bioihbjkbjnl/mcl2 huggingface dataset:
Role of microRNAs in T Cell-Driven Inflammation in Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional

Summary: 
      This will be a single center study of asthmatic subjects and healthy controls which will
      investigate mechanisms of asthma through detailed molecular analysis of airway tissues and
      fluids. The primary goal will be investigate the role of microRNAs in Th2-driven inflammation
      in asthma. The investigators hypothesize that asthma is associated with abnormal expression
      of miRNAs in T cells which favors differentiation into Th2-cells. The investigators further
      hypothesize that asthma is heterogeneous based on the presence and absence of Th2-driven
      inflammation and that abnormalities in T cell miRNA expression will be most prominent in a
      subgroup with high levels of Th2-driven inflammation (as assessed using molecular markers
      that the investigators have previously established). Finally, the investigators hypothesize
      that inhaled corticosteroids will normalize the T-cell miRNA abnormalities observed in
      asthma, as corticosteroids treat Th2-driven inflammation. The samples collected will also
      facilitate the pursuit of secondary analyses designed to investigate mechanisms of
      inflammation and remodeling in asthma as well as molecular phenotypes of asthma.
    


Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
Other intervention name(s): Pulmicort
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Wound Dressings in the Reduction of Shear- Force
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer
Study type: Observational

Summary: 
      The purpose of this study is to investigate if wound dressings are capable in reducing the
      effects of shear- force at the skin. With our own shear- force model we are able to apply 19
      Newton shear- force combined with 9 newton pressure at the skin of the non- dominant forearm.
      After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow (Laser
      doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect of
      shear- force application at the skin.

      Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant
      fore-arm but this time we put a wound dressing between the skin and shear- force model. After
      half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and the
      erythema index.

      This research consists of three research day, each day we are going to investigate a
      different wound dressing
    


Intervention name(s): shear- force
Intervention type(s): Other
Intervention description(s): 19 Newton shear- force and 3,9 kPa pressure for half an hour
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ten healthy volunteers
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Condition: Acute Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with
      quetiapine fumarate in combination with lithium in the treatment of a major depressive
      episode in patients with bipolar disorder.
    


Intervention name(s): Quetiapine fumarate XR; Lithium carbonate
Intervention type(s): Drug; Drug
Intervention description(s): Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.; Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
Other intervention name(s): SEROQUEL XR; LITHURIL Tb in TURKEY; LITOCARB in PERU
Intervention MeSH terms: Quetiapine Fumarate; Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute bipolar depression; Lithium carbonate; quetiapine fumarate; MADRS
Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of
      acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil,
      AC-1202, AC-1204, and Axona®.
    


Intervention name(s): Caprylic Triglyceride Oil; AC-1202; Axona; AC-1204
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1; 60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1; 40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1; 40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy volunteers; Caprylic triglyceride oil; AC-1202; AC-1204; Pharmacokinetic; ketone body; Axona
Study of Atorvastatin Dose Dependent Reduction of Proteinuria
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized controlled double blind study of parallel groups to evaluate the comparative
      effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic
      kidney disease.
    


Intervention name(s): Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive); Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Other intervention name(s): lipitor 10mg; lipitor 40mg
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic kidney disease
Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether treatment with a fixed dose combination
      dapagliflozin/metformin tablet is affected by food.
    


Intervention name(s): Dapagliflozin/Metformin
Intervention type(s): Drug
Intervention description(s): oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Dapagliflozin; Diabetes Type 2; Food interaction
Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment
Condition: Hypertension
MeSH terms: Hypertension; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Systemic arterial hypertension is a disease with high prevalence in several countries,
      including Brazil. Many studies have correlated hypertension with accelerated loss of
      cognitive function, especially executive functions. There is some evidence that working
      memory (WM) is compromised in these populations. However, some computerized training has been
      developed to rehabilitate the WM, and among them the investigators highlight the Cogmed.
      Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance
      of WM and attention of hypertensive patients, as well as the impact of training in the
      structure and brain function.
    


Intervention name(s): Cogmed
Intervention type(s): Other
Intervention description(s): The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Hypertension; Cognition; Computerized Training; Cogmed
Early SARS-CoV-2 Tracheostomy
Condition: Tracheostomy; Characteristics Disease; Metabolic Disturbance
Study type: Observational

Summary: 
      Objective of this case series was to evaluate the characteristics of early COVID-19
      tracheostomy and its effect on laboratory parameters. A series of 17 patients with
      COVID-19undergo surgical tracheostomy in our intensive care unit. Demographic parameters,
      duration indicators, and laboratory parameters before and after tracheostomy were analyzed in
      patients. Of the 17 patients, 4 were men and 13 women with a mean age of 59 years. The
      average length of total hospitalization were 12 days, the length of stay in intensive care
      were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of
      tracheotomy. Neurological and thyroid diseases and withdrawal had a statistically significant
      difference (p <0.05), with laboratory parameters without statistically difference. Critically
      ill COVID-19 patients undergoing early tracheostomy has a lower possibility of weaning from
      mechanical ventilation, and early tracheostomy itself has no significant effect on renal
      parameters, lactate and D-Dimer.
    


Intervention name(s): Tracheostomy
Intervention type(s): Procedure
Intervention description(s): We collected data from all tracheotomised patients including age, sex, existing comorbidities, duration indicators (length of endotracheal intubation, day of tracheotomy, length of stay in the intensive care unit (ICU), and total length of hospital stay), respirator weaning marked with YES / NO. From the laboratory parameters, we analyzed: lactate, urea, creatinine, potassium and D-dimer. They were collected at two time intervals, before tracheotomy and after tracheotomy.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We performed a retrospective review of all COVID-19 critically ill patients who underwent
        tracheotomy between 2020 and 2022. All tracheotomized patients were included in the
        analysis, age 18 and older.
      
Keywords: COVID-19; tracheostomy; demographic; lactate; D-dimer
Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea
Condition: Psoriasis; Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect and safety of adalimumab in approximately 20 subjects
      with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment center
      located in Montreal.

      Patients with psoriasis often have additional disorders such as obesity. Obese patients are
      more at risk of developing obstructive sleep apnea. This is believed to be caused by both the
      collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently approved
      by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha
      (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is
      believed that adalimumab could improve obstructive sleep apnea by lowering the levels of
      TNF-alpha.
    


Intervention name(s): Adalimumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.; Patients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter.
Other intervention name(s): Humira; mannitol; citric acid monohydrate; sodium citrate; disodium phosphate dihydrate; sodium dihydrogen phosphate dihydrate; sodium chloride; polysorbate 80; water for injection; sodium hydroxide.; mannitol; citric acid monohydrate; sodium citrate; disodium phosphate dihydrate; sodium dihydrogen phosphate dihydrate; sodium chloride; polysorbate 80; water for injection; sodium hydroxide
Intervention MeSH terms: Adalimumab; Mannitol; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; adalimumab; obstructive sleep apnea; obesity
Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a
      Biomarker improvement symptom and quality of life women with functional constipation after
      supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from
      indigenous probiotics from Dadih, West Sumatra) for 21 days
    


Intervention name(s): Lactobacillus plantarum; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fermented milk containing probiotic Lactobacillus plantarum for three weeks; Fermented milk containing placebo for three weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: SCFA; Probiotic; Lactobacillus plantarum; Functional constipation
The Effect of Virtual Reality Glasses Applied During Vaginal Incision Suturing on Pain and Satisfaction
Condition: Episiotomy; Dehiscence
Study type: Interventional

Summary: 
      The research was conducted as a randomized controlled clinical study to determine the effect
      of virtual reality glasses on pain and patient satisfaction during the episiotomy repair
      procedure. The sample consisted of 50 pregnant woman of whom 25 were in the control group and
      25 were determined by randomization among primiparous pregnant woman who met the reasearch's
      criteria and agreed to participate in the study.
    

Detailed description: 
      Objective: The research was conducted as a randomized controlled clinical study to determine
      the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy
      repair procedure.

      Method: The research population consisted of 50 primiparous pregnant women who applied to the
      delivery room of Necip Fazıl City Hospital Gynecology and Child Additional Service Building
      between 15 June 2021 and 15 December 2021 for vaginal delivery. Data were collected with the
      Mother Identification Form and Visual Analogum Scales (VAS) Pain - Satisfaction Evaluation
      Forms. During the episiotomy repair procedure, 5 ml of lidocaine was administered to the
      patients in the intervention group; A video with music was watched with virtual reality
      glasses for an average of 10 minutes, just before starting the process and throughout the
      process. No application was made to the mothers in the control group, except for 5 ml of
      lidocaine, which was applied during episiotomy repair. In the evaluation of the data, mean,
      standard deviation, percentage and number values are given. Student's t test was used to
      compare normally distributed variables in two groups, and Mann Whitney U test was used to
      compare non-normally distributed variables in two groups. In testing the variables in
      different groups and times, repeated measures of variance analysis were applied.
      Relationships between categorical variables were tested with CI-square test, and relations
      between non-normally distributed numerical variables were tested with Spearman rank
      correlation coefficient. SPSS 22.0 Windows version package program was used in the analysis.
      P<0.05 was considered significant.
    

