bioihbjkbjnl/mcl2 huggingface dataset:
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
Condition: Anxiety; Fear
MeSH terms: COVID-19; Anxiety Disorders
Study type: Interventional

Summary: 
      Aim: This research will be carried out to determine the effect of distracting methods on fear
      and anxiety in children before the COVID test.
    

Detailed description: 
      Inroduction: In the literature review, it has been seen that the positive effect of different
      nanpharmacological methods is supported to reduce pain and anxiety caused by medical
      procedures. Non-pharmacological methods are classified as physical methods, cognitive
      behavioral methods, and environmental or emotional intervention methods. In order to draw
      attention to another direction, which is among these methods; watching cartoons, inflating
      balloons, creating balloons by blowing foam, talking about things unrelated to the
      initiative, virtual reality glasses, listening to music, using kaleidoscope and distraction
      cards etc. is located. The subject of the study is the application of distraction methods in
      reducing the pain associated with short-term medical interventions.
    

Intervention name(s): The Kaleidescope; The visual illusion cards
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During the nasopharyngeal swab collection process, the researcher held a kaleidoscope to each child's eye, leisurely turning it and asking about the colors and shapes seen within it.; Just before the nasopharyngeal swab participants were allowed to check the cards andwere askedwhat they saw in them.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an RCT with parallel groups conducted between March, 2022 and August, 2022 at the pediatric emergency unit of a hospital in Black Sea Region Turkey
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COVID-19 test; nasopharyngeal swab collection; pediatric nursing; distraction methods
Timing of Low Vision Rehabilitation in Anti- Vascular Endothelial Growth Factor (VEGF) Therapy
Condition: Low Vision; Neovascular Age-related Macular Degeneration
MeSH terms: Vision, Low; Macular Degeneration
Study type: Interventional

Summary: 
      The purpose of this research is to collect preliminary data in preparation for conducting a
      randomized clinical trial to determine the relative effectiveness of vision rehabilitation in
      improving overall visual ability (primary aim) and reducing depression (secondary aim) in
      patients receiving anti-VEGF therapy for neovascular age-related macular degeneration
      integrated over time.
    

Detailed description: 
      This is a pilot study to understand the feasibility of conducting a randomized, controlled
      trial regarding the timing for vision rehabilitation in patients receiving anti-VEGF therapy
      for neovascular age-related macular degeneration. Prior to initiating the clinical trial, the
      investigators must be assured that patients with loss in visual ability are willing to be
      randomized and amenable to deferring vision rehabilitation intervention. Although it is
      typical for patients receiving usual care to present for vision rehabilitation services years
      after the onset of anti-VEGF therapy, this manifestation may result from patients being
      unaware of the existence of vision rehabilitation services to enhance function and reduce
      depression. As part of the study recruitment, patients will be informed about vision
      rehabilitation care and, if suffering with difficulty performing everyday activities, they
      may be unwilling to defer vision rehabilitation. Additionally, the study design may not be
      feasible to answer the aim should patients in the delayed intervention arms suffer
      progressive loss in visual ability and seek vision rehabilitation services, resulting in a
      high drop-out rate.
    

Intervention name(s): Vision rehabilitation
Intervention type(s): Other
Intervention description(s): A service menu containing the minimum vision rehabilitation visits will be provided and assessed according to the participant's vision needs. Minimum vision rehabilitation visits include refraction, best-corrected visual acuity assessment, near vision, contrast sensitivity, central visual field test, education and consultation; rehabilitation visit will then be individualized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Reducing Beverages and Sugar and Increasing Physical Activity in Public School Adolescents From Brazil
Condition: Sugar Intake; Beverage Intake; Fruit Intake; Beans Intake; Physical Activity
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective is to evaluate the effect on BMI of a school-based program that
      discourages the consumption of all sweetened beverages, encourages the reduction in sugar
      intake, and encourages the increase in physical activity among adolescents and their families
      from a low socioeconomic area.
    

Detailed description: 
      Specific objectives are:

        1. To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from
           7th and 8th grades from schools under intervention and from the ones not subjected to
           the intervention program.

        2. To compare sweetened beverages consumption and sugar intake before and after the
           intervention in both groups of schools.

        3. To evaluate the impact of the intervention on the selling of sweetened beverages in the
           cafeterias.

        4. To compare change in family expenditures with sweetened beverages and sugar.
    

Intervention name(s): lifestyle
Intervention type(s): Behavioral
Intervention description(s): Based on beliefs and behaviors of children sections of education will be delivered via classroom activities.
Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
Children will also be stimulated to increase everyday activities such as walking and playing games at home and school. Also, activities with parents and family members such as walking around the neighborhood on weekends will be promoted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: school children; body mass index; sugar intake; beverage intake
Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to examine the short and long-term effect of myofascial
      trigger point injections with either a local anesthetic or saline in patients with chronic
      low back pain presenting with myofasical pain syndrome.
    


Intervention name(s): Bupivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit; 2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
Other intervention name(s): lidocaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Condition: Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV
      vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine,
      formulated with or without aluminum hydroxide, or placebo, and investigate safety and
      characteristics of antibodies in their infants.
    

Detailed description: 
      This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety,
      tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F
      subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose
      levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as
      assess safety and characteristics of transplacentally transferred antibodies in their
      infants.
    

Intervention name(s): RSV vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): RSV vaccine; Normal saline solution for injection (0.9% sodium chloride injection)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory tract infection; Respiratory Syncytial Virus; RSV; Vaccine
The Metabolic Effects of Breaks in Sedentary Time
Condition: Feasibility; Insulin; Glucose; Lipids; Eating
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or
      without breaks and/or structured physical activity) result in measurable changes in metabolic
      health in children and youth.
    

Detailed description: 
      North American children spend the majority of their waking hours engaging in sedentary
      behavior (e.g. sitting). Research in adults and animal models suggests that even short bouts
      of uninterrupted siting may result in acute changes increases in cardiometabolic risk,
      although to date no studies have investigated this relationship in children and youth. The
      purpose of this study is to assess the feasibility of a protocol which will expose
      participants aged 10-14 years to a full day of uninterrupted sitting, and to determine the
      impact of this protocol on markers of cardiometabolic risk (insulin, glucose, triglyceride,
      HDL-C and LDL-C) as well as subsequent food intake and physical activity. The impact of
      uninterrupted sitting will be compared to the impact of interrupted sitting, with and without
      the inclusion of moderate physical activity.
    

Intervention name(s): Sedentary; Sedentary With Breaks; Sedentary With Breaks and Physical Activity
Intervention type(s): Other; Other; Other
Intervention description(s): In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.; In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.; In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sedentary Behavior; Cardiometabolic Risk; Pediatrics
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
Condition: Sleep Initiation and Maintenance Disorders; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the efficacy and safety of zolpidem modified
      release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary
      insomnia.
    


Intervention name(s): Zolpidem MR; Estazolam
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Stilnox CR; Ambient CR; Eurodin
Intervention MeSH terms: Estazolam; Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Zolpidem; Estazolam
Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Aim: It was aimed to investigate the effectiveness of three-dimensional scoliosis exercises
      and balance-coordination exercises in patients with adolescent idiopathic scoliosis.
    

Detailed description: 
      Method: Thirty patients who were diagnosed with adolescent idiopathic scoliosis were randomly
      divided into three groups. The first group was treated with 3-dimensional scoliosis exercise
      program according to Schroth method, second group was treated with Schroth exercises and
      balance-coordination exercises in addition to brace. Exercises were performed for a total of
      6 weeks (18 sessions). The third group was treated only with brace and the control group
      consisted of healthy individuals. Patients were assessed for their curve angle (Cobb method),
      rotation angle (scoliometer), spinal flexibility (anterior and lateral bending tests),
      quality of life (Scoliosis Research Society-22), cosmetic effects (Walter Reed Visual Rating
      Scale), balance parameters (Balance Master System NeuroCom International Inc. Clackamas, OR,
      USA ver 8.1), vertical perception (Subjective Vertical Detection test) and brain responses
      (electroencephalography) were assessed before and after treatment. SPSS 20.0 statistical
      program was used for data analysis of the study.
    

Intervention name(s): 3 dimensional scoliosis exercise; Balance Exercise; Brace treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Schroth exercises; Balance-coordination exercises; Brace usage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: rondomized controlled trail
Masking: Single (Participant)
Primary purpose: Treatment
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
Condition: DMARD Resistant Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      In this project the investigators decide to evaluate the efficacy and safety of half dose
      mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of
      rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs
      limited in the investigators refractory patients as the first line drugs because of its cost.
    


Intervention name(s): Rituximab; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): two 500 mg rituximab infusions 2 weeks apart; 500mg,two times with two weeks interval
Other intervention name(s): Mabthera; Mabthera
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; Rheumatoid arthritis; Biologics; Anti-tumour necrosis factor; Disease-modifying anti-rheumatic drugs; DAS28; European League Against Rheumatism response
Stabilometric and Baropodometric Evaluation After Osteopathic Scaphoid Tug Manipulation
Condition: Manipulation; Osteopathic
Study type: Interventional

Summary: 
      This is a clinical, longitudinal, prospective and randomised study in which the subject will
      be assessed by stabilometric and baropodometric techniques on two occasions (before being
      subjected to the scaphoid tug manipulation for the experimental group or placebo technique in
      the case of the control group).
    


Intervention name(s): Experimental: Osteopathic manipulation TUG for scaphoid bone; Sham group: Sham osteopathic manipulation TUG for scaphoid bone
Intervention type(s): Procedure; Procedure
Intervention description(s): The sequence of execution of the scaphoid TUG technique shall be applied as follows. Patient in the supine position. The inner hand of the intervener makes contact with the pisiform through the hypothenar eminence and ulnar border of the hand over the scaphoid tubercle, the outer hand reinforces the contact. The thumbs are directed to the sole of the patient's foot. The parameters are sought by bringing the sole of the foot into eversion, thus bringing the scaphoid into internal rotation (the direction of correction). In order to reduce the slack, the operator drops his body weight backwards while increasing the internal rotation parameter of the scaphoid. The manipulation is performed by associating a rapid traction movement with an increase of the correction parameter towards the internal rotation of the scaphoid.; The intervention will be performed in the same way as the intervention group, without actually performing the TUG manipulation on the scaphoid bone, only placing it in tension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,
      tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers
      (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.

      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will
      assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing
      pharmacokinetics and safety in subjects with CHC genotype 1 infection.
    


Intervention name(s): ALS-002200; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ALS-002200; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Memantine - Communication Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is to evaluate the effects of memantine treatment on communication
      abilities and other cognitive abilities in moderate to severe DAT patients.
    


Intervention name(s): Memantine-HCl
Intervention type(s): Drug
Intervention description(s): 20 mg per day (once daily)
Intervention MeSH terms: Memantine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Aged Garlic Extract on Atherosclerosis
Condition: Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will be assessing the effect of Aged Garlic Extract on the coronary
      arteries. The investigators will enroll patients in a double blind study, where half the
      patients will receive placebo, and have the patients undergo a series of tests of plaque (CT
      scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and
      then repeat the tests and blood work at the end of one year. The investigators will assess if
      being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The
      investigators will also assess the effect of aged garlic extract on markers of inflammation.
      Patients will receive free drug, free testing and be compensated, and learn more about their
      heart and neck arteries. if successful, more patients can use this drug to benefit their
      health. The harms include the radiation from the CT scan and the medication, which has mild
      side effects.
    

Detailed description: 
      The investigators will be assessing the effect of Aged Garlic Extract on the coronary
      arteries. The investigators will enroll patients in a double blind study, where half the
      patients will receive placebo, and have the patients undergo a series of tests of plaque (CT
      scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and
      then repeat the tests and blood work at the end of one year. The investigators will assess if
      being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The
      investigators will also assess the effect of aged garlic extract on markers of inflammation.
      Patients will receive free drug, free testing and be compensated, and learn more about their
      heart and neck arteries. if successful, more patients can use this drug to benefit their
      health. The harms include the radiation from the CT scan and the medication, which has mild
      side effects. The study will perform advanced CT angiography at baseline and follow up along
      with carotid intimal media thickness testing, to see if plaque is slowed down by Aged Garlic
      Extract
    

Intervention name(s): aged garlic extract; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2400 mg a day; placebo
Other intervention name(s): Kyolic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: garlic; ct angiography; atherosclerosis; carotid IMT
Study of TLBZT Based Herbal Therapy Plus Chemotherapy for Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies
      have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will
      evaluate the safety and efficacy of TLBZT based herbal therapy in combination with
      chemotherapy in patients with metastatic colorectal cancer.
    

Detailed description: 
      A phase I/II, multicentric,randomized, controlled clinical trial.
    

Intervention name(s): Chemotherapy; Herbal therapy
Intervention type(s): Drug; Drug
Intervention description(s): Oxaliplatin (130 mg/m2) was given intravenously (iv) for at least 2 h on day 1; Capecitabine (1000 mg/m2) was given orally, twice daily on days 1-14. Each cycle was 21 days. Cycles were repeated until disease progression or unacceptable toxicity.; TLBZT based herbal decoction administered orally twice a day
Other intervention name(s): Oxaliplatin; Capecitabine; Traditional Chinese Medicine
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer; Chemotherapy; Traditional Chinese Medicine (TCM); Teng-Long-Bu-Zhong-Tang