bioihbjkbjnl/mcl2 huggingface dataset:
Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      To compare responses to electrical pulp test (EPT) and cold test among molar incisor
      hypomineralization (MIH)-effected and not MIH-effected carious teeth before and after
      administration of local anesthesia for caries removal.
    

Detailed description: 
      Fifty carious permanent first molar teeth (25 MIH-effected, 25 not MIH-effected) were
      included. Firstly, radiographic caries depth, International Caries Detection and Assessment
      System (ICDAS) codes and MIH levels of teeth were recorded. Then, during the treatment, EPT
      and cold test were performed before and after the administration of local anesthesia. Visual
      Analog Scale for Pain was used to evaluate cold test and pain during treatment. When
      interpreting results, significancy level was stated for the values of p<0.05.
    

Intervention name(s): Evaluation of cold test; Evaluation of electrical pulp test; Evaluation of pain during the treatment
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.; Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.; Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Anesthesia; Cold test; Electrical pulp test
Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing
Condition: Lung Cancer
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      To implement a new method of performing chest CT imaging in young children at Packard
      Children's Hospital entitled controlled ventilation infant/young child chest CT scanning.
      This technique will be used to evaluate early lung disease comparing quantitative chest CT
      air trapping and airway measurements with lung function measurements in infants, toddlers,
      and young children with chronic lung disease.
    


Intervention name(s): Intubation with a cuffed ET Tube; CT scan Radiation
Intervention type(s): Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infants/young children with cystic fibrosis, primary ciliary dyskinesia, or other chronic
        lung disease, followed at our CF Center or Pulmonary Clinics
Phase II Dose Titration Study in Patients With Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of various increasing doses of
      Ralfinamide in patients with neuropathic pain.
    


Intervention name(s): Ralfinamide
Intervention type(s): Drug
Intervention description(s): Oral tablets administered at rising doses of 80 - 320 mg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Basic Science
A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      BCN03 is a Single-site, randomized, double-blind, placebo-controlled, phase I study to
      evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that
      includes a sequence of the T- and B-cell immunogens ChAdOx1.HTI and MVA.HTI and ConM SOSIP.v7
      gp140 adjuvanted with MPLA liposomes in 30 virologically-suppressed ART-treated HIV-1
      positive individuals.
    

Detailed description: 
      Participants will be randomized to receive either the combined regimen with T- and B-cell
      immunogens (CSSMS) or placebo (PPPPP) in a double-blinded fashion at a ratio of 2:1. Safety
      and immunogenicity of the combined T- and B-cell regimen will be measured up to week 30 (2
      weeks after last ConM SOSIP.v7/placebo administration). At week 30, all participants will
      undergo an ATI of 24 weeks of duration. At visit week 54 (End-of-ATI visit), or before
      according to pre-specified criteria, ART will be resumed. Efficacy endpoints will be measured
      at 12 and 24 weeks of ATI (study visits week 42 and 54). After ART resumption, participants
      will be followed during an additional safety period of 12 weeks (study visit week 66,
      End-of-Study visit). Treatment allocation will remain blinded until week 54 (End-of-ATI
      visit).
    

Intervention name(s): ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).; Normal saline solution
Intervention type(s): Biological; Other
Intervention description(s): Intramuscular administration of 1 x ChAdOx1.HTI (5x1010 Vp), 3 x ConM SOSIP.v7 (100μg) adjuvanted with MPLA liposomes (500μg), and 1 x MVA.HTI (2x108pfu); Intramuscular administration of normal saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive either the combined regimen with T- and B-cell immunogens (CSSMS) or placebo (PPPPP) in a double-blinded fashion at a ratio of 2:1.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Human immunodeficiency; Virus; Vaccine; HIV; Safety; Tolerability
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
Condition: Joint Disease; Pain, Acute; Pain, Chronic
MeSH terms: Joint Diseases; Acute Pain; Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Post-discharge pain after total knee arthroplasty remains problematic; many patients have
      excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has
      become a national goal, due to the 'epidemic' in opioid misuse.

      In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.
    


Intervention name(s): Cymbalta; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain; Placebo to compare outcomes against Duloxetine
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
Condition: Pelvic Girdle Pain Post Partum; Low Back Pain Post Partum
MeSH terms: Back Pain; Low Back Pain; Pelvic Pain; Pelvic Girdle Pain
Study type: Interventional

Summary: 
      The purpose of this study is to identify how many females have persistent low back pain
      and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can
      continue in the study and be examined by a chiropractor. They will then divide the females
      into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain
      will be invited to participate in a randomised controlled study where chiropractic
      intervention is compared to exercises.
    

Detailed description: 
      The study is a follow up study to "Prevalence of low back pain and pelvic pain in the
      pregnant population in Stavanger".
    

Intervention name(s): exercise advise; chiropractic treatment and exercises
Intervention type(s): Other; Other
Intervention description(s): Exercises; Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments
Other intervention name(s): Pregnancy; Back pain; Exercise; Post partum; chiropractic; Manipulation; Pregnancy; Back pain; Exercise; Post partum; chiropractic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; pelvic pain; pelvic girdle pain; post partum
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
Condition: Surgery; Diverticulitis; Neoplasms; Postoperative Complications
MeSH terms: Diverticulitis; Postoperative Complications
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this multi-center randomized trial is to identify any differences in the
      complication rates of patients undergoing Hartmann's (end colostomy) versus Primary
      Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the
      stoma reversal operation).
    

Detailed description: 
      Hartmann's operation: the surgical resection of the rectosigmoid colon with closure of the
      rectal stump and end colostomy.

      End colostomy: A stoma is created from one end of the bowel while the other portion of the
      bowel is either removed or sewn shut (Hartmann's pouch).

      The second operation (reversal) requires a colo-rectal anastomosis.

      Primary anastomosis: colonic resection with primary anastomosis and defunctioning ileostomy.
      The second operation (stoma reversal) requires an entero-enteral anastomosis.

      Anastomosis: is to join together two bowel ends to restore continuity after resection or
      stoma formation.

      Colostomy: is a reversible surgical procedure in which a stoma is formed by drawing the
      healthy end of the colon through an incision in the anterior abdominal wall and suturing it
      into place. This opening, in conjunction with the attached stoma appliance, provides an
      alternative channel for feces to leave the body.

      Ileostomy is a surgical opening constructed by bringing the loop of small intestine (the
      ileum) out onto the surface of the skin.
    

Intervention name(s): Hartmann's operation; Primary anastomosis
Intervention type(s): Procedure; Procedure
Intervention description(s): Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.; Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
Other intervention name(s): Colectomy with a proximal-end colostomy; Colectomy, primary anastomosis and defunctioning ileostomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emergency Surgery; Bowel perforation; Diverticulitis; Neoplasms; Postoperative Complications; Randomized Controlled Trial
The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology
Condition: Myopia; Orthokeratology
MeSH terms: Myopia
Study type: Observational

Summary: 
      Orthokeratology lens is an effective method for myopia control. This study analyzed the
      effects of treatment zone decentration on axial length elongation in adolescents with
      orthokeratology lens.
    

Detailed description: 
      Orthokeratology lens is an effective method for myopia control. This study aimed to
      investigate the effects of treatment zone decentration on axial length elongation in
      adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth
      were also analyzed.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Myopia children with orthokeratology lens and complete follow-up.
      
Keywords: Myopia; Orthokeratology; Axial length; Decentration
The Effect of Synbiotics on the Upper Respiratory Tract Infection
Condition: Upper Respiratory Tract Infection; Gut Microbiota; Immune Function
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against
      respiratory infections. However, clinical trials of synbiotics, one of the
      microbiota-targeted intervention, in this regard is few. Therefore, this study aims to
      examine the effect of synbiotics on the incidence and severity of upper respiratory tract
      infection, gut microbiota composition and function, as well as biomarkers of immune function.
    


Intervention name(s): Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma
Condition: Exercise-induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to examine the effectiveness of two bronchodilator inhalers in
      patients who have exercise-induced asthma.
    


Intervention name(s): albuterol aerosol by HFA MDI; albuterol aerosol by HFA BOI; placebo aerosol by HFA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): albuterol HFA MDI 160 mcg; albuterol HFA BOI 160 mcg; placebo HFA
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: albuterol; aerosol inhaler; metered-dose inhaler; breath-actuated inhaler; exercise-induced bronchospasm
Investigation of the Impact of Concomitant Use of Multiple Doses of Clopidogrel With Multiple Doses of Dabigatran Etexilate on the Pharmacokinetic and Pharmacodynamic Parameters in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study (Main Part 2) was to investigate whether and to which
      extent a combination of multiple oral doses (steady state conditions) of 75 mg of clopidogrel
      q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran etexilate
      b.i.d. at steady state affects pharmacokinetic and pharmacodynamic parameters of dabigatran
      etexilate and clopidogrel.

      The objective of the preceding Pilot Part 1 of the study was to explore the effect of a
      single dose of 300 mg clopidogrel administered after multiple doses of 75 mg and 150 mg
      dabigatran had reached steady state, regarding safety as well as pharmacokinetic and
      pharmacodynamic parameters.

      The Main Part 3 of the study moreover was to compare intra-individually the effects of a
      single dose of 600 mg clopidogrel with the same dose, 600 mg clopidogrel, given additionally
      to multiple doses of 150 mg dabigatran in steady state condition with respect to safety and
      pharmacokinetic and pharmacodynamic parameters.
    


Intervention name(s): Clopidogrel; Dabigatran high dose; Dabigatran low dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dabigatran; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
Condition: Prostate
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objectives were to determine the efficacy and safety of the GITS formulation of
      Doxazosin in Taiwanese patients with prostate enlargement.
    


Intervention name(s): Doxazosin mysylate GITS
Intervention type(s): Drug
Intervention description(s): Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.
Intervention MeSH terms: Doxazosin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign Prostate Hyperplasia
Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test
Condition: Healthy
Study type: Interventional

Summary: 
      Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two
      device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA).
      Each probes are attached to both thenar muscles and vascular occlusion test (VOT) is
      performed. The investigators will compare the Invos® data to InSpectra™ to investigate
      whether tissue oxygen saturation values by INVOS® can substitute for InSpectra™.
    

Detailed description: 
      Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two
      device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA).
      InSpectra™ was introduced later than INVOS®.

      With InSpectra™, clinicians have used a vascular occlusion test (VOT) to evaluate dynamic
      changes in tissue oxygen saturation during ischemia and reperfusion, and thus,
      microcirculatory function. There have been little data about VOT using INVOS®, although it is
      more popular device.

      We hypothesized that there would be a difference between the values from INVOS® and
      InSpectra™. The aim of this study is to evaluate changes in tissue oxygen saturation in the
      thenar muscle during VOT using INVOS® and comapre it to InSpectra™ in a normal population.
    

Intervention name(s): vascular occlusion test; vascular occlusion test
Intervention type(s): Device; Device
Intervention description(s): Using Invos® probe attacted to one thenar muscle, tissue oxgyenation is measured by VOT.; Using Inspectra™ probe attacted to another thenar muscle, tissue oxgyenation is measured by VOT.
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Measures; near-Infrared spectroscopy; ischemia; reperfusion
The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions
Condition: Lumbar Degenerative Conditions
MeSH terms: Disease
Study type: Interventional

Summary: 
      Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients
      with lumbar degenerative conditions with the aim of improving pain relief and quality of
      life. However, there is a lack of evidence on the indication for postoperative bracing, as
      surgeons choose to use braces mainly based on their experience and training.

      The aim of this study is to investigate whether wearing a brace after PSIF can improve pain
      relief and quality of life (QOL) 6 weeks and 3 months after surgery.
    


Intervention name(s): Brace Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours.
All patients will complete the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (preoperatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.; All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours.
Bracing will not be prescribed postoperatively for this group. All patients will the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (pre-operatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Post-operative Bracing; Rigid Lumbosacral Orthosis; Posterior Spine Fusion; Quality of Life; Lumbar Degenerative Conditions
A Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to
      renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute
      kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)
    

Detailed description: 
      The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter
      cartridge. The device is connected in series to commercially available Continuous Renal
      Replacement Therapy (CRRT) devices. Blood from the CRRT circuit is diverted after the CRRT
      hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through
      this space and it is returned to the patient via the venous return line of the CRRT circuit.
      Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
    

Intervention name(s): SCD-F40
Intervention type(s): Device
Intervention description(s): CRRT with SCD
Other intervention name(s): Selective Cytopheretic Device (SCD)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Renal Failure; Acute kidney injury; Continuous Renal Replacement Therapy; Selective cytopheretic device; Pediatric
Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
Condition: Heart Diseases; Pain
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      Studies show that chest pain is a common complaint presented in both general practice and in
      emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies
      about treatment of chest pain from the intercostal muscles were found by search in medical
      literature databases. The purpose of this study is to evaluate the effect of two different
      physical therapy interventions on intercostal pain in patients with stable heart disease.

      The hypothesis was that deep friction massage combined with heat-pack is more effective than
      heat-pack only.
    


Intervention name(s): heat-pack with massage; heat-pack only
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thorax; Intercostal Muscles; massage; heat-pack; hot temperature