bioihbjkbjnl/mcl2 huggingface dataset:
PGE2 Levels in Patient Treated With NSAIDs
Condition: Ocular Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs
      (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.

      All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted
      vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples
      were immediately frozen and stored at -80°C until analysis.

      Sample analyses were performed using an high-performance liquid chromatography system. The
      lower limit of quantitation was 0.8 ng/mL.

      PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical
      Company) according to the manufacturer's instructions.
    


Intervention name(s): Placebo; Dicloftil; Nevanac; Indom; Yellox
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): Artificial tears for 3 days preoperatively; Dosing of drug 3 days prior to surgery; Dosing of drug 3 days prior to surgery; Dosing of drug 3 days prior to surgery; Dosing of drug 3 days prior to surgery
Other intervention name(s): Tears; Diclofenac Na 0.1% Oph Soln; Nepafenac 0.3% Ophthalmic Suspension; Indomethacin 5 MG/ML Ophthalmic Suspension; Bromfenac 0.09 % Ophthalmic Solution
Intervention MeSH terms: Diclofenac; Indomethacin; Nepafenac; Bromfenac; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vitreoretinal surgery; epiretinal membrane; macular hole; non steroidal antinflammatory drugs; prostaglandin E2
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Condition: Uncontrolled Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      An international, multi-center, prospective, randomized, controlled study of the safety and
      effectiveness of renal denervation in patients with uncontrolled hypertension.
    


Intervention name(s): Renal Denervation (Symplicity® Renal Denervation System)
Intervention type(s): Device
Intervention description(s): Catheter-based renal denervation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; renal denervation; sympathetic nervous system; RDN
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent
      to that for oral administration of tolvaptan 15-mg tablet will be investigated by
      administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with
      congestive heart failure.
    


Intervention name(s): OPC-61815 injection 2mg; OPC-61815 injection 4mg; OPC-61815 injection 8mg; OPC-61815 injection 16mg; Tolvaptan tablet 15mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.; Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.; Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.; Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.; Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess Platelet Dysfunction With Verify Now Assay
Condition: Platelet Aggregation Defects
Study type: Observational

Summary: 
      The purpose of this study is to conduct a Verify now assay to detect platelet aggregation
      defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura (ITP)
      and myeloproliferative disorders (MPD).
    

Detailed description: 
      Verify Now is a rapid, simple, point-of service assay to measure platelet aggregation. The
      verify now assay is designed to assess platelet function based on the ability of activated
      platelets to bind fibrinogen. It is hoped that this study will detect the subtle platelet
      functional abnormalities in patients with hematological disorders.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with platelet defects
      
Keywords: verify now assay for hematological disorders
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Respiratory Sounds
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the
      clinical diagnosis of asthma and the frequency of wheezing in infants and children with
      respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo)
      and have completed their last planned study-related visit in a feeding Phase 2 study
      (64041575RSV2004).
    

Detailed description: 
      RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis
      is that treatment of RSV-infected infants/children with lumicitabine (also known as
      JNJ-64041575 or ALS-008176) will decrease subsequent wheezing/asthma compared to placebo
      (looks like lumicitabine). The participants who have completed treatment course
      (lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the
      treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this
      study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in
      infants/children with a history of RSV infection. The participants will be assessed via
      monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.
    

Intervention name(s): Lumicitabine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.; Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Other
Effects of a Small Protein and Lipid Preload on Glucose Tolerance in Subjects With Impaired Glucose Homeostasis
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  to measure the size of the effect on glucose tolerance of a small mixed protein and
           lipid meal given as a pre-load in individuals with different glucose tolerance status

        -  to investigate the underlying mechanisms by accurately evaluating beta cell function,
           insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous
           production, rate of utilization) together with gut hormones plasma concentration.
    

Detailed description: 
      As supported by experimental and clinical data, oral carbohydrate tolerance is influenced by
      the coingestion of nutrients through multiple mechanisms. The ingestion itself, the contact
      with the gastric mucosa, the arrival into the intestine and the subsequent digestion are
      known to produce neural reflexes, hormonal responses and plasma substrates gradients which,
      by modulating gastric emptying, insulin secretion and insulin clearance participate in the
      regulation of postprandial glycaemia. The size of this effect is influenced by a number of
      factors: the specific nutrient chemical characteristics (fat vs protein and composition) and
      their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally
      the individual glucose tolerance status. To our knowledge, the effect on glucose excursions
      of a combination of protein and fat given before carbohydrate is still unknown and also
      unknown is the contribution of different mechanisms involved in the control of glucose
      homeostasis in subjects with different degrees of glucose tolerance.
    

Intervention name(s): Small mixed protein and lipid meal
Intervention type(s): Dietary Supplement
Intervention description(s): Ingestion of a small mixed protein and lipid meal 30 minutes before glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome
Condition: Periventricular Pseudocysts
Study type: Interventional

Summary: 
      The present study aims to improve the information given to the parents during the screening
      of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with
      retrospective cases screened during the last 5 years in university hospital of Bordeaux.
    

Detailed description: 
      Antenatal ultrasound screening for periventricular pseudocysts is steadily increasing,
      enabled in part by technological advances in ultrasound equipment.

      Most of studies dealing with periventricular pseudocysts and subsequent neurodevelopment are
      based on neonatal screening, mostly performed in neonatal units.

      Current data in the literature on the postnatal outcome of children screened antenatally are
      scarce; there are only 5 cohort studies with small numbers on the subject.

      The present study aims to improve the information given to the parents during the screening
      of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with
      retrospective cases screened during the last 5 years in university hospital of Bordeaux.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): questionnaire on postnatal development
Intervention model: Single Group Assignment
Intervention model description: questionnaire on postnatal development
Masking: None (Open Label)
Primary purpose: Other
Keywords: periventricular pseudocysts; postnatal development
Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction
Condition: Injury of the Anterior Cruciate Ligament (ACL)
Study type: Observational

Summary: 
      The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years
      after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct
      comparison to ACL reconstruction and to identify potential deficits compared to the
      contralateral healthy side as well as with a knee-healthy age-matched collective. In
      addition, socio-economic aspects such as return to work and sports and treatment cost will be
      compared between both techniques.
    

Detailed description: 
      Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the
      knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with
      direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel.

      The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest
      2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and
      functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM
      augmentation now in direct comparison to ACL reconstruction and to identify potential
      deficits compared to the contralateral healthy side as well as with a knee-healthy
      age-matched collective. In addition, socio-economic aspects such as return to work and sports
      and treatment cost will be compared between both techniques.
    

Intervention name(s): collection of Patient Reported Outcome (PRO) data; collection of anthropometric and clinical functional data; gait analysis
Intervention type(s): Other; Other; Other
Intervention description(s): collection of Patient Reported Outcome (PRO) data by questionnaires; collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity; gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent ACL reconstruction using an autologous hamstring tendon between
        03/18 and 04/20 at University Hospital Basel.

        30 age-matched control subjects without previous history of knee injury and/or surgery will
        be included for comparison.
      
Keywords: ACL rupture; primary ACL repair; ACL reconstruction using autologous hamstring tendons; InternalBraceTM Ligament Augmentation
To Investigate the Effects of Altering the Time of Day of Dosing (Morning or Evening) With Fluticasone Furoate 100 Micrograms Once Daily Administered Via a Dry Powder Inhaler in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effects of altering the time of day of dosing (morning or
      evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a
      dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose,
      double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect
      of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and
      female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable
      subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo
      AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days
      with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be
      approximately 13 to18 weeks for each subject.
    


Intervention name(s): Fluticasone Furoate (FF); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation powder 100 microgram per blister strip to be administered via dry powder inhaler either in the morning (AM dose with FF and PM dose with +/-2 days).; Placebo in single strip to be administered via dry powder inhaler in the morning and evening for 14 days (+/- 2 days).
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone Furoate, FF Inhalation Powder, morning dosing, evening dosing, efficacy, FEV1
A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the difference between the performance of a new enema
      (TF037) against Fleet enema in distal bowel cleansing.
    


