous studies
      were found that examined HRQoL in low MELD transplant patients. A better understanding of the
      HRQoL of these patients will allow clinicians to better meet their needs. Therefore, the aims
      of the proposed pilot capstone project are to examine HRQoL and to identify demographic and
      clinical characteristics including liver-disease related symptoms, functional status,
      perceived social support, biological functioning and mental health associated with HRQoL in
      pre-liver transplant candidates with low MELD scores. The revised Wilson and Cleary Quality
      of Life Model will be used to guide the project. Fifty pre-transplant liver candidates with
      MELD scores < 15 will be enrolled in the descriptive, cross-sectional pilot study.
      Participants will complete a written questionnaire measuring perceived HRQoL and clinical
      characteristics. Descriptive and correlational statistics will be used to analyze the data.
      Findings from this project will identify trends in factors that contribute to a HRQoL of this
      population and provide the foundation for a larger future project.
    

Sampling method: Non-Probability Sample
Study population: 
        Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with
        MELD score </=15
      
Keywords: Cirrhosis of the liver; Pre-liver transplant Candidate; Depression; Poor social support; Liver disease symptoms; Health releated quality of life
Obturator Nerve Block With Femoral and Sciatic Block
Condition: Nerve Block; Pain Medication
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how many patients require the addition of the
      obturator nerve block in the recovery room after the total knee surgery. Also to study the
      efficacy of blocking the obturator nerve in controlling their knee pain.
    


Intervention name(s): Oburator Nerve block; Sham Injection in pectineus muscle.
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of selective pain block.; Five minutes after the sham block pain was assessed in these patients. If pain score was 5 or greater a true obturator nerve block was performed on these patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction
Condition: Acute Kidney Injury; Ventricular Dysfunction; Myocardium; Injury
MeSH terms: Acute Kidney Injury; Ventricular Dysfunction; Wounds and Injuries
Study type: Observational

Summary: 
      Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible
      reduction in the excretion of nitrogenous waste products, including urea, nitrogen and
      creatinine. Acute kidney injury definition emphasizes on the filtration function of the
      kidney, a measure that is unique and easily and routinely measured .

      Acute kidney injury is associated with significantly increased resource utilization and
      health care costs.

      Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of
      morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI)
      among patients undergoing non cardiac surgery is between 3% and 6%.
    


Intervention name(s): kidney assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Urea, BUN, and Creatinine BLOOD LEVELS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with normal kidney functions and free normal heart functions
Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA
Condition: Orthostatic Intolerance; Orthostatic Hypotension; Postoperative Complications
MeSH terms: Hypotension, Orthostatic; Orthostatic Intolerance; Hypotension; Postoperative Complications
Study type: Observational

Summary: 
      Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension
      in Patients Undergoing Unilateral Total Knee Arthroplasty
    

Detailed description: 
      Early postoperative mobilization is a cornerstone in the so-called fast track multimodal
      perioperative approach and is essential in preventing postoperative morbidity and reducing
      hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early
      postoperative mobilization. However, early postoperative mobilization can be delayed due to
      postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure > 20 mmHg
      and/or diastolic pressure > 10 mmHg or due to postoperative orthostatic intolerance (POI),
      characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization.

      Previous prospective studies of major surgery have reported that OI and OH are common problem
      during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies
      with a less-defined mobilization protocols have reported am OI prevalence in the range of
      12-60 % across surgical procedures.

      The aim of our study is to determine the incidence of OI during early postoperative
      mobilization in fast track unilateral total knee arthroplasty.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and
        standardized fast-track setting
      
Keywords: Orthostatic Intolerance; Orthostatic Hypotension; Knee arthroplasty
The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET
      to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders,
      including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive
      supranuclear palsy (PSP).
    

Detailed description: 
      40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP,
      will be enrolled. Each evaluable subject involved in this study must fulfill all the
      inclusion and exclusion criteria according the subject grouping, each subject will have 3
      visits in this study, as one screening visit, one imaging visit, and one safety evaluation
      visit.

      Safety measurement will be evaluated by medical history, vital signs, physical examinations,
    

Intervention name(s): 18F-FDG
Intervention type(s): Drug
Intervention description(s): During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging.
The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-FDG
Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin
Condition: Skin Aging
Study type: Interventional

Summary: 
      The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with
      indication for improvement of the appearance of wrinkles and general aspects of the skin.
    


Intervention name(s): MEDGEL ANTIAGE
Intervention type(s): Device
Intervention description(s): The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Utilization of Confocal Microscopy During Cardiac Surgery
Condition: Atrial Septal Defect
MeSH terms: Heart Septal Defects, Atrial
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators propose to translate confocal microscopy for use during open heart surgery.
      This tool will help discriminate between various types of tissues in the heart during
      surgery. One of the most feared complication after heart surgery is heart block. This
      flexible fiberoptic confocal microscope will help discriminate between the various types of
      tissues in the heart and thus help avoid injury to the conduction tissue during surgery.
    

Detailed description: 
      This is an interventional pilot study that proposes to evaluate the safety, logistical
      feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal
      microscopy during cardiac surgery to discriminate between cardiac tissue and conduction
      tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to
      the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System
      with Confocal Miniprobe) will be used to record images in several different locations of the
      heart. The image files will be provided to blinded raters who will attempt to identify
      whether they contain cardiac tissue or conduction tissue. All subjects will be monitored
      while they are inpatient after surgery for any adverse events.
    

Intervention name(s): Fluorescite; Cellvizio 100 Series System with Confocal Miniprobes
Intervention type(s): Drug; Device
Intervention description(s): Dilute fluorescite will be applied to cardiac tissue prior to imaging; Microscopy system will image cardiac tissue.
Other intervention name(s): fluorescein sodium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based
      program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with
      hypertension. I-START will be evaluated using objective outcome indices: systolic and
      diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and
      baroreflex sensitivity. The Heart and Stroke Foundation of Canada "Blood Pressure Action
      Plan(TM)" (BPAP) will be adminisered over a 4-month period, and evaluated in a 2
      (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design,
      blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada),
      and stratified for sex and age group (45-59, 60-74 years).
    


Intervention name(s): Web-based lifestyle counseling messages; Generic Information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 email messages based on readiness-to-change over a 4 month period; Waitlist control plus educational material on lifestyle behavior and hyptertension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
Condition: Retinal Degeneration; Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa; Retinal Degeneration
Study type: Interventional

Summary: 
      Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones
      (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
    


Intervention name(s): surgical implantation of subretinal device; surgical implantation of subretinal device
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical implantation of subretinal device; intra-individual implant OFF
Other intervention name(s): Retinal implant, subretinal implant; Retinal implant, subretinal implant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hereditary retinal; degeneration outer; retinal layers; photoreceptor rods cones; Retinitis pigmentosa; blindness; reading ability; retina implant; subretinal