bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Buzzy and Puppet on Pain and Fear
Condition: Pain; Fear; Nurse's Role
Study type: Interventional

Summary: 
      Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy,
      external vibrating cold application, and the use of puppets on pain and fear in children aged
      3 to 6 years during phlebotomy.

      Method: This study is a randomized controlled trial. The study was conducted with 105
      children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital.
      The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet;
      group 3, control) by block randomization. Children's pain and fear scores were evaluated
      using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report,
      after phlebotomy, their parents, and the nurse who attempted phlebotomy.
    


Intervention name(s): Implementation of Bee Buzzy; Implementation of Puppet Zuzu
Intervention type(s): Procedure; Procedure
Intervention description(s): Implementation of Bee Buzzy It is defined as the use of a device called Bee Buzzy, which applies cold and vibrates in the form of a toy bee, by the researcher for fear and pain during phlebotomy in children.
Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this application, the researcher puts the Bee Buzzy device on the child's arm just above the area from which blood was taken, and remains attached to the arm during the phlebotomy procedure. This device applies cold and vibrates. Pain and fear during the procedure are evaluated by the researcher, the nurse, and the child's parent.; Implementation of puppet zuzu It is defined as the use of a puppet that is seized and made to talk by the researcher for fear and pain during phlebotomy in children.
Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this practice, a puppet is seized by the researcher and made to talk, and the child's attention is tried to be drawn. While this procedure is in progress, the researcher, the nurse, and the child's parent evaluate the pain and fear during the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a randomized controlled experimental study.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Pain; Fear; External cold and vibration; pediatrics; Puppet
Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation
Condition: Bone Narrow Transplantation
Study type: Interventional

Summary: 
      Background and Aims: Nutritional support is considered an integral part of the supportive
      care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with
      omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare
      plasma cytokines levels in children after bone marrow transplantation using a lipid formula
      enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.

      Methods: A randomized double blinded controlled study including 14 children with BMT and
      requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or
      soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to
      analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha
      (TNF-α).
    


Intervention name(s): Formula with soybean oil, medium-chain triglycerides; Soybean oil formula commonly used in the hospital
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
Condition: Acupressure; Post-Op Complication; Cesarean Section; Bowel Ileus
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Research objectives To compare the efficacy of acupressure with no acupressure to examine
      time to first flatus in patient post cesarean section

      ; Acupressure at ST-36 Zusanli (lateral to anterior crest of tibia, in the tibialis anterior
      muscle)

      Research hypothesis Patients who received acupressure will have earlier flatus passage
    

Detailed description: 
      Research design Randomized controlled trial. Compare between The investigators is who assess
      the acupressure with control group is the participants do not assess the acupressure
    

Intervention name(s): Acupressure
Intervention type(s): Device
Intervention description(s): Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study on PK of Hydronidone in Patients and Special Population
Condition: Hepatitis b & Liver Dysfunction
MeSH terms: Hepatitis B; Hepatitis; Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target
           patients (patients with chronic viral hepatitis b with liver fibrosis) and special
           population (patients with mild liver dysfunction).

        2. To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic
           viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.
    


Intervention name(s): Hydronidone
Intervention type(s): Drug
Intervention description(s): First take Hydronidone capsule, single-dose and then Multiple-dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination
      therapy on patients of essential hypertension who are not properly controlled by candesartan
      cilexetil monotherapy.
    


Intervention name(s): Candesartan cilexetil 16mg; Amlodipine 10mg, Candesartan cilexetil 16mg
Intervention type(s): Drug; Drug
Intervention description(s): Daily oral administration for 8 weeks; Daily oral administration for 8 weeks
Other intervention name(s): Atacand 16mg; Norvasc 10mg, Atacand 16mg
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity,
      promoting apoptosis and regulating oncogenic targets in breast cancer. However their clinical
      use is still experimental especially in preoperative setting, where there are still no data
      of antioxidant and antiinflammatory beneficial roles. This study is a prospective
      observational clinical study enrolling 50 patients with primary breast cancer (T1-2, N0-1,
      M0) who received 4-weeks oral treatment of delta-T3 before surgery (200 mg/twice daily) with
      personalized nutritional and psychoeducational support. This study evaluates the effects of
      treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li
      Starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell
      immunity, immunologic serum markers (miRNA)), immunological response on tumor (gene
      expression profiling on preoperative tissue tumor biopsy and on surgical specimen),
      TNF-alpha, IL-6 and VEGF and proliferation/apoptosis, anti-inflammatory and anti-oxidant
      activity of breast cancer cell lines.

      This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and
      antioxidant capacity (TAC Track, Li Starfish), on anti-inflammatory activity (complete
      profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), on
      immunological response on tumor (gene expression profiling on preoperative tissue tumor
      biopsy and on surgical specimen), on TNF-alpha, IL-6 and VEGF, on proliferation/apoptosis,
      anti-inflammatory and anti-oxidant activity of breast cancer cell lines.
    

Detailed description: 
      An open-label, single center, phase 2 prospective observational clinical study
    

Intervention name(s): Tocotrienol
Intervention type(s): Drug
Intervention description(s): Tocotrienol 200 mg orally twice a day
Intervention MeSH terms: Tocotrienols; Vitamin E; Tocopherols
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study examines the bioequivalence between an oral nicotine replacement product and
      Nicorette® gum.
    

Detailed description: 
      The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will
      receive all treatments). The investigational products will be given as single doses at
      separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at
      least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be
      drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and
      10 hours after start of product administration. Used gums will be collected and analyzed to
      determine the amount of remaining nicotine. Subjects will also be monitored to capture any
      adverse events that may occur.
    

Intervention name(s): Nicotine; Nicotine Gum
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose of new NRT product; Single-dose of marketed nicotine gum
Other intervention name(s): Nicotine NRT / not yet marketed; Nicorette® Gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; Nicotine pharmacokinetics
Behavior of Infants Fed Formula Supplemented With Prebiotics
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on
      symptoms of formula intolerance in healthy term infants.
    


Intervention name(s): Infant formula supplemented with prebiotics
Intervention type(s): Other
Intervention description(s): Sole source nutrition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Asymmetric Movement of the Diaphragm
Condition: Healthy
Study type: Observational

Summary: 
      The aim of this study is to investigate the movement of the right hemidiaphragm when lifting
      a load with the left and right hand.
    

Detailed description: 
      Hemidiaphragm movement will be assessed by m-mode ultrasonography in a standing position. The
      study will include 30-40 healthy adult volunteers. The examination will consist of two tidal
      inspirations and expirations, two inspirations and expirations during lifting the kettlebell
      with the left hand and two inspirations and expirations during lifting the kettlebell with
      the right hand. The weight of the kettlebell will correspond to about 10% of the
      participant's body weight.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy Subjects
Clinical and Instrumental Evaluation on Definisse Threads
Condition: Face
Study type: Interventional

Summary: 
      The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face
      with Definisse Threads double needle and Definisse threads free floating insertion, at day
      30. 6 clinical follow up visit will be performed
    

Detailed description: 
      The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face
      with Definisse Threads double needle and Definisse threads free floating insertion, at day
      30. 6 clinical follow up visit will be performed to evaluate the modification of skin surface
      characteristics, the reshaping effect of the face, the subject's satisfaction at each visit,
      the presence/absence of the threads after the implantation and the global pain perception
      during the implant procedure..
    

Intervention name(s): Definisse threads free floating and definisse threads double needle
Intervention type(s): Device
Intervention description(s): Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30
Intervention model: Single Group Assignment
Intervention model description: Monocentric, prospective, open label, uncontrolled, post-market clinical investigation
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Modified Banxia Xiexin Decoction for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome)
Condition: Postprandial Distress Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The study aims to evaluate the efficacy of a modified Banxia Xiexin Decoction (BXD) for
      Wei-Pi through a randomized, waitlist controlled trial.
    

Detailed description: 
      After being informed about the study plan, potential risk and benefits, all subjects will
      give written informed consent prior to participation and undergo eligibility screening.
      Eligible participants will be randomized, in a 1:1 ratio, into BXD group and waitlist group.
    

Intervention name(s): Banxie Xiexin Decoction (BXD)
Intervention type(s): Other
Intervention description(s): A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chinese medicine; Postprandial distress syndrome; Wei Pi; Banxia Xiexin Decoction
Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris. The study
      aims to determine whether treatment with daylight as an illumination source is as effective
      as conventional, red light illumination.

      15 patients with acne vulgaris received 4 treatment sessions at three-week intervals. First,
      5-aminolevulinic acid (ALA) was applied to the entire face. Then the face was divided into
      two symmetrical contralateral treatment areas: the left was covered with a light-impermeable
      dressing, while the right face was exposed to sunlight. After 2 hours outdoors, the right
      side of the face was covered, and the left half was illuminated with red light.
    

Detailed description: 
      Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris .One of the
      most important drawbacks of PDT is the pain during illumination.

      It has been shown that daylight PDT is an effective treatment for actinic keratosis. In order
      to examine the efficacy of daylight PDT for acne vulgaris, we used a split-face design: the
      face was divided into two symmetrical contralateral treatment areas: the left was covered
      with a light-impermeable dressing, while the right face was exposed to daylight. After 2
      hours outdoors, the right side of the face was covered, and the left half was illuminated
      with red light.
    

Intervention name(s): 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form
Intervention type(s): Drug
Intervention description(s): 5-Aminolevulinic Acid was applied to both sides of the face.
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: "Split Face design" is a common model used in dermatology to study the difference between two treatments on a facial condition. The face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to sunlight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne vulgaris; photodynamic therapy; PDT; Daylight PDT
Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion
Condition: Iliac Vein Stenosis; Iliac Vein Occlusion
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      Clinical study on safety and efficacy of Zylox peripheral venous stent system in the
      treatment of iliac vein stenosis or occlusion.
    

Detailed description: 
      The purpose of this study was to evaluate the safety and efficacy of Zylox peripheral venous
      stent system in the treatment of iliac vein stenosis or occlusive lesions compare with
      conventional venous stent.
    

Intervention name(s): Zylox Peripheral Venous Stent; Zilver Vena Venous Stent
Intervention type(s): Device; Device
Intervention description(s): Self-expanding stent implantation during the index procedure.; Self-expanding stent implantation during the index procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Peripheral venous stent system; Iliac vein patency rate
Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet in Patients With Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy
      and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with
      mild to moderate essential hypertension.
    


Intervention name(s): metoprolol succinate prolonged-release tablet and felodipine
Intervention type(s): Drug
Intervention description(s): a regimen that starts with metoprolol succinate prolonged-release tablet 47.5mg once daily, orally and allows for dose escalation to 95mg once daily, orally at 4 weeks if not controlled; at week 8 allows for the addition of felodipine sustained release tablet 5mg once daily, orally
Other intervention name(s): Betaloc ZOK and Plendil
Intervention MeSH terms: Metoprolol; Felodipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post marketing study
The Role of Vitamin D, A, and Beta Carotene in Tuberculosis Patients With Vitamin D Receptor Gene Polymorphism
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      Recent studies showed that vitamin D and A has an effect in improving sputum conversion in
      tuberculosis. This study aims to find out the effect of vitamin D 1000 IU and A 6000 IU
      supplementation on Tuberculosis patients with vitamin D receptor gene polymorphism, who live
      in North Sumatera, Indonesia. This study is a randomized control clinical trial, with 48
      tuberculosis patients with vitamin D receptor gene polymorphism which are TaqI and FokI
      participating, divided into two groups, each with 24 participants, which are treatment group
      (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU, and control
      group (C) which only receives nutritional counseling for 28 days. Patients who participated
      was found to be heterozygous with TaqI (T>C) or FokI (C>T) genotype variants.
    

Detailed description: 
      Recent studies showed that vitamin D and A has an effect in improving sputum conversion in
      tuberculosis. This study aims to find out the effect of vitamin D 1000 IU and A 6000 IU
      supplementation on Tuberculosis patients with vitamin D receptor gene polymorphism, who live
      in North Sumatera, Indonesia. This study is a randomized control clinical trial, with 48
      tuberculosis patients with vitamin D receptor gene polymorphism which are TaqI and FokI
      participating, divided into two groups, each with 24 participants, which are treatment group
      (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU, and control
      group (C) which only receives nutritional counseling for 28 days. Patients who participated
      was found to be heterozygous with TaqI (T>C) or FokI (C>T) genotype variants. The result of
      this study showed that at the start, serum 25(OH)D levels in group I were lower compared to
      group C (19.746.59 ng/mL vs 25.21±7.57 ng/mL). Group I showed significant correlation between
      vitamin D level categories with sputum conversion (mean: standard deviation= 2.25±0.68
      weeks). Supplementation of vitamin D 1000 IU provides an accelerated sputum conversion in
      tuberculosis patients with vitamin D receptor gene polymorphism.
    

Intervention name(s): vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling; nutritional Counseling
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU; control group (C) which only receives nutritional counseling for 28 days
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 25(OH)D serum; calcium; counseling; FokI; retinol; TaqI