bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Hysterectomy With Prior Uterine Artery Ligation
Condition: Uterine Artery Injury; Hysterectomy
Study type: Interventional

Summary: 
      A randomized controlled trial was done on 127 women planned for TLH, and divided into two
      groups; group A includes women that underwent conventional TLH, and group B includes women
      that underwent TLH with prior uterine artery ligation at its origin. Both grouped were
      compared regarding the blood loss, operation time, intraoperative complications and
      post-operative follow-up.
    


Intervention name(s): conventional Total laparoscopic hysterectomy; Total laparoscopic hysterectomy with prior uterine artery ligation at its origin
Intervention type(s): Procedure; Procedure
Intervention description(s): the ascending branch of the uterine artery was identified close to the isthmus then ligated at this level, close to the uterus or coagulated, using bipolar diathermy. The utero-vesical fold was dissected and the bladder was pushed down done, thus moving the ureters laterally, which decreases the risk of including them in a suture. The vasculature of the uterus is now secured and this is evidenced by the pale color of the fundus.
Using either bipolar diathermy or the harmonic ultracision, the cornual pedicles on one side were desiccated and cut. Also, both the uterosacral and cardinal ligaments were desiccated and cut. So that, the opposite side pedicles can be taken care of, the direction of manipulator was changed. The infundibulopelvic ligaments were desiccated and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which was then cut laparoscopically using a monopolar hook, where the specimen was completely detached.; the uterine artery was dissected using the lateral approach; where dissection begins from the anterior leaf of the broad ligament. The triangle enclosed by the round ligament, external iliac artery, and infundibulopelvic ligament was opened. The areolar space was dissected and the origin of the uterine artery from the internal iliac and the ureter was identified. The uterine artery was then isolated from the surrounding structures and ligated by Hem-o-lok clips.
then same steps as conventional Total laparoscopic hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hysterectomy; Laparoscopy; Uterine Artery Ligation
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase III, multi-centre, randomized, double-blind study to assess the safety
      and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and
      adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The
      treatment period will be up to 8 weeks.
    


Intervention name(s): Esomeprazole (Nexium)
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-site, interventional clinical trial evaluating the safety and
      efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation
      of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using
      the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.
    


Intervention name(s): IS-002
Intervention type(s): Drug
Intervention description(s): Intravenous injection of IS-002 Investigational Drug
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Exercise Training in Children With Congenital Heart Defect
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of exercise training on exercise
      capacity, physical activity (PA), health-related quality of life (HRQoL), and the
      psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and
      healthy sedentary children. The degree of improvement after exercise training were compared
      between CHD children and healthy sedentary children.
    

Detailed description: 
      Exercise groups took 12-week exercise training, twice in hospital and once at home, using a
      video game so-called Dance Dance Revolution (DDR), while the control group kept their daily
      routines.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Using a video game so-called Dance Dance Revolution (DDR)
Other intervention name(s): Dance Dance Revolution (DDR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Exercise capacity; Physical activity; Quality of life
Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment
Condition: Malignant Neoplasm; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This pilot clinical trial studies psycho-educational program in increasing knowledge and
      satisfaction and decreasing distress in younger patients with cancer receiving treatment.
      Psycho-educational program may increase knowledge and satisfaction and decrease distress in
      younger patients with cancer receiving treatment
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Providing a psycho-educational group to young adults while examining the feasibility of
      such a group with patients on treatment.

      II. Examining effectiveness of the program through evaluating pre-post changes in participant
      distress, evaluating increases in participant' knowledge regarding disease issues and coping,
      and evaluating participant satisfaction.

      OUTLINE:

      Patients undergo psycho-educational program comprising medical/symptom management and
      communication with a medical team, coping skills, self image, and relationships and
      communication for 1.5 hours once weekly for 6 weeks.

      After completion of study treatment, patients are followed up for 30 days.
    

Intervention name(s): psychosocial assessment and care; educational intervention; communication skills training; questionnaire administration
Intervention type(s): Procedure; Other; Other; Other
Intervention description(s): Participate in psycho-educational program; Participate in psycho-educational program; Participate in psycho-educational program; Ancillary studies
Other intervention name(s): psychosocial assessment; psychosocial assessment/care; psychosocial care; psychosocial care/assessment; psychosocial studies; intervention, educational
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Kinesio Taping in Muscle Damage Response Induced by Eccentric Exercise
Condition: Bandages; Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      Sixty volunteers with a mean age of 21,8 ± 2,6 years participated in this study, randomly
      distributed into one of the following groups: control, Kinesio taping group with tension in
      the anterior arm region and Kinesio taping group without tension in the same region. All
      subjects underwent an eccentric exercise protocol and three evaluations: before the protocol,
      immediately after and 48h after protocol. The following variables were analyzed: sensation of
      pain as the primary outcome; peak torque normalized by body weight; average peak torque;
      total work and average power, using an isokinetic dynamometer. In addition, muscle activation
      amplitude (Root Mean Square) and median frequency were recorded using surface
      electromyography.
    


