bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 4)
Condition: Impression Cytology
Study type: Observational

Summary: 
      This is a single-visit, non-randomized, bilateral, cross-sectional study. In a pre-screening
      assessment, potential subjects will be invited to complete a web-based questionnaire that is
      validated to determine symptomatic vs asymptomatic contact lens wearers. Results of this
      questionnaire will be used to determine whether subjects are eligible to proceed to Visit 1.
      During Visit 1, cell samples will be collected from the front surface of the subject's eyes.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible subjects aged 18 years and above with normal healthy eyes will be recruited for
        this work.
      
Biospecimen description: 
      ocular surface cells
Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a
      more immunogenic and effective response compared with conventional influenza vaccines in
      elderly and adults.

      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6
      to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted
      trivalent influenza vaccine (TIV).
    


Intervention name(s): Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29); Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).
Intervention type(s): Biological; Biological
Intervention description(s): A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).; A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Emotional Association Bias Modification Training in Individuals With IGD
Condition: Internet Gaming Disorder
MeSH terms: Internet Addiction Disorder
Study type: Interventional

Summary: 
      This project aims to investigate (1) the efficacy of emotional association bias modification
      (EABM) training on internet gaming disorder (IGD); (2) the underlying neural mechanisms of
      such efficacy
    

Detailed description: 
      As with the efficacy, the experiment aims to test whether EABM training will reduce positive
      emotional association bias towards gaming, compulsive choice of gaming pictures, cue-induced
      craving for gaming, the severity of gaming behaviors in individuals with IGD.

      As with the underlying neural mechanisms, the experiment aims to test whether EABM training
      will alter the activation of reward circuits in response to gaming pictures, the activation
      of executive control network (mainly refering to the prefrontal cortex) regarding regulation
      ability for craving and response inhibition ability.
    

Intervention name(s): EABM training; sham training
Intervention type(s): Procedure; Procedure
Intervention description(s): The training aims at associating gaming pictures with negative words and pictures of healthy activities with positive words. Gaming pictures are always presented with a pair of negative words. Pictures of healthy activities are always presented with a pair of positive words. Each picture is presented with a fixed pair of words. Participants will be instructed to select one word to get the most monetary reward. Specifically, in response to each gaming picture, selecting one word will have a 70% chance to get a monetary reward and the other word will have a 30% chance to get a monetary reward. A similar rationale applies to the pictures of healthy activities. The reward setting will help consolidate target associations.
Each training session includes 300 times/trials of each type of association, presented in pseudorandom way. The whole training includes 6 training sessions. Participants will receive one training session every days.; In the control group, neutral words instead of emotional words are used. All other settings are the same with those in the intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, between-subject design, including an intervention group and a control group
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC
Condition: Smokers
Study type: Observational

Summary: 
      We wish to discover if there is a difference in the presentation, response to treatment and
      survival of never- smokers with lung cancer as compared to ever- smokers.

      We also plan to obtain tumor specimens to compare the genetic and proteomic expression
      between smokers and never smokers
    

Detailed description: 
      Lung cancer is the most lethal of all malignant tumors affecting humans. In the United States
      alone an estimated 160,440 patients died of lung cancer 2004[1]. It is well known that
      tobacco smoking is a major risk factor and accounts for the majority of all lung cancer
      cases. But there is a sub group of patients with lung cancer who have never actively smoked
      tobacco. This group exhibits certain unique characteristics which separates them from lung
      cancer in smokers. It has been shown that never- smokers with adenocarcinoma have better
      outcomes in terms of overall survival as well as lung cancer specific survival when compared
      to current smokers with adenocarcinoma of the lung[2]. Also patients who are current smokers
      at diagnosis have decreased survival when compared to people who quit smoking[3]. The
      improved survival in never smokers could be due to several reasons. Such as increased
      incidence of co-morbid factors in smokers as result of exposure to tobacco smoke, differences
      in metabolism of chemotherapeutic agents or a reflection of differences in the underlying
      molecular biology of the tumor.

      It has been demonstrated that chromosomal abnormalities are common in lung cancer patients
      with a smoking history when compared to never- smokers[4]. Gene mutations such as p53
      mutations are more frequent in never- smokers than in previous smokers[5]. In addition
      mutations that are specific only to lung cancer in never smokers have been discovered,
      demonstrating the possibility of a separate or overlapping carcinogenesis pathway for lung
      cancer in never smokers vs. smokers [6].
    

Intervention name(s): smoking
Intervention type(s): Behavioral
Time perspective: Retrospective
Study population: 
        Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31
        2002.
      
Keywords: presentation; outcome; response; never- smokers
Headache in Undergraduate Students and Biopsychosocial Status
Condition: Headache Disorders, Primary; Prevalence; Migraine; Student; Psychosocial Problem
MeSH terms: Headache Disorders; Headache Disorders, Primary; Headache
Study type: Observational [Patient Registry]

Summary: 
      The primary aim of this study was to determine the prevalence of headache in undergraduate
      students. The frequency, duration, localizations and symptoms of headache will be determined
      with the information obtained as a result of the forms filled in by the participants.

