bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial
Condition: Low Back Pain; Medicine, Korean Traditional
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study is a single blind, randomized controlled trial. condition/disease: acute low-back
      pain treatment/intervention: Motion Style Acupuncture Treatment using Traction (T-MSAT)
    

Detailed description: 
      Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle
      created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a
      kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the
      patient's body through the device and giving instructions for walking while being
      acupuncture.This treatment involves patients with musculoskeletal pain to move the part of
      their body actively during acupuncture treatment under physicians' observation. This
      treatment is known to relieve pain and improve musculoskeletal disfunctions. However, there
      has been no specific studies for the effect of this treatment.

      So, investigators conduct a randomized controlled trials to verify the effectiveness and
      safety of T-MSAT. From September 2020 to March 2021, investigators recruit 100 inpatients who
      are suffered from acute low-back pain with the numeric rating scale(NRS) over 5 by traffic
      accident(TA). For experimental group(n=50), investigators conduct T-MSAT three times(on 2nd,
      3rd and 4th day of hospitalization) and other Korean medical treatment. For control
      group(n=50), just Korean medical treatment except T-MSAT is conducted. For these two groups,
      investigators compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of
      Motion(ROM), , Oswestry Disability Index(ODI), the 12-Item Short Form Health Survey(SF-12),
      and PTSD Checklist for DSM(Diagnostic and Statistical Manual of Mental Disorders,
      DSM)-5(PCL-5)
    

Intervention name(s): T-MSAT(Motion style acupuncture treatment using traction); Korean medicine treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture therapy
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
Condition: Agitation; Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Schizophreniform Disorders
MeSH terms: Psychomotor Agitation; Schizophrenia; Psychotic Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the
      acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to
      characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of
      DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or
      schizophreniform disorder.
    

Detailed description: 
      The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg,
      120µg BXCL501, or placebo. Male and female adults with acute agitation associated with
      schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled.
      Eligible subjects may be identified in outpatient clinics, mental health, psychiatric or
      medical emergency services including medical/psychiatric observation units, or as newly
      admitted to a hospital setting for acute agitation or already in hospital for chronic
      underlying conditions. Subjects will be domiciled in a clinical research setting or
      hospitalized to remain under medical supervision while undergoing screening procedures to
      assess eligibility. Efficacy and safety assessments will be conducted periodically before and
      after dosing.
    

Intervention name(s): Sublingual film containing dexmedetomidine (BXCL501); Placebo Film
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual film containing dexmedetomidine (BXCL501); Placebo Film for BXCL501
Other intervention name(s): Dexmedetomidine; Placebo
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions
Condition: Pigmented Skin Lesion
MeSH terms: Pigmentation Disorders
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the safety and efficacy of a fractional diode laser
      for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar
      lentigos (sunspots), and ephelides (freckles).
    

Detailed description: 
      Prospective, open-label, clinical trial to study the effects of the nonablative, fractional
      diode laser for treatment of pigmented lesions.

      Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will
      receive up to three (3) treatments in the following treatment areas: face, hands, arms, back,
      chest, or legs. Participants will complete follow-up visits for clinical evaluation and
      photography at 1 and 3 months after the final study treatment.
    

Intervention name(s): FRAX 1940 nm laser
Intervention type(s): Device
Intervention description(s): A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
Condition: Tibial Fractures; Open Fractures
MeSH terms: Fractures, Bone; Tibial Fractures; Fractures, Open
Study type: Interventional

Summary: 
      This is a prospective, multi-national, multicenter, randomized, two arms, single blind,
      Standard of Care (SOC) controlled, with blinded central reading center study. This study will
      assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo
      IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.
    

Detailed description: 
      The study population include subjects with a classification of Gustilo I, II, IIIA or IIIB of
      tibial open fractures, assigned for surgical procedure, who meet eligibility criteria and
      provide signed informed consent.

      Subjects will be randomized into either Study investigational arm or Study control arm, using
      a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ;
      IIIB).

