bioihbjkbjnl/mcl2 huggingface dataset:
Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
Condition: Focus of Study
Study type: Interventional

Summary: 
      As of today there is very limited scientific knowledge in whicj of the two vascular access
      devices (PICC-line or venous ports) that offers the lowest complicationrates in
      cancerpatients. The study group wants to clearify this unsolved matter by comparing the two
      systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are
      also looking at all catheter related complications and patient satisfaction.
    


Intervention name(s): PICC or subcutaneous venous port
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open label pragmatic
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
IVIg to Treat BK Viremia in Kidney Transplant Recipients
Condition: Kidney Transplantation; BK Virus; Isoantibodies
MeSH terms: Viremia
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this study is to rapidly improve clearance of BK viremia with
      Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies
      in renal transplant recipients that have had immunosuppression reduction due to BK viremia.
      Our approach is to perform a prospective, randomized, placebo controlled trial intravenous
      immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus
      placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney
      transplantation.
    


Intervention name(s): IVIg; Placebo
Intervention type(s): Biological; Other
Other intervention name(s): Privigen®
Intervention MeSH terms: Immunoglobulins, Intravenous
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of Two Marketed Lenses in a Controlled Environment
Condition: Eye Dryness
Study type: Interventional

Summary: 
      This study is comparing two silicone hydrogel contact lenses in a controlled environment for
      identification of characteristics associated to vision.
    


Intervention name(s): senofilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.; Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
Condition: Itching
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids.
      Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in
      postpartum patients and 69% in non-pregnant patients including males and females (1). Some
      researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and
      effective way to reduce the incidence and severity of hypotension during cesarean section
      under spinal anesthesia (2). In this new research I want to investigate the effect of slow
      injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence
      of itching In this double blind randomized study two hundred parturient will be randomly
      allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution
      with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All
      parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will
      be those with allergy to any medications, contraindications to spinal anesthesia, those who
      requested sedation, presence of skin lesions that may cause itching and opioid addiction.

      Parturient will be monitored regarding the incidence of itching, hypotension, nausea and
      vomiting. Onset and level of sensory block will also be recorded.
    


Intervention name(s): (R) Rapid spinal fentanyl injection; (S) Slow spinal fentanyl injection
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.; Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines
      for application site reaction (ASR) after administration of SPM 962 in healthy subjects
    


Intervention name(s): Topical steroid (Dexamethasone); Topical antihistamine (Diphenhydramine)
Intervention type(s): Drug; Drug
Intervention description(s): for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal; for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal
Intervention MeSH terms: Diphenhydramine; Promethazine; Dexamethasone; Histamine H1 Antagonists; Histamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SPM 962; rotigotine; application site reaction
Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring
      System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to
      evaluate the usability of the device when used by laypersons.
    

Detailed description: 
      The objectives for this study are to evaluate the blood glucose level results obtained from
      the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a
      reference device from one of three Android smart mobile device families as compared to the
      results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood
      Glucose Monitoring System when paired with a reference device from one of three Android smart
      mobile device families and used by laypersons is also evaluated.
    

Intervention name(s): Dario Blood Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Accuracy with usability assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Dolutegravir Renal Impairment Study
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of
      human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of
      Shionogi-ViiV Healthcare LLC. DTG is metabolized primarily by uridine diphosphate
      glucuronyltransferase (UGT)1A1, with a minor role of cytochrome P450 (CYP)3A, and with renal
      elimination of unchanged drug being extremely low (< 1% of the dose). Fifty-three percent of
      the total oral dose is excreted unchanged in the feces but it is unknown if all or part of
      this is due to unabsorbed drug or some percentage of biliary excretion of the glucuronide
      conjugate which can be further degraded to form the parent compound in the gut lumen. The
      current Food and Drug Administration (FDA) draft guidance for renal impairment studies states
      that a pharmacokinetic (PK) study in patients with renal impairment should be conducted even
      for those drugs primarily metabolized or secreted in bile, because renal impairment can
      inhibit some pathways of hepatic and gut drug metabolism and transport.

      This study is planned as an open label, single-dose, pharmacokinetic study to evaluate plasma
      DTG pharmacokinetics following oral administration to subjects with severe renal impairment
      (creatinine clearance < 30 ml/min) and matched healthy controls. Results from this study are
      expected to enable the development of appropriate dosing recommendations in patients with
      renal impairment.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): Dolutegravir 50 mg
Intervention type(s): Drug
Intervention description(s): Dolutegravir is an experimental drug in the integrase inhibitor class of HIV medications. There will be a one single dose of 50 mg.
Other intervention name(s): GSK1349572
Intervention MeSH terms: Dolutegravir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
Condition: Diagnostic Imaging
MeSH terms: Head and Neck Neoplasms; Breast Neoplasms; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)
      images obtained after a single intravenous injection of BAY86-9596 in patients with cancer
      and inflammation
    


Intervention name(s): BAY86-9596; BAY86-9596; BAY86-9596; Fludeoxyglucose (18F)-IBA
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine; Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.; Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.; Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
Intervention MeSH terms: Fluorodeoxyglucose F18
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Neoplasm; PET/CT diagnosis; PET tracer; Inflammation
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children
Condition: Coagulation Abnormalities
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or
      ventilation tubes insertion in children.

      A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time
      (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for
      further evaluation and recommendations before surgery.

      The purpose of this study is to summarize the causes of referrals in a cohort of 200 children
      and to assess the further laboratory analysis preformed and the results obtained.
    

Detailed description: 
      Data from about 200 children that were evaluated for abnormal coagulation tests performed
      before minor surgery.

      The data will include cause of referral, laboratory analysis performed and results.

      If the data allows the outcome of the operation and bleeding complications, will also
      recorded.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Data from about 200 children that were evaluated for abnormal coagulation tests performed
        before minor surgery.

        The data will include cause of referral, laboratory analysis performed and results.

        If the data allows the outcome of the operation and bleeding complications, will also
        recorded.
      
Keywords: Adenoidectomy; Tonsillectomy; Ventilation Tubes; Preoperational screening; Coagulation Profile; Lupus anticoagulant
Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is designed to evaluate the effect of koji-extracted beverage fermented with
      Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.
    


Intervention name(s): Placebo; Koji-extracted beverage fermented with Pediococcus pentosaceus LP28
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Program for Caregivers Involved With Mental Health Services
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting
      intervention for implementation with female adult caregivers who have or are at risk for
      long-term interpersonal conflict with family members, children, or significant others and are
      caring for a child between the ages of birth and 7 years.
    

Detailed description: 
      The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting
      intervention (Parenting from the Inside Out or PIO) originally developed for substance
      abusing mothers (as part of an ongoing NIDA-funded treatment development study; R01 DA17294)
      for implementation with female adult caregivers who have or are at risk for long-term
      interpersonal conflict with family members, children, or significant others and are caring
      for a child between the ages of birth and 7 years. The PIO intervention involves 12-24 weekly
      1 hour individual therapy sessions with Masters level therapists who are trained and
      supervised by Dr. Suchman (the Principal Investigator) in the PIO approach.
    

Intervention name(s): Mentalization based therapy
Intervention type(s): Behavioral
Intervention description(s): 12-24 weekly 1 hour individual therapy sessions with Masters level therapists who are trained and supervised by Dr. Suchman (the Principal Investigator) in the Parenting from the Inside Out approach. The broad goals of the program are to help prevent the onset of substance abuse and psychiatric disorders, promote adaptive interpersonal relationships and social-emotional functioning in caregivers and their children, and help prevent the transmission of psychiatric illness across generations
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parenting; Mental Illness; Maternal sensitivity; Parent-child relationship
Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.
Condition: Cardiovascular Resuscitation; Venovenous Extracorporeal Membrane Oxygenation
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment
      and optimal on-site resources. The population of patients treated by venovenous
      extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging
      group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in
      these patients have not been studied. We are aiming to conduct a retrospective observational
      study of all vv-ECMO patients treated at our ARDS centre.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) for
        respiratory failure in acute respiratory distress syndrome (ARDS). And in addition required
        mechanical cardiovascular resuscitation treatment during existing therapy with veno-venous
        extracorporeal membrane oxygenation (vv-ECMO).
Computed Tomography-Guided Nasotracheal Intubation Procedure
Condition: Computed Tomography-guided Nasotracheal Intubation; The Space Where the Tube Will be Passed in the Internal Nasal Valve Region
MeSH terms: Epistaxis
Study type: Observational

Summary: 
      Background: Nasotracheal intubation can lead to severe complications like epistaxis with
      excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is
      one of the fundamental causes of this condition. The present study aimed to evaluate the
      effectiveness of Computed tomography-guided nasotracheal intubation in predicting tube
      advancement difficulty and preventing epistaxis.

      Material and Methods: 60 maxillofacial surgery patients were included in the study. The space
      where the tube will be passed in the internal nasal valve region was measured horizontally
      (distance between inferior concha and septum) and vertically (distance between inferior
      concha and hard palate) by Computed Tomography. The patients were divided into two groups,
      'easy' (n=28) or 'difficult' (n=32), according to the effort required to advance the tube
      through the nasal passage.

      ROC analysis was performed, and cut-off values were determined to reveal the distance values
      at which difficulty may be experienced while advancing the tube. The cut-off values were 1.09
      cm and 0.39 cm for the vertically and horizontally distances, respectively.
    


Intervention name(s): computed tomography-guided nasotracheal intubation
Intervention type(s): Procedure
Intervention description(s): Before intubation, the lower part of the nasal valve region, aka the narrowest area of the nasal passage, was measured by calculating the distance between the anterior border of the inferior concha and the septal cartilage
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sixty health volunteers who went orthognathic surgery
      
Keywords: Computed Tomography; epistaxis; Maxillofacial Orthognathic Surgery; Intubation
Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
Condition: Progressive Keratoconus
MeSH terms: Keratoconus
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in
      impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with
      progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to
      penetrate the cornea without the need to remove the epithelium, the outer most layer of the
      cornea.
    

Detailed description: 
      Up to 275 study eyes with progressive keratoconus will be enrolled. Study eyes will be
      randomized in a 2:1 ratio to receive CXL treatment or sham/control treatment.The primary
      efficacy endpoint is a difference of ≥ 1 diopter between treatment groups in the mean change
      in Kmax from baseline to Month 6.
    

Intervention name(s): Test Article A; Test Article B; Placebo; KXL medical device system; KXL medical device system
Intervention type(s): Drug; Drug; Drug; Device; Device
Intervention description(s): Riboflavin Ophthalmic Solution A; Riboflavin Ophthalmic Solution B; Placebo Vehicle of Test Article; Mock UVA light source; Cross-linking UVA light source
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization was by eye (active or sham). However an individual participant could receive active/active, active/untreated, sham/sham, sham/untreated or active/sham
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate
      during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid
      Cycling.
    


Intervention name(s): quetiapine fumarate or valproate
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder I or II with Rapid Cycling
Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects
Condition: Malignant Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aimed to assess the effects of omeprazole on single-dose SHR2554 in healthy
      subjects, exploring the pharmacokinetic changes of SHR2554 and ensuring the safety when
      SHR2554 is co-administered with omeprazole.
    


Intervention name(s): SHR2554 tablet dosing; Omeprazole tablet dosing
Intervention type(s): Drug; Drug
Intervention description(s): SHR2554 350mg taken on Day 1 and Day 10; Omeprazole taken from Days 5 to Day 10
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-dose, two-period, fixed sequence, self-controlled study
Masking: None (Open Label)
Primary purpose: Treatment