bioihbjkbjnl/mcl2 huggingface dataset:
Intraosseous vs Submucosal Injection of Dexamethasone
Condition: Tooth, Impacted
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group
      of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by
      one surgeon.

      Postoperative pain was evaluated by visual analog scale score immediately after surgery and
      on postoperative days 1, 3, and 7.

      Swelling (determined using two linear measurements) were assessed just before the surgery and
      on postoperative days 1, 3, and 7 by using a digital vernier caliper.

      Early healing of periodontal soft tissue wound was assessed by using Early Wound Healing
      Score (EHS) which composed of 3 parameters: clinical signs of re-epithelization (CSR),
      clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI) and were
      assessed on postoperative days 1, 7, and 14. Mouth opening (determined by measurement of the
      maximum inter-incisal distance) were assessed just before the surgery and on postoperative
      days 1, 3, and 7 by using a digital vernier caliper.
    


Intervention name(s): Intraosseus; Submucoal
Intervention type(s): Other; Other
Intervention description(s): IO dexamethasone injection Dexamethasone 4 mg; SM dexamethasone injection Dexamethasone 4 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation
Condition: Trigeminal Neuralgia, Idiopathic
MeSH terms: Trigeminal Neuralgia; Neuralgia; Recurrence
Study type: Observational

Summary: 
      This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo
      stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under
      fluoroscopic guidance, a protocol that was modified from the originally described parameters
      for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being
      that the higher temperature of the probe tip would lead to a more long-lasting lesion and
      lesser recurrence, but at the cost of more frequent sensory and motor deficits.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Adult patients of all genders presenting to Pain Clinic, referred of otherwise, diagnosed
        to have trigeminal neuralgia without concomitant central nervous pathologies including
        space occupying lesions, vascular and auto-immune disorders, who were planned for
        stereotactic rhizotomy under deep sedation and monitored anesthesia care as daycare cases.
      
Keywords: trigeminal neuralgia; stereotactic rhizotomy; radiofrequency ablation; recurrence
Physical Activity and Basal Metabolic Rate in Postmenopausal Women
Condition: Postmenopausal Metabolic Health
Study type: Interventional

Summary: 
      The primary purpose of this study is to expand research on the effects of physical activity
      on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the
      effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training
      program. The investigators will measure BMR by indirect calorimetry and normalize it across
      subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will
      be compared: an intervention group (no previous participation in regular exercise, newly
      enrolled in this study's 16 week training program), and a long-term athlete group (have
      engaged in at least 5 hours of exercise per week for the past 10 years or longer). A
      secondary aim is to generate an equation for the prediction of BMR from fat free mass in
      physically active postmenopausal women, to be applied to hypotheses in biological
      anthropology. The investigators expect to find at baseline that, controlling for fat free
      mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention
      group. At 16 weeks the investigators expect no change in BMR for the long-term group, while
      BMR will have increased in the intervention group. At the same time, the investigators expect
      to find that after completing the training regimen, the intervention group will have BMR
      similar to that of the long-term athletes.
    


Intervention name(s): Resistance and aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): Following baseline measurements, sedentary women were enrolled in a 16-week exercise training program at the YMCA in La Jolla, CA. Exercise occurred 3 times per week, for 1.5 hours each time. Exercise consisted of stretching, 20 minutes of aerobic exercise on elliptical machines, and 3 sets of 10-12 repetitions to failure for each of ten weight lifting exercises: abdominal crunch, arm curl, arm extension, chest press, lat pull-down, leg curl, leg extension, leg press, seated row, and trunk extension. Women started at 65-75% of 1-repetition-maximum, and resistance was increased as necessary to maintain the number of sets and reps and to continue to work to failure. Exercise was monitored by a TechnoGym electronic key system, and trainers instructed and supervised subjects in the gym.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: basal metabolic rate; resting energy expenditure; menopause; physical activity; metabolic syndrome
Robot-assisted Gait Training in Multiple Sclerosis Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Aims of the study:

      This is a randomized-controlled trial to test the effects of robot-assisted gait training on
      locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait
      impairments. The control group will be treat with conventional physical therapy.

      Subjects and methods:

      60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.

      Informed consent will be obtained. Participants will be randomized to Robot-assisted gait
      training (experimental group) or conventional therapy (control group) through a randomization
      stratification approach, according to a block randomization of 4.

      The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2
      sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks
      (2 sessions/week), that will focus on gait training.

      Primary outcome measures will be both neurophysiological measures (motor unit firing rate
      characteristics) and clinical test for gait speed (10m walking test). Secondary outcome
      measures will include: clinical tests of walking endurance (six minute walking test), balance
      (Berg Balance Test) and mobility (Up and Go Test).

      Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue
      (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored.
      Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale.
      Outcome measures will be assessed the week prior to treatment initiation (T0), after 6
      sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to
      evaluate treatments retention, by a clinician blinded to the treatment.
    


Intervention name(s): Lokomat (Hocoma, Switzerland); Conventional Therapy
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): robotic-driven gait orthosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; gait rehabilitation
Perioperative Analgesia for Total Hip Arthroplasty
Condition: Regional Anesthesia
Study type: Interventional

Summary: 
      This study is comparing the effect of lumbar plexus block and fascia iliaca block with
      general anesthesia to provide perioperative pain control and compare their effects on
      hemodynamics
    

Detailed description: 
      Different groups receive different interventions at same time during study. patients were
      randomly allocated in two groups :

      Group A: lumbar plexus block using shamrock technique by 0.3 ml/kg of 0.5% bupivacaine with
      1:200000 adrenaline.

      Group B: Fascia iliaca block by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.
    

Intervention name(s): bupivacaine 0.5% with 1:200000 adrenaline
Intervention type(s): Procedure
Intervention description(s): regional anesthesia to block lumbar plexus for analgesia of lower limb
Intervention MeSH terms: Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is comparing the effect of Lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Music During ESWL for Half Treatment
Condition: Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Study type: Interventional

Summary: 
      The aim of this study is to evaluate if music listening relieves pain and discomfort during
      Extracorporeal Shock-Waves Lithotripsy (ESWL).
    

Detailed description: 
      Patients undergoing ESWL and interested in music listening are randomly divided in two
      groups: patients in group A listen to music during the first part of the treatment (first
      1800 SW), patients in group B during the second part.

      At the end of the treatment patients are asked to fill in a questionnaire. They are asked if
      they were pleased to have had the opportunity to listen to music during ESWL, if they would
      like to listen to music again in case of further treatments, if they consider music helpful
      in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of
      pain during each part of the treatment on a visual analogue scale (VAS) for pain.
    

Intervention name(s): Music during the first part of ESWL; Music during the second part of ESWL
Intervention type(s): Other; Other
Intervention description(s): Music listening during first part of ESWL; Music listening during second part of ESWL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Urolithiasis; Kidney Calculi; Lithotripsy; Pain Management; Music
An Integrative Intervention for Preventing Children's Emotional Disorders
Condition: Emotional Problem
Study type: Interventional

Summary: 
      The general objective of the study is to test an online platform for the prevention of
      emotional disorders in children aged 8-12 without any clinical symptoms.
    

Detailed description: 
      The general objective of the study is to test an online platform for the prevention of
      emotional disorders in children aged 8-12 without any clinical symptoms. The game will be
      used by children and adolescents for a period of four weeks. Pre-test and post-test
      measurements will be taken.
    

Intervention name(s): Rethink game
Intervention type(s): Behavioral
Intervention description(s): REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: online therapeutic game; emotional problems; prevention
Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts
Condition: External Anogenital Warts
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the
      treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the
      study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and
      Drug Administration (FDA) Draft Guidance for Podofilox recommendations
    

Detailed description: 
      This is a multicenter, parallel group, randomized, double-blind, placebo-controlled, trial
      with clinical endpoint comparing Podofilox Topical Gel 0.5% to Condylox® Gel 0.5% and a
      matching placebo. The study will be conducted among adult male and female patients with
      external anogenital warts. The Investigator will assess vital signs and perform physical
      examination identifying any clinically significant abnormalities. Laboratory samples will be
      collected, including HIV, Hepatitis B&C, and urine pregnancy tests (UPT) for women of
      childbearing potential. The Investigator will confirm the diagnosis of External Anogenital
      Warts (EAW) and the absence of contraindications specified in the exclusion criterion 4
      during the visual examination. The biopsy of skin lesions will be performed per the
      discretion of the Investigator for microscopic verification of the diagnosis of EAWs if any
      doubts of the diagnosis.
    

Intervention name(s): Podofilox Gel 0.5%; Condylox Topical Gel 0.5%; Placebo Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Intervention MeSH terms: Podophyllotoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients
Condition: End Stage Renal Disease
MeSH terms: Hepatitis C; Hepatitis; Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being conducted to determine safety and effectiveness of transplanting kidneys
      from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant
      waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after
      the single kidney transplantation.
    

Detailed description: 
      Open-labelled pilot clinical trial of Zepatier (Grazoprevir + Elbasvir), Mavyret (Glecaprevir
      + Pibrentasvir), Epclusa (Sofosbuvir + Velpatasvir), or another appropriate DAA in at least
      75 HCV-negative subjects with end-stage renal disease receiving a kidney transplant from a
      HCV-positive donor. Eligible subjects will receive a kidney transplant from a deceased-donor,
      and then will receive DAA treatment after kidney transplantation when infection with HCV is
      confirmed in these kidney transplant recipients. Treatment will be complete after 12 weeks
      for most subjects.
    

Intervention name(s): Zepatier; Mavyret
Intervention type(s): Drug; Drug
Intervention description(s): Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.; Mavyret (glecaprevir 100 mg and pibrentasvir 40 mg) is taken by mouth for 8 weeks. Study subjects with treatment failure will be provided an alternative DAA + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Intervention MeSH terms: Elbasvir-grazoprevir drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end-stage renal disease
A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to estimate the relative bioavailability and food effect
      of a PF-05089771 tablet.
    


Intervention name(s): PF-05089771; PF-05089771; PF-05089771
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dispersion TS formulation- fasted; Tablets TS formulation- fasted; Tablets TS formulation- fed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
Condition: SARS-CoV-2
Study type: Observational

Summary: 
      Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of
      the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal
      viruses, which complicates the diagnosis. For mild forms, which represent the vast majority
      of cases, hospitalization is not necessary and treatment is symptomatic. However in more
      severe cases, hospitalization is required and sometimes even admission to an intensive care
      unit.

      Several diagnostic tests are already available, but they require, in all cases, the
      intervention of qualified health personnel to carry out the sample, which includes a risk of
      contagion and an expensive and time-consuming laboratory analysis and reagents. These tests
      are therefore not very suitable for massive screenings.

      We want to evaluate the performance of a detection test performed on a salivary sample in the
      diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical
      device and will restore its qualitative result "infected versus non-infected" in less than 1
      hour (30min objective).
    

Detailed description: 
      Study taking place at the Montpellier University Hospital, comparing a salivary sample group
      with active infection (participants) for SARS-COV2 with a salavary sample tested negative
      (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)
    

Intervention name(s): Sampling salivary
Intervention type(s): Diagnostic Test
Intervention description(s): Collection of 1 to 2 ml of saliva
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The samples size is 90 samples with active infection to SARS-COV2 and at least 90 with no
        active infection
      
Biospecimen description: 
      Salivary sampling (1 to 2 ml of salivary)
    
Keywords: Diagnosis test; Salivary sampling
Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors
Condition: H1N1 Influenza Virus; Invasive Solid Tumors
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, randomized, controlled, open label study with two vaccine regimens. The
      study will assess the relative safety and immunogenicity of vaccine regimens comparing
      adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine
      in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a
      contemporaneously enrolled control group of age-comparable, healthy subjects.

      Because certain individuals may be hypo-responsive to influenza vaccination, additional
      studies with high-risk groups are warranted in order to determine the optimal vaccine
      formulation and dosing schedule for prevention of novel H1N1 virus infection.
    


Intervention name(s): adjuvanted A(H1N1) influenza vaccine; non-adjuvanted A(H1N1) influenza vaccine; non-adjuvanted A(H1N1) influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 7.5 ug of HA antigen; adjuvanted; monovalent; 15ug of HA antigen, non-adjuvanted; trivalent; 15 mcg of antigen; non-adjuvanted; trivalent
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza A Virus; Virus Diseases; Influenza, Human; H1N1; Immunogenicity; safety; tolerability; tumors; oncology
Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over
      a seven-day period, of a low calorie paediatric peptide based tube feed formula for the
      dietary management of participants with short bowel syndrome; intractable malabsorption;
      preoperative preparation of undernourished patients; inflammatory bowel disease; total
      gastrectomy; dysphagia; bowel fistulae;

      The acceptability data from 15 participants will be collected in order to submit an
      application to the Advisory Committee on Borderline Substances (ACBS).
    

Detailed description: 
      Patients well established and stable on a standard or peptide enteral tube feed will be
      changed to a low calorie paediatric formula for a period of seven days. This group will act
      as their own controls. Each child will receive for a period of seven days the paediatric
      formula.

      The dietitian will determine the feeding regimen on an individual basis and the enteral
      formula will be provided via a feeding tube. A baseline questionnaire will be completed by
      the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight
      at the start of the study.

      The parents will complete a week intake chart to monitor how much feed has been consumed each
      day and a tolerance diary to review gastrointestinal symptoms at the start and end of the
      study.
    

Intervention name(s): Paediatric Formula
Intervention type(s): Dietary Supplement
Intervention description(s): Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Hibiscus Tea and Green Tea Supplements on Athletic Performance, Blood Pressure, Muscle Damage Indices and Oxidative Stress
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluated effect of Hibiscus tea and green tea supplements on athletic
      performance, blood pressure, muscle damage indices and oxidative stress in male athletes
      18-35 years old and cardiovascular disease prevention approach.
    


Intervention name(s): Hibiscus tea; green tea; placebo (dextrose)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: healthy male athletes; 18-35 years old