bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
Condition: Visual Performance
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a bilateral, non-dispensing, randomized, subject masked, four visits, 3-period by 3-
      treatment crossover study. The objective of this study is to evaluate the effect of JJVC
      senofilcon A - based contact lens with new UV-blocker on vision and driving performance in
      both daytime and nighttime lighting under real world driving conditions. This will be
      achieved through field-based driving studies on a closed-road driving circuit at night and
      during the day. Quantitative methods will be used to assess vision and driving performance
      under a range of challenging conditions and appropriate masking, order of testing,
      randomization and control conditions will be used.
    


Intervention name(s): Investigational Contact Lens; Commercial ACUVUE OASYS; Commercial ACUVUE OASYS and Spectacles
Intervention type(s): Device; Device; Device
Intervention description(s): JJVC senofilcon A-based contact lens with new UV-blocker; senofilcon A; Senofilcon A and Spectacles
Other intervention name(s): Test; Control 1; Control 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Muscle Strength Loss In Stroke Individuals - Control Study
Condition: Stroke Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      ABSTRACT The muscle strength (MS) is necessary to overcome the resistance encountered during
      the activity. The present study aims to determine MS loss in stroke individuals (SI). 33 SI
      and 33 healthy individuals (HI) were included in this study. MS and handgrip force were
      assessed using a power track dynamometer and Jamar hand dynamometer, respectively. The total
      MS of the HI was calculated by summing the muscle strength of the trunk, lower and upper
      extremities. In the SI, the muscle strength of the trunk, unaffected upper and lower
      extremities were summed to calculate the total MS. To compare MS of unaffected sides (US)
      between groups, 27 SI who was dominant and not affected on the right side and 33 HI who was
      dominant on the right side were used.
    


Intervention name(s): assesment
Intervention type(s): Other
Intervention description(s): muscle strength assessment in stroke individuals
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: individuals with stroke and healthy subject
Masking: None (Open Label)
Primary purpose: Other
Environmental Design for Behavioral Regulation in People With Dementia
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional

Summary: 
      Individuals with dementia present with changes in behaviors throughout the continuum of
      cognitive decline. Environmental features may be influential in behavioral regulation. The
      purpose of this study is to assess the feasibility of environmental design protocols in older
      adults with dementia and their caregivers. Thirty subjects with moderate to severe
      Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned
      to one of three arms: standard care; standard environmental design protocol; or personalized
      environmental design protocol.
    


Intervention name(s): Standard Environmental Design; Individual Environmental Design; Placebo
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.; Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.; Participants' caregivers will receive a set script of placebo modifications.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: environment; Occupational therapy
A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to is to look at how much LY3437943 gets into the
      bloodstream and how long the body takes to get rid of it in healthy male participants. This
      study will involve a single dose of 14C radiolabeled LY3437943. his means that a radioactive
      tracer substance, C14, will be incorporated into the study drug to investigate the study drug
      and its breakdown products and to find out how much of these pass from blood into urine,
      feces and expired air.

      The study will last up to approximately 15 weeks including the screening period of 28 days.
    


Intervention name(s): [¹⁴C]-LY3437943
Intervention type(s): Drug
Intervention description(s): Administered SC.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radioactive; ADME
A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use
Condition: Alcohol Use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Alcoholism
Study type: Interventional

Summary: 
      The purpose of this study is to compare the feasibility, acceptability, and efficacy of a
      dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients
      and community members seeking treatment for substance use, across those who receive immediate
      versus delayed access to the intervention (e.g., a waitlist control condition).
    

Detailed description: 
      Seventy adult outpatients and community members seeking treatment for substance use from the
      Centre for Addiction and Mental Health Addictions Program will be randomized to receive
      immediate or delayed (1 month) access to a web-based DBT skills training intervention called
      Pocket Skills in addition to standard care. Participants will complete interviews and
      questionnaires at baseline. Following baseline, participants complete questionnaires at
      months 1, 2, and 3 months. Measures will assess alcohol and drug consumption, substance use
      disorder symptoms, and other clinical features.
    

Intervention name(s): Dialectical behavioral therapy skills training (DBT-ST)
Intervention type(s): Behavioral
Intervention description(s): Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app will occur primarily over 1 month, followed by 2 months of follow-up, and will be supplemented with a walk through manual and links to DBT worksheets.
Other intervention name(s): Pocket Skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dialectical behavior therapy, digital health
Evaluating Simvastatin's Potential Role in Therapy
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects
      processes related to the development of Alzheimer's disease, including: 1) levels of a
      substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood
      flow in the brain, 3) inflammation in the brain, and 4) cognitive function.
    

Detailed description: 
      Some studies suggest that statin medications, which are a group of cholesterol-lowering
      medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans.
      The purpose of this study is to see how simvastatin affects a substance in the spinal fluid
      around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's
      disease. This study also evaluates whether simvastatin improves regional brain blood flow (on
      magnetic resonance imaging [MRI]), reduces inflammation, and improves cognitive function.

      The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100
      middle-aged adults with a parental history of Alzheimer's disease. Participants were
      randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets.
      Fifty of the ESPRIT subjects participated in the MRI sub-study.

      Participants had the following data collected: fasting blood tests (baseline and months 3 and
      9), medical history and medication questionnaires (each visit), study medication side effect
      review (all visits), lumbar puncture procedure (baseline and month 9), memory testing
      (baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants).
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg tablet each night for one month, then 80 mg for 8 months; Matching tablet each night for 9 months
Other intervention name(s): Zocor
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: amyloid protein; apolipoprotein; cerebrospinal fluid; cerebrovascular circulation; inflammation; magnetic resonance imaging; prevention & control
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus
Condition: Skin Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in
      male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID
      topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
    


Intervention name(s): PAC-14028 cream 0.1%; PAC-14028 cream 0.3%; PAC-14028 cream 1.0%; PAC-14028 cream vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application; Topical application; Topical application; Topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Genetic Studies in Patients and Families With Infantile Spasms
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Study type: Observational

Summary: 
      Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often catastrophic
      developmental consequences, is known in some patients to have many different genetic,
      metabolic and structural etiologies. However, for most patients IIS is the only presenting
      clinical feature and the specific cause is unknown. Only two FDA approved pharmacologic
      treatments for IIS exist, Adrenocorticotropic hormone (ACTH) and vigabatrin. While vigabatrin
      may be the treatment of choice for Tuberous Sclerosis as a cause for IS, ACTH is the
      treatment of choice for all others. Unfortunately, a substantial number of patients may still
      not respond to ACTH and there is no a priori way that suggests which patients may be
      responders. This has led to the following key questions:

      Can novel genetic analyses determine known genetic causes of IS with greater efficiency (more
      timely and cost-effective)? Can novel genetic analyses determine previously unknown disease
      modifying genes that predispose individuals to develop IS? Can novel genetic analyses
      elaborate genes and gene polymorphisms that favor ACTH responsiveness? Do these polymorphisms
      suggest strategies to improve ACTH responsiveness?
    

Detailed description: 
      Primary Aim 1: Apply whole-exome sequencing to determine possible causes of cryptogenic IS
      and evaluate adding whole-exome sequencing to standard practice for determining causes of IS.
      Sub-aim 1: Determine the effectiveness of whole-exome sequencing in suggesting
      disease-modifying genes that may contribute to triggering IS.

      Primary Aim 2: Determine genes, through whole-exome sequencing, that may play a role in
      determining ACTH responsiveness for IS. Sub-aim 2: Correlate genes or genetic factors
      (haplotypes) associated with ACTH responsiveness and disease modification.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients trios (both parents + patient with IIS = trio) with IIS retrospectively
        identified to have been treated with ACTH according to FDA-approved protocol will be
        eligible for inclusion in this study regardless of age, sex, ethnicity/race, or
        socioeconomic status. The principal recruitment venues will be Neurology clinics,
        in-patient service and Medical Genetics Clinics at Children's Hospital Colorado and
        University of Colorado Health Sciences Center (UCHSC)
      
Biospecimen description: 
      blood, saliva, buccal cells,urine
Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
Condition: Exotropia or Intermittent Exotropia
MeSH terms: Strabismus; Exotropia
Study type: Interventional

Summary: 
      This study is to investigate protective effect of biodegradable collagen implant in scleral
      showing after lateral rectus recession in patients with exotropia.
    


Intervention name(s): lateral rectus recession with biodegradable collagen implant; Lateral rectus recession without biodegradable collagen implantation
Intervention type(s): Device; Procedure
Intervention description(s): Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done. After lateral rectus recession, no degradable collagen implant was placed in the area, where lateral rectus was original inserted. One eye was randomly selected for the comparison.; Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Biodegradable collagen implant; scleral thinning; strabismus surgery
Menstrual Wellbeing in Woman Living in Turkey; an Epidemiological Study
Condition: Menstrual Problem; Quality of Life
MeSH terms: Menstruation Disturbances
Study type: Observational [Patient Registry]

Summary: 
      Women with endometriosis in our country and around the world face various difficulties during
      their menstrual periods in reproductive age. While some of these difficulties are caused by
      the environment, some of them are due to the insufficient development of personal
      consciousness. In our study, we aim to reveal the perspective of individuals and society on
      the menstrual period. Our primary aim in our study is to understand what kind of problems are
      experienced in different regions of our country during the menstrual period for women and how
      they are spent. Secondly, the effect of this period on women's quality of life will be
      examined.
    

Detailed description: 
      Our research will be conducted between January 1, 2022, and February 1, 2022, in 7 different
      regions of our country, by asking questions to women of reproductive age from different
      groups. Each participant will be asked to answer the survey questions and the results will be
      analyzed. The survey will be done face to face. The questionnaire contains questions about
      women's socio-demographic data, their perspectives on their menstrual period, their
      information about endometriosis, and their perspectives on pads and birth control pills.
      Menstruating women of reproductive age between the ages of 18- 45 will be included in this
      study. As a result of the study, the problems experienced by women of reproductive age in
      different regions will be evaluated.
    

Intervention name(s): not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)
Intervention type(s): Behavioral
Intervention description(s): This is a prospective cross-sectional analytical study conducted through a questionnaire.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Menstruating women of reproductive age between the ages of 18- 45 will be included in this
        study.
      
Keywords: menstrual wellbeing; reproductive age; oral contraceptive; endometriosis
Yoga: Effect on Attention in Aging & Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Changes in visual attention are common among elders and people with multiple sclerosis. The
      visual attention changes contribute to difficulty with day to day functioning including
      falls, driving and even finding one's keys on the kitchen counter as well as contributing to
      deficits in other cognitive domains. Yoga emphasizes the ability to focus attention and there
      is some evidence that the practice of yoga may improve one's cognitive abilities.
      Additionally, yoga practice may improve cognitive function through other non-specific means
      such as improved mood, decreased stress or declines in oxidative injury. We propose a
      randomized, controlled 6 month phase II trial of yoga in two separate cohorts: healthy elders
      and subjects with mild multiple sclerosis. We will determine if yoga intervention produces
      improvements on a broad attentional battery that especially emphasizes attentional control.
      To further understand the reported beneficial effect of yoga on its practitioners, we will
      also determine if there is a positive impact on measures directly related to yoga practice
      (flexibility and balance) as well as mood, quality of life and oxidative injury markers. The
      yoga intervention consists of a Hatha yoga class meeting twice per week. The class is taught
      by experienced yoga teachers who are supervised by a nationally known yoga instructor. There
      are two control groups. An exercise group will have a structured walking program prescribed
      by a certified Health and Fitness Instructor and Personal Trainer. The program will attempt
      to match the Hatha yoga class for metabolic demand. The second control group will be assigned
      to a 6 month waiting list. The outcome measures are assessed at baseline and after the 6
      month period. The primary outcome measures are alertness (quantitative EEG and self-rated
      scale), ability to focus attention (Stroop) and ability to shift attention (extradimensional
      set shifting task). Secondary attention outcome measures include the ability to sustain
      attention (decrement in reaction time) and ability to divide attention (Useful Field of
      View). Other secondary outcome measures include flexibility, balance, mood, quality of life,
      fatigue (in MS cohort) and decreased markers of lipid, protein, and DNA oxidative injury.
    


Intervention name(s): Yoga
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Yoga
Corneal Lesions in Intensive Care Unit (ICU) Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center
Condition: Keratitis; Corneal Ulcer
MeSH terms: Corneal Ulcer; Keratitis
Study type: Interventional

Summary: 
      The purpose of the study is find out the better measure to achieve corneal protection in an
      Intensive Care Unit.
    

Detailed description: 
      Critically ill patients are at higher risk for corneal injury and the mechanisms responsible
      for ocular lubrication and protection can be compromised. However, the literature diverges on
      which is the best clinical practice for treatment. There is a scale for assessing the risk
      for corneal injury. Thus, the general objective of this study was to evaluate the risk for
      developing corneal injury in critically ill patients and the effectiveness of three types of
      interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its
      prevention. The specific objectives were: verify the most effective intervention for the
      prevention of corneal injury from the available literature and provided by: eye gel, eyedrops
      and polyethylene film compared to the control group who received eye care through randomized
      controlled clinical trial. Patients and methods: This study was a randomized controlled trial
      to determine the best care for the prevention of corneal injury from those available on the
      market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in
      the period from 09/07/2013 to 03/15/2014 .
    

Intervention name(s): LACRIBELL®; LIPOSIC®; Glad wrap
Intervention type(s): Device; Device; Device
Intervention description(s): Hypromellose and dextran based eyedrop, used in the treatment of dry eye.; Carbomer and Sorbitol based gel, used in the treatment of dry eye.; A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.
Other intervention name(s): Eyedrop; Occular Gel; Polyethylene film
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Corneal Diseases; Corneal Ulcer; Nursing Diagnosis; Intensive Care Units; Nursing; Randomized Clinical Trial