Intervention name(s): Kinesio Taping; Placebo Kinesio Taping
Intervention type(s): Other; Other
Intervention description(s): Kinesio Taping application with tension (Kinesio Tex Gold®, Japan) in the anterior region of the non-dominant arm.; Kinesio Taping application without tension (Kinesio Tex Gold®, Japan) in the anterior region of the non-dominant arm.
Other intervention name(s): Functional elastic tape; Placebo functional elastic tape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
Condition: Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in
      subjects at 9 months and at 12 months of age when the second dose is given concomitantly with
      other pediatric vaccines routinely administered in the US.

      Safety Objective:

      To describe the safety profile of two doses of Menactra® Vaccine.
    


Intervention name(s): Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Measles-mumps-rubella-varicella vaccine; Routine paediatric vaccine - Pneumococcal conjugate (PCV); Routine paediatric vaccine - Hepatitis A
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, IM at age 9 and 12 months; 0.5 mL, intramuscular at 12 months of age; 0.5 mL, Intramuscular at age 12 months; 0.5 mL, Intramuscular at age 12 months
Other intervention name(s): Menactra®; MMRV: ProQuad; Pneumococcal conjugate (PCV),; Hepatitis A
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Menactra® vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine
Effectiveness of a Protocol of Specific Activation.
Condition: Injuries:Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      In football, knee is the joint that suffers the most severe injuries. Sometimes, this is
      produced by poor pre-activation of the musculature that is responsible for knee stability and
      central stability.

      OBJETIVE: Study the efficacy of specific gluteus medius and core activation protocol in knee
      stability in youth football players.
    

Detailed description: 
      A randomized, longitudinal clinical trial with a blinded and prospective evaluator will be
      carried out, in which the knee stability will be evaluated with the following tests:
      Y-balance test and Flamingo balance test. The measurements will be made before and after the
      intervention. The study will be carried out with patients evaluated by a specialist in
      Traumatology and will be randomly divided by a system of numerical tables through a computer
      program between the experimental and control groups. The control group will perform a typical
      warm-up of competitive football; and the experimental one will do this above, added to a
      specific activation of gluteus medius and core. Dynamic stability (Y-balance test) and
      postural and static stability (Flamingo balance test) will be measured before and after the
      intervention.
    

Intervention name(s): Experimental group; Control group
Intervention type(s): Other; Other
Intervention description(s): Experimental group will perform a typical warm-up of competitive football, added to a specific activation of gluteus medius and core.; Control group will perform a typical warm-up of competitive football
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A specialist physician will be diagnosed the process.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Knee stability.; Core; Gluteus medius; Warm-up; Football
The Use of Biorepair Peribioma Toothpaste and Mousse for Home Oral Care in Patients Undergoing Periodontal Therapy
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This is a split-mouth randomized clinical trial in which a new domiciliary oral care protocol
      with Biorepair Peribioma Toothpaste and Mousse is evaluated in periodontal patients.
    

Detailed description: 
      This is a split-mouth randomized clinical trial that aims to suggest an innovative protocol
      for domiciliary oral care of periodontal patients. In details, home use of Biorepair
      Peribioma Toothpaste and Mousse is proposed as a support of professional hygiene sessions.

      Patients that respond to the eligibility criteria and that sign the informed consent are
      recruited for periodontal therapy.The first professional hygiene session is performed at the
      baseline (T0); the following ones will be performed after 3 (T1) and 6 months (T2) from the
      baseline. In each session, periodontal indices of inflammation are detected; then,
      subgingival removal of plaque and tartar is performed, followed by glycine air-flow
      application in periodontal pockets. A microbiological test is perfomed in order to detect red
      and orange complex bacteria. At this time, patients are randomly allocated into two groups:

        -  Trial Group: domiciliary oral hygiene with Biorepair Peribioma Toothpaste and Mousse
           twice a day until T2 session.

        -  Control Group: home oral hygiene with Curasept Toothpaste (0,2% Chlorhexidine) twice a
           day until T2 session.

      At the end of T1 and T2 professional session, a satisfaction survey about Peribioma
      Toothpaste and Mousse will ben given to the patients.
    

Intervention name(s): Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse; Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)
Intervention type(s): Other; Other
Intervention description(s): Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session.; Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a study in which patients are divided into two groups:
Trial Group: professional dental hygiene at T0, T1 and T2 + Biorepair Peribioma Toothpaste and Mousse for domiciliary oral care twice a day until T2;
Control Group: professional dental hygiene at T0, T1 and T2 + Curasept Toothpaste with chlorhexidine 0,2% twice a day until T2.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental hygiene; periodontal non-surgical therapy; split-mouth
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Condition: Elderly; Pharmacokinetics; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the penetration through the blood-brain-barrier of trospium chloride at
      plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium
      levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured.
      Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change
      index to assess if any study subject shows evidence of a clinically and statistically
      significant change in memory.
    


Intervention name(s): Trospium Chloride
Intervention type(s): Drug
Intervention description(s): Extended release, 60 mg, oral daily
Other intervention name(s): Sanctura XR™ 60 mg
Intervention MeSH terms: Trospium chloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of RDQ Questionnaire
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the accuracy of the Reflux Disease
      Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease. Symptom
      evaluation by the RDQ will be compared with other established approaches to the diagnosis of
      gastroesophageal reflux disease (GERD) in a primary care patient population with symptoms
      thought to be of upper gastrointestinal (GI) tract origin.
    


Intervention name(s): Esomeprazole; Bravo technique
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Esomeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: GERD
Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms
Condition: Functional Gastrointestinal Disorders; Healthy Subjects
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Dyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the
      Rome IV criteria, functional dyspepsia (FD) symptoms included meal-related fullness, early
      satiation, epigastric pain or burning which are unexplained after routine investigation. FD
      causes substantial psychophysical burden because of its unknown etiology and high prevalence.
      Although FD is currently associated with local inflammation of the gastrointestinal tract and
      microbiota alteration, current available treatments for FD are of limited effectiveness. In
      view of this, many studies have applied Chinese herbal medicine in FD and achieved some
      therapeutic benefit. The Jing Si Herbal Tea composed of eight native Taiwanese herbs
      (wormwood, hickory grass, Ophiopogon japonicus, houttuynia cordata, platycodon, licorice,
      perilla leaves, chrysanthemum) has obtained a special export license from the Ministry of
      Health and Welfare. The Jing Si Herbal Tea also has been registered in clinical trials as a
      complementary treatment for COVID-19. The preliminary data demonstrated that the Jing Si
      Herbal Tea may improve gastrointestinal symptoms and anxiety in patients with COVID-19.
      Therefore, this study aims to investigate the impact of the Jing Si Herbal Tea on
      psychophysical burden and metabolites of microbiota in patients with FD through a
      double-blind randomized manner.
    


Intervention name(s): Jing Si Herbal Tea Liquid Packet; Jing Si Herbal Tea Liquid Packet Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with Coronavirus disease 2019(COVID-19). Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.; Compared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Jing Si Herbal Tea Liquid Packet; psychophysical burden
Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405
Condition: Hypertension(HTN)
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic interaction and safety
      between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy
      male volunteers
    


Intervention name(s): HGP0904; HGP0608; HGP1405
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): amlodipine; losartan; chlorthalidone
Intervention MeSH terms: Losartan; Amlodipine; Chlorthalidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
Condition: Immunization Status; Well Child Care Visit
Study type: Interventional

Summary: 
      The investigators will design and implement a randomized clinical trial to test, on a
      community-wide level, the effectiveness of managed care based tracking/reminder/recall on
      improving vaccination coverage among adolescents.

      The investigators propose a randomized controlled trial to evaluate the effectiveness of
      reminder/recall for adolescents: 10,599 adolescents within the managed care organization
      (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone
      messages or 3) standard of care of their practice (no messages from the intervention).

      Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive
      services

      Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders

      Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which
      have low baseline immunization rates.

      Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone
      reminders.
    


Intervention name(s): Autodialer; Letters
Intervention type(s): Other; Other
Intervention description(s): Autodialer telephone calls; Mailed reminder letters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Immunization status for:; Tdap; Menactra; HPV (if female); Well child care visit
Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity
Condition: Dentinal Sensitivity; Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      A pilot study to determine the ability of a stannous fluoride containing toothpaste to
      provide immediate and short term relief from dentine Hypersensitivity compared to a control
      toothpaste.
    


Intervention name(s): Test Toothpaste; Negative Control Toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): 0.454% stannous fluoride toothpaste; 0.76% sodium monofluorophosphate toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dentinal; hypersensitivity