bioihbjkbjnl/mcl2 huggingface dataset:
Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach
Condition: Injury of Cervical Spine
Study type: Interventional
Phase: Phase 4

Summary: 
      Intubation must be done with utmost care in cervical trauma patients. cervical spine motion
      must be minimized and intubation must be fast. The aim of this study was to compare the
      effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients
      undergoing elective surgery were enrolled in this trial. After standard monitorisation
      including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with
      propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were
      divided into two groups glidescope and fastrach. Rigid collar was placed then patients were
      intubated with one of these devices. Mask ventilations with or without collar were recorded.
      insertion times, intubation times of the devices were recorded. Peroperative hemodynamic
      parameters and postoperative minor complications were also recoded.
    

Detailed description: 
      inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring
      intubation exclusion criteria:

      - pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks
    

Intervention name(s): Glidescope; ILMA
Intervention type(s): Device; Device
Intervention description(s): videolaryngoscope; handling of the device till the optimal ventilation achieved
Other intervention name(s): FASTRACH
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cervical spine; intubating laryngeal mask airway; Glidescope videolaryngoscope; collar
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the efficacy and safety of aripiprazole orally
      administered over a period of 8 weeks in pediatric patients with Autistic Disorder
    


Intervention name(s): Placebo of Aripiprazole; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): administered orally once daily; Flexibly dose administered orally once daily
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autistic Disorder, children and adolescents; Aripiprazole; Double-blind; Randomized; children and adolescents
Neural Correlates of Successful Cognitive Aging
Condition: Aging
Study type: Interventional

Summary: 
      Normal aging is associated with gradual cognitive declines. These mild neurocognitive
      disturbances affect daily functioning, health status, and quality of life, and likely account
      for the roughly $2.9 billion lost by the elderly each year to fraud. The goal of this project
      is to compare two different 8-week training programs to promote successful neural and
      cognitive aging. Changes in neural structure and cognitive function will be assessed in a
      cohort of older adults, as well as the long-term stability of these changes over 24 months.
    

Detailed description: 
      Normal aging is associated with gradual cognitive declines. These mild neurocognitive
      disturbances affect daily functioning, health status, and quality of life, and likely account
      for the roughly $2.9 billion lost by the elderly each year to fraud. People are paying
      millions out of pocket for cognitive training programs like Lumosity to stave off these
      declines. These cognitive decreases have been strongly associated with normal age-dependent
      declines in neural structure and function, including cortical thickness decreases
      (approximately 0.02 mm per decade) across most of the cortical mantle, as well as decreases
      in the volume of the hippocampus (approximately 1-2% annually), white matter microstructure,
      and functional connectivity across the brain. Life expectancy is increasing and so
      identifying interventions that can be widely implemented and that can slow or reverse normal
      cognitive decline are clinical and public health priorities. Some training programs can
      improve cognitive performance in cognitively normal older adults, and gains are maintained
      post training. The investigators hypothesize that different techniques to boost cognition
      likely works through different neural mechanisms, and thus may provide different cognitive
      benefits. The goal of this project is to compare two different 8-week training programs to
      promote successful neural and cognitive aging. Changes in neural structure and cognitive
      function will be assessed in a cohort of older adults, as well as the long-term stability of
      these changes over 24 months.
    

Intervention name(s): Cognitive training program
Intervention type(s): Behavioral
Intervention description(s): 8 week cognitive training program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years)
      to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's
      H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).
    


Intervention name(s): H1N1 influenza A Vaccine (PANFLU.1); Trivalent Inactivated Influenza Vaccine (ANFLU)
Intervention type(s): Biological; Biological
Intervention description(s): H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm); Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.
Condition: Degenerative Arthritis; Knee Osteoarthritis
MeSH terms: Arthritis; Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of intra-articular injection
      of autologous adipose tissue derived mesenchymal stem cells compared after high tibial
      osteotomy to negative control in the osteoarthritis patients
    

Detailed description: 
      In this clinical trial, the investigational product is administered intra-articularly at 1
      week after high tibial osteotomy in a patient with degenerative arthritis of the medial side.

      The investigational product is autologous adipose-derived mesenchymal stem cells. As it does
      not use allogenic tissue and is incubated without additional genetic modification or
      mechanical and chemical modification through differentiation, it is classified as 'autologous
      cell therapy' and is completely free of immunologic rejection.

      It primarily aims to regenerate cartilage, to improve pain and joint function. The
      intra-articular injection of the investigational product is expected to stimulate the
      regeneration and growth of cartilage, and to innovatively improve pain and joint function
      with cartilage regeneration compared to high tibial osteotomy alone.
    

Intervention name(s): Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
Intervention type(s): Biological
Intervention description(s): biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution
Other intervention name(s): JOINTSTEM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipose tissue derived mesenchymal stem cell; osteoarthritis; degenerative arthritis; kyung hee university hospital; biostar; Rbio; Osteoarthritis, Knee; High tibial osteotomy; Joint Diseases
Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to study how people respond differently to capsaicin in
      different racial groups and the effect it has on your pain levels. Capsaicin is a natural
      product made from hot chili peppers that is useful for treating the itch symptoms of skin
      disease.
    

Detailed description: 
      To comprehensively evaluate the ethnic differences in response to topical capsaicin and its
      effect on thermal sensory thresholds.
    

Intervention name(s): Capsaicin; Placebo moisturizing cream
Intervention type(s): Drug; Drug
Intervention description(s): Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A; Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
Other intervention name(s): Topical capsaicin, 0.1%, Capzasin HP; Cetaphil
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers
Prognostic Factors of Importance on Who Develops Chronic Low Back Pain
Condition: Low Back Pain; Life Style; Illness Perception
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP
      are unclear. Based on questionnaires, different prognostic factors are being explored over
      time.
    

Detailed description: 
      Despite massive efforts of trying to find predictors and prevention for LBP, it remains to be
      clarified, why some individuals develop severely disabling low back pain while others never
      experience noteworthy back pain. There is no evidence that numbers of chronically affected
      individuals have diminished; rather, the incidence of LBP has increased continuously over the
      last 20 years which is also reflected in rising numbers of lumbar surgical treatments. The
      prevalence and burden increase with age and prevention of LBP in an aging population seems
      more urgent than ever. As LBP is undoubtedly a multifaceted disorder that tends to fluctuate
      throughout life, there is a need for longitudinal research, exploring the effect of both life
      style and psychosocial factors on the development of chronic low back pain.

      The aim of this study is to identify whether a history of low back pain during adolescence
      represents an increased risk of experiencing low back pain later in life.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will comprise all available subjects who have been part of the Elsinore
        cohort since 1965
      
Keywords: Cohort; Low Back Pain; Illness perception; Life Style
Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation
Condition: Sleep
Study type: Observational

Summary: 
      Mechanically ventilated (MV) patients in the Intensive Care Unit (ICU) are highly susceptible
      to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor
      sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold
      standard method for evaluating sleep quality and quantity).

      Patient-ventilator interaction is frequently poor leading to asynchronies of varied type and
      consequences. Moderate-to-severe asynchronies are associated with longer mechanical
      ventilation, weaning failure and mortality.

      The goal of this study is to look for an association between poor sleep quality and
      patient-ventilator asynchronies.

      This study is an observational, physiological study investigating sleep quality and quantity
      in MV patients by recording portable PSG (from 22:00 to 08:00) at night while continuously
      monitoring 24h/day of patient-ventilator interaction (BetterCare system).
    

Detailed description: 
      This clinical physiological study took place after MV patients have survived the initial
      critical admission phase (severe hypoxemia or shock) and before approaching weaning.

      After enrolment, a single night, sleep architecture was recorded using standard PSG
      (electroencephalography, right and left electrooculography, submental electromyography and
      electrocardiography) from 24:00 to 8:00. Pulse oximetry (SpO2) and heart rate will be
      recorded continuously during the PSG.

      Assessment of delirium was performed using the Confusion Assessment Method for the Intensive
      Care Unit (CAM-ICU) every 8 hours (at 08:00, 16:00 and 24:00) from day 0 until discharge.
    

Intervention name(s): Polysomnography
Intervention type(s): Device
Intervention description(s): Sleep architecture will be recorded using portable PSG (Prodigy) from 24:00 to 8:00. Pulse oximetry (SpO2) and heart rate were recorded continuously during the PSG. Simultaneously, the waveforms from the ventilator were recorded using Bettercare (R) system.
Other intervention name(s): Ventilator waveforms recording
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        After initial stabilization period, patients and relatives were invited to participate and
        to perform a sleep study.
      