      Total duration of the study is expected to be approximately 32 months from first subject
      enrolled until last subject completed.

      It is expected that each subject will be in the study for approximately 52 weeks

      Subjects will be followed at the following time points:

        -  Immediately post index procedure

        -  During hospitalization

        -  Discharge visit

        -  4 weeks and then monthly up to 24 weeks, 36 and at 52 weeks.

      This is a single blind clinical trial. Subjects and their family members will be blinded to
      the treatment arms assignment. The study site personnel present at the baseline procedure as
      well as the physician performing the procedure will be trained not to disclose the treatment
      arm to the subject, his/her family, and to health care providers outside of the Orthopedic
      department.

      An independent X-ray reading center assessing all subjects' images will be blinded to the
      treatment arms assignments, for the entire trial period. However, due to the radiographic
      appearance of the BonyPid-1000 as compared to SOC may differ, it is not entirely possible to
      blind the evaluating radiologists.
    

Intervention name(s): BonyPid-1000; Standard of Care (SOC) treatment
Intervention type(s): Device; Other
Intervention description(s): BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment; Standard of Care (SOC) treatment only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized into either Study investigational arm or Study control arm, using a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ; IIIB).
In the study treatment arm patients will receive BonyPid-1000 in addition to the standard of care treatment. in the control arm patients will receive the standard of care treatment alone.
Masking: Single (Participant)
Primary purpose: Prevention
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg
Condition: Type2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, multiple dosing, three treatment, three period, two sequence
      clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of
      evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects
    

Detailed description: 
      A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence,
      crossover study
    

Intervention name(s): Evogliptin→Evogliptin+Glimepiride→Glimepiride; Glimepiride→Evogliptin→Evogliptin+Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.
Glimepiride : Glimepiride 4mg QD
Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD; After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.
Other intervention name(s): Suganon, Amaryl; Suganon, Amaryl
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      The present study was based on secondary analysis using the non-intervention control
      conditions of five separate studies with common measures. The current analysis examine the
      indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy
      intake in individuals at or close to energy balance.
    

Detailed description: 
      The current analysis examine the indirect and direct effects of fat-free mass, fat mass and
      resting metabolic rate on energy intake in individuals at or close to energy balance.

      The present study was based on secondary analysis using the non-intervention control
      conditions of five separate studies conducted between the dates of 1998 and 2007. In total,
      242 subjects (114 males; 128 females; mean body mass index = 25.6 ± 5.0 kg/m2) were included.
      In these studies, body composition (air displacement plethysmography), energy expenditure
      (indirect calorimetry and flex heart rate) and energy intake (weighed dietary records) were
      measured using common procedures.
    

Intervention name(s): Dietary energy restriction
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The baseline non-intervention control arm only used in the present secondary data analysis
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Appetite; Energy Intake; Body Composition; Energy Expenditure
EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
Condition: Retinal Evaluation in Patients With GDM.
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational [Patient Registry]

Summary: 
      Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes
      and it is responsible for the morbidity of both mother and child. The aim of this study was
      to determine retinal findings of gestational diabetes mellitus (GDM).
    

Detailed description: 
      We have three groups; the first group consisted of pregnant volunteers with GDM. The second
      group consisted of healthy pregnant participants. The third group consisted of healthy,
      non-pregnant women at the reproductive age. Macular, choroid and retinal nerve fiber layer
      (RNFL) thicknesses were evaluated in patients with GDM and comparisons were made among GDM,
      healthy pregnant and healthy non-pregnant subjects for these parameters by using optic
      cohorence tomography.
    

Intervention name(s): Pregnant volunteers with GDM
Intervention type(s): Other
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      no biospecimens are to be retained
    
Keywords: gestational diabetes mellitus; optical coherence tomography; pregnancy; retinal nerve fiber layer.
PreView: The Preventive Video Education in Waiting Rooms Program
Condition: Health Status Unknown
Study type: Interventional

Summary: 
      This clinical trial studies how well PreView, preventive video education, works in increasing
      rates of breast, cervical and colorectal cancer screening, improving participants' stage of
      change with respect to age appropriate cancer screening and increasing patient-provider
      discussions about prostate cancer screening.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the extent to which PreView increases the likelihood that primary care
      patient participants will receive mammograms, pap tests, colon cancer tests or prostate
      specific antigen (PSA) testing discussions with primary care physicians compared with
      participants who receive usual care.

      II. To determine the extent that PreView increases participants' readiness to be screened for
      breast cancer, cervical cancer or colorectal cancer (CRC) compared with usual care.

      III. To determine the extent that PreView increases the likelihood that PSA testing will be
      discussed in primary care physician visits compared with usual care.

      OUTLINE: Patients are randomized into 1 of 2 groups.

      GROUP I: Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on
      an iPad in the waiting room before a doctor visit.

      GROUP II: Patients watch a video about healthy lifestyles including information about
      exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor
      visit.
    

Intervention name(s): Computer-Assisted Intervention; Computer-Assisted Intervention; Questionnaire Administration
Intervention type(s): Other; Other; Other
Intervention description(s): Complete PreView; Watch an educational video; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Video-visit Behavior Therapy for Anxiety and Depression in Youth
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This project focuses on adapting and pilot testing an efficacious brief behavioral therapy
      (STEP-UP) for youths with anxiety or depression to be delivered as a telehealth intervention
      by clinic staff in low-resource community health centers (CHCs).
    


Intervention name(s): Brief Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 8-12 sessions of brief behavioral therapy administered by behavioral health / mental health staff at participating community health centers (CHCs)
Other intervention name(s): STEP-UP; BBT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child; Adolescent
Effect of Intrapulpal Injections on the Post-endodontic Pain
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      To achieve painless treatment in patients with a failed primary IANB, supplementary
      anesthesia has been advised. The majority of the studies evaluating intrapulpal injections
      have been performed on asymptomatic teeth. Very limited research has been dedicated to the
      evaluation of different variables in intrapulpal injections in patients with symptomatic
      irreversible pulpitis. The aim of this study was to evaluate postoperative pain after an
      intrapulpal anesthesia injection given after a failed inferior alveolar nerve block (IANB),
      in patients with symptomatic irreversible pulpitis. This prospective, randomized,
      double-blind clinical trial was carried out at the Department of Conservative Dentistry and
      Endodontics, Faculty of Dentistry, Jamia Millia Islamia. One hundred and eight adult
      patients, with symptomatic irreversible pulpits in a mandibular first or second molar
      received an initial IANB with 2% lidocaine. Pain during the endodontic treatment was assessed
      using a visual analog scale (VAS). Patients experiencing pain on endodontic intervention were
      randomly allocated to one of the two treatment groups: one group received a supplementary
      intrapulpal injection while the other received a supplementary intraligamentary injection The
      presence of postoperative pain was assessed at 1, 2, 3, and 7 days after treatment.
    


Intervention name(s): Supplementary anesthetic injections
Intervention type(s): Procedure
Intervention description(s): Supplementary anesthetic injections after failed primary nerve block
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine
      administered as needed (PRN) compared with placebo in patients with moderate to severe acute
      pain after abdominoplasty.
    


Intervention name(s): Oliceridine; Placebo; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
HUmira in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a
      estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a
      progressive, erosive arthritis causing severe disability and increased mortality.

      The biologic treatment infliximab and etanercept have recently been introduced for treatment
      of PsA and psoriasis, and current data indicate a higher efficacy than with previously
      available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but
      preliminary data are encouraging. The improved treatment options have increased the need for
      sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient
      therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography
      (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not
      yet sufficiently studied, methods for this.

      The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel
      imaging- and biomarkers can provide additional information, compared to clinical measures and
      radiography, concerning activity, destructive progression and prediction of therapeutic
      response in PsA patients receiving adalimumab. The perspective is a potential improvement in
      diagnosis, monitoring and prognostication of patients with PsA.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab 40 mg every other week
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment