bioihbjkbjnl/mcl2 huggingface dataset:
Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
Condition: Liver Failure; Liver Diseases; Liver Cancer; Liver Neoplasms; Liver Dysfunction
MeSH terms: Liver Neoplasms; Liver Diseases; Liver Failure
Study type: Interventional

Summary: 
      Comparison of biliary complications in right lobe living donor liver transplantation patients
      undergoing biliary reconstructions using microscope versus surgical loupes .
    

Detailed description: 
      Liver transplantation (LT) is the most effective treatment modality in patients with
      end-stage liver disease and it is also established as a viable treatment option in the field
      of oncology. Living donor liver transplantation (LDLT) using the right lobe (RL) is a major
      achievement despite its technical challenges, which has created a significant increase in
      graft supply. While a secure bile duct anastomosis is one of the basic principles of a
      successful liver transplant procedure, biliary reconstruction remains the Achilles' heel of
      LDLT because of the high incidence of posttransplant biliary complications associated with
      significant recipient morbidity and mortality. Some of these complications are related to
      technical difficulties due to multiple small biliary orifices, particularly in right lobe
      grafts. In our center, we have been using microsurgical reconstruction technique for
      duct-to-duct biliary anastomosis in such grafts. The routine use of this technique has been
      shown to significantly decrease biliary complications in single-center retrospective studies.
      However, prospective controlled studies comparing microsurgical and standard biliary
      reconstruction techniques are lacking. In this study, our objective is to compare
      posttransplant complications of the two techniques of biliary reconstruction in RL LDLT.

      40 patients will be included in the study. They will be randomly allocated in the equal
      groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2
      biliary anastomosis will be performed using microscope. The patients will be followed for one
      year after the transplant to compare biliary complications.
    

Intervention name(s): Surgical Loupes; Microscope
Intervention type(s): Other; Other
Intervention description(s): Biliary reconstruction will be performed using surgical loupe; Biliary reconstruction will be performed using microscope
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation; Living donor liver transplantation; Biliary anastomosis
High Versus Low Dose of Caffeine for Apnea of Prematurity
Condition: Apnea; Preterm Infants
MeSH terms: Apnea
Study type: Interventional
Phase: Phase 3

Summary: 
      The optimum caffeine dose for apnea of prematurity has not been well investigated so the
      objective of the study is to compare high versus low dose of caffeine citrate to facilitate
      successful extubation in mechanically ventilated preterm infants.
    

Detailed description: 
      A randomized, double blind, clinical trial which will be conducted in Neonatal Intensive Care
      Unit, Mansoura University Children Hospital, Egypt on preterm infants born less than 32 weeks
      gestation mechanically ventilated within the first 10 days of life to study the optimum
      caffeine dose for apnea of prematurity and compare High dose (loading 40 mg/kg/day equivalent
      to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day
      of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of
      caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base)
      caffeine citrate started within the first 10 days of life and its effect on need of
      re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome
      and frequency and duration of apnea, duration of mechanical ventilation and oxygen support,
      length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis,
      intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of
      prematurity, and caffeine side effects as secondary outcomes.
    

Intervention name(s): Caffeine citrate
Intervention type(s): Drug
Intervention description(s): Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2
Intervention MeSH terms: Caffeine; Caffeine citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: high dose of caffeine; low dose of caffeine; prevention
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect
      intravenous drug users from becoming infected with HIV.
    

Detailed description: 
      Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes
      infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior
      effects associated with study participation are assessed.
    

Intervention name(s): MN rgp120/HIV-1 and A244 rgp120/HIV-1
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Recombinant Proteins; HIV-1; AIDS Serodiagnosis; Substance Abuse, Intravenous; Enzyme-Linked Immunosorbent Assay; Blotting, Western; HIV Envelope Protein gp120; AIDSVAX
Evaluation of SAFER Latinos' Program to Prevent Youth Violence
Condition: Violence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an evaluation of a primary prevention program to prevent youth violence by improving
      family cohesion, networking among families, school bonding, and access to services for
      Latinos in Langley Park, MD.
    

Detailed description: 
      To prevent youth involvement in violence, outreach workers will work with families and youth
      to improve school bonding, family cohesion and awareness and utilization of existing
      services; and a youth drop-in center will provide youth with an adult supervised place to
      "hang out", do homework, or participate in sports and job training.

      Following implementation of the intervention, we will collect detailed process data
      (regarding implementation), and evaluate impact/outcome using a quasi-experimental design
      with baseline (prior to intervention) and two followup data collections in both the
      intervention and a control community (Culmore, Virginia), measuring change in a selected set
      of aggregate community variables that represent mediating factors and outcomes for youth
      violence in Langley Park. Data will be collected via a survey and focus groups.
    

Intervention name(s): SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)
Intervention type(s): Behavioral
Intervention description(s): community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;
youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence;
school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;
Youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: violence
Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury
Condition: Ischemic Reperfusion Injury; Liver Injury; Cancer Recurrence; Malignancy; Liver Cancer
MeSH terms: Neoplasms; Reperfusion Injury; Ischemia; Recurrence; Wounds and Injuries
Study type: Observational

Summary: 
      Severe ischemic changes of the liver remnant after hepatectomy could expedite tumor
      recurrence on the residual liver. Our study aimed at assessing the effect of warm
      ischemic/reperfusion (I/R) injuries on surgery-to-local recurrence interval and patient
      overall survival, during major hepatectomies under inflow and outflow vascular control.
    

Detailed description: 
      One hundred and eighteen patients were subjected to liver resection under total inflow and
      outflow vascular clamping and were assigned as study group. These individuals were
      retrospectively matched to 112 counterparts, who underwent liver surgery applying inflow and
      outflow vascular clamping only of the segment harboring the tumor, sparing the liver remnant
      from any I/R injury (control group). The two cohorts were compared regarding recurrence-free
      survival and overall survival.
    

Intervention name(s): selective hepatic vascular exclusion; semielective hepatic vascular exclusion
Intervention type(s): Procedure; Procedure
Intervention description(s): major hepatectomy with vascular control of blood inflow and outflow of the whole liver; major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        retrospective analysis of an internal hepatectomy database
      
Keywords: ischemia reperfusion injury; liver surgery; cancer recurrence; malignancy; hepatectomy
Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)
Condition: Hereditary Tyrosinemia, Type I
MeSH terms: Tyrosinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1)
      and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are
      bioequivalent to the reference product Orfadin 10 mg hard capsules.
    

Detailed description: 
      The specific aim is to conduct a randomized, single dose, three-period crossover
      bioequivalence study in at least 18 healthy male and female subjects at a single study center
      to evaluate the in vivo performance of two formulations of Nitisinone 10 mg and the reference
      product Orfadin under fasting.

      A total of 24 healthy female and male volunteers (age 18 to 55 years old) will be entered
      into the study. Volunteers will be determined to be free of significant medical conditions as
      assessed by medical history, physical examination, and blood and urine tests. Volunteers will
      be randomly allocated to a treatment sequence, before administration of investigational
      medicinal product (IMP) under fasting conditions.

      There will be a minimum 23 calendar days washout between treatments. Blood samples will be
      collected at pre-dose (0 hours) and at 15 minutes, 30 minutes, 1 hour, 2 hours, 2 hours and
      30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10
      hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours post-dose
      (total: 21 samples per treatment period).
    

Intervention name(s): Nitisinone; Nitisinone Baked Tablet; Orfadin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of Nitisinone 10 mg Tablet will be administered.; A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.; A single oral dose of Orfadin 10 mg hard capsule will be administered.
Other intervention name(s): Nitisinone (Baked); Nitisinone
Intervention MeSH terms: Nitisinone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HT-1; Tyrosinemia; Nitisinone; Bioavailability; Healthy Volunteer; Food-Effect
EMLA and Sterile Water Injections - Pain From Injections
Condition: Pain
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile
      water injections.
    

Detailed description: 
      Sterile Water Injection (SWI) was previously shown to give good pain relief for lower-back
      pain during childbirth, chronic neck pain and ureterolithiasis. However, the pain associated
      with the injections remains problematic, and therefore it is important to find a less painful
      injection technique.
    

Intervention name(s): EMLA patches
Intervention type(s): Other
Intervention description(s): EMLA patches 1.5 hrs before sterile water injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sterile water injections; Pain; VAS; Complementary method
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
Condition: Common Cold; Influenza
MeSH terms: Infections; Influenza, Human; Virus Diseases; Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective
      and safe in the treatment of influenza and other acute respiratory viral infections in the
      course of standard therapy in 3-6 years old patients.
    


Intervention name(s): Imidazolyl ethanamide pentandioic acid; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Ingavirin
Intervention MeSH terms: Pentanedioic acid imidazolyl ethanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ingavirin; Common Cold; Influenza; Acute Respiratory Viral Infections; pediatric clinical trial; Imidazolyl ethanamide pentandioic acid
Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone
      deficient adults
    


Intervention name(s): NNC126-0083; NNC126-0083; NNC126-0083; NNC126-0083; placebo; placebo; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Other intervention name(s): pegylated long-acting human growth hormone; pegylated long-acting human growth hormone; pegylated long-acting human growth hormone; pegylated long-acting human growth hormone
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses
Condition: Inflammation; Obesity; Inflammatory Response; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      This study will investigate the effect of a 7-day westernised high-fat (65% of kilocalories),
      high-calorie (150% of requirements) diet on markers of inflammation in the blood and white
      adipose tissue. Participants will firstly complete a 3-day weight maintenance phase (Days
      1-3) before completing a 7-day high fat diet intervention (Days 4-10). On days 4 and 11
      participants will complete a laboratory visit where anthropometric measurements, blood and
      adipose samples will be collected.

      The investigators hypothesise that consuming a high-fat, high-calorie diet for 7 days will
      alter the inflammatory responses in white adipose tissue and will induce metabolic
      endotoxaemia / systemic inflammation.
    


Intervention name(s): High Fat Diet
Intervention type(s): Other
Intervention description(s): Participants will consume a high fat diet for 7 days with 65% of energy from fat. The diet will also provide an energy excess at 150% of energy requirements.
Participants will be provided with all of their meals and snacks throughout the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Screw Lengths in Radius Volar Plates
Condition: Radius; Fracture, Lower or Distal End; Tendon Injury - Upper Limb; Fracture Fixation, Internal
MeSH terms: Fractures, Bone; Tendon Injuries; Radius Fractures
Study type: Observational

Summary: 
      Background Fractures of the distal radius are among the most common. Major complications,
      including irritation and rupture of the extensor tendons, may occur if epiphyseal screws of
      inappropriate length are used.

      Questions/Purposes The main objective of the present study was to determine whether the
      optimal epiphyseal screw length can be determined by reference to the diaphyseal screw
      length.

      Methods Forty CT scans were semi-automatically segmented. A 3D model of the volar plate was
      affixed to each distal radius with simulation. The maximum lengths of the diaphyseal screws,
      as well as the four distal epiphyseal screws, were measured. Linear regression analysis was
      performed.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that underwent for a CT-Scan of the distal radius from October 2016 to February
        2018
      
Keywords: Bone trauma-fracture; Radius; CT-scan; Internal fixation
Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with
      diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using
      Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global
      Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week
      treatment period after randomization into the trial. Secondary efficacy is improvement of
      mobility Treatment effect will be compared in a 2-1 Apitox vs active control
    

Detailed description: 
      feasibility and Site selection has been completed in the US and India
    

Intervention name(s): Apitox, purified honeybee toxin, lyophilized in saline; histamine
Intervention type(s): Biological; Biological
Intervention description(s): intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections; imitates pain and erythema of honeybee venom
Other intervention name(s): Apitoxin in Korea
Intervention MeSH terms: Histamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: honeybee toxin; Apitox; pain; inflammation; osteoarthritis; Apitoxin
Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This pragmatic trial will compare two team-based care models for managing hypertension, Best
      Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care
      system in Minnesota. Clinics in the study are randomized to offer one of the two treatment
      models to participants with uncontrolled hypertension.

      The investigators aim to determine a) whether one model is more effective than the other for
      lowering patient's blood pressure and b) which model patients prefer.
    

Detailed description: 
      The objectives of the study are:

      Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and
      other outcomes important to patients: best-practice clinic-based care and home-based
      telehealth care.

        -  Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care,
           patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in
           systolic blood pressure over 12 months of follow-up.

        -  Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care,
           patients in clinics assigned to telehealth care will report: a) fewer treatment side
           effects; b) better ratings of patient experience of hypertension care; and c) higher
           self-monitoring rates and confidence in self-care.

      Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the
      telehealth care and clinic-based care interventions using a mixed-methods approach supported
      by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).
    

Intervention name(s): Best Practice Clinic-Based Care; Telehealth Care
Intervention type(s): Other; Other
Intervention description(s): Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote:
Improved recognition of uncontrolled BP at primary care encounters,
Therapeutic action to address uncontrolled BP at primary care encounters,
Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.; All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically:
Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device
Systematic home BP telemonitoring with data transmitted into patient medical record
Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinic care; Team-based care; Medication Therapy Management (MTM); Telehealth; Cluster-randomized; Home blood pressure monitoring; Pharmacist