Intervention name(s): TF037; Fleet enema
Intervention type(s): Device; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Effects of Anesthetic Methods on Hepatic Cancer Cell Function in Vitro
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional

Summary: 
      Numerous studies find that anesthetic methods may influence the recurrence of tumor and the
      overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is
      now widely used in the clinic for treatment of hepatocellular carcinoma (HCC). Currently,
      diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local
      anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients
      randomized to receive either GA or LA during surgery, we will investigate the effects of
      anesthetic methods on cellular invasion, migration and proliferation of HepG2 hepatic cancer
      cells in vitro. The expression levels of inflammatory cytokines in the serum from patients of
      both groups will also be analyzed.
    

Detailed description: 
      Patients diagnosed with hepatocellular carcinoma (HCC) undergoing elective radiofrequency
      (RF) ablation surgery will be randomly allocated to general anesthesia(GA) group or local
      anesthesia(LA) group.

      Patients from GA group will receive anesthesia induced with 0.05-0.1mg/kg intravenous
      midazolam, 3-6ug/kg fentanyl, 1.0-2.5mg/kg propofol and 0.1-0.2mg/kg atracurium. Laryngeal
      mask will be used to maintain ventilation. Anesthesia will be maintained with 4-8mg/kg/h
      propofol and 0.1-0.3ug/kg/min remifentanil, and additional non-depolarizing muscle relaxant
      when necessary. In patients from LA group, analgesia will be provided by a subcutaneous
      injection of 2% lidocaine by the surgeons before insertion of the needles.

      Serum will be collected from patients of both groups at before induction and 1h post-surgery.
      The HepG2 hepatic cancer cell line will be treated with patient serum from both groups. The
      effects of anesthetic methods on cellular invasion, migration, proliferation will be
      measured. The expression levels of inflammatory cytokines in the serum from patients of both
      groups will also be analyzed.
    

Intervention name(s): general anesthesia; local anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): the patient will receive general anesthesia during surgery in this group.; the patient will receive local anesthesia during surgery in this group.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF)
      and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female
      stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the
      other half will be operated with PP ones.
    


Intervention name(s): PVDF transobturator tape; Polypropylene transobturator tape
Intervention type(s): Device; Device
Other intervention name(s): Dynamesh-SIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary incontinence; Materials; Surgery; Transobturator tape; Polyvinylidene fluoride; Polypropylene
Primary Dysmenorrhea Severity in Athletic vs. Non-Athletic Females
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Observational

Summary: 
      The aim of the study is to investigate the difference in the severity of primary dysmenorrhea
      between athletic and non-athletic females.
    

Detailed description: 
      Primary dysmenorrhea is defined as colic pain in the lower abdomen which starts with the
      onset of menstruation. It is one of the most common gynecological disorders, an important
      cause of morbidity, and the most common cause of pelvic pain in menstruating girls and women
      it affects women in any age group. The prevalence varies widely, ranging from 17% to as high
      as 91%. Between 16% to 29% of women with dysmenorrhea have significant impairment in quality
      of life and the women's well-being. The rate of absenteeism from school, work, or other
      activities represents up to 15% of women with dysmenorrhea, dysmenorrhea is considered a
      source of considerable economic losses due to the costs of medications, medical care, and
      decreased productivity. Yoga, pilates, stretching, and other types of exercises have a
      noticeable effect on decreasing pain, and improving general health, and quality of sleep with
      different health conditions including primary dysmenorrhea. In addition, exercise and
      physical activity are used widely and proven to not only decrease pain but also improve
      quality of life, decrease stress, improve mental health, and in management of depression and
      stress.

      For dysmenorrhea the mechanism that explained the effect of exercises on primary dysmenorrhea
      has been classified according to the intensity of the exercises; moderate -high-intensity
      exercise was believed to increase the anti-inflammatory cytokines, decrease the overall
      amount of prostaglandins released because of the decrease of the overall amount of menstrual
      flow. Low-intensity exercise reduces cortisol levels and prostaglandin synthesis
    

Intervention name(s): no intervention it is considered (Epidemiological Study)
Intervention type(s): Other
Intervention description(s): It was a survey used Visual Analog Scale and WaLIDD scale to measure the severity of primary dysmenorrhea between both groups
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The athletic group will be selected from different clubs in Egypt for example; Benha,
        Tanta, Maadi, and Wadi-Degla clubs.

        Non- athletic will be selected from females and their their accompanying individuals