bioihbjkbjnl/mcl2 huggingface dataset:
Eye and Growth in Adolescents Born Moderate-to-late Preterm
Condition: Preterm Birth; Visual Impairment; Eye Abnormalities
MeSH terms: Vision Disorders; Vision, Low; Eye Abnormalities; Premature Birth
Study type: Observational

Summary: 
      During recent years, the interest in studying the risks of being born moderate-to-late
      preterm (MLP), defined as birth between gestational week 32 to 36, has increased. Today the
      investigators know that morbidity and mortality are significantly higher in these individuals
      compared to individuals born full-term. However, few studies have focused on the development
      of the eye in MLP individuals. The purpose of the study is to evaluate eye morphology and
      visual function in relation to growth, metabolism, blood pressure, neuropsychiatric factors,
      and quality of life in adolescents born MLP. The results of the examinations will be compared
      to an age-matched control group. The study will evaluate the structural, functional, and
      metabolic aspects of the eye with the hypothesis that early eye abnormalities may detect the
      risk of developing metabolic and cardiovascular diseases.
    


Intervention name(s): Structural, functional and metabolic eye examinations
Intervention type(s): Other
Intervention description(s): Structural, functional and metabolic eye examinations
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Year 2002 to 2004, 247 children born moderate-to-late preterm i Gothenburg, Sweden, were
        enrolled in a prospective, longitudinal and population-based cohort study. These children
        will be asked to participate in the present follow-up study 15 years later. The age-matched
        control group born full-term will be recruited from schools in Gothenburg.
      
Keywords: Moderate-to-late preterm
Heart Rate Variability and Postoperative Nausea Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      Propofol and sevoflurane have different effects on heart rate variability. It has not yet
      been reported whether this difference in effect remains at recovery time after anesthesia and
      the difference is related to postoperative nausea and vomiting has not been studied. The aim
      of this study is observe whether propofol and sevoflurane have different effects on heart
      rate variability during recovery and the differences can predict the occurrence of
      postoperative nausea and vomiting.
    

Detailed description: 
      Different types of anesthetics have different effects on heart rate variability. However It
      has not yet been reported whether this difference in effect remains at recovery time after
      anesthesia.

      Several studies have been reported that preoperative heart rate variability predicted the
      occurence of postoperative nausea and vomiting. However, whether the difference in heart rate
      variability after anesthesia is related to the difference in postoperative nausea and
      vomiting has not been studied. Therefore, this study aims to observe whether propofol and
      sevoflurane have differences during recovery period after anesthesia in heart rate
      variabiliy. In addition, we want to examine that these differences during recovery period in
      heart rate variability can predict the occurrence of nausea and vomiting within 24 hours
      after surgery.
    

Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): General anesthesia using propofol infusion; General anesthesia using sevoflurane
Other intervention name(s): Propofol infusion; Sevoflurane inhalation
Intervention MeSH terms: Propofol; Sevoflurane
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        20~50 years old female patients who scheduled breast surgery under general anesthesia
      
Keywords: postoperative nausea and vomiting; heart rate variability; propofol; sevoflurane
Observational Study to Assess Optimal ECPR Settings After Resuscitation
Condition: Extracorporeal Cardiopulmonary Resuscitation; Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary
      resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well
      established that reperfusion injury of the brain can cause microvascular and endothelial
      dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the
      European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to
      minimize ischemia-reperfusion injury of the brain.

      Objective: In this study, we want to elaborate on the optimal ECMO settings in the first
      three hours after initiation of ECPR.

      Study design: Prospective, multi-centre, observational study Study population: All patients
      receiving ECPR in the age between 18 and 70 years, with low flow duration<60min and receiving
      cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry
      sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients.

      Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific
      enolase (NSE) will be determined from routine blood drawings.
    


Intervention name(s): Settings of the extracorporeal membrane oxygenation (ECMO)
Intervention type(s): Other
Intervention description(s): Compare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score
Other intervention name(s): Measurements of cerebral saturation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients receiving ECPR will be included. The decision to perform an ECPR is made
        by the local protocol and clinical judgment of the attending physician.
Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults
Condition: Anesthesia
Study type: Interventional

Summary: 
      Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of
      this study is to determine if head rotation improves the efficiency of mask ventilation of
      anesthetized apneic adults.
    

Detailed description: 
      When apnea is achieved after induction, face mask ventilation is started in either a neutral
      head position or a head position axially rotated 45 degrees to the right. Mask ventilation
      will be carried out for 1 minute (Step 1) with pressure control ventilation of an anesthesia
      machine at peak inspiratory pressure 15 cmH2O, 10 breaths per minute, inspiration time to
      expiration time ratio 1:2 and no positive end-expiratory pressure. Then, mask ventilation
      will continue but head position will be crossed over (Step 2) and Step 1 will be repeated
      (Step 3). Expiratory tidal volume (VTE) will be measured by using respiratory inductive
      plethysmograph.
    

Intervention name(s): Head rotation during mask ventilation
Intervention type(s): Procedure
Intervention description(s): Patient's head position is axially rotated 45 degrees to the right.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Anesthesia induction; Airway; Mask ventilation
Impact of Vaccenic Acid Consumption on the Metabolism of Saturated Fatty Acids: Relationship With Cardiovascular Risk Factors
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators' project has for principal objective to evaluate the impact of three
      specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2%
      obtained by modification of the cow's diet on cardiovascular risk factors in healthy
      subjects.
    

Detailed description: 
      111 healthy, normolipemic men and women (18y to 50y) have been recruited for a monocentric,
      randomised, double-blind, controlled 4-week study. All the volunteers consumed 3 experimental
      products (butter, dessert cream and cakes) made with one of the 3 specific milk fats up to 55
      g fat/day.
    

Intervention name(s): Ruminant trans fatty acid enriched diet - lowest ratio; Ruminant trans fatty acid enriched diet - medium ratio; Ruminant trans fatty acid enriched diet - highest ratio
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period; the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed; the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: TFA; SFA; Clinical trial; fat milk
Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh
Condition: Nasolabial Fold
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and safety of the investigational device,
      RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.

      Study hypothesis

        -  level of significance: alpha=0.05( two-side)

        -  power of test: (power= 1-beta),power=0.08

        -  H0: P equals P0

        -  H1: P unequals P0

        -  The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre
           and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)
    

Detailed description: 
      1. Benefits

        -  enhancing self-satisfaction and quality of life by improving skin elasticity and
           correcting folds in the nasolabial fold area 2. Risks

        -  erythema, swelling, pain and redness in the facial area generally resolve in 1 week
           3.Duration of study

        -  entire duration: approximate 36weeks

        -  Follow-up period: 7 weeks

        -  Enrollment period: 12 weeks 4. study design

        -  2 step operation process

             -  First step- insert polypropylene mesh under the skin

             -  Second step- pull the polypropylene mesh 3 weeks later
    

Intervention name(s): Non-absorbable polypropylene mesh
Intervention type(s): Device
Intervention description(s): 2 step procedures
first step is insertion of Non-absorbable polypropylene mesh under the facial skin
second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-absorbable polypropylene mesh; WSRS; Rhytidectomy
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The primary objective of this study is to test the effectiveness of internet-delivered and
      therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety
      disorders (including social anxiety disorder, separation anxiety disorder, generalized
      anxiety disorder, panic disorder and specific phobia) in a randomized trial where
      participants will be allocated to either ICBT or to a supportive control condition.
      Non-responders (defined as those participants who still uphold their primary anxiety disorder
      after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are
      conducted at 3 and 12 months after treatment completion.
    


Intervention name(s): Internet-based CBT
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of internet-based CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive behavior therapy; child; randomized controlled trial; internet
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2
      diabetes mellitus.
    

Detailed description: 
      This will be a randomized, double-blind and placebo-controlled study with multiple oral doses
      of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic
      drug for treatment before.

      The primary objective is to characterize the safety and tolerability of HMS5552 following
      multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8
      days.

      The secondary objectives include:

        1. To determine the single dose and steady state pharmacokinetics of HMS5552 in patients
           with type 2 diabetes

        2. To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients
           with type 2 diabetes

        3. To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics

      A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose
      levels). There will be 8 active and 2 placebo patients in each dose group. The safety,
      tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be
      reviewed in blinded fashion before escalation to the next dose cohort.
    

Intervention name(s): HMS5552; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucokinase activator; Phase I; Type 2 diabetes mellitus
Progestrone and Doppler Indices
Condition: Preterm Labor
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal
      doppler indices
    

Detailed description: 
      A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an
      independent investigator blinded to the treatment, before and 48 hours after the ﬁrst
      administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria)
      ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color
      imaging capabilities, was used in all cases.
    

Intervention name(s): A complete Doppler ﬂow assessment of the maternal and fetal circulation
Intervention type(s): Diagnostic Test
Intervention description(s): A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, 48 hours after receiving 400mg of vaginal progestrone .Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine ,equipped with a 3.5-MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: progestrone; doppler indices
Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)
Condition: Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with
      high blood pressure and thickening of the main pumping chamber of the heart. The results
      showed that after an average treatment time of 4.8 years, treatment that was based on
      losartan was better than treatment based on atenolol for reducing the risk of having a
      stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.
    


Intervention name(s): MK0954, /Duration of Treatment : 5 Years; Comparator : atenolol /Duration of Treatment : 5 Years
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Vascular Endothelial Growth Factor and Endostatin in Angiogenesis After Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after
      cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role
      in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators
      sought to compare the expression of VEGF and ES in serum and the circulating EPCs in patients
      after AIS with that of healthy control subjects. The investigators obtained peripheral blood
      and serum samples from study subjects. EPCs in blood samples from AIS patients and healthy
      controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7 days after AIS. VEGF
      and ES were measured by enzyme linked immunosorbent assay at the same time points. The
      relation between them and the relation of them to prognosis of such patients with acute
      ischemic stroke were assessed.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patient group comprised twenty male and ten female. Their age ranged from 45 to 74
        years. Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs,
        included the territories of the middle cerebral artery (9 cases), the posterior cerebral
        artery (8 cases) the anterior cerebral artery (6 cases), vertebrobasilar area (5 cases),
        and watershed area (2 cases with cortical and subcortical low densities crossing typical
        vascular territories).
      
Biospecimen description: 
      Peripheral blood samples
    
Keywords: Acute ischemic stroke; Vascular endothelial growth factor; Endostatin
Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in
      subjects with moderate to severe pain associated with osteoarthritis of the knee following
      cessation of pain therapy.
    

Detailed description: 
      This is a randomized, double-blind, vehicle-controlled, repeat-dose, multi-center Phase 2
      efficacy and safety clinical trial of subjects with moderate to severe pain associated with
      osteoarthritis of the knee. Eighty-four subjects, randomized in a 2:1 ratio (OLT1177 Gel to
      vehicle control) will receive up to 40 doses of the Investigational Drug (56 subjects OLT1177
      Gel and 28 subjects vehicle control) over 14 consecutive days given 3 times per day (4 mL per
      dose, TID on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1)
      and will have safety data collected through Day 28. Subjects with moderate to severe pain
      associated with osteoarthritis of the knee will be evaluated twice for eligibility: 1) at the
      Screening visit; and 2) at the Baseline (Day 0) visit, after a 7-day washout period of all
      pain medications except for trial provided Rescue Medication (500 mg/dose of acetaminophen)
      for those that experience unacceptable pain during the washout and 14-day treatment period.

      Subjects will be encouraged not to take any pain medication during the 7-day washout period;
      however, for the first 5 days they are allowed to take only Rescue Medication. No pain
      medication, including Rescue Medication, is allowed during the 2-day pain intensity
      assessment period or within 48 hours of the Baseline (Day 0), Day 7 and Day 14 visits.

      Subjects will be asked to record and report their level of pain at different time points
      throughout the 14-day trial.
    

Intervention name(s): OLT1177 Gel; Placebo gel
Intervention type(s): Drug; Other
Intervention description(s): 4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1; Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)
Other intervention name(s): OLT1177
Intervention MeSH terms: Dapansutrile
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Osteoarthritis; OA; Knee pain; Moderate pain; Severe pain; Inflammation; Safety; Efficacy; Randomized; Topical; Gel; Olatec; OLT1177; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Therapeutic; Analgesic
Fluoxetine in Multiple System Atrophy Patients
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a French national trial, conducted using a double-blind, placebo-controlled,
      randomised design involving 15 centers and 88 patients of both sexes.

      The primary objective of the trial is to evaluate the effect of a selective inhibitor of
      serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for
      depressed patients, after three months in patients suffering from an atypical Parkinson's
      disease called Multiple System Atrophy, compared to the placebo effect.

      Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six
      weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the
      effects on mortality, quality of life, autonomic disorders, particularly orthostatic
      hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.
    

Detailed description: 
      Fluoxetine is first introduced in dose of 20 mg/day and after six weeks the dose is increased
      to 40 mg/day. If patients have side effects at the dose of 40 mg/day, the dose may be reduced
      at 20 mg/day. Assessment visits will be conducted at 6 weeks, 3 months, and 6 months of
      treatment. After 6 months, trial's treatment with fluoxetine is discontinued gradually. A new
      assessment will be conducted one month after the end of treatment. The expected results are
      the demonstration of improved scores of the scale UMSARS after 3 and 6 months in the
      fluoxetine group compared to the placebo group.
    

Intervention name(s): FLUOXETINE
Intervention type(s): Drug
Intervention description(s): 20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other intervention name(s): PROZAC®
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Fluoxetine effect; Multiple System Atrophy; MSA