bioihbjkbjnl/mcl2 huggingface dataset:
Posterior Capsule Opacification (PCO) With Single Piece Hydrophobic Versus Hydrophillic Intraocular Lens (IOL)
Condition: Posterior Capsule Opacification
MeSH terms: Capsule Opacification
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study was to compare the postoperative PCO results of the single-piece
      hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in
      patients undergoing bilateral cataract surgery.
    

Detailed description: 
      Amongst several surgical techniques and IOL technology that influence the opacification of
      the posterior capsule, the role of IOL material and optic design remain crucial in
      determining its development. The single-piece Acrylic IOLs with a hydrophobic surface have
      been widely used in practice. The single-piece Acrylic IOLs with a hydrophilic surface became
      commercially available more recently. Although there is a study that compared the single
      piece hydrophobic and the single piece hydrophilic IOL, it was conducted on the older
      generation of the hydrophilic IOL. Moreover, experimental and clinical study has been
      performed to evaluate the posterior capsule opacification between the Hydrophilic acrylic IOL
      with a sharp optic edge design excluding the optic-haptic junction, versus the newer
      generation hydrophilic IOL design which has an improved 360-degree sharp edge, with results
      favouring the latter design. There is little data that compares the single-piece Acrylic IOLs
      with a hydrophobic surface to the newer generation single-piece Acrylic IOLs with a
      hydrophilic surface. Because the IOL characteristics play a crucial role to prevent posterior
      capsule opacification (PCO), it is of clinical importance, as well as investigational
      interest to assess the PCO following implantation of these IOLs. We conducted a prospective,
      randomised, intra-individual study to compare the 3 year postoperative PCO results of the
      single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic
      Acrylic IOLs in patients undergoing bilateral cataract surgery.
    

Intervention name(s): Phacoemulsification
Intervention type(s): Procedure
Intervention description(s): Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hydrophobic acrylic; PCO; posterior capsule opacification; hydrophilic acrylic IO
PET in Breast Cancer Receiving Neoadjuvant Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy
      differ from those of early breast cancer.

      The purpose of this study was to identify the clinical significance of potential predictive
      and prognostic factors including serial FDG PET/CT in breast cancer patients treated by
      neoadjuvant chemotherapy.
    


Intervention name(s): docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)
Intervention type(s): Drug
Intervention description(s): The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated.
Intervention MeSH terms: Docetaxel; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant chemotherapy; molecular marker; FDG PET; locally advanced breast cancer
Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
Condition: Respiratory Tract Infections
MeSH terms: Infections; Influenza, Human; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      - Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture
      confirmed influenza illness in children.
    

Detailed description: 
      -  The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T
           with TIV against culture confirmed influenza illness in children with a history of
           recurrent RTIs aged at least 6 months and less than 72 months of age.

        -  The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on
           acute otitis media.
    

Intervention name(s): CAIV-T or TIV
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
Condition: Bipolar I Disorder
MeSH terms: Mania
Study type: Interventional
Phase: Phase 3

Summary: 
      This extension study is designed to investigate the long-term safety and tolerability of
      licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind
      study CLIC477D2301.
    

Detailed description: 
      A 52-week, open-label extension study to evaluate the safety and tolerability of
      licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder
    

Intervention name(s): Licarbazepine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar disorder, manic episode/treatment/licarbazepine
Autism Biomarker Consortium for Clinical Trials
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      This is a multicenter longitudinal study that aims to identify, develop and validate a set of
      measures that can be used as stratification biomarkers and/or sensitive and reliable
      objective measures of social impairment in autism spectrum disorders (ASD) that could serve
      as markers of long term clinical outcome. The main study will include 275 individuals: 200
      ASD subjects between 6-11 years old, and 75 TD subjects roughly matched by age and sex to the
      ASD group.
    

Detailed description: 
      The specified aims of this study are to accelerate the development of effective treatments
      for social impairment in ASD by validating outcome measures that will be sensitive and
      reliable assessments of response to treatment and electroencephalography (EEG) and
      eye-tracking (ET) biomarkers. These hypothesized outcomes could then be used to reduce the
      heterogeneity of samples via stratification, could possibly indicate early efficacy, and/or
      demonstrate target engagement. The consortium will conduct a naturalistic, longitudinal study
      of preschool and school-aged (6-11 years) children with ASD and typical development (TD) with
      intelligence quotient(s) (IQ) ranging from 50-150. Children will be assessed across three
      time points (Baseline, 6 weeks and 24 weeks) using clinician, caregiver and lab-based (LB)
      measures of social impairment, along with a battery of conceptually related EEG and ET tasks
      and independent ratings of clinical status.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 children with an autism spectrum disorder between 6-11 years old, and 75 typically
        developing children
      
Biospecimen description: 
      Whole blood.
Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism
Condition: Insulin Resistance; Cardiovascular Disease; Bone Loss; Eating Disorders; Thrombosis
MeSH terms: Cardiovascular Diseases; Thrombosis; Insulin Resistance; Feeding and Eating Disorders
Study type: Observational

Summary: 
      Objective:

      The purpose of this study is to determine the etiology of the weight increase in
      Depot-medroxyprogesterone Acetate (DMPA) users.

      Method:

      Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users
      of a non hormonal method follow for two years. Will be included only women who never used
      DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of
      corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their
      control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance
      of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with
      ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic
      alterations should elucidate the etiology, and the beginning of the sub clinical
      cardiovascular disease should be shown/discarded with the arterial evaluation.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Will be included women new-users DMPA, looking for the clinic's family planning
        FCM-UNICAMP, from primary care centers in Campinas, São Paulo, Brazil.
      
Biospecimen description: 
      Serum samples for determination of lipid profile, insulin, glucose, coagulation factors,
      neuropeptide Y and factors related to bone mineral density.
    
Keywords: DMPA; insulin resistance; cardiovascular disease; BMI; weight gain; thrombosis
Telmisartan and Amlodipine Versus Monocomponent Tablets
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, two-treatment, two-period, two-sequence
      crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer
      Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination
      tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).
    


Intervention name(s): Telmisartan/Amlodipine Combination Tablet; Amlodipine Monocomponent
Intervention type(s): Drug; Drug
Intervention description(s): Combination Tablet; Active Comparator
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Basic Science
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial was to establish the dose-response relation of sugammadex given as
      a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during
      sevoflurane anesthesia for Caucasian participants
    


Intervention name(s): Sugammadex
Intervention type(s): Drug
Intervention description(s): After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.
Other intervention name(s): Org 25969; MK-8616; Bridion^TM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Probiotic Formula DE111® on Immune System in Preschool Children
Condition: Immune System Support
Study type: Interventional

Summary: 
      Healthy preschool children will be recruited, gastrointestinal infection and respiratory
      infection symptoms will be followed during the 8-week treatment and 4-week follow-up period,
      to evaluate the effect of the used probiotic formula on immune system in comparison to the
      group using placebo.
    


Intervention name(s): Probiotic Formula Bacillus subtilis DE111®; Placebo comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks; Placebo comparator, once a day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Exhaled Nitric Oxide and Nasal Lavage Fluid
Condition: Asthma
Study type: Observational

Summary: 
      The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic
      diseases in children. The airway inflammation plays an important role in their
      pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS)
      exacerbates the symptoms of asthma and allergies.

      The aim of this study is to assess the impact of environmental tobacco smoke on the
      measurement of exhaled nitric oxide (eNO) and biomarkers of nasal inflammation in atopic
      asthmatic children.
    

Detailed description: 
      Type of study :

      This study is a epidemiological observation study type exposed or unexposed to environmental
      tobacco smoke.

      Methods :

      The eNO is determined by a method On-line, at a rate expiratory 50 mL / s, using a
      chemiluminescence NO analyzer, before the allergy assessment (skin tests and assay of serum
      total and specific IgE ) and measurement of lung function (spirometry). Nasal lavage is
      performed by using a validated technique . Cells are counted and differentiated after Giemsa
      staining. We measured 1-anti-trypsin, neutrophil elastase, albumin, urea, IL4 , IL6, IL8 and
      IL13. Exposure to ETS is assessed by questionnaire to the parents. Statistical analysis
      include a narrative strand to verify the normality of distribution and an analytical
      analysis, including a bivariate followed by a multivariate analysis by multiple linear
      regression and / or logistic regression to model concentrations of biomarkers of inflammation
      and adjustment variables such as age, sex, atopic status, eosinophilia and severity of
      asthma.
    

Intervention name(s): Measurement of exhaled nitric oxide (eNO); Measurement of biomarkers of nasal inflammation
Intervention type(s): Device; Device
Intervention description(s): Chemiluminescence NO analyzer Measurement of lung function (spirometry); Nasal lavage
Intervention MeSH terms: Nitric Oxide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Atopic asthmatic children followed in the Asthma Center, Trousseau Hospital, Paris
      
Biospecimen description: 
      Whole blood
    
Keywords: Children; Tobacco smoke exposure; Exhaled nitric oxide; Nasal lavage; Cytokines
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Condition: Hypoxic Ischaemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Hypothermia; Asphyxia
Study type: Interventional

Summary: 
      This is a randomised controlled trial in newborn infants with perinatal asphyxial
      encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve
      cerebral metabolism and structure.
    

Detailed description: 
      The study hypothesis is that: Following perinatal asphyxia treatment with a combination of
      hypothermia and inhaled xenon preserves cerebral metabolism and structure. Following informed
      parental consent, infants that continue to require endotracheal tube ventilation following
      resuscitation will be randomised to treatment with hypothermia only or hypothermia and xenon.
      All infants in both groups will be treated with hypothermia for 72 hours started within 6
      hours of delivery and infants allocated to hypothermia and xenon will also receive 30% xenon
      (balanced with oxygen and air) for 24 hours through a purpose designed delivery system.
      Structured neurological examination will be done daily during the 1st week after birth and at
      discharge. MRS and MRI will be performed once between 4-10 days of age. MRS/MRI data analysis
      will be by investigators blinded to the allocated intervention.
    

Intervention name(s): Xenon gas
Intervention type(s): Other
Intervention description(s): 30% Xenon gas inhaled for 24 hours
Other intervention name(s): LENOXe
Intervention MeSH terms: Xenon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: perinatal asphyxia; encephalopathy; neuroprotection
Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a
      Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete
      both treatment periods as per protocol. For all subjects, in addition to the two treatment
      periods, there will be a 21 day screening period, one baseline evaluation (the day preceding
      deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS).
      Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS
      evaluation (final safety assessment) will be performed 7-10 days after the last dose of
      rifampicin.
    


Intervention name(s): Deferasirox; Rifampicin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rifampin; Deferasirox
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Pharmacokinetics; Deferasirox; Exjade; ICL670; Rifampicin; Healthy, Volunteers
One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      In recent years, the positive results of trials for mechanical thrombectomy (MT) have brought
      a new era for large artery occlusion patients, especially those beyond the time window of
      intravenous thrombolysis. However, interventional procedures can cause endothelial injuries
      leading to local activation of platelet aggregation and subsequent thromboembolic
      complications or early re-occlusion.Tirofiban is a specific antagonist of the platelet
      glycoprotein (GP) IIb/IIIa receptor, which is considered highly effective against the final
      common pathway of platelet aggregation and preventing vascular reocclusion. However, there is
      no consensus on if AIS patients treated with MT also benefit from intravenous tirofiban. This
      study aims to evaluate the effectiveness and safety of profiles of tirofiban during MT and
      provide reliable clinical evidence for the treatment of tirofiban in AIS patients.
    

Detailed description: 
      This study is a multicenter, prospective, open-label, randomized controlled, blinded-endpoint
      trial with two parallel groups and a 3-month follow-up. A total of 200 eligible participants
      recruited from 4-6 stroke centers will be randomly allocated to either an experimental group
      (intravenous tirofiban + MT therapy) or a control group (MT alone) in a 1:1 ratio. The
      primary outcome is a composite endpoint, including the rate of recanalisation after the first
      embolectomy and the risk of symptomatic intracerebral haemorrhage. The secondary outcomes
      include clinical and neuroimaging outcomes, procedure-related complications, and adverse
      events to evaluate the effects of MT in combination with tirofiban treatment compared to MT
      alone in AIS patients. Intention-to-treat (ITT) analysis will be undertaken in this study,
      and the full analysis set (FAS) population serves as the primary population for the analysis
      of efficacy data.
    

Intervention name(s): Intravenous tirofiban combination therapy
Intervention type(s): Drug
Intervention description(s): Patients will enter the tirofiban treatment protocol immediately within half an hour after randomization and prior to the femoral artery puncture. Tirofiban is administered as an intravenous bolus dose of 10 μg/kg injection within 3 min and then by an intravenous infusion at a rate of 0.1 μg/(kg·min) for 24 hours.
Other intervention name(s): Tirofiban
Intervention MeSH terms: Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, controlled, open-Label, assessor-blind, multicenter clinical study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Ischemic Stroke; Tirofiban; Mechanical thrombectomy; Revascularisation; Haemorrhage
Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults
Condition: Colonic Diseases [C06.405.469.158]
MeSH terms: Colonic Diseases
Study type: Interventional

Summary: 
      Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea
      because of their ability to stimulate beneficial bacteria. In-vitro results showed a
      promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids
      (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota.
      As the microbiota is nowadays considered as a key factor in human health, a further
      understanding of the gut microbiota functioning in-vivo is essential. This understanding of
      the use of specific prebiotics may possibly be beneficial in the prevention or recovery of
      antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota
      composition and activity from healthy adults receiving amoxicillin have never been tested
      in-vivo, the investigators propose the current study as a proof of principle.

      Objective:

      To explore whether the promising effects of GOS supplementation on the composition and
      activity of gut microbiota from healthy adults as found by in-vitro, can also be observed
      in-vivo.

      Study population:

      10 healthy men and women volunteers, 18 - 40 yr old
    


Intervention name(s): GOS addition; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): GOS (2.5g 3x per day) supplemented during 12 days; Maltodextrine(2.5g 3x per day) supplemented during 12 days
Other intervention name(s): Galacto-oligosaccharide; Vivinal GOS; maltodextrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intestinal microbiota composition; intestinal microbiota activity; gastro-intestinal complains