bioihbjkbjnl/mcl2 huggingface dataset:
Transversus Abdominus Plane Block in Living Donor Hepatectomy
Condition: Living Donor Hepatectomy
Study type: Interventional

Summary: 
      Comparing different drugs used in Transversus abdominus plane analgesia after donor
      hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group,
      and Dexmedetomedine group according to the used drug
    

Detailed description: 
      Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery
      using three different drugs control group, Bupivecaine group, and Dexmedetomedine group
    

Intervention name(s): surgically inserted Transversus abdominus plane catheter; Intravenous morphine; Bupevecaine; Dexmedetomedine
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle; Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Gel-200 Versus Placebo in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a single intra-articular injection of Gel-200 is
      superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with
      symptomatic osteoarthritis of the knee.
    


Intervention name(s): Gel-200; Placebo
Intervention type(s): Device; Device
Intervention description(s): Single intra-articular injection; Single intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer
Condition: Superficial Esophageal Neoplasia
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for
      diagnosis of early esophageal cancers among high risk patients.
    

Detailed description: 
      The investigators recruited consecutive patients with head and neck cancers, history of
      squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic
      surveillance first started with NBI for detection and characterization of early esophageal
      cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial
      esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy
      would be performed subsequently and suspicious neoplasia were classified as understain or
      unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to
      Lugol chromoendoscopy with histology serving as a gold standard.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Patients with Head and Neck Cancer

          2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2
             years

          3. Patients with esophageal cancer treated by endoscopic resection
Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children
Condition: Dental Anxiety; Pain; Infant Behavior; Heart Rate and Rhythm Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio
      will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique
      versus a conventional technique (covering the patient´s vision) during an inferior alveolar
      and lingual nerve block in preschool children referred for treatment at the School of
      Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52
      children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or
      tooth extraction of primary molars. Preschool children with no history of allergies to
      Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the
      study will be include in this research.
    

Detailed description: 
      Children will be randomly allocated to treatment groups (n=26 for each group) according to
      the technique: 1)"Hands/Eyes/mouth" and 2) Conventional. Anxiety and pain will be evaluated
      by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation
      of the patient will be evaluated by behavioral Scale Frank
    

Intervention name(s): inferior alveolar and lingual nerve block procedure
Intervention type(s): Procedure
Intervention description(s): The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution.
The application of anesthesia shall be in accordance with the following guidelines:
Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain).
Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain)
anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain).
Syringe: carpule syringe-conventional harpoon with suction system.
Other intervention name(s): inferior alveolar and lingual nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pain; Infant Behavior; Heart rate; Dental Anxiety
Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis
Condition: C.Delivery; Surgery (Previous), Gynecological
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators investigated whether laparoscopic versus open surgical approaches affected
      the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or
      cisatracurium.
    


Intervention name(s): rocuronium; cisatracurium
Intervention type(s): Drug; Drug
Intervention description(s): Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus; cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus
Intervention MeSH terms: Rocuronium; Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: rocuronium; cisatracurium; pharmacokinetic
The Inflammatory Response to Stress and Angiogenesis in Liver Resection
Condition: Liver Cancer; Colorectal Cancer; Metastatic Cancer; Liver Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      Patients with resectable liver metastases of colorectal origin will be assigned to
      laparoscopic liver resection or conventional open liver surgery.

      Blood samples will be drawn preoperatively and 24 hours after resection. Determination of
      Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and
      laparoscopic liver resection (Elisa test).

      The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2
      (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular
      endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and
      normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction
      (RT-PCR).
    

Detailed description: 
      According to the null hypothesis, no difference in the IL6 postoperative value, between the
      two groups would be expected. To calculate sample size, a IL6 postoperative value of 100±40
      pg/mL in the laparoscopic group and 60±40 mL/m pg/mL in the open group was hypothesized.
      Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve
      statistical significance was 17 subjects in both groups in a 1:1 randomization. Laparoscopic
      group was increased by 20% of patients considering a conversion rate of 20% accordingly.
      Randomization will be performed using computer-generated random numbers the day before
      operation and stopped when 20 patients per group will be reached.
    

Intervention name(s): Liver resection
Intervention type(s): Procedure
Intervention description(s): liver resections for colorectal liver metastases
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer
Condition: Cancer Cachexia; Head and Neck Cancer; Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms; Wasting Syndrome; Anorexia; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and
      advance stage head and neck cancer (stage III, IV)
    


Intervention name(s): Curcumin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.; We give a control arm to consume placebo for 60 consecutive days.
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cancer cachexia; Head and neck cancer; Curcumin; Tumuric; Cancer anorexia cachexia
Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether asimadoline is safe and effective at
      treating D-IBS.
    

Detailed description: 
      The primary objective of the study is to compare the efficacy of the two treatments with
      respect to improvement in IBS-related abdominal pain severity and reduction in stool
      frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity
      score and daily frequency of bowel movements will be averaged over each week to determine
      average values for each endpoint. For each subject, weekly response to treatment will be
      based on the following parameters:

        -  Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain
           severity score

        -  Decrease from baseline of at least 25% in the average number of daily bowel movements A
           subject must meet both criteria to be considered a weekly responder. The primary
           efficacy endpoint is based on an "overall study responder," defined as a subject having
           6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment
           period. Overall study responder will be stratified by timing of bowel preparation and
           endoscopy.
    

Intervention name(s): Asimadoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg Asimadoline BID; Placebo
Other intervention name(s): EMD 61 753; EMR 63 320
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diarrhea predominant irritable bowel syndrome
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Condition: Pertussis; Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis
      vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.

      To describe and characterize adverse events occurring after vaccination with REPEVAX®
      (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated
      poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular
      pertussis) vaccine among two groups: Group 1 - adolescents 10-14 years of age who
      participated in study 371-03/01 (and thus received a 5th dose of TRIPEDIA® vaccine) and Group
      2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell
      pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their
      2nd through 7th year of life.
    


Intervention name(s): COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): REPEVAX®; COVAXIS™; IPV Merieux™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis,; Diphtheria,; Tetanus,; Poliomyelitis
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's
      Disorder. There will be an up to 21-day screening period in which subject eligibility will be
      determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of AZD5213
      will be assessed during a 1- week period.

      In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses
      (depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed
      through six consecutive four-week crossover periods. Each subject will receive both AZD5213
      and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of
      study drug.
    

Detailed description: 
      This is a multicenter, randomized, two-part study of AZD5213 in adolescents (ages 12-17
      years) with Tourette's Disorder.

      In Part 1 of the study, following an up to 21-day screening period, on Day 1, after baseline
      procedures are performed, eligible subjects will receive a single, low dose of AZD5213,
      in-clinic.

      After study drug dosing on Day 1, safety and tolerability will be assessed in-clinic, and
      blood samples will be taken for pharmacokinetic (PK) analysis. On Days 2, 3, 4, 5, 6 and 7
      subjects will take study drug, and will be contacted via telephone and adverse events and
      concomitant medications will be assessed. On Day 8, safety, tolerability, and blood sampling
      for PK analysis (predose and 2-4 hours post-dose) will be performed in-clinic. Part 2 of the
      study will consist of six consecutive crossover periods. In Part 2 of the study, each study
      drug will be administered in two 4-week periods (six treatment periods, total). Each study
      drug will be received in one of Periods 1-3, and again in one of Periods 4-6. Approximately
      24 subjects will receive study drug in Part 1 of this study in order to complete
      approximately 18 subjects in Part 2.
    

Intervention name(s): AZD5213 and placebo
Intervention type(s): Drug
Intervention description(s): low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Combined Multiple Motor and Vocal Tic Disorder; Tourette Disorder; Gilles de la Tourette Syndrome; Tourette Disease
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy
Condition: Anxiety; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      One important part of individual nursing care is that that nurses teach and apply breathing
      exercises, which are vital and increase the patient's quality of life, in the light of their
      current knowledge and skills. The purpose of this study was therefore to determine the effect
      of postoperative breathing exercises on pain and anxiety in patients hospitalized in the
      general surgery clinic and who had undergone laparoscopic cholecystectomy.
    

Detailed description: 
      Introduction: Several methods are employed for overcoming pain and anxiety that are
      frequently experienced in the postoperative period. This study was planned to determine the
      effect of a breathing exercise on patient pain and anxiety after laparoscopic
      cholecystectomy.

      Methods: The sample determined using power analysis in this randomized, controlled,
      semi-experimental research performed in two hospitals in the west of Turkey between January
      and November 2019 consisted of 74 individuals (37 experimental and 37 controls). An
      information form involving descriptive characteristics, a visual analogue scale (VAS), and
      the State-Trait Anxiety Inventory (STAI I/II) were used for data collection. Descriptive
      statistical methods and parametric tests were employed in the data analysis.
    

Intervention name(s): Educational and Research Hospital
Intervention type(s): Other
Intervention description(s): breathing exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety
Condition: Surgery; Anxiety State
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety is a psychologic and physiological state that could be characterized by somatic,
      emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an
      anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to
      negative physiological signs that slow down healing, lowers imune response and increases
      post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality.
      Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of
      alternative treatment such as musicotherapy has been demonstrated in several randomized
      control trials. Nevertheless, most of these studies have investigated the effect of
      musicotherapy in groups with our without musical listening.

      In the present study, investigators assume that a personal musical sequence composed by
      favourite songs of the patients could have beneficial effect on presurgical anxiety than
      selective sequence of the medical device MUSIC CARE.

      In this study, the anxiolytic effect of predefined U musical sequences that alternate slow
      and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in
      women with planned gynecological surgery.
    

Detailed description: 
      Patients are randomly allocated in two groups:

        -  control group: patients are asked to choose one of the U sequence among the preselected
           music style proposed by the medical device MUSIC CARE

        -  test group: patients are asked to prepare their own play-list containing their favourite
           songs

      Anxiety is assessed before and after a 20 min-musicotherapy session by using the State-Trait
      Anxiety Inventory (STAI) for anxiogenic situation.

      Other parameters are measured such as blood pressure, cardiac frequency, level of pain after
      surgery, care stay duration, potent post-surgery complications.
    

Intervention name(s): MUSIC CARE; PERSONAL PLAY-LIST
Intervention type(s): Device; Other
Intervention description(s): Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles; Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
Other intervention name(s): Music Care U sequence; Patient's paly-list
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control randomized, single blind, monocentric
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in
      terms of social and economic, are palliative and do not contemplate healing by regenerative
      therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in
      vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated
      that MSC are able to modulate immune responses and to control inflammation through its action
      on T lymphocytes. Preliminary studies in animal models, including one carried out in an
      equine by the investigators research group, confirms feasibility, safety and efficacy
      evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential
      and safety of mesenchymal stem cells in improvement of osteoarthritis clinical
      manifestations.This study is designed to evaluate therapeutic potential and safety of
      mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.
    

Detailed description: 
      Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They
      have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue,
      representing a new clinical strategy in regenerative medicine.An increasing number of reports
      have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic
      disease. In this study we perform a single intra articular injection of cultured mesenchymal
      stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical
      safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC
      osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.
    

Intervention name(s): Mesenchymal Injection
Intervention type(s): Biological
Intervention description(s): Intra Articular Injection of Mesenchymal cells to the knee joint
Other intervention name(s): Cell Injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal cells; osteoarthritis; intra articular injection