bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities
Condition: Dentofacial Deformities
MeSH terms: Dentofacial Deformities; Congenital Abnormalities
Study type: Interventional

Summary: 
      The correlation between tooth inclination and bone thickness and the comparison between
      thickness measurements and buccolingual inclination before and after dental decompensation
      will be evaluated through tridimensional images in individuals with class III dentofacial
      deformities.
    

Detailed description: 
      Class III dentofacial deformity is associated with important functional, psychological and
      aesthetic changes and thus individuals affected by this type of deformity are motivated in
      seeking treatment. The sample will consist of three-dimensional images of 40 individuals with
      Class III dentofacial deformities. From these images generated by CBCT scans, the
      buccolingual inclinations of all teeth and maxillo-mandibular alveolar bone thickness in
      three different heights will be measured (3, 6 and 8 mm) from the cementoenamel junction
      through the Dolphin 3D® program. The 3D scans of the sample will be evaluated in two stages:
      the initial stage and after dental decompensation at the end of pre-surgical orthodontic
      phase. Pearson correlation test will be used to verify the relationship between tooth
      inclination and bone thickness. The thickness measurements and buccolingual inclination will
      be compared between treatment times (initial and pre-surgical) using paired Student t-test.
    

Intervention name(s): orthodontic decompensation
Intervention type(s): Procedure
Intervention description(s): Evaluation of the correlation between bone thickness and tooth inclination previously and after orthodontic treatment of decompensation due to orthognathic surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Angle class III; tomography; tooth inclination; bone thickness
A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy
Condition: Diabetic Neuropathies; Diabetes Mellitus, Type 2; Polyneuropathies
MeSH terms: Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of topiramate on clinical and
      electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The
      study will also evaluate the safety of topiramate in this patient population.
    

Detailed description: 
      This is a multicenter, double-blind, placebo-controlled study to evaluate the effect of
      topiramate on clinical and electrophysiological parameters in patients with diabetic
      peripheral polyneuropathy. Patients will undergo the Baseline Phase when they are tapered off
      other pain medications, have diabetes controlled and eligibility reassessed. Patients will
      then be randomized to receive either topiramate or placebo and enter the Double-Blind Phase,
      which consists of Titration Period (topiramate dose will be titrated from 25mg/day to
      200mg/day over 42 days) and Maintenance Period (study medication will be continued for 12
      weeks). After the Double-Blind Phase, study medication will be tapered off during the Taper
      Phase, whose duration will vary depending on each patient. The evaluations include
      electrophysiological assessment, quantitative sensory assessment, and clinical assessment
      such as subjective pain scales. Safety evaluations (vital signs, clinical laboratory
      evaluations, physical and neurological examination, and evaluations of adverse events) will
      be conducted during the trial. During the first 42 days, doses of topiramate gradually
      increase to achieve the target dose (200mg daily by mouth), and then the dose is maintained
      for 12 weeks, after which the dose is slowly reduced and stopped over 12 weeks.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): Increasing dosing of topiramate gradually to 200 mg daily by mouth, dose maintenance for 12 weeks, then decreasing dose until stopped over 12 weeks
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetic peripheral polyneuropathy; Electrophysiology; Nerve Conduction Study; Neurological Examination; Quantitative Sensory Testing; Topiramate
Safety Profile Following Pentabio Vaccination in Indonesian Infants
Condition: Healthy
Study type: Observational

Summary: 
      To assess any serious systemic reaction within 30 minutes after Pentabio immunization
    

Detailed description: 
      Any local and systemic reaction after Pentabio immunization
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        4000 infants, 2-11 months old From 4 provincial health primary center
      
Keywords: Pentabio Vaccine; Safety; Infants; Booster Dose; DTwP/HepB/Hib
Support To Reunite Involve and Value Each Other
Condition: Family Relations; Runaway Behavior; Risky Sexual Behavior; Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Runaway and homeless youth are at risk for HIV based upon their rates of substance use,
      particularly injection drug use, unprotected sexual intercourse, multiple partners, and
      sexually transmitted diseases. Risk increases as the time away from home increases. STRIVE is
      a family intervention aimed at increasing residential stability, decreasing runaway episodes,
      and decreasing HIV risk. Families are randomly assigned to a cognitive-behavioral
      skills-building intervention consisting of five weekly sessions delivered at family homes, or
      are assigned to standard care. Sessions are aimed at increasing problem solving, role
      clarity, and positive interactions. It is hypothesized that the intervention will result in
      improved family dynamics, less runaway behavior, and less risky behavior.
    


