bioihbjkbjnl/mcl2 huggingface dataset:
Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy
Condition: Congenital Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      In this prospective study , a cohort of 58 eyes with congenital cataract from Wenzhou medical
      university was erolled.33 eyes with congenital cataract was after lensectomy and anterior
      vitrectomy as post-surger group, 26 eyes without cataract surgery as control group. The
      cytokines of MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15 was
      evaluated
    

Detailed description: 
      Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and
      primary IOL implantation in children with congenital cataract were both performed by the same
      surgeon(Z.Y.E) and videos were collected to review the capsular reconstruction condition and
      lens implantation position.

      Aqueous humor (100-200 μl) was aspirated from each patient before the surgery. The research
      was to evaluate the relationship between the cytokine profile in aqueous humor and the state
      of capsule after Lensectomy and Anterior Vitrectomy.Aqueous humor was obtained , Human
      Magnetic Luminex Screening Assay was used to determine the aqueous humor levels of cytokines.
    

Intervention name(s): secondary IOL implantation; primary IOL implantation
Intervention type(s): Procedure; Procedure
Intervention description(s): reopened the fibrotic, closed capsular bag and achieve IOL placement; lensectomy and anterior vitrectomy and primary IOL implantation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        congenital cataract age from 10 months to 72 months who underwent cataract surgery or
        aphakic children age from 15 months to 72 months who underwent secondary IOL implantation
      
Keywords: inflammatory cytokines
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or
      three times a day to children with non-severe community-acquired pneumonia.
    


Intervention name(s): Amoxicillin
Intervention type(s): Drug
Intervention description(s): amoxicillin 50mg/kg/day given in two different administration schemes
Other intervention name(s): Placebo with amoxicillin,in the opposite posologic scheme
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: children aged under 5 years; Non-severe
Foreign Body Removal With the Assistance of Ultrasound Guidance and Methylene Blue Staining in Children
Condition: Foreign Bodies; Ultrasound
MeSH terms: Foreign Bodies
Study type: Interventional

Summary: 
      Soft-tissue foreign bodies (FB) are very commonly observed in pediatric emergency
      departments. Some are metallic and can be diagnosed easily via X-ray radiography, whereas
      others are radiolucent and are hence less easily diagnosed. Not all FB can be removed
      effectively, even via open surgery and C-arm guidance. This deficiency may potentially be
      addressed through the ultrasound (US) skills instrument, which is increasingly popular and is
      convenient for use in the operation room. In the current study, we evaluated the efficiency
      of FB removal with the assistance of US and methylene blue (MB) staining.
    


Intervention name(s): US guidance and MB staining
Intervention type(s): Procedure
Intervention description(s): Ultrasound guidance and methylene blue staining
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of RPT193 in Healthy Adult Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.
    

Detailed description: 
      A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall
      mass balance of RPT193 in urine and feces
    

Intervention name(s): 14C RPT193
Intervention type(s): Drug
Intervention description(s): Radiolabelled RPT193
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability and efficacy of intranasal
      ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers
      experimentally inoculated with RSV
    


Intervention name(s): ALN-RSV01
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus
A Study of a Single Subcutaneous Dose of ALXN1210 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety and tolerability of a single dose of ALXN1210 subcutaneous
      (SC) compared to ALXN1210 intravenous (IV) in healthy participants and to determine the
      absolute bioavailability of ALXN1210 SC.
    

Detailed description: 
      The participants were randomly assigned in a 2:1 ratio to Cohort 1a in a blinded fashion to
      receive either a single dose of ALXN1210 SC 400 mg or single dose of placebo SC. The Safety
      Review Committee (SRC) evaluated the first 48 hours of postdose clinical safety data for
      participants in Cohort 1a to determine if enrollment into Cohorts 1b or 2 could begin.
      Following the SRC review, participants were randomly assigned in a 2:1 ratio to either Cohort
      1b or Cohort 2. Within Cohort 1b, participants were blinded and further randomly assigned in
      a 5:1 ratio to receive either a single dose of ALXN1210 SC 400 mg or a single dose of placebo
      SC, respectively. The participants in Cohort 2 received a single dose of ALXN1210 IV 400 mg
      in an open-label fashion. Safety, PK, PD, and immunogenicity assessments were performed on
      the follow-up period after the last dose.
    

Intervention name(s): ALXN1210 SC; ALXN1210 IV; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All doses of ALXN1210 SC were administered by four 100-milligram (mg) SC injections of 1 milliliter (mL) each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.; All doses of ALXN1210 IV were administered by IV infusion, using IV sets with in-line filters, at a maximum rate of 333 mL/hour, excluding interruption for safety or technical reason. There were at least 15 minutes between the end-of-infusion/injection in 1 participant and the start-of infusion/injection in the next participant.; All doses of placebo SC were administered by four 100-mg SC injections of 1 mL each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.
Other intervention name(s): Ravulizumab; Ultomiris; Ravulizumab; Ultomiris
Intervention MeSH terms: Ravulizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; ALXN1210; Safety; Immunogenicity
Role of Placenta Growth Factor in Sickle Acute Chest Syndrome
Condition: Anemia, Sickle Cell
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell
Study type: Observational

Summary: 
      The purpose of this research study is to find out whether Placenta Growth Factor (PlGF) and
      related tests can predict the development of acute chest syndrome (ACS) in patients with
      sickle cell disease (SCD) during a period where patients are well and during admission to the
      hospital for an acute sickle event to see if these measures can predict the development of
      ACS. Understanding events precipitating ACS may lead to preventative and interventional
      therapies which will improve patient outcomes and quality of life.
    

Detailed description: 
      The proposed research is a clinical study designed to test the hypothesis that PlGF levels in
      blood at baseline in patients with SCD will correlate with leukotriene (LT) levels and will
      be reflective of the degree of airway obstruction; and that acute elevations in PlGF levels
      will occur during an acute sickle event and precede clinical and radiological recognition of
      ACS. This is a biological study that does not fall into the criteria of a phase I-IV trial.

      Measurements will be done at two stages. First, patients who are admitted to the hospital
      with an acute sickle event will have a daily evaluation for the first 4 days of the admission
      or up until the patient has an ACS event. Measurements of inpatient spirometry (at primary
      site only) and impulse oscillometry will be performed daily. Measurements on 35 ACS events
      with ACS developing on the 3rd/4th day of admission will be collected. Measurements on
      patients developing ACS will be compared to those who do not develop ACS will allow for
      earlier prediction of ACS. Finally, patients who have an ACS or admission for an acute
      sickling event will be evaluated again after 3-4 weeks in order to get a baseline
      measurement. One hundred baseline measurements will be made. Twenty of these baseline
      patients will also have one or two additional baseline evaluations at subsequent clinic
      visits to evaluate the overall non-event baseline distribution and intra-subject baseline
      variability. Patients will have measurements repeated if admitted for an acute event greater
      than one year since the last baseline measurement . These measurements will be used to see if
      there is any prognostic information for a subsequent acute or ACS event. Some patients may
      only have baseline data collected.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will have sickle cell disease (HbSS, HbSC, or Hb Sbeta-thalassemia) and will
        be equal to or greater than 5.5 years old.
      
Keywords: Anemia, sickle cell
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521
      given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension
      (PAH).
    


Intervention name(s): Riociguat (Adempas, BAY63-2521); Riociguat (Adempas, BAY63-2521); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks; BAY63-2521: 1.5mg tid orally for 12 weeks; Matching Placebo tid orally for 12 weeks
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary arterial hypertension; PH; Stimulator
Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers
Condition: Healthy Adult
Study type: Interventional

Summary: 
      This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics
      and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The
      investigators will apply ranitidine and verapamil to the drug interaction study of metformin.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Diavex 1000mg on Day1 and 750mg on Day2
Other intervention name(s): Diavex®
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
DDI Between BI Empagliflozin (10773) and Verapamil
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Relative bioavailability of BI 10773 given alone and together with verapamil
    


Intervention name(s): Verapamil; BI 10773; BI 10773
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose verapamil; single dose BI 10773; single dose BI 10773
Intervention MeSH terms: Empagliflozin; Verapamil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sterimar Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The study aims to confirm the safety and performance of a hypertonic seawater-based nasal
      spray enriched with manganese and calcium, in relief/reduction of nasal symptoms (congestion,
      itchy nose, runny nose and sneezing) among subjects with symptomatic allergic rhinitis. This
      will be a prospective, longitudinal, single-cell and product blinded clinical trial. A
      sufficient number (65-70) of adult subjects with allergic rhinitis meeting all eligibility
      criteria will be enrolled in this study to ensure that approximately 50 subjects complete the
      study. Subjects will be enrolled during allergy season. The study will consist of four visits
      with a total duration of 3 weeks (1 week of pre-screening and 2 weeks for investigational
      product use). The full schedule of events is presented in the CIP. Subjects recruited for
      this study will be screened for inclusion/exclusion criteria after reading and signing the
      informed consent form. Eligible subjects who show a positive reaction to the skin prick test
      at Visit 1/ Day -7 will be enrolled for a one-week pre-run screening period. At baseline
      (Visit 2/Day 0), those subjects meeting all inclusion criteria including the results of the
      Total Nasal Symptoms Score will be enrolled in the active study phase. The subjects will use
      the product during two weeks (from Day 7 to Day 14), applying at least once and maximum 6
      times daily per instructions for use.

