bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Asthmatic Patients to Determine if There is Any Difference in Dosing With Fluticasone Furoate/Vilanterol Inhalation Powder in the Morning or Evening on Lung Function
Condition: Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way
      crossover study in patients with persistent bronchial asthma to compare the effect of morning
      (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder
      on lung function. Following screening there will be a run-in period of 14 days. There will be
      3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each
      with a 14-21 day washout period between starting the next. Key assessments include; forced
      expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs,
      electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.
    

Detailed description: 
      This will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover
      study in patients with persistent bronchial asthma to compare the effect of AM and PM dosing
      with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder(100/25mcg) on lung function.
      Twenty-four male and female patients will be enrolled in this study to ensure twenty
      evaluable subjects. After the screening there will be a run-in period of 14 days prior to
      first dose. Subjects will be dosed for 14 days (± 2 days) in each of the 3 treatment periods,
      with serial forced expiratory volume in one second (FEV1) measurements taken over a 24 hour
      period following the Day 14 PM dose in order to determine FEV1 weighted mean (0-24 hours).
      Peak expiratory flow (PEF) will also be monitored throughout the study, from the start of the
      run-in period until the end of the third treatment period. Between treatment periods there
      will be a washout period of 14-21 days. Safety assessments will include vital signs,
      electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests,
      however, with the exception of AEs these will not constitute study endpoints. The results of
      the study will provide supporting information to understand the implications of time of day
      of dosing on the therapeutic response to the FF/VI Inhalation Powder.
    

Intervention name(s): FF(100mcg)/Vilanterol(25mcg) AM; FF(100mcg)/Vilanterol(25mcg) PM; Placebo AM; Placebo PM
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhalation powder; Inhalation powder; Inhalation powder; Inhalation powder
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone furoate; Vilanterol; Efficacy; FEV1; FF/VI Inhalation powder
Multiple Sclerosis Intimacy and Sexuality Questionnaire
Condition: Multiple Sclerosis; Sexual Dysfunction; Questionnaires
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Aims: This study aimed to psychometrically evaluate the Turkish version of the Multiple
      Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15) in women with MS.

      Methods: The study included 130 women with MS. The Turkish linguistic validation process of
      the original English MSISQ-15 was performed according to standardized guidelines. Reliability
      analysis was evaluated with test-retest analysis and intra-class correlation (ICC). Internal
      consistency between the items was analyzed using the Cronbach's alpha coefficient. Item
      analysis results were used to assess the contribution of the items to the scale. In
      evaluating the validity of the scale, the relationship between the MSISQ and the Female
      Sexual Function Index (FSFI), the Multiple Sclerosis Quality of Life Questionnaire-54
      (MSQOL-54), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PSIQ-12)
      was investigated. Psychometric properties were analyzed using internal consistency, test-rest
      reliability, construct validity, and floor-ceiling effect.
    


Intervention name(s): descriptive study
Intervention type(s): Other
Intervention description(s): descriptive study
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Multiple Sclerosis women
      
Keywords: Multiple sclerosis; questionnaires; sexual dysfunction; self-report
Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate
      hydrochloride extended-release) capsules under fed conditions in male or female children 4 to
      under 6 years of age with ADHD.
    

Detailed description: 
      This will be a multi-center, open-label, single-dose, study to assess the pharmacokinetics of
      Aptensio XR® (methylphenidate hydrochloride extended-release) capsules in male and female
      children 4 to under 6 years of age with ADHD in fed condition.

      Screening Procedures: After obtaining written informed consent from parents, subjects will
      undergo a complete medical and medication history, demographic data (including sex, age,
      race, ethnicity, body weight (kg), height (cm), Body Mass Index (BMI) (kg/m2), physical
      examination, vital signs evaluation (sitting blood pressure, pulse rate, respiration rate,
      temperature and pulse oximetry), resting 12-lead electrocardiogram (ECG), clinical laboratory
      tests and concomitant medication within 28 days prior to receiving study drug. On Day 1:
      subjects will receive a single oral dose of Aptensio XR®.
    

Intervention name(s): Methylphenidate HCl ER Capsules, 10 mg; Methylphenidate HCl ER Capsules, 15 mg; Methylphenidate HCl ER Capsules, 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning; Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning; Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning
Other intervention name(s): Aptensio XR®, 10 mg; Aptensio XR®, 15 mg; Aptensio XR®, 20 mg
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, single-dose
Masking: None (Open Label)
Primary purpose: Other
Keywords: ADHD; Children; Pharmacokinetics
Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.
Condition: Lidocaine Spray
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in
      treatment of patients with premature ejaculation (PE). The current study has been designed as
      a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE
      patients with normal erection. They were randomized evenly categorized into two treatment
      groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75);
      was given placebo in form on demand alcohol spray for 8 weeks.
    

