bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block
Condition: Pain, Postoperative; Serratus Anterior Plane Block; Thoracic Paravertebral Block; Multimodal Analgesia; Thoracic Surgery, Video-Assisted
MeSH terms: Aortic Dissection; Pain, Postoperative
Study type: Interventional

Summary: 
      Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery.
      Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods
      such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block
      (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods,
      ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of
      application of plane blocks as a component of multimodal analgesia has been increased. ESPB
      and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB
      (DSAPB) application, a local anesthetic agent is given under the serratus anterior muscle. In
      the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the
      serratus anterior muscle. Since it is done by entering from the same point in two
      applications, it is possible to perform these two applications at the same time with a single
      needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery
      operations are also different from each other. Therefore, it may be possible to obtain a more
      effective analgesic effect in patients by combining the mechanism of action of DSAPB and
      SSAPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB
      and combined SAPB (CSAPB) after VATS.
    


Intervention name(s): Combined Serratus Anterior Plane Block; Thoracic Paravertebral Block
Intervention type(s): Procedure; Drug
Intervention description(s): Combined deep and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.; Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.
Other intervention name(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Condition: Nasal Congestion Associated With the Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in
      children for the temporary relief of nasal congestion due to the common cold, an indication
      described under 21 CFR 341.80(b)(1).
    


Intervention name(s): pseudoephedrine hydrochloride 30 mg tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of micronized
      dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection,
      USP placebo control for the treatment of knee osteoarthritis
    

Detailed description: 
      Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for
      efficacy and safety during a 12-month observation period. A second injection (open-label
      access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and
      365-day time points, it may only be used once. Blinding for the first injection treatment
      allocation will be maintained until the end of the study.

      Subjects who receive the open-label access treatment will continue to be followed for 180
      days after this second injection, regardless of the time at which treatment was received.
    

Intervention name(s): Micronized dHACM; Saline
Intervention type(s): Biological; Drug
Intervention description(s): Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP; Injection of 1 mL 0.9% Sodium Chloride, USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Consequences of a Maternal-fetal Chikungunya Virus Infection
Condition: Chikungunya Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Chikungunya Fever
Study type: Interventional

Summary: 
      Chikungunya is an infectious disease caused by an alphavirus transmitted by the Aedes
      mosquitoes which has known a worldwide expansion since its re-emergence in 2004. Regarding to
      an unprecedented epidemic, Reunionese pediatricians described in 2005-2006 a vertical
      maternal-fetal transmission of this virus, at the time of childbirth. Since then, this mode
      of transmission has been widely confirmed, with an absolute risk estimated between 15.5% and
      48.3%. The main consequences for the child are neuromotor, neurosensory or neurocognitive.
      They were studied around the age of 2 in 33 children in the CHIMERE cohort, as well as at the
      age of 5 in a small fraction of these children followed at the C.A.M.S.P (Center for Early
      Medico-Social Action). The results suggested an overall delay in psychomotor acquisitions
      secondary to neonatal infection, affecting the functions of the prefrontal region (in
      particular coordination and language). Performance was correlated with the severity of the
      clinical presentation (more severe in case of encephalitis or encephalopathy) while remaining
      suboptimal in children with uncomplicated infection. During neurodevelopmental monitoring,
      other disturbing traits complemented the spectrum of problems presented by these children,
      such as microcephaly, cerebral palsy, epilepsy, interaction disorder or attention deficit
      disorder. At around age 10, the investigators reassessed 21 of these children using the
      Childhood Cognitive Function and Learning (EDA) screening test. The investigators would now
      like to confirm and characterize their impairments using a battery of confirmatory tests
      around the age of 13.
    


Intervention name(s): OPHTHALMOLOGICAL ASSESSMENT; NEUROPSYCHOLOGICAL ASSESSMENT
Intervention type(s): Other; Other
Intervention description(s): assessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination; completion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as a single ascending dose study in healthy subjects to evaluate
      safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and
      Cerebrospinal (CSF) following single oral doses of E2212.
    


Intervention name(s): E2212; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single ascending doses ranging from 10mg to 250mg; a single dose of matching placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection
Condition: Liver Cancer
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      This prospective non-randomized controlled trial aims to determine whether autotransfusion of
      red blood cells salvaged before liver resection is associated with the recurrence-free
      survival in patients with hepatocellular carcinoma.
    