      At each visit within intervention period (Visits 2, 3 and 4), the subjects will be asked to
      assess their nasal and ocular symptoms (using Nasal Symptom Score and Ocular Symptom Score
      grading tools) before product application, as well as at 1 minute, 10 minutes and 1-hour
      post-product application. Besides, they will complete Weekly Rhinitis questionnaire for the
      past week. Additionally, the subjects will complete Daily Diaries to record their nasal and
      ocular symptoms, sleep disturbance, and need for use of other medication.
    


Intervention name(s): Seawater nasal spray
Intervention type(s): Device
Intervention description(s): Subjects will use the nasal spray (moderately hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and calcium) at least once and up to 6 times as necessary per day during the 14-day test period. Each application is composed of two irrigating sprays per nostril for a total of 4 sprays per application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how patients use and engage with a game-based mobile
      application that is designed to treat opioid use disorder.
    

Detailed description: 
      This is a randomized, controlled, open-label, decentralized study to evaluate patient
      engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use
      disorder.

      PEAR-008 is a new version of reSET-O, an FDA-authorized mobile application treatment
      (available by prescription only) for opioid use disorder. The study will examine if changing
      the application's delivery format and enhancing clinical content affects how patients use and
      interact with the intervention.

      Prospective participants will complete a short screening assessment and if eligible complete
      informed consent procedures at the beginning of the Baseline visit. Qualifying participants
      will attend weekly virtual study visits during the 8-week treatment period.

      In addition to weekly assessments, additional assessments will be administered at week 4 and
      week 8. Participants will be asked to complete a follow-up assessment 4 weeks after
      completing treatment.
    

Intervention name(s): reSET-O; PEAR-008
Intervention type(s): Device; Device
Intervention description(s): reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.; PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive either the game-based treatment (PEAR-008) or the original, FDA-authorized treatment (reSET-O).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: digital therapeutic
Capnography in Infants Ventilated With High Frequency Ventilation
Condition: Infants in NICU Ventilated With HFV
Study type: Observational

Summary: 
      The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a
      double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent
      the arterial CO2 (PaCO2).
    

Detailed description: 
      All infants with double lumen ETT on HFV are eligible.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants in NICU ventilated with HFV
      
Keywords: HVF; Premature infants; ETCO2
A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
Condition: Hypervascular Tumor and Arteriovenous Malformation
MeSH terms: Hemangioma; Arteriovenous Malformations; Congenital Abnormalities
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in
      Japanese subjects with hypervascular tumor or arteriovenous malformation
    


Intervention name(s): E7040
Intervention type(s): Device
Intervention description(s): E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypervascular tumor; arteriovenous malformation; arterial embolization
Brief Interventions on Smoking for Hormonal Contraceptive Users
Condition: Smoking
Study type: Interventional

Summary: 
      Despite rising smoker rates, particularly in girls and young women, only few studies have
      focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal
      setting to proactively intervene with young female smokers. Elevated health risks of smoking
      while using hormonal contraceptives could be a successful approach to gain young women's
      attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of
      a smoking cessation intervention for girls and young women visiting gynaecologist practices
      and using hormonal contraceptives.
    

Detailed description: 
      In the randomized controlled trial, female smokers aged 14-25 will be recruited in practices
      of gynaecologists. Intervention within the practice consists of a 30 minutes counseling
      session based on Motivational Interviewing, a standardised physician letter focusing on the
      elevated health risks of smoking while using hormonal contraceptives and a stage-matched
      self-help manual. After four weeks, an expert system feedback letter will be sent. In the
      intervention group, no smoking intervention will be given. Follow-up assessments will be
      conducted after 12 months, including saliva cotinine measures.
    

Intervention name(s): Brief intervention, Motivational Interviewing, Expert System
Intervention type(s): Behavioral
Intervention description(s): Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Brief Intervention; Smoking Cessation; Motivational Interviewing; Expert System; Readiness to Change; Hormonal Contraceptive; Adolescents
Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
Condition: Impotence
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to:

        1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the
           end of the double-blind phase

        2. To assess the relationship between treatment with sildenafil citrate or placebo and
           responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience
           Questionnaire (SEX_Q).
    


Intervention name(s): Sildenafil Citrate
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
Condition: Warm Antibody Autoimmune Hemolytic Anemia
MeSH terms: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the efficacy of fostamatinib in subjects
      with warm antibody autoimmune hemolytic anemia (wAIHA).
    


Intervention name(s): Fostamatinib disodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fostamatinib (100mg PO bid or 150 mg PO bid)
The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed.; Placebo
Other intervention name(s): R935788; Fostamatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: wAIHA; Warm Antibody Autoimmune Hemolytic Anemia; Warm Autoimmune Hemolytic Anemia