Intervention name(s): STRIVE family intervention
Intervention type(s): Behavioral
Intervention description(s): Adolescent and parent attend a 5-session family-oriented cognitive-behavioral intervention aimed at giving runaway youths and their parents the tools to effectively deal with conflict.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Runaway youth; Homeless youth; Family intervention; Family functioning; HIV risk behavior; HIV Seronegativity
Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT
      interval corrected for heart rate).
    


Intervention name(s): BMS-708163; BMS-708163; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days; Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days; Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days; Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin; BMS 708163
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy
Condition: Peripheral Pulmonary Nodules
MeSH terms: Multiple Pulmonary Nodules
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the feasibility and safety of navigation guided virtual
      transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of
      peripheral pulmonary nodules (PPN).
    

Detailed description: 
      Accessing peripheral pulmonary nodules is problematic because they are often not visible
      endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial
      biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators
      hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB)
      combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.

      Patients meeting inclusion criteria who consent will undergo a convex Endobronchial
      Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum.
      Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with
      a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or
      radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a
      fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if
      one is present, appropriate clinical measures will be taken at the discretion of the treating
      team (tube thoracostomy, observation, etc.) and no further sampling techniques will be
      utilized. If the lesion was not able to be localized via NB and/or the physician feels
      insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the
      patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned
      that between 8-12 patients will require a N-TTNA to complete diagnosis.
    

Intervention name(s): Navigation guided bronchoscopy
Intervention type(s): Device
Intervention description(s): Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lung nodule biopsy
Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus
      Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.

      Primary Objectives: Safety and Immunogenicity:

      To describe the safety and immunogenicity profiles of:

        -  A single dose of each formulation of TetraMen-T vaccine

        -  A single dose of NeisVac-C® vaccine.
    

Detailed description: 
      The study is designed to evaluate the safety profile and the immunogenicity response after a
      single dose of TetraMen-T in toddlers.
    

Intervention name(s): Meningococcal Polysaccharide Tetanus Protein Conjugate; Meningococcal Polysaccharide Tetanus Protein Conjugate; Meningococcal Polysaccharide Tetanus Protein Conjugate; Meningococcal Polysaccharide Tetanus Protein Conjugate; Meningococcal Polysaccharide Tetanus Protein Conjugate; Meningococcal polysaccharide group C conjugated
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Dietary Supplement
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): NeisVac-C® vaccine (Baxter Healthcare)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neisseria meningitidis
Oxycodone User Registry (OUR)
Condition: Pain
Study type: Observational

Summary: 
      The purpose of this study is to describe clinical and demographic characteristics of patients
      receiving prescription medications containing oxycodone immediate release (OXYRX), to
      characterize patient and prescriber perceptions of the effectiveness outcomes and
      tolerability of OXYRX treatment, to describe prescriber decision-making about pain management
      with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain
      medications.
    

Detailed description: 
      Real-world utility of Schedule II immediate release opioids depends on both efficacy and side
      effects. Few existing data sources systematically captured opioid-related side effects and
      their impact on patient outcomes and physician practice. This study is expected to lead to an
      in-depth understanding of patient and prescriber perceptions of both effectiveness and side
      effects associated with medications containing the most widely prescribed oral Schedule II
      immediate release opioid for pain management, oxycodone immediate release (OXYRX), alone (eg,
      Roxicodone®) or in combination (eg, Percocet®, Tylox®) in actual clinical practice. This is a
      prospective, multi-center, observational patient registry. Adult outpatients who have pain
      due to a non-cancerous condition meeting study eligibility will be enrolled. Prescribers will
      treat patients according to their usual practice. Prescribers will treat patients, meeting
      study eligibility, with OXYRX according to their usual practice.
    

Intervention name(s): oxycodone immediate release (OXYRX)
Intervention type(s): Drug
Intervention description(s): Characteristics of pts. receiving prescription medications containing OXYRX
Intervention MeSH terms: Oxycodone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting for treatment of a painful condition with a Schedule II opioid at an
        outpatient setting will be potential candidates for enrollment for this registry.
      
Keywords: Pain conditions; Oxycodone immediate release; Percocet®, Tylox®; Roxicodone®; Registry; Side effects; Observational; Pain management
Thyroid Medication and Antidepressants for Treating Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of treatment with supplemental triiodothyronine
      (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in
      improving symptoms of major depressive disorder (MDD).
    

Detailed description: 
      The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the
      antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores
      compared to placebo in the treatment of Major Depressive Disorder (MDD).

      The goals of this proposal are to examine the relationship between Major Depressive Disorder
      (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will
      systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with
      sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD.
      The focus will be on two overlapping populations: 1) those with evidence of HPT
      abnormalities, and 2) those who did not respond to a previous adequate SSRI trial
    

Intervention name(s): Triiodothyronine; Placebo; Sertraline
Intervention type(s): Drug; Other; Drug
Other intervention name(s): Cytomel; Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Mental Health; Depression
Effects of Fruit Consumption on Risk Factors of Chronic Disease
Condition: Vascular Stiffness
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Acute, randomized, placebo controlled, double blind, postprandial crossover study in male
      subjects. 4 intervention arms consisting of control, orange juice, whole orange, and
      processed whole orange to determine the effect of the interventions on the primary measure of
      flow mediated dilatation (FMD) and additional biomarkers of health. The study will also
      identify and quantify the main micronutrients and phytochemicals in each of the products and
      will identify and quantify the main micronutrients and phytochemicals and their metabolites
      in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited
      to participate in an additional arm of the main study which is summarised below.
    


Intervention name(s): macro- and micro-nutrient matched control (240 ml); Orange juice; whole orange fruit; Processed whole orange
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease
Condition: Chagas' Disease (Chronic) Nos
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study focuses on the evaluation of low doses (600 and 1200 mg) and short treatment
      duration (at 3, 7 and 10 days) of fexinidazole (Fexi) to determine the minimal efficacious
      and safe dose for the treatment of adult patients with chronic indeterminate Chagas Disease
      (CD).
    

Detailed description: 
      Fexi anti-protozoal activity against T. cruzi has been demonstrated by various in vitro and
      in vivo studies.

      Patients will be randomly assigned to receive one of three different treatment regimen arms
      containing either the active drug or matching placebo tablet

      Following conclusion of 12 months of follow-up of DNDi-CH-FEXI-001 clinical trial, unblinded
      data review showed high sustained parasite clearance rates of FEXI even at the lowest dose
      tested (1200 mg 2 weeks), including in patients that received < 3days treatment.
    

Intervention name(s): Fexinidazole; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Drug: fexinidazole (FEXI); Drug: fexinidazole
Other intervention name(s): FEXI; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is designed as a double-blind, randomized, prospective, comparative, pharmacokinetic-pharmacodynamic, and proof-of-concept trial design, with three-parallel groups and historical placebo control in patients with chronic indeterminate Chagas Disease.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Trypanosoma cruzi Infection; Chagas' Disease; Trypanosomiasis, South American; American Trypanosomiasis; Kissing bug
Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion
      from AF
    


Intervention name(s): AZD7009, no generic name available
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Accuracy of Continuous and Non-invasive Hemoglobin Monitoring
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The primary purpose of this observational study is to investigate the accuracy on the
      continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.
    


Intervention name(s): SpHb monitoring
Intervention type(s): Other
Intervention description(s): Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring
        during surgery.
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Condition: Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness
      and functional recovery of patients suffering acute Achilles tendinopathy.

      It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to
      diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles
      tendinopathy.
    


Intervention name(s): etoricoxib; diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days; diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
Intervention MeSH terms: Diclofenac; Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSAID; tendon; pain; stiffness; Achilles
The Effect of Bike Exercise on Joint and Muscles
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The design of our study is a prospective. It is planned to be completed in twenty-four weeks
      with 34 participants. The main purpose of this study is to examine and compare the effects of
      two different bike exercises on knee joint and lower extremity muscles by ultrasonographic
      method.
    


Intervention name(s): Recumbent Bike; Upright Bike
Intervention type(s): Device; Device
Intervention description(s): The first group will exercise with a recumbent bike for 20 minutes, 3 sessions/week for 6 weeks.; The first group will exercise with a upright bike for 20 minutes, 3 sessions/week for 6 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Joint; Exercise; Ultrasound; Bicycle