bioihbjkbjnl/mcl2 huggingface dataset:
A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis
Condition: Smoking; Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The investigators propose to recruit patients who have experienced a recent first episode of
      psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective
      Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify
      themselves as a current cigarette smoker. Aiding this population with smoking cessation is
      crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke, which
      is leading to early mortality. While these individuals can benefit from standard
      evidence-based treatment, these treatments are underutilized. Web based programs, such as the
      EDSS and thetruth.com, can provide education and motivational tools to help people with a
      recent onset of psychosis use evidence-based smoking cessation treatments. This study aims to
      test these two web-based programs among young people with a recent episode of psychosis for
      usability and likeability and to explore whether use of these two programs will motivate
      users to seek smoking cessation treatment or to engage in other quitting behaviors in the
      month following use of the programs. Information gathered from this proposal will be used to
      help the researchers decide whether either of these two programs will be reasonable to
      include in a larger study of a comprehensive treatment for individuals with first episode
      psychosis.
    


Intervention name(s): Web-based computer program
Intervention type(s): Behavioral
Intervention description(s): Web-based computer programs will be used to help education people with a recent first episode of a mental illness learn about smoking. The programs are designed to help young smokers become motivated to being a smoking cessation program.
Other intervention name(s): EDSS
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Smoking Cessation; First episode psychosis; Electronic Decision Support System
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in
      patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
    


Intervention name(s): Methylnaltrexone (MNTX)
Intervention type(s): Drug
Intervention MeSH terms: Methylnaltrexone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI
Condition: Crohn's Disease; CAM
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether acupuncture or moxibustion therapies are
      effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate
      the efficacy by functional magnetic resonance imaging.
    

Detailed description: 
      The purpose of this study is to determine whether acupuncture or moxibustion therapies are
      effective in the treatment of Crohn's disease. meanwhile, the investigators aim to evaluate
      the efficacy by functional magnetic resonance imaging.

      Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for
      12 weeks, Compare the different brain activation by the different therapies and observe the
      correlation between brain activation and efficacy.
    

Intervention name(s): electroacupuncture; moxibustion
Intervention type(s): Other; Other
Intervention description(s): Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.; patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
Other intervention name(s): acupuncture; herbs-partitioned moxibustion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's disease; acupuncture; moxibustion; fMRI; Gut
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Condition: Lassa Fever
MeSH terms: Lassa Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability
      and immunological profile of INO-4500 administered by intradermal (ID) injection followed by
      electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
    


Intervention name(s): INO-4500; CELLECTRA™ 2000; Placebo
Intervention type(s): Drug; Device; Drug
Intervention description(s): INO-4500 will be administered ID on Day 0 and Week 4.; EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.; Placebo will be administered ID on Day 0 and Week 4.
Other intervention name(s): SSC-0001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Healthy volunteer
Acute Health Effects of Ozone Exposure
Condition: Pulmonary Function
Study type: Interventional

Summary: 
      This is a randomized controlled human exposure crossover study. Investigators aim to
      investigate the acute health effects of ozone exposure in healthy young adults.
    

Detailed description: 
      The investigators will conduct a randomized controlled human exposure crossover study among
      32 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to clean
      air and once to 200 ppb ozone in a chamber for 2 hours. During the 2-hour exposure, each
      subject will be requested to alternate 20 minutes of rest and 10 minutes of exercise on a
      treadmill. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~
      27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). Ozone will be generated
      by a silent electric discharge method (HTU-500, AZCO Industries Ltd., Canada) and introduced
      into the chamber. The temperature and relative humidity in the chamber will be maintained at
      22±1℃ and 55%±5%, respectively. Health examinations will be conducted immediately prior to
      exposure, immediately after exposure, 2 hours after exposure and again the next morning.
      Health examinations include symptom questionnaire, skin tests, spirometry, and Holter
      monitoring. We plan to collect blood, buccal, urine, nasal secretion, saliva, exhaled breath
      condensate, sebum, and D-squame samples.
    

Intervention name(s): 200 ppb ozone group; 0 ppb ozone group
Intervention type(s): Other; Other
Intervention description(s): The exposure group will be exposed to 200 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.; The control group will be exposed to 0 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the
      patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had
      been studied that are also correlated to sputum eosinophils in similar patients group.
      According to well controlled asthma, althoug hin clinical practice guidelines recommend that
      the stepping down therapy should be considered to those patients due to the risks or costs of
      daily treatment, there is previous study has been shown that the airway hyperresponsiveness
      and sputum eosinophilia are predictors of loss of control during dose reduction. And, these
      tests are not readily available in primary care. However, there is limit number of clinical
      study to study the correlation of biologic markers among the patients with well controlled
      level before the stepping down management.
    

Detailed description: 
      This is a single prospective trial. Enrollment will continue until 50 patients with well
      controlled asthma have been entered into this trial and have completed blood tests and
      spirometry. In this trial, the following parameters are to be evaluated:

      Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF,
      MMEF 25-75%, % reversibility
    

Intervention name(s): Patients with well controlled asthma
Intervention type(s): Diagnostic Test
Intervention description(s): Patients with well controlled asthma
The following parameters are to be evaluated:
Blood eosinophils FeNO Findings on lung function test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with well controlled asthma treating with step 3 base on GINA by only low dose
        ICS/LABA based on ACT (> = 23) and ACQ-7 (<0.75) for at least 12 weeks
      
Biospecimen description: 
      Blood for CBC analysis
    
Keywords: FeNO; Blood eosinophil; Pulmonary function test; Well controlled asthma
Agomelatine in Depressed Patients With Fibromyalgia
Condition: Major Depression; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is a
      new antidepressant with sleep-promoting properties. The objective of this study include the
      assessment of agomelatine therapy in patients with depression and fibromyalgia both on the
      severity of depressive symptomatology and sleep quality.
    

Detailed description: 
      One of the most frequent comorbidities of fibromyalgia is major depression. Agomelatine is a
      new antidepressant whose mechanims of action include both agonism at melatonin receptores and
      5-HT2C blocking properties which, in addition to antidepressant efficacy, has shown
      sleep-improving properties. As unrefreshed sleep is a common symptom in fibromyalgia we
      hypothetized that agomelatine treatment of patients with concomitant depression and
      fibromyalgia could improve both depressive symtomatology and sleep quality. Thus, the
      objectives of the present study are the following:

        -  to assess the effectiveness and tolerability of agomelatine on the severity of
           depressive symptomatology in patients with fibromyalgia and concomitatnt depresssion

        -  to evaluate the effect of agomelatine treatment on sleep quality in these patients
    

Intervention name(s): agomelatine
Intervention type(s): Drug
Intervention description(s): Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration
Other intervention name(s): Valdoxan
Intervention MeSH terms: Agomelatine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients suffering fibromyalgia and concomitant major depression
      
Keywords: major depression; fibromyalgia; agomelatine; Becks' Depression Inventory (BDI); Pittsburgh's Sleep Quality Index (PSQI)
Embryo Transfer: Embryo Expulsion and Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      According to the studies, about 80% of patients undergoing in vitro
      fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer
      process, but only a few of them become pregnant.

      The cause of this difference can be due to some factors such as the endometrial receptivity,
      quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s)
      following embryo transfer is (are) one of the factors which may be effective on outcome. The
      purpose of this randomized clinical trial study is "Lowering embryo expulsion following
      embryo transfer to improve outcome."
    

Detailed description: 
      A total of 134 infertile women who undergo IVF or ICSI treatment cycle at Royan Institute
      (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective
      randomized clinical trial study and will randomly be divided into two groups of 67 patients.
      This study has been approved by Royan ethics committee and written consent will be obtained
      from each patient. The patients with frozen-thawed embryo transfer cycle and those with
      oocyte donation cycle, the women with uterine abnormality and the subjects with submucosal
      and intramural myoma, will be excluded from this study.

      After the ovarian stimulation and oocyte retrieval, The IVF and intracytoplasmic sperm
      injection (ICSI) procedures will be performed to produce the embryos.

      Embryo transfer will be done only by one skilled physician. The patients will be divided into
      two groups of A and B by computerized randomly chart. In group A, the prevention technique of
      embryo expulsion will be carried out following embryo transfer, but no intervention will be
      performed in group B (control group).

      After 2 weeks, the patients will be tested for serum β-hCG for assessing the pregnancy. The
      clinical pregnancy will be clarified by the number of women with gestational sacs on
      transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the
      number of gestational sacs will be considered.
    

Intervention name(s): prevention of embryo expulsion
Intervention type(s): Procedure
Intervention description(s): The prevention of embryo expulsion will be carried out after embryo transfer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Embryo transfer; IVF/ICSI; Embryo expulsion
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial
      to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the
      Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced
      Fibrosis
    

Detailed description: 
      The primary objective is to determine the difference between placebo and GR-MD-02 treatment
      in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1)
      mapping as determined from LiverMultiScan (LMS), a multi-parametric MRI protocol.

      Secondary objectives include evaluating differences between subjects treated with GR-MD-02
      versus placebo in:

        -  The baseline-adjusted change in liver stiffness as measured by MR-elastography

        -  The baseline-adjusted change in liver stiffness as measured by FibroScan® scores.

      An exploratory objective will be to evaluate the correlation of the three diagnostic
      modalities of LiverMultiScan, MR-Elastography, and FibroScan®.
    

Intervention name(s): GR-MD-02; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GM-MD-02 active; Placebo
Other intervention name(s): galactoarabino-rhamnogalacturonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CD36 and Human Fat Taste Perception
Condition: Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of common human variants in in taste
      related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception.
    

