bioihbjkbjnl/mcl2 huggingface dataset:
Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
Condition: Spinal Stenosis With Nocturnal Calf Cramps
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The
      purpose of this study is to evaluate the effect of botulinum toxin A injection into the
      gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We
      will compare pain score, insomnia severity, functional ability, patient satisfaction, and
      neurophysiological variables change using electrical stimulator between control (conservative
      management for spinal stenosis) and botox group (conservative management for spinal stenosis
      plus botox injection into the gastrocnemius muscle).
    


Intervention name(s): botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle; no intervention
Intervention type(s): Drug; Other
Intervention description(s): ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).; Patients in the control group will not receive any injection on the gastrocnemius muscle.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Pharmacokinetics and Safety Between the Treatment of CKD-383 and Treatment of CKD-501, D745, D150, and D029
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the
      Co-administration of CKD-501, D745, D150 and D029 for Healthy Subjects in Fed State
    


Intervention name(s): CKD-383; CKD-501, D745, D150, D029
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spoken Discourse Biomarker of PD Cognitive Impairment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to identify unique profiles of speech and language changes that
      distinguish individuals with Parkinson's disease from adults without Parkinson's disease and
      individuals with Parkinson's disease with cognitive (e.g., memory, thinking skills)
      impairment from those without cognitive impairment.
    

Detailed description: 
      Aim 1 will characterize PD-MCI (Parkinson's disease mild cognitive impairment), PDN
      (Parkinson's disease without cognitive impairment), and HA (healthy adult) spoken discourse,
      cognitive, and motor speech profiles. Phase 2 biomarker development requires robustly
      characterized cohorts in which to test candidate biomarkers. Using a standardized battery of
      cognitive, language, and motor speech tests PD participants will be assigned to PD-MCI
      (single/multi-domain) or PDN groups. The investigators propose collecting spoken discourse
      samples using standardized elicitation protocols. The same tasks will be extracted from the
      extant HA database. Researchers will transcribe, code, and analyze discourse samples. Group
      differences (including sub-analyses for single and multi-domain MCI subtypes), elicitation
      stimuli effects, and group x stimuli interactions will be examined using multivariate and
      mixed-design ANOVA procedures.

      Aim 2 will develop and evaluate the classification accuracy of an optimally weighted
      discourse classification function for PD-MCI and PDN. The investigators propose using
      discriminant function analysis to identify an optimized composite variable that best predicts
      PD-MCI, PDN, and HA group membership. Sensitivity/specificity analyses, positive/negative
      predictive values, and receiver operating characteristic curves will be used to evaluate the
      discourse classification function properties.

      The primary endpoint is an optimally weighted discourse function that can classify PD-MCI
      with > 80% sensitivity/specificity.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Only individuals with PD will be newly recruited and enrolled as part of the study. Healthy
        adult data will be extracted from extant databases (publicly available) from NIH-funded
        studies.
Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
Condition: Child, Only; Chronic Diseases in Children
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Purpose: This study was conducted to find out the effects of colour by number mandala in
      decreasing the stress of hospitalized children with chronic disease.

      Design: A randomized controlled study. Methods: This study was conducted with 120 children
      between the ages of 8 and 11. 60 children formed the experimental group, while 60 children
      formed the control group. Descriptive Information Form and Perceived Stress Scale were used
      in data collection.
    

Detailed description: 
      Experimental group: The children, along with their parents, were interviewed by one of the
      researchers on their first day of hospitalisation. The parents were informed about the
      Descriptive Information Form and the Perceived Stress Scale for Children, which the
      researcher filled out in the presence of the children and their parents. The children were
      then given a colour-by-number mandala and colouring pencils. A different colour-by-number
      mandala was given to each participant every day; the mean length of hospital stay was 3 days.
      At the end of the third day, the same researcher interviewed the children and filled out
      again the Perceived Stress Scale for Children.
    

Intervention name(s): This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.
Intervention type(s): Other
Intervention description(s): Colour by number Mandala in different sizes includes pictures and numbers. The child has to find the colour specified in the number and colour it with the specified colour. Colourful pictures emerge as a result of colouring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Accumulation of Dietary Bioactives and Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Current research suggests that diets rich in multiple food types (such as broccoli, onions
      and garlic) are beneficial to our health and may reduce the risk of some cancers, including
      prostate cancer. The purpose of this study is to investigate the relationship between
      ingestion of the bioactive compounds from broccoli and garlic, and prostate metabolism.
    


Intervention name(s): Allin; Sulforaphane; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement; Dietary supplement; Dietary supplement
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents
Condition: Palatal Expansion Technique; Malocclusion; Posterior Crossbite; Maxillary Hypoplasia
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Miniscrew-supported maxillary expanders provide advantages over conventional tooth-supported
      expanders. However, there is no consensus in the literature regarding their activation
      protocol. The purpose of the clinical trial is to evaluate and compare the effects of slow
      and rapid activation rates of miniscrew-supported expanders on the skeletal changes,
      dento-alveolar changes and the pain experience.
    

Detailed description: 
      Transverse maxillary deficiency is one of the problems that are commonly encountered in the
      orthodontic practice. Miniscrew-supported maxillary expansion represents a promising modality
      for the treatment of transverse maxillary deficiency. However, controversies still exist
      regarding the activation protocol. One of these controversies is whether using a slow
      activation protocol would be more beneficial to the patients compared to a rapid activation
      protocol. Another question that consequently ensues is whether such activation protocol would
      result in less pain compared to the rapid activation protocol.

      The null hypothesis of the current study is that there is no difference between slow and
      rapid activation protocols of miniscrew-supported expander.
    

Intervention name(s): Miniscrew-Supported Maxillary Expander- Slow activation; Miniscrew-Supported Maxillary Expander- Rapid activation
Intervention type(s): Device; Device
Intervention description(s): A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated slowly by turning the expansion screw once every other day to correct the transverse maxillary deficiency.; A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated rapidly by turning the expansion screw twice per day to correct the transverse maxillary deficiency.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rapid Palatal Expansion; Slow Palatal Expansion; Miniscrew; Bone-borne Expander
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use
Condition: Use; Tobacco, Harmful; Alcohol Abuse; Drug Abuse
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the project is to improve adolescent behavioral counseling services in
      healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy
      (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.
    

Detailed description: 
      We have previously developed and tested in a treatment population a promising MET program for
      alcohol and drug use. We will broaden the MET intervention to also target tobacco use and
      convert the new materials into a self-administered format.
    

Intervention name(s): iMET; iMET/TE
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive the iMET intervention; Participants will receive the iMET intervention and also receive TEs (Technological Extenders)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol abuse; marijuana abuse; drug abuse; tobacco use; tobacco dependence
Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Observational

Summary: 
      Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and
      Symptoms in Infants and Toddlers in Thailand
    

Detailed description: 
      Primary:

      To assess the prevalence of specific FGIDs (infant regurgitation, infantile colic and
      functional constipation) and related signs and symptoms in infants and toddlers in Thailand,
      according to information provided by the parents.

      Secondary:

      To assess the impact of FGIDs (Infant regurgitation, Infantile colic and functional
      constipation) and related signs and symptoms of infants and toddlers on the quality of life
      (QoL) of parents/caretakers and family, according to information provided by the parents.

      Exploratory:

      To assess treatments and practices employed in real-life to manage FGIDs according to the
      Rome IV criteria (infant regurgitation, infantile colic, and functional constipation) and
      related signs and symptoms in infants and toddlers, according to information provided by the
      parents.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        otherwise healthy infants and toddlers aged 2 to 19 months
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Condition: Intercritical Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study was to determine the safety and effectiveness of
      an experimental drug called rilonacept in subjects with gout who are beginning allopurinol
      treatment for gout. Subjects will participate in this study for approximately 22 weeks.
      Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
    


Intervention name(s): Placebo; Rilonacept 80 mg; Rilonacept 160 mg
Intervention type(s): Other; Drug; Drug
Intervention description(s): Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.; Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.; Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
Intervention MeSH terms: Rilonacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolism, Inborn Errors; Allopurinol; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
Relationship Between ANI, Anxiety, and Pain in Conscious Patients Undergoing CSEA
Condition: Combined Spinal-epidural Anesthesia
Study type: Observational

Summary: 
      Analgesia Nociception Index can be used to detect noxious stimulation during general
      anesthesia.The aim of this study is to observe ANI under combined spinal epidural anesthesia
      procedures in conscious patients.
    

Detailed description: 
      Analgesia Nociception Index which is derived by heart rate variability, can be used to detect
      noxious stimulation during general anesthesia. However, the impact of anxiety on ANI
      evaluation and the correlation between ANI, pain, and anxiety in awake patients remains
      unclear. This study aimed to investigate the correlation between ANI, pain, and anxiety in
      conscious patients undergoing combined spinal epidural anesthesia procedures.
    

Intervention name(s): Combined spinal epidural anesthesia
Intervention type(s): Procedure
Intervention description(s): The Anxiety (Visual Analogue Scale for Anxiety), pain (Visual Analogue Scale), and the Analgesia Nociception Index (ANI) assessments are conducted at four specific time points: lateral position, local anesthesia, epidural needle puncture and 2 minutes after puncture.
Intervention MeSH terms: Anesthetics
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with ASA status I or II, aged between 18 and 65 years old, scheduled for
        elective knee or ankle ligament reconstruction surgeries under CSEA were included in the
        study. Participants with chronic pain, cardiovascular dysfunction, arrhythmia,
        dysautonomia, pacemaker usage, medication affecting the autonomic nervous system,
        contraindications to CSEA, or previous exposure to CSEA or surgery were excluded.
Application of n-3 Fatty to Patient of Jaundice
Condition: Obstructive Jaundice; Surgical Procedure, Unspecified
MeSH terms: Jaundice; Jaundice, Obstructive
Study type: Observational

Summary: 
      The safety and efficacy of ω-3 fatty acid in patients with obstructive jaundice is not known.
      This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved
      postoperative recovery for patients with obstructive jaundice.
    

Detailed description: 
      Lipid emulsion enriched in n-3 fatty acid (FA) has been reported to improve postoperative
      recovery for surgical patients with biliary tract disease, and to improve laboratory and
      clinical outcomes. The role of it for postoperative patients with jaundice is not clear yet.
      The object of this research was to evaluate the safety and efficacy of n-3 fatty acid-based
      parenteral nutrition (PN) for patients with jaundice following Surgical procedure.

      This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from
      May 2014 to June 2017.
    

Intervention name(s): trail cohort; control cohort
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.; Drug: Structolipid Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.
Other intervention name(s): trail; control
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This cohort study was a pragmatic, retrospective, single center, matched, clinical trial
        from May 2014 to June 2017.The trail included obstructive jaundice patients ≥20 years who
        received PN treatment for ≥5 days for maintenance and improvement of their nutrition status
        round the operation period. All patients received PN along with the three macronutrients,
        compounded in an "All-In-One" manner, included amino acids, lipids and glucose,
        electrolytes, and micronutrients (trace elements and vitamins). The administration was
        performed with a perfusion pump through a central line within 24 h.
      
Keywords: n-3; Parenteral nutrition; Jaundice; Propensity score match
Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children
Condition: Behavior, Child; Cognitive Change
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of 15 mg/kg lemon verbena, in comparison
      to placebo, on the attention deficit hyperactivity disorder (ADHD) type behaviour and
      cognitive function of children who do not have a diagnosis of ADHD, but who exhibit high
      scores (highest tertile) on ADHD behaviour parameters. Multiple aspects of mood will also be
      assessed.

      The proposed randomised, double-blind, placebo-controlled, parallel groups design methodology
      will assess the psychological effects of 15 mg/kg lemon verbena extract and a matched placebo
      prior to and after 4 and 8 weeks of supplementation. The trial will utilise the COMPASS
      cognitive assessment system (Northumbria University) and a range of mood measures during
      laboratory testing visits.

      Parents and children will also take part in a concomitant smartphone study, comprising the
      collection of the parent's assessment of the child's behaviour/cognitive function and the
      child's self-report of the same, plus their mood. These assessments will take place on Days
      -1, 14, 28, 42 and 56.
    


Intervention name(s): Lemon verbena; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lemon verbena supplement administered at an estimated daily dose of 15mg/kg; Placebo supplement containing carrier material only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Telephone-supported Joint Protection Technique Training
Condition: Woman; Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      There is limited evidence of the efficacy of joint protection principles in individuals
      diagnosed with lateral epicondylitis in the literature. The aim of this study was to
      investigate the effect of training of the telephone supported joint protection technique
      education on pain and upper extremity function in individuals with lateral epicondylitis. New
      information will be obtained according to the results.
    

Detailed description: 
      There is limited evidence of the efficacy of joint protection principles in individuals
      diagnosed with lateral epicondylitis in the literature. The aim of this study was to
      investigate the effect of training of the telephone supported joint protection technique
      education on pain and upper extremity function in individuals with lateral epicondylitis. New
      information will be obtained according to the results.
    

Intervention name(s): telephone-suppoted joint protection technique; joint protection technique training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After joint protection technics training, patients will be followed up with telephone support for 1 month.; Training will be given to individuals about joint protection technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vedic Medical Astrology in Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      Previous studies have explored the correlation and impact of astrological events in relation
      of diseases, health concerns and relationship between birth chart and disease risk.
      Cardiovascular conditions, sleep and fertility were found significantly associated with moon
      phase. However, to best of our knowledge no study has documented the impact of astrological
      intervention in disease management.

      This is a randomised, multi-center, double blind placebo controlled clinical trial with two
      parallel arms. This trial aims to evaluate the effectiveness of Vedic medical astrological
      intervention for patients with mild to moderate hypertension,with respect to decreasing their
      blood pressure and improving their quality of life.
    


Intervention name(s): Vedic Medical Astrology; Placebo vedic medical astrology (PMA)
Intervention type(s): Combination Product; Other
Intervention description(s): Individualised astrological based interventions were given including vedic counselling, diet, colors, gems, mantras and the worship deities as an adjuvent to ongoing conventional treatments; Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care