      The second aim of this study is to examine the effects of headache on physical, social and
      psychological status in undergraduate student(participants) from a biopsychosocial
      perspective.
    

Detailed description: 
      Headache is one of the most common nervous system disorders in society. 95 percent of the
      population has experienced a headache at least once in their life. The one-year prevalence is
      almost 1 in 2 people.

      The prevalence of headache increases with age. While there is no difference between the sexes
      in terms of incidence before adolescence, it is more common in the female population in the
      post-adolescent period.

      The ICF model, developed by the World Health Organization, adopts the biopsychosocial
      approach to provide a holistic perspective. According to this approach, it is aimed to
      develop interventions by evaluating and examining the biological and psychosocial effects of
      illness and disability, functionality, needs and demands of the individual.

      Headache is also a disease that should be addressed from a biopsychosocial perspective.

      Therefore, the primary aim of this study was to determine the prevalence of headache in
      undergraduate students. The frequency, duration, localizations and symptoms of headache will
      be determined with the information obtained as a result of the forms filled in by the
      participants.

      The second aim of this study is to examine the effects of headache on physical, social and
      psychological status in undergraduate student(participants) from a biopsychosocial
      perspective.
    

Intervention name(s): personal information form; headache-specific questionnaires; Questionnaires for assessing biopsychosocial status
Intervention type(s): Other; Other; Other
Intervention description(s): undergraduate student(participants) will be asked; age, weight, height, smoking and alcohol use, and headache.; ıd migraine test, numeric rate scale, hit-6 headache impact test, headache information form; hospital anxiety depression, Discomfort Intolerance Test, pittsburgh sleep quality index, fatigue severity scale, self compassion scale, Body Awareness Questionarre, cervical range of motion, İnternational Physical Activity Questionnaire, 12-Item Short-Form Health Survey
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        undergraduate students
      
Keywords: headache; biopsychosocial; migraine; psychosocial
Improving Physical Activity and Mobility Via Live Online Exercise Sessions for Older Adults
Condition: Aging
Study type: Interventional

Summary: 
      The COVID-19 pandemic has undoubtedly resulted in an increased level of personal anxiety,
      reduced access to support services, and as a secondary complication, increased physical
      inactivity. Older people appear to be at higher risk of several secondary complications and
      long-term negative health outcomes. These complications include declines in physical health
      and mobility, social isolation, and worsening mental health. There is strong evidence in
      older persons that supports the role of exercise and physical activity in: the alleviation of
      strength and mobility declines, reducing anxiety and depression, and alleviating cognitive
      declines. Exercise-based intervention trials have also been shown to reduce social isolation
      and loneliness. This study will compare an online exercise program delivered via Zoom and a
      waitlist control group in healthy older persons.
    

Detailed description: 
      This study will examine the impacts of an online exercise program in healthy older persons
      compared to a waitlist control group. Briefly, participants (healthy persons, age 65-80 years
      old) will participate in an online group exercise program (designed to meet Canada's Physical
      Activity Guidelines) via Zoom delivered by Registered Kinesiologists and Physiotherapists for
      a total of 8 weeks. Participants will be randomly assigned to the exercise group or the
      waitlist control group. Participants' will undergo assessments of physical activity,
      life-space mobility, nutrition, loneliness, depression, and anxiety at baseline, end of
      study, and 8-weeks following the end of the intervention.
    

Intervention name(s): Online exercise
Intervention type(s): Behavioral
Intervention description(s): Participants will participate in an online exercise program on Zoom delivered by Registered Kinesiologists and Physiotherapists three times a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a randomized parallel-group trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exercise; Online
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess if Abatacept given for six months will prevent
      rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison
      to placebo. High risk patients are defined as those having a positive laboratory test for
      anti-cyclic citrullinated peptide (anti-CCP2).
    


Intervention name(s): Abatacept; placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution, intravenous injection, monthly, 169 days
weight based:
<60 kg = 500 mg
60 to 100 kg = 750 mg
>100 kg = 1 g; solution, intravenous injection, 0 mg, monthly, 169 days
Other intervention name(s): Orencia
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study
Condition: Schizophrenia; Bipolar Episodes
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The aim of the study is to describe patient characteristics (demographic and clinical) and
      the patterns of use of Quetiapine XR in patients receiving the drug for the first time in
      real-life practice regardless the final diagnosis.
    

Detailed description: 
      Description of the use of Quetiapine Extended Release (XR) in real-life practice in France
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hospital, clinic
      
Keywords: Schizophrenia; Bipolar episodes; France; Xeroquel; Real-life
Influence of Wrap Fixation Technique on the Results of Fundoplication
Condition: Gastro Oesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Patients who underwent anti-reflux surgery were divided into two groups. In the I group
      Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach
      using two non-absorbable stitches on each side. Control group included patients who underwent
      classic Nissen fundoplication without wrap fixation. All patients were assessed before and
      after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h
      impedance-pH monitoring and barium-swallow.
    


Intervention name(s): Nissen Fundoplication with wrap fixation; Nissen Fundoplication without wrap fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side.; Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastro Oesophageal Reflux Disease, Nissen Fundoplication
Autologous Fat Graft Alleviate Scar Pain
Condition: Scar
Study type: Observational

Summary: 
      Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic
      pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar
      quality, but scantly study has explored its effects on pain. The aim of the study was to
      survey its effect on pain.
    

Detailed description: 
      Methods: From February 2008 and June 2013, a total of 36 patients received autologous fat
      grafting in scar areas. Patients who Douleur Neuropathique 4 Questions (scores >4/10) were
      enrolled this study. The Visual Analogue Scale (VAS), and Neuropathic Pain Symptom Inventory
      (NPSI) were used to evaluate pain preoperatively and postoperatively after 1 week, 4 weeks,
      and 24 weeks. The mechanism of trauma, duration of allodynia, fat graft volume, and total
      follow-up time were recorded.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients received autologous fat grafting in scar areas
Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Specific aims:

        1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of
           treatment with topiramate or placebo or topiramate plus nicotine patch for smoking
           cessation.

        2. To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus
           combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking
           satisfaction, and adverse effects during smoking cessation.

        3. To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus
           combination of topiramate plus nicotine patch for smoking cessation.
    

Detailed description: 
      This is a 10-week, randomized, double-blind, single-site study of treatment with either:
      topiramate, or placebo, or topiramate plus nicotine patch. Approximately, 90 subjects ages
      18-65 who smoke at least 10 cigarettes per day will be screened for study participation, with
      the intention of 60 subjects being eligible for randomized treatment (20 per arm).
    

Intervention name(s): Placebo (sugar pill); Topiramate; Nicotine patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients receive; 25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper; On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Other intervention name(s): sugar pill; topimax; nicoderm
Intervention MeSH terms: Topiramate; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine patch; smoking; topiramate
A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose of your child's participation in this study is to determine whether
      LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD);
      and assess the safety of LY2216684 and any side effects that might be associated with it.
    


Intervention name(s): LY2216684; Methylphenidate; Placebo (tablet); Placebo (capsule)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Taken in tablet form QD po.; Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, QD po as a capsule for the 8-week double-blind treatment phase.; Placebo given as a tablet for LY2216684 blind QD po for the 8-week double-blind treatment phase, followed by 2 weeks in the taper phase.; Placebo given as a capsule for methylphenidate blind QD po for the 8-week double-blind treatment phase followed by 2 weeks in the taper phase.
Other intervention name(s): Edivoxetine
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cytokines and Vascular Inflammation in Psoriasis
Condition: Vascular Inflammation; Psoriasis; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Psoriasis; Inflammation
Study type: Observational

Summary: 
      Psoriasis is an inflammatory disease involving the skin, the joints and the vascular
      compartment. The mechanisms linking inflammation in the skin and joints and in the vascular
      walls are poorly understood. One hypothesis for the increase in vascular inflammation
      observed in patients with psoriasis involves circulating pro-inflammatory cytokines. Patients
      with psoriasis have an increase in serum levels of tumor necrosis factor alpha (TNF-alpha),
      Interleukin-17 (IL-17), IL-22, IL-6 as well as a the chemokine S100A913. It is possible that
      one of those cytokines/chemokine induces vascular inflammation in the vascular compartment.
      The purpose of this cross sectional retrospective study is to highlight the correlation
      between vascular wall inflammation using 18F-2-fluoro-2-deoxy-D-glucose - Positron Emission
      Tomography (FDG-PET) fluorodeoxyglucose technology and pro-inflammatory cytokines/chemokine.
    

Detailed description: 
      Baseline frozen serum samples will be identified from the 107 enrolled Inno-6025 (Abbvie
      A13-935) (ClinicalTrials.gov Identifier NCT01722214) patients who also underwent a
      pre-adalimumab FDG-PET scan for the study. Serum cytokine and chemokine levels in these
      samples will be measured; IL-17 and IL-22 using the Singulex immunoassay platform, and
      S100A9, IL-6 and TNF alpha using multiplex ELISA. Vascular inflammation will be measured as
      the target to background ratio (TBR) in the ascending aorta using PET-scan technology.
      Correlation analyses will be performed between serum levels of cytokines and a chemokine and
      vascular inflammation.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects previously enrolled in the Inno-6025 Trial (ClinicalTrials.gov Identifier
        NCT01722214)
      
Keywords: Psoriasis; Vascular Inflammation; Coronary Atherosclerosis; Ascending aorta; PET scan; Cytokine; Chemokine