Detailed description: 
      Preoperative and intraoperative blood salvage autotransfusion is used in various surgical
      procedures. However, because of the risk of reinfusion of salvaged blood contaminated by
      tumor cells, the use of autotransfusion in hepatocellular carcinoma (HCC) patients undergoing
      liver resection is controversial. The critical points include whether tumor cells can be
      cleared by autotransfusion, whether autotransfusion increases the risk of recurrence or
      metastasis, and what are the indications for autotransfusion. Moreover, some other issues are
      still not addressed. For example, is it warranted to take the risk of tumor dissemination by
      using autotransfusion to avoid allogeneic blood transfusion? Do the remaining tumor cells
      after additional filtration by leukocyte depletion filters still possess potential
      tumorigenicity?
    

Intervention name(s): Autotransfusion; Control group
Intervention type(s): Procedure; Other
Intervention description(s): These group of patients will receive autotransfusion before liver resection.; These group of patients will not receive autotransfusion before liver resection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      Young infants are most vulnerable to severe disease and even death when infected with
      Bordetella pertussis. The current vaccines and vaccination programs do not guarantee
      protection of neonates from this disease. Maternal acquired pertussis-specific antibodies
      show low concentrations with short persistence in newborns creating a susceptibility gap for
      infection between birth and the first vaccinations. A possible strategy to protect infants
      from birth is pertussis vaccination during pregnancy, which will increase the amount of
      passively transferred maternal antibodies.

      However, little is known regarding the effect of high titers of maternal antibodies on the
      infants immune responses to different pertussis vaccines (whole cell versus acellular).
      Humoral immune responses will be assessed in infants receiving whole cell versus infants
      receiving acellular pertussis vaccines. Functionality of the antibodies will also be
      analyzed.
    


Intervention name(s): Boostrix; Infanrix hexa; Quinvaxem; OPV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.; Children from group A will be vaccinated with an acellular pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.; Children from group B will be vaccinated with a whole cell pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.; Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Other intervention name(s): Acellular pertussis containing vaccine; Acellular pertussis containing vaccine; Whole cell pertussis containing vaccine; Oral Polio Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Pregnancy; Humoral immune response; Functionality; Vaccination
Inflammatory Response to Opioid Versus Opioid Free Anesthesia
Condition: Morbid Obesity; Opioid Use; Fentanyl Adverse Reaction; Cytokine Storm
MeSH terms: Obesity, Morbid; Cytokine Release Syndrome
Study type: Interventional

Summary: 
      Anesthetic agents, including opioids can modulate the altered immune function in patients
      with obesity through mechanisms that involve the expression and release of cytokines. For
      this reason, anesthetic care in patients with obesity remains controversial. Therefore, the
      aim of the study was to compare the effect of opioid-containing anesthesia vs opioid-free
      anesthesia using the Cortínez-Sepúlveda model on serum levels of IL-6, IL-1β and TNF-α before
      and after surgery in obese patients undergoing bypass surgery.

      Methods: A randomized cross-sectional study of 40 unrelated obese adults was performed in the
      Anesthesiology and Bariatric Surgery Service at the Civil Hospital of Guadalajara "Dr. Juan
      I. Menchaca". Before undergoing laparoscopic Roux-en-Y gastric bypass, patients were randomly
      assigned to two anesthesia groups: opiod-containing (n=20) or opioid-free (n=20). The opioid
      used in the opioid-containing anesthesia group was fentanyl. To characterize the disposition
      of intravenous propofol for the target-controlled infusion technique in obese patients, the
      Cortínez-Sepúlveda pharmacokinetic model was used. Body mass was determined to the nearest
      0.05kg using a balance scale (Seca 703; Seca, Hamburg, Germany). Blood samples were taken
      before and immediately after surgery and cytokine serum levels were determined with ELISA
      kits. Statistical analyses were performed using the IBM Statistical Package for the Social
      Sciences software package version 20.0 (IBM Corp., Armonk, NY, USA).
    


Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): TIVA opioid-containing anesthesia: fentanyl in a bolus dose of l3 mcg/kg (corrected weight) TIVA opioid-free anesthesia: dexmedetomidine 1-1.5 mcg/kg (corrected weight) for 40 minutes
Intervention MeSH terms: Fentanyl
Intervention model: Single Group Assignment
Intervention model description: Patients were randomly assigned to two anesthesia groups: opioid-containing (n=20) or opioid-free (n=20). The opioid used in the opioid-containing anesthesia group was fentanyl.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Morbid obesity; Gastric bypass; Opioid containing anesthesia; Opioid free anesthesia; Cytokines
The Effect of High-intensity Laser Therapy in Patients With Chronic Shoulder Pain
Condition: Chronic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of biostimulating, analgesic and
      noninvasive high intensity laser therapy on pain, functionality and quality of life in
      patients with chronic shoulder pain. Participants between the ages of 18-75 and without any
      cognitive, communication and psychiatric problems were included in the study. Patients were
      randomized into two groups and both received conventional physiotherapy and rehabilitation
      program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the
      control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional
      physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was
      evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer';
      disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.
    

Detailed description: 
      The aim of this study was to investigate the effects of biostimulating, analgesic and
      noninvasive high intensity laser therapy on pain, functionality and quality of life in
      patients with chronic shoulder pain. Participants between the ages of 18-75 and without any
      cognitive, communication and psychiatric problems were included in the study. Patients were
      randomized into two groups and both received conventional physiotherapy and rehabilitation
      program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the
      control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional
      physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was
      evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer';
      disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.
    

Intervention name(s): Conventional physiotherapy; High-intensity laser therapy (HILT)
Intervention type(s): Other; Device
Intervention description(s): Conventional therapy (CT) included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation, 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and exercises.; HILT stimulates oxidation of mitochondria and ATP creation by delivering high energy output inside the tissues and with this photochemistry effect, metabolism and blood circulation is increased resulting HILT to cause quick absorption of edema and removal of exudates.
HILT (BTL 6000, BTL Industries, Inc., USA) application was to the shoulder area in the analgesic mode of the device at a frequency of 25 Hz with a power of 10 W and a dosage of 12 j/cm2 for 2 minutes: 5 sessions a week for 3 weeks and 15 sessions in total.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center, multiple-dose, randomized, double-blind,
      placebo-controlled, parallel-group study in healthy male and female subjects. The study will
      consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and
      Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be
      conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by
      the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel
      with the 10-mg cohort of Part A, with the possibility of overlap.
    


Intervention name(s): E2006 2.5 mg; E2006 10 mg; E2006 25 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Condition: Kaposi´s Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Kaposi sarcoma remains the most common malignancy among persons with HIV.

      Lesions localized to the airway may cause bleeding, pain and dyspnea.

      New therapeutic approaches for local disease are needed.

      The purpose of this study is to compare the effectiveness of intralesional bevacizumab +
      HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with
      AIDS.
    

Detailed description: 
      Once disseminated disease is excluded, histologically confirmed HIV-positive patients with
      localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART +
      intralesional bevacizumab.

      The primary outcome will be the size of lesions according to RECIST criteria. Patients in the
      HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3.
      Follow-up will be carried out through scheduled meetings for office setting examination every
      week for the first 8 weeks, then every 15 days for two months and finally every month for
      eight months.

      Size of the lesions will be assessed by an independent observer and adverse events will be
      recorded.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kaposi sarcoma; HIV; Bevacizumab
Clinical & Community Approaches to Weight Management
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This project seeks to build on innovative strategies to optimize the care of low-income
      children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement
      a new clinical-community intervention, theoretically grounded in the Integrated Clinical and
      Community Systems of Care Model, to address obesity through optimized screening and
      management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy
      Weight and Your Child weight management program (originally known as MEND). The study will
      examine outcomes for children that matter most to a broad group of stakeholders including
      parents, clinicians, and public health practitioners as well as inform the care of >7 million
      children with obesity covered by the Children's Health Insurance Program or Medicaid.
    

Detailed description: 
      This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management
      intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center
      (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A
      comparison sample of children receiving care in eight demographically similar FQHCs serve as
      a comparison group.
    

Intervention name(s): Healthy Weight Clinic; Healthy Weight and Your Child
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program.
A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment