bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the ProAdjuster Analysis to the Penning Method of Determining Intersegmental Motion of the Cervical Spine
Condition: Cervical Spine Instability
Study type: Observational

Summary: 
      The purpose of this study is to determine if the ProAdjuster system of analysis can be used
      to determine cervical spine instability using the Penning system of radiographic marking as a
      standard of comparison.
    

Detailed description: 
      This study will utilize the ProAdjuster Device as a method of assessing the motion of the
      cervical spine in participants with instability as determined by a Penning Radiographic
      analysis. Only participants with existing radiographic studies will be included in the study.
      No additional Radiographic will be required.
    

Intervention name(s): motion analysis by durometer
Intervention type(s): Device
Observational model: Defined Population
Time perspective: Retrospective
Keywords: Cervical spine instability; Penning Study
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
Condition: Moderate/Severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend
      remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric
      patients over a period of 6 months.
    

Detailed description: 
      This study includes three periods. First a screening period of up to one week. Second an
      open-label treatment period of up to six weeks where all participants apply tacrolimus
      ointment. Third an open-label disease control period of up to six months where half of the
      participants apply tacrolimus ointment and the other half of the participants do not apply
      treatment.
    

Intervention name(s): tacrolimus
Intervention type(s): Drug
Other intervention name(s): Protopic
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tacrolimus; Protopic; pediatric; atopic dermatitis; China
Epidemiology and Acute Oral Effects Electronic Cigarette
Condition: Nicotine Dependence, Cigarettes
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco
      smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently
      referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use
      and awareness of these devices has grown exponentially in recent years, with millions of
      people currently using them.

      The benefits and risks of electronic cigarette use are uncertain. There is no research on the
      acute oral effects of electronic cigarette in the scientific literature and no hungarian
      epidemiological survey has been performed in this topic.

      Regulation of electronic cigarettes varies across countries in the European Union, ranging
      from no regulation to banning them entirely.

      The investigators research could help to integrate the regulation of this device in Hungary
      and in the EU as well.

      The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey
      would be novel in this topic.
    

Detailed description: 
      The epidemiological survey is performed with online questionnaires, which are published on
      e-cigarette-selling websites and on other forums dealing with this topic.

      The main outcome of interest was whether or not e-cigarette use helped people to quit smoking
      or reduce the number of conventional cigarettes. Participants were also asked about the
      reason for starting e-cigarette use. Nationality, habitation, citizenship status were
      included as demographic predictors in analyses.

      Measurements of acute oral effects before and after using electronic cigarette with nicotine,
      without nicotine, conventional cigarette and placebo device:

        -  measurement of exhaled CO changes by Smokerlyzer piCO

        -  measurement of saliva MMP-8 by PerioSafe Home

        -  measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check
           Buffer Kit (GC)

        -  measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution
           (LASCA method)
    

Intervention name(s): ProVari v2.5 (E-cigarette); Marlboro Gold (Conventional cigarette); Cigarette tip
Intervention type(s): Device; Device; Device
Intervention description(s): An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings.; Conventional cigarette; Placebo device
Other intervention name(s): ProVari v2.5; Marlboro Gold 0,6mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: e-cigarette; blood flow; oral effects; oral pH
Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
Condition: Bioavailability; Metabolism; Avenanthramides
Study type: Interventional

Summary: 
      The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in
      oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of
      AVAs and their potential metabolites after ingestion. The blood and urine concentrations will
      be quantified at several different time points after the oat flour cookies are consumed to
      characterize the "concentration-time profile".
    


Intervention name(s): Avenanthramides
Intervention type(s): Other
Intervention description(s): AVAs are a group of diphenolic acids that are found only in oats (Avena sativa). In this study, each dietary group of subjects will receive three cookies made with oat flour containing high-AVA (H-AVA, 229.56 mg/kg) and low-AVA (L-AVA, 32.69 mg/kg).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by
      gene mutations or changes. These gene mutations cause low levels of an enzyme needed to
      harden bone. The purpose of this study was to test the safety and efficacy of two doses of
      the study drug called asfotase alfa as compared to a control group to see effects on
      adolescents and adults with HPP.
    

Detailed description: 
      Asfotase alfa was formerly referred to as ENB-0040

      Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease
      characterized by defective bone mineralization and impaired phosphate and calcium regulation
      that can lead to progressive damage to multiple vital organs, including destruction and
      deformity of bones, profound muscle weakness, seizures, impaired renal function, and
      respiratory failure. There are limited data available on the natural course of this disease
      over time, particularly in patients with the juvenile-onset form.
    

Intervention name(s): asfotase alfa; asfotase alfa
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week); Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total)
Intervention MeSH terms: Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue-specific alkaline phosphatase (TNSALP); rickets; osteomalacia
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations:
      Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The
      hypothesis was that gabapentin would decrease both subjective and objective features of
      tinnitus in the trauma group, but would be less effective in the non-trauma group.'
    

Detailed description: 
      Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on
      tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus
      etiology as either secondary to acoustic trauma, or not associated with acoustic trauma.
      Participants were restricted to those with moderate-to-severe tinnitus for at least one year.
      All participants received gabapentin in a graduated ascending-descending dose series over 20
      weeks (peak dose of 2400 mg/day).

      Results. There was a significant improvement in tinnitus annoyance for the trauma group (p =
      0.05). Other subjective aspects of tinnitus were not significantly affected in either group.
      Between-subject variability of therapeutic response was considerable. Nevertheless,
      considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma
      participants showed an improvement of 20 percent or better. Considering psychoacoustic
      loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL)
      improvement. Evenly dividing each group into high and low responders revealed significant
      improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p =
      0.007). No significant improvement was obtained for other subgroups.
    

Intervention name(s): gabapentin
Intervention type(s): Drug
Intervention MeSH terms: Gabapentin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Chronic; Tinnitus; Acoustic trauma; Psychophysics; Loudness match; gabapentin
Breathing Exercises and Adhesive Capsulitis
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effects of abdominal breathing exercises on
      pain, sleep quality and quality of life with adhesive capsulitis patients. The 41 adhesive
      capsulitis patients, 29 women and 12 men aged between 40-65 years, had divided into two
      groups by simple random sampling. In the study group, abdominal breathing exercise training
      was applied to routine physiotherapy program, in the control group routine physiotherapy
      program was applied for 8 weeks. Individuals were assessed for lung function test, range of
      motion, pain, sleep quality and quality of life. First assesment were performed at the
      beginning of treatment, 2nd assesment were performed at the end of 8 th week.
    

Detailed description: 
      Pain in the early stages of adhesive capsulitis leads to many symptoms such as sleeping
      problems. Breathing exercises also began to take place among the applications towards pain.
      Abdominal respiration is considered the easiest method to reveal relaxation response. Slow
      breathing increases parasympathetic activity in the body and reduces sympathetic activity.
      This is the first and fundamental step of real healing. The reduction of pro-inflammatory
      markers with respiratory exercises suggests that respiratory exercises are effective in
      inflammation.

      On study group; Hotpack was applied for 15 minutes and TENS was applied for 15 minutes and
      ultrasonics for 5 minutes. Then, scapular mobilization and passive stretching exercises were
      applied in 10 sets of 3 sets (flexion, abduction, internal and external rotation) to increase
      joint range of motion by physiotherapist. Then abdominal respiratory exercise training was
      given 3 times a week as 30 sets of 3 times a week and patients were treated for 8 weeks.

      For the control group; Hotpack was applied for 15 min and TENS was applied for 15 min and
      ultrasonics for 5 min. Then scapular mobilization and passive stretching exercises were
      applied for 8 weeks in 10 sets of 3 sets (flexion, abduction, internal and external rotation)
      to increase joint range of motion by physiotherapist.
    

Intervention name(s): Abdominal breathing exercise
Intervention type(s): Other
Intervention description(s): Deep Breathing Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adhesive Capsulitis; Breathing exercises; Pain; Sleep quality; Quality of life
Effects of Caffeine on Upper Extremity Performance
Condition: Sportive Performance; Caffeine
Study type: Interventional

Summary: 
      It was aimed to apply caffeine supplement to elite basketball players and to investigate the
      effects of this supplement on upper extremity performance, lactic acid level and fatigue. The
      investigators also aimed to investigate the effects of blood lactate level on performance and
      fatigue.
    

Detailed description: 
      The aim of this study is to examine the effects of caffeine supplementation on upper
      extremity performance, lactic acid and fatigue in elite basketball players and compare them
      with the placebo group. A total of 50 elite basketball players, 25 each in the caffeine and
      placebo groups, will participate in the study. Caffeine supplement will be given 1 hour
      before the measurements (5mg/kg). Muscular endurance before and after reinforcement, scapular
      muscular endurance test (SKET); arm movement speed, disc touch test (DDT); anaerobic power,
      medicine ball throwing (STF); lactic acid (LA) level will be evaluated by finger blood
      measurement and fatigue visual analog scale (VAS).
    

Intervention name(s): Caffeine Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Caffeine tablet
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research is a double-blind randomized controlled comparative cross-sectional study.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Caffeine; Performance; Lactic Acid; Basketball; Fatigue
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects.
      This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the
      pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in
      healthy Japanese male and pre- and post-menopausal female subjects.
    

Detailed description: 
      This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple
      Dose (SD and MD).
    

Intervention name(s): ESN364; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ESN364 will be administered orally.; Placebo will be administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ASP2693; Pharmacodynamics; Pharmacokinetics; ESN364; Safety
Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery
Condition: Hypopharyngeal Mean Pressure
Study type: Interventional

Summary: 
      We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal
      pressure than patients with supraglottic airway does by using high resolution impedance
      manometry. We expected that the patients with endotracheal intubation have higher
      hypopharyngeal pressure than the patients with supraglottic airway devices.
    

Detailed description: 
      Background: More and more older patients required to receive orthopedic surgery recently. The
      intubation or supraglottic airway device are required to maintain airway during general
      anesthesia. Previous studies only reported the subjective swallowing discomfort feeling,
      however, the objective data was limited. The high-resolution impedance manometry could detect
      the swallowing muscle power changes with multiple pressure sensors and impedance channels.

      Objectives: we aimed to investigate whether patients with tracheal intubation has high
      hypopharyngeal pressure than patients with supraglottic airway does Patients and methods: The
      patients receive orthopedic surgery with older than 60 years old. They received high
      resolution impedance manometry examination at preoperative day, in the post-anesthetic care
      unit, postoperative day 3 to 7 (pick a day) along with subjective questionnaires. We also
      followed the IDDSI guideline to test different viscosity of the patients' tolerance for food.

      Expected result: The patients with endotracheal intubation have higher hypopharyngeal
      pressure than the patients with supraglottic airway devices.
    

Intervention name(s): supraglottic airway device; endotracheal intubation
Intervention type(s): Device; Device
Intervention description(s): under general anesthesia, patients received supraglottic airway device; under general anesthesia, patients received endotracheal intubation
Other intervention name(s): laryngeal mask airway
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: controll group: tracheal intubation; intervention group: supraglottic airway device
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The study looked at relationship between escitalopram and heart rate variability and QT
      variability in veterans with PTSD.
    

Detailed description: 
      The investigators are studying if taking escitalopram will normalize heart rate variability
      and a decrease (or no effect implying a lack of serious cardiac side effects) including QT
      variability in veterans with PTSD.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 10-20mg daily for 12 weeks
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Condition: Vaccines
Study type: Interventional
Phase: Phase 4

Summary: 
      A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent
      Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine
      Pediatric Vaccines In Healthy Infants In India
    

Detailed description: 
      A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And
      Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials
      When Given With Routine Pediatric Vaccines In Healthy Infants In India
    

Intervention name(s): 13vPnC
Intervention type(s): Biological
Intervention description(s): 13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Condition: Colorectal Cancer; Bladder Cancer; Ovarian Cancer; Cervical Cancer; Uterine Cancer
MeSH terms: Uterine Neoplasms
Study type: Interventional

Summary: 
      This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the
      innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance
      personalized supportive care for cancer patients and caregivers during post-treatment care
      transition.
    

Detailed description: 
      In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized
      clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed
      Symptom Management System (PRISMS) to enhance personalized supportive care for cancer
      patients and caregivers during post-treatment care transition. We will randomly assign 21
      cancer patients with newly created ostomies for cancer treatment with curative intent and
      their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a
      total of 42 individuals). PRISMS is defined as a personalized psychoeducational website
      including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL
      and PRO (symptoms) at baseline upon enrollment and 2 months later.
    

Intervention name(s): Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
Intervention type(s): Behavioral
Intervention description(s): Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: ostomy (colostomy, urostomy, and ileostomy); symptom; self-management; caregiving; family research; telehealth; self-efficacy; quality of life; post-treatment care transition