Keywords: Mechanical Ventilation; Asynchronies; Sleep
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether desmoteplase is effective and safe in the
      treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of
      stroke symptoms.
    

Detailed description: 
      Acute stroke is a major cause of mortality and long-term disability in the developed world.
      The only currently approved thrombolytic intervention for acute ischemic stroke, which
      constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator;
      rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom
      onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of
      acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus
      Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology
      has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus.
      Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin
      specificity and non neurotoxicity.

      The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of
      patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of
      stroke symptoms.
    

Intervention name(s): Desmoteplase; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day; IV, single bolus over 1 - 2 minutes on 1st day
Intervention MeSH terms: Salivary plasminogen activator alpha 1, Desmodus rotundus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute ischemic stroke; Angiography; Desmoteplase; Thrombolytic
Corticosteroids for Children With Febrile Urinary Tract Infections
Condition: Acute Urinary Tract Infection; Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigators will determine whether corticosteroids given at the time of
      urinary tract infection help prevent permanent damage to the kidneys.
    

Detailed description: 
      Because host inflammatory response is the final and most important step in the formation of
      renal scars, the use of anti-inflammatory agents may be the best strategy to reduce renal
      scarring. In animal studies, the use of corticosteroids has been shown to be effective in
      preventing post-pyelonephritic scarring. We will conduct a randomized, double-blind,
      placebo-controlled trial to determine the efficacy of 3 days of daily adjuvant dexamethasone
      on the incidence of renal scarring 4 to 6 months after a first febrile urinary tract
      infection (UTI). We hypothesize that the proportion of children with UTI who develop renal
      scarring will be lower among children who are treated with both dexamethasone and antibiotics
      as compared with children treated with antibiotics alone.
    

Intervention name(s): Placebo; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily for 3 days; 0.15 mg/kg/dose twice daily for 3 days
Other intervention name(s): Inactive medicine; Prelone; Orapred; Corticosteroid
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Renal scarring; Dexamethasone; Child; Corticosteroids; Pediatric; Urinary tract infection; Escherichia Coli Urinary Tract Infection
Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      In this study, the investigators hypothesize that preemptive scalp block in neurosurgical
      patients may decrease incidence of PONV after craniotomy through decreasing intraoperative
      inhalational agents' concentration and decreasing intraoperative opioids requirements, with
      better intraoperative hemodynamics and lesser recovery time
    

Detailed description: 
      Patients will be recruited after admission to the hospital for surgery. Randomization will be
      performed using computer-generated random number tables in opaque sealed envelopes prepared
      by an anesthesiologist who will be not part of the study

      Patients will be randomly divided into two groups using a computer generated random number
      chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received
      scalp block using 20 mL normal saline and will be considered as control group.
    

Intervention name(s): Scalp block; Control Group
Intervention type(s): Procedure; Other
Intervention description(s): Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.; Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)
Condition: Colitis, Ulcerative; Recurrence
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine
      granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine
      granules for maintenance of remission in patients with ulcerative colitis
    


Intervention name(s): mesalamine granules; mesalamine granules; mesalamine granules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;; 1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;; 0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening
Other intervention name(s): Salofalk granules; Mesalazine; Salofalk granules; Mesalazine; Salofalk granules; Mesalazine
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: maintenance; 5-ASA; mesalamine; mesalazine; ulcerative colitis
Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to compare the safety, tolerability and antiviral effects of omega
      interferon administered alone to omega interferon administered with ribavirin in the
      treatment of subjects with chronic Hepatitis C virus (HCV) infection.
    

Detailed description: 
      Omega interferon is administered subcutaneously daily for up to 48 weeks.
    

Intervention name(s): omega interferon; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon omega 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Omega Interferon; Interferon; HCV genotype 1
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug
      measuring progression free survival.
    

Detailed description: 
      To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as
      dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer
      (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin
    

Intervention name(s): AMG 386; AMG 386; AMG 386 Placebo; Pemetrexed; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 15mg/kg; 30 mg/kg; AMG 386 Placebo; Pemetrexed 500 mg/m2; Carboplatin AUC 6
Intervention MeSH terms: Carboplatin; Pemetrexed; Trebananib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment