bioihbjkbjnl/mcl2 huggingface dataset:
Infrared Imaging in Complex Regional Pain Syndrome
Condition: Complex Regional Pain Syndromes
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Study type: Observational

Summary: 
      This research proposal aims to investigate the potential use of Infrared (FLIR) imaging to
      monitor the successful achievement of the sympathetic blockade in patients with complex
      regional pain syndrome (CRPS).
    

Detailed description: 
      Sympathetic blocks are clinically used to diagnose and treat sympathetically mediated pain.
      Despite the frequent use of these blocks, there remains a need for an objective method to
      determine the achievement of a sympathetic block in the clinical setting.

      Current clinical practice assess the success of a sympathetic block by observation of
      clinical signs of sympathetic blockade. These signs include monitoring skin temperature,
      pulse amplitude, blood oxygen, or any combination of these methods. However, clinical signs
      of sympathetic blockade often demonstrate an unpredictable or delayed response and can make
      monitoring difficult.

      Therefore, it is necessary to develop an objective monitoring method that is reliable, rapid
      response, and not affected by the other confounders. One potential method is the use of
      thermal camera imaging (FLIR).

      Such a monitor could increase procedural accuracy and efficiency, thus improving patient
      care. To plan the prospective treatment options, objective confirmation of successful
      sympathetic block is essential to differentiate sympathetically mediated pain (SMP) versus
      sympathetically independent pain (SIP).

      In this context, utilization of a monitor with a rapid response and easy clinical
      applicability, would serve as an objective endpoint for evaluating sympathetic blockade both
      clinically and for future research.

      Therefore, this research proposal aims to investigate the infrared (FLIR) thermal camera as
      an objective method for determining the achievement of sympathetic block in the clinical
      setting.
    

Intervention name(s): Forward Looking Infrared Radar (FLIR) thermal imaging
Intervention type(s): Device
Intervention description(s): The FLIR camera will collect temperature recordings pre-procedure and 5 minutes post-procedure, which will be used to calculate a delta T to assess achievement of a successful sympathetic block.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study is designed to be implemented in a single center in an academic pain center that
        is specialized in musculoskeletal pain. In a pain center with a high experience in clinical
        and academic fields, it is planned to apply lumbar sympathetic blocks to the patients
        diagnosed with CRPS. The Budapest Clinical Diagnostic Criteria will be used to diagnose
        CRPS Type 1 patients.
      
Keywords: complex; regional; pain; FLIR; Sympathetic Block
A Randomized, Double-blind, Sham-controlled Pilot Study to Evaluate the Treatment Efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in College Students With ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate
      the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with
      ADHD. A total of 40 subjects will be treated.
    

Detailed description: 
      This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate
      the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with
      ADHD. A total of 40 subjects will be treated.

      Twenty (20) subjects will receive active treatment with MeRT and the other 20 with sham.
      Subjects in each study group will be treated 30 min a day, 5 days a week for 4 weeks. This is
      known as Phase 1. During this study period, subjects and clinicians will be blind to
      treatment condition.

      Subjects will be recruited from a flyer describing the study. The flyer will be posted at the
      Kortschak Center for Learning and Creativity, the McKay Center, and through Student
      Counseling Services in the Engemann Student Health Center. In addition, students who have
      been diagnosed with ADHD and have been seen at one of these facilities for ADHD may be
      provided contact information for the study.
    

Intervention name(s): Active MeRT Treatment; Sham MeRT Treatment
Intervention type(s): Device; Device
Intervention description(s): A personalized biometrics-guided protocol known as magnetic EEG/EKG resonance therapy (MeRT) treatment that is tailored specifically to each patient's higher harmonic frequency of heart rate, which is nearest to the characteristic frequency of alpha EEG frequency.; A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.
Other intervention name(s): rTMS Active Stimulator; rTMS Sham Stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixteen (16) subjects will receive active treatment with MeRT and the other 15 with sham. Subjects in each study group will be treated 30 min a day, 5 days a week for 4 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Children on the autism spectrum often show aggressive behavior. Treatment can train children
      to be more aware of their emotions. Investigators studied the effectiveness of an
      attention-based intervention tailored on aggressive behavior problems and the use of anger
      coping strategies of school aged autistic children with anger regulation problems.
    

Detailed description: 
      Investigators studied the effectiveness of an attention-based intervention tailored on
      aggressive behavior problems and the use of anger coping strategies of school aged autistic
      children with anger regulation problems. Using a randomized controlled trial (RCT), children
      were allocated to the attention-based treatment in combination with a psycho-educational
      parent-training (treatment group) or to the parent-training only (active control group).
    

Intervention name(s): Anger can go!; Parent psycho-education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention "Anger Can Go!" was designed to treat anger regulation problems in autistic children aged 8 to 13 years old. The intervention consists of nine sessions of 60 minutes and is divided in four phases. Phase 1: psycho-education, affect-education and measuring anger with an anger-thermometer. This is a self-report scale presented as the drawing of a thermometer, that allows the child to indicate his level of anger, as linked to specific bodily and behavioral representations on a scale from 0 to 3. Phase 2: making a functional behavior assessment (FBA) and taking a time-out at a low anger-level (between 1 and 2 on the scale 0 to 3) to prevent aggressive outbursts. Phase 3: taking a time-out at a low anger-level (between 1 and 2 on the scale 0 to 3) to prevent aggressive outbursts, shifting attention away from aversive stimuli, to cope with the stress of the anger provoking situation. Phase 4: creating solutions to cope with an anger provoking situation.; Three psycho-educational parent group sessions (take place before the children's sessions in intervention group). Parents meet with other parents and a therapist to learn about the nature of their Expressed Emotion (EE) and how it relates to the child's aggressive behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism spectrum disorder; Anger; Randomized controlled trial
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The purpose of this study is to collect alcohol calibration data for the driving simulator.
    


Intervention name(s): Road-tracking test; Car-following test; Harsh-braking test
Intervention type(s): Other; Other; Other
Intervention description(s): Driving with simulator program for SDLP measurement; Driving with simulator program for DCV measurement; Driving with simulator program for BRT measurement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Attempt to Find Out Root Cause of a Pain Producing Knee Disease
Condition: Knee Osteoarthritis; Arthroplasty; Knee
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This study was focused on a type of arthritis (knee) in which patients develop pain with
      disabilities in sitting and walking etc. In advance stage the person is bereft of his/her
      personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A
      new treatment was designed and a trial was conducted on 125 patients (100 in the trial group,
      25 in the control group) for a duration of six months.
    

Detailed description: 
      The study was focused on establishing the cause and treatment of a painful knee joint disease
      (Primary Osteoarthritis Knee = OA Knee). At present the cause and treatment are not known.
      The study was based on a hypothesis, designing a treatment and testing it through a clinical
      trial. This established that the deficient full flexion or deficient full extension of knee
      joints, producing contracture in their capsules was the cause and the correction (Contracture
      Correction Therapy = CCT) was the cure of the disease. The correction was carried out by
      passive flexion or passive extension of affected knee through eight body postures designed
      specifically during the study.

      To test the efficacy a multi-centre, multi surgeon six months study on 125 patients was
      carried out, patients were divided into Trial and Control groups. The effects were measured
      by primary outcome measure - The Western Ontario and McMaster Universities Arthritis Index
      (WOMAC) score and other measure EuroQol-Visual Analogue Scales (EQ-VAS) score, DFF*, DFE^ at
      0, 6 ,12 and 24 weeks.

      The "Intervention" for 1st group was CCT and for the 2nd group was "No intervention".

      * Deficient full flexion

      ^ Deficient full extension
    

Intervention name(s): Contracture Correction Therapy
Intervention type(s): Other
Intervention description(s): Non-drug and non-surgical treatment of contracted knee capsules
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Gwalior a city in India and multiple surrounding towns
      
Keywords: Deficient full flexion; Deficient full extension; Contracture Correction Therapy
Bioavailability of Folic Acid Fortified Bread
Condition: Red Blood Cell Folate
Study type: Interventional
Phase: Phase 2

Summary: 
      Folic acid is the synthetic form of vitamin folate. Because of its high stability and
      bioavailability, it is the form of folate added to bread in Canada to reduce birth defects.
      There are health concerns about long-term folic acid consumption. Another form of folate,
      L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these
      health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators
      have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a
      randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic
      acid.

      The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell
      folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.
    

Detailed description: 
      See above.
    

Intervention name(s): Folic acid; L-5-MTHF; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): One roll/bun per day fortified with 400 µg of folic acid; One roll/bun per day fortified with 452 µg of L-5-MTHF; Placebo contains no folic acids
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function
Condition: Pain Response, Stress, Trauma
Study type: Observational

Summary: 
      The study design is to assess the between groups factor (controls, chronic pain, addicted
      individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a
      longitudinal component to assess stress, pain and addictive behaviors in daily life.
    

Detailed description: 
      This proposal aims to systematically examine the physiologic, neuroendocrine and behavioral
      stress and pain responses to an adapted Cold Pressor Test and also assess specific cognitive
      and executive function tests in community volunteers with a history of stress and trauma,
      social users of alcohol, cannabis and individuals with alcohol use disorder, cannabis use
      disorder, opioid use disorder, cocaine use disorder and chronic pain.
    

Intervention name(s): Yale Stress Pain Test (YSPT)
Intervention type(s): Diagnostic Test
Intervention description(s): Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers and those with chronic pain, those with alcohol use disorder, and those
        with cannabis use disorder.
      
Biospecimen description: 
      Stress hormones Cortisol and ACTH
Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons
Condition: Medical School Student; Healthy Population
Study type: Interventional

Summary: 
      To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was
      applied to the various surgery area . And the complete understanding and practice of the
      robotic system is very important condition for successful robotic surgery.

      Investigator developed a home made robotic surgery simulator for novice robotic surgeons. And
      investigator want to study about the ability of home made robotic surgery simulator versus
      existing robotic simulation system.
    


Intervention name(s): existed simulation system user; home made simulator user
Intervention type(s): Procedure; Procedure
Intervention description(s): Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.; Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Dry Needle In Management of Cervicogenic Headache
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      Headache is an important health problem. It is the commonest type of all signs of illness in
      the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in
      physiotherapy practice. This study's main objective was to evaluate effectiveness of Dry
      Needle with exercise in decreasing pain and improving function in patients with Cervicogenic
      Headache.
    

Detailed description: 
      50 patients were included and assigned randomly to group A and B. Group-A received Dry Needle
      plus exercise and group-B received Dry Needle alone. Baseline assessment was taken before and
      after treatment; treatment was given for four weeks twice a week. Outcome indicators were
      measured by Visual analog scale, Neck Disability Index and Cervical Range Of Motion.

      The study findings indicate that both groups improve the symptoms of a headache. Clinically
      better improvement was indicated by Dry Needle plus exercise group than Dry Needle alone
      group. As per our results, Dry Needle plus exercise should be preferred for the management of
      cervicogenic headache over Dry Needle alone.
    

Intervention name(s): Dry Needle and Exercise
Intervention type(s): Other
Intervention description(s): A 0.25 X 15 mm acupuncture needle was used for sub occipital muscle and 0.25 X 40 mm needle was used for paraspinal and trapezius muscle. All the necessary precautions were maintained before inserting the needle. Therapists wore hand gloves for all purposes.
The exercise for the muscles of cervical group, for group A was carried out by elevating head from lying in supine position repeating 20 times in three sets and pressing a theraband forward in one set of 15 repetitions, to right side and to left side and back side
Other intervention name(s): Ice pack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry Needle; Exercise; Neck pain; Trigger point
Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To evaluate the effect of single and repeated administration of rifapentine given as daily
      or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and
      tenofovir given as a fixed dose combination (ATRIPLA™ ).

      Secondary Objective:

      - To evaluate the safety and tolerability of concomitant administration of rifapentine and
      ATRIPLA™ given to HIV+ patients
    

Detailed description: 
      -  Screening to admission: up to 21 days

        -  Admission to the end of the follow-up: up to 41 days

             -  Period 1: Treatment period of 15 days with ATRIPLA™ (background therapy). Patients
                should receive the same regimen and dose of ATRIPLA™ during the all study screening
                and period 1.

             -  Period 2: Treatment over a period of 21 days in co-administration with rifapentine.

             -  Follow up: 3 to 5 days after the last rifapentine administration.
    

Intervention name(s): rifapentine (M000473); EFZ EMT TDF
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:tablet
Route of administration: oral; Pharmaceutical form:tablet
Route of administration: oral
Other intervention name(s): ATRIPLA™
Intervention MeSH terms: Rifapentine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will
      compare pharmacopuncture therapy and physical therapy for chronic low back pain.
    

Detailed description: 
      This is a pragmatic RCT, so the physicians will choose the type and volume of
      pharmacopuncture and the type and time of physical therapy according to participants'
      conditions, respectively.
    

Intervention name(s): pharmacopuncture therapy; physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.; This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
Condition: Sleep
Study type: Interventional

Summary: 
      A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant
      derived cannabinoids on sleep and overall health outcomes
    

Detailed description: 
      The aim of this study is to determine the safety and effects (if any) of different single
      agent and combination cannabinoid formulations on self-reported sleep and health in adults
      (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study
      that will recruit up to 300 participants per study arm (up to 1800 total). Participants will
      be followed for 5 weeks as they answer electronic surveys about their health, study product
      usage, and its impact on their health. There are no in-person visits for this study.

      After study completion, study investigators will compare the effects of each cannabinoid
      study product to melatonin isolate. Study investigators will also run post-hoc analyses
      (correcting for multiple comparisons) to evaluate the significance of health score changes
      within individual study product arms, and whether there were significant differences in the
      effect with the addition of components to comparable cannabinoid study products.
    

Intervention name(s): Sleep Study Product Usage
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be stratified based on gender and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms
Masking: Double (Participant, Investigator)
Primary purpose: Other