Detailed description: 
      This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in
      treatment of patients with premature ejaculation (PE). The current study has been designed as
      a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE
      patients with normal erection. They were randomized evenly categorized into two treatment
      groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75);
      was given placebo in form on demand alcohol spray for 8 weeks. All medications were applied
      on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse.
      Patients were evaluated with Arabic Index of Premature Ejaculation (AIPE) scores,
      intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before
      and after treatments.
    

Intervention name(s): Lidocaine 5% spray; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system).; Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system). Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks (One to two applications (1-2 ml) of alcohol 70% sprays).
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Premature Ejaculation
Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing
      doses in healthy young volunteers
    


Intervention name(s): BIIR 561 CL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Condition: Wheezy Bronchitis; Asthmatic Bronchitis; Wheezing; Obstruction Airway
MeSH terms: Bronchitis; Bronchiolitis; Acute Disease; Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed
      versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as
      needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or
      shortness of breath.
    

Detailed description: 
      Up to 30% of all children suffer from episodic wheeze or shortness of breath, i.e. asthmatic
      bronchitis, during the first three years of life. The condition is usually induced by viral
      respiratory infections, and short-acting beta-agonists are recommended as a monotherapy for
      symptoms unless there are at least four physician-confirmed episodes of wheeze or shortness
      of breath, or three episodes plus asthma risk factors. There is a current need for new
      therapeutic agents to treat asthmatic bronchitis in young children.

      In viral-induced wheeze, increased parasympathetic nerve activity results in increased
      acethylcholine release from nerve endings. Tiotropium bromide, an inhaled anticholinergic
      agent, prevents the acetylcholine function and achieves mild bronchodilatation and decrease
      in mucus secretion from the submucosal glands.

      The aim of the study is to find out the effect of intermittent tiotropium bromide and
      salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or
      solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent
      episodes of wheeze and/or shortness of breath. Episode-free days are defined as those days
      during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled
      medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary
      controller medications.
    

Intervention name(s): Tiotropium Bromide; Fluticasone Propionate; Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tiotropium Bromide 2.5 µg/dose inhaled aerosol; Fluticasone Propionate 125 µg/dose inhaled aerosol; Salbutamol 0.1 mg/dose inhaled aerosol
Other intervention name(s): Spiriva Respimat; Flixotide Evohaler; Ventoline Evohaler
Intervention MeSH terms: Fluticasone; Xhance; Bromides; Albuterol; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wheeze; shortness of breath
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Condition: Opioid Use; Opioid Dependence; Opioid Misuse; Post-Surgical Complication
MeSH terms: Pain, Postoperative; Opioid-Related Disorders
Study type: Interventional

Summary: 
      Following inpatient surgery, more than 80% of patients are prescribed opioids for use after
      discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize
      non-opioid therapy. The proposed research seeks to test a provider-facing decision support
      tool and a patient-facing smartphone app to reduce the amounts of opioids prescribed and
      taken following discharge, while ensuring effective treatment of pain after surgery.
    

Detailed description: 
      Prior to discharge from the hospital, patients will be approached regarding interest in the
      study with an introductory letter that describes the content and purpose of the study.
      Following informed consent, patients will be randomized to receive the consumer health
      informatics app (UControlPain) versus provision of an app with only data collection function
      (no educational components). Randomization will be implemented via REDCap by the study
      coordinators. Further, information on which type of app was installed will not be shared with
      providers or patients.
    

Intervention name(s): Empowering patient to steer their pain management after surgery; Provider-facing prescription aid
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, patients will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or patients.; Providers will be given information to inform a patient-centered post-discharge pain management plan.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The patient-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design.
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
Condition: Pruritus; Cholestasis; Kidney Failure
MeSH terms: Cholestasis; Renal Insufficiency; Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and
      pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and
      subjects with cholestatic or uremic pruritus.
    

Detailed description: 
      This study consists of both single and multiple ascending doses in healthy subjects and in
      subjects with cholestatic or uremic pruritus.

      Up to 48 healthy subjects will receive a single dose of EP547 or placebo. There will be a
      screening period of up to 28 days prior to the first dose, and a follow up visit 7 days after
      dosing is completed.

      24 healthy subjects will receive multiple doses of EP547 or placebo for 7 days. There will be
      a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days and
      then 14 days after dosing is completed.

      6 subjects with cholestatic disease will receive a single dose of EP547. There will be a
      screening period of up to 28 days prior to the first dose, and a follow up visit 7 days after
      dosing is completed.

      Up to 16 subjects with cholestatic pruritus will receive multiple doses of EP547 or placebo
      for 7 days. There will be a screening period of up to 28 days prior to the first dose, and a
      follow up visit 7 days and then 14 days after dosing is completed.

      6 subjects with uremic disease will receive a single dose of EP547. There will be a screening
      period of up to 28 days prior to the first dose, and a follow up visit 7 days after dosing is
      completed.

      Up to 16 subjects with uremic pruritus will receive multiple doses of EP547 or placebo for 7
      days. There will be a screening period of up to 28 days prior to the first dose, and a follow
      up visit 7 days and then 14 days after dosing is completed.

      12 healthy subjects will receive two doses of EP547 under fasted or fed condition.
    

Intervention name(s): EP547; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EP547; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This study is designed to evaluate the impact of the regular consumption of probiotic
      Lactobacillus reuteri-containing lozenges over a period of 42 days on parameters of oral and
      general health in crew members of a naval ship at sea.
    

Detailed description: 
      Probiotic strains of Lactobacillus reuteri have demonstrated a significant impact on the
      composition of the oral and intestinal microbiome as well as modulating the host response in
      several clinical trials and in vitro experiments.

      This two-arm double blind placebo controlled clinical trial will evaluate the impact of the
      regular consumption of L.reuteri-containing lozenges over a period of 42 days on parameters
      of oral and general health in crew members of a naval ship at sea.

      2 x 36 healthy study subjects will be recruited from the crew members of the ship.

      At baseline and at the end of the study (day 42) the following parameters will be recorded at
      the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44):

      Bleeding on Probing (BoP) as the primary outcome

      Secondary outcomes will be Gingival Index (GI) Plaque Control Record (PCR) Pocket Probing
      Depth (PPD) Pooled oral and intestinal (stool) microbial samples will be taken at baseline
      and at the end of the study for the subsequent analysis of the

        -  composition of the oral microbiome

        -  composition of the intestinal microbiome by whole genome sequencing

      Furthermore the frequency of short-term sick leave due to respiratory or intestinal diseases
      among the study participants during the observation period will be recorded.
    

Intervention name(s): Lactobacillus reuteri; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days; 2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigators aim to determine Epidiolex's promise as a pharmacotherapy for cannabis use
      disorder. Investigators hypothesize that Epidiolex, when added to medical management, will
      result in greater reductions in marijuana use compared to placebo as measured by the 2
      primary outcome measures: 1) quantitative THC levels and 2) self-report by Timeline Follow
      Back. Secondary outcome measures will include treatment retention, patient satisfaction,
      cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, , compliance,
      and cigarette use.
    

Detailed description: 
      Investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to begin to
      evaluate Epidiolex as a pharmacotherapy for adults with cannabis use disorder. In this
      randomized, double-blind, placebo-controlled trial, cannabis-dependent subjects ages 18-65
      will receive medical management over a 6-week period, with half receiving Epidiolex treatment
      and half receiving placebo. Participants will receive either up to 800 mg Epidiolex or
      placebo over a 6-week treatment period. Following treatment completion, participants will
      have a follow-up visits at 10 and 14 weeks. Primary outcomes will include self-report of
      cannabis smoking and results of quantitative urine drug screens for cannabis. Secondary
      outcome measures will include treatment retention, patient satisfaction, cannabis withdrawal,
      cannabis craving, depressive symptoms, anxiety symptoms, compliance, and cigarette use.
    

Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.; Participants will receive placebo over a 6-week treatment period.
Other intervention name(s): Epidiolex
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this randomized, double-blind, placebo-controlled trial, cannabis-dependent subjects ages 18-65 will receive medical management over a 6-week period, with half receiving Epidiolex treatment and half receiving placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cannabidiol
The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Aim: The study was carried out in randomized control to determine the effect of two different
      distractions on pain and anxiety during blood collection.

      Methods: The population of the study consisted of children between ages of 4-10 years who
      applied for venipuncture to a training and research hospital in Turkey between July and
      December 2018. A total of 139 children were included in the study, 46 of them with virtual
      reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale,
      Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.
    


Intervention name(s): distraction methods
Intervention type(s): Other
Intervention description(s): The children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: acute pain; blood collection; nursing; children; distraction