Detailed description: 
      At present, the general agreement is that humans perceive five taste qualities: sweet, sour,
      bitter, salty and umami (the savory, meaty taste of some amino acids). It is believed that
      these qualities evolved to help us find nutrients (e.g. sweets, umami signaled calories) and
      avoid potential harmful substances (e.g. bitter signalized poison). Despite the fact that
      some fats, which can only be obtained through the diet, are essential for life, fat is not
      considered a basic taste; and, the issue of how fats are precisely sensed is unresolved.
      However, increasing evidence suggests that, in addition to smell and texture, taste plays an
      important role in fat perception. Putative fat taste receptor classes have been identified in
      animal models. One such receptor is the glycoprotein CD36, previously documented to be
      involved in trafficking and storage of fat. CD36 was recently found in rodents' and humans'
      taste buds. In rodents, CD36 deletion blunts specifically fat recognition. Although CD36
      variants are frequent in humans, its role in humans' fat taste perception and preferences
      remains incompletely understood and will be the focus of the current proposal. The main goal
      of this study is to determine the effect of a common human variant in the CD36 gene on fat
      taste perception by using standardized sensory evaluation techniques. In addition, we will
      examine whether common variants in taste related genes (other than CD36) are associated with
      individual differences in the perception of flavors of milkshakes prepared with different
      amounts of fats.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be men and women, 21 to 50 yrs of age of all races and ethnic groups. The two
        groups (i.e. groups with different CD36 genetic variants) will be matched as closely as
        possible in age, sex, body mass index and race distributions. Subject population will
        consist of lean subjects (BMI >18-<25 kg/m2) and subjects with obesity (BMI >29.9 kg/m2).
      
Biospecimen description: 
      Extracted genomic DNA
    
Keywords: taste perception; individual differences; fat; genetics
Pharmacokinetics of Epinephrine During Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      To determine the pharmacokinetics of epinephrine during cardiac arrest.
    

Detailed description: 
      The aim of out study is to determine the pharmacokinetics in humans during cardiac arrest,
      following a single dose of epinephrine. Venous samples will be withdrawn every minute the
      first five minutes following a single dose.

      The aim of the study is to determine T1/2 in a clinical setting and to determine time to peak
      concentration.
    

Intervention name(s): Epinephrine
Intervention type(s): Drug
Intervention description(s): This is truly an observational study to determine T1/2 for epinephrine and time to peak concentration following a single dose of epinephrine in a cardiac arrest setting
Other intervention name(s): Adrenaline
Intervention MeSH terms: Epinephrine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with cardiac arrest of an assumed cardiac origin, treated by the Bergen Emergency
        Medical Service.
      
Biospecimen description: 
      Blood samples with determination of medical concentration in plasma
    
Keywords: epinephrine
Effect of Postural Correction Exercises on Shoulder Muscles Tenderness and Performance in Subjects Addicting Smartphones
Condition: Ergonomics
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      smartphones have replaced most of the keypad phone products due to their small size and easy
      of portability. As a result, smartphone users experience an increase in musculoskeletal
      problems in the neck and shoulder. Therefore, the importance of exercise and proper training
      should be emphasized for people who are likely to develop postural deformities due to
      incorrect posture habits and daily living patterns
    

Detailed description: 
      Prolonged VDTs operation is a leading cause of musculoskeletal disorders and cumulative
      trauma disorders such as stiff shoulders, neck soreness, carpal tunnel syndrome, and low back
      pain among office employees. The problems are intensified by wrong work postures, such as
      flexed neck, wrists, or excessively flexed forearms.Smartphone is a mobile hand-held VDT
      device with advanced computing capability, such as internet communication, information
      retrieval, video display and other capabilities. Being portable, smartphones have had a large
      impact on modern everyday life on terms of inducing continuous mechanical stress on shoulder
      and neck tendons and muscles caused by it's prolonged use.

      Attaining ideal posture puts least stress on spinal structures. A good posture of head and
      shoulder is attaining by keeping ears aligned with the shoulders and shoulder joints
      retracted. Person attaining ideal posture put least stress on spinal structures. The
      commonest posture adapted by smartphone users is bending their neck and staring at the mobile
      screen, which subsequently causes postural alteration and leads to neck pain. It is found
      that there is extremely significant correlation between prolonged use of smartphone and
      forward head posture.

      Posture correction exercises correct postural alterations like forward head posture and
      rounded shoulder posture. It is found that deep neck flexors, isometric extension, prone chin
      tucks and chest stretches are effective in correcting forward head posture by improving
      craniovertebral angle. Scapular stabilization exercises are found to be effective in
      increasing shoulder range of abduction and external rotation and in decreasing forward head
      and shoulder postures.
    

Intervention name(s): Postural exercises
Intervention type(s): Other
Intervention description(s): Postural correction exercises are effective in improving forward head posture and it effectively decrease neck pain and increase ROM Exercise training and ergonomic guidelines concerning the use of touchscreen smartphones will reduce the risk of developing upper extremity musculoskeletal disorders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Smartphone addiction; Shoulder mechanics