Intervention name(s): Virtual reality glasses
Intervention type(s): Device
Intervention description(s): watching a video with music with virtual reality glasses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Obstetrics; Episiotomy; Virtual reality; Pain; Satisfaction
fMRI in Posttraumatic Stress Disorder (PTSD) During Working Memory Updating
Condition: Post-Traumatic Stress Disorders; Anxiety; Amnesia, Dissociative
MeSH terms: Amnesia; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder
      (PTSD) subjects have generally underlined the significantly poorer performance of tasks that
      require attention, concentration, and verbal memory, and difficulty in regulating memories
      surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry,
      2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales,
      and lower on processing speed tests. Moreover, the study showed significant impairment in
      working memory partially mediated by speed processing, but not by anxiety or depression.
      These results suggest that processing speed makes a major contribution to trauma-related
      working memory decline, and needs to be investigated in further studies.The aim of the
      present study is to explore correlation between hippocampus volume, frontal dysfunction and
      cognitive slowing in trauma-exposed subjects, while examining brain activation during
      performance of working memory tasks using functional magnetic resonance.
    

Detailed description: 
      Working memory performance will be assessed using the "3-back test", and processing speed
      evaluated with "words comparison test". The study will be conducted on 2 years. The study
      should include 18 right-handed females victims of sexual abuse and suffering from PTSD, and
      18 controls right-handed females without any history of abuse ad not suffering from PTSD.
      Brain activation will be measured during performance of working memory tasks (3-back test)
      and processing speed test using functional magnetic resonance.
    

Intervention name(s): Magnetic Resonance Imaging, Functional
Intervention type(s): Procedure
Intervention description(s): Structural and functional MRI
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        PTSD related to sexual abuse vs controls, in right-handed females.
      
Keywords: PTSD; MRI, Functional; Anxiety; Working Memory; Processing speed
Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor
Condition: Preterm Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional

Summary: 
      The investigators study objective is to investigate the effectiveness of vaginal micronized
      progesterone in prolonging pregnancy after an episode of preterm labor which responded to
      tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions
      of progesterone supplementation by examining its effect on the two components of parturition:
      cervical ripening and myometrial contractility. The investigators will utilize transvaginal
      ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal
      uterine EMG to assess the uterine muscle activity. The investigators will also look at the
      effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is
      expected to provide much more information.
    


Intervention name(s): Progesterone; placebo vaginal capsules
Intervention type(s): Drug; Drug
Intervention description(s): Two micronized progesterone capsules (Utrogestan® 200 mg, i.e. 400 mg of micronized progesterone in sunflower oil) placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.; Two placebo capsules placed (soy lecithin and sunflower oil) into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.
Other intervention name(s): Brand name: Utrogestan® 200 mg
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: preterm birth; preterm labor; progesterone; uterine electromyography; cervical length
Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Protocol Title: Open-label,single center study to evaluate the savety and efficacy of an
      intramuscular 12 week-course of Alefacept in patients with atopic dermatitis.

      Study Phase: II

      Study Design: Open-label, single center Primary Study Objective: to determine the safety and
      efficacy of one course of Alefasept when administered as a 15 mg intramuscular ( IM)
      injektion to patients with atopic dermatitis

      Secondary Study Objective: to investigate key immunological parameters involved in the
      pathology of this common skin disease to interpret the clinical findings

      Number of patients: 10

      Study Population: Male and female patients, at least 18 years of age with atopic dermatitis,
      aktive inflammation, a severity score of 6-9 according to Langeland and Rajika and an EASI of
      >20

      Treatment Groups: Alefacept will be administered as a 15 mg IM injection once a week for 12
      weeks, followed by a 12-week follow-up period.
    

Detailed description: 
      Atopic dermatitis is a common chronic eczematous skin disease,wich often begins early in
      infancy and runs a course of remissions and exacerbations. T-lymphocytes play a prominent
      role in this skin disease. they represent the majority of skin-infiltrating cells and
      patients suffering from AD also have increased levels of activated circulating T cells and
      increased levels of markers of lymphocyte activation such as L-selectin and IL-2R.
    

Intervention name(s): Alefacept
Intervention type(s): Drug
Intervention description(s): 15 mg i.m. once weekly for 12 weeks
Intervention MeSH terms: Alefacept
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic