bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine
      1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard
      drop instillation of the same mydriatic regimen, which constitutes routine care for pupil
      dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care
      unit. Comparison, also, will be made to the subsequent adverse events and the drug
      concentration in peripheral blood samples.
    

Detailed description: 
      A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose.
      Participants will be randomly assigned to receive either a) microdrops on their first and
      standard drops on their second screening examination a week later (M/S group), or b) standard
      drops first and microdrops a week later (S/M group). Microdrops (6.5 μL) will be instilled
      using a calibrated micropipette, while standard drops (28-34 μL) will be instilled directly
      through the commercially available plastic multi-dose mydriatic dropper bottle.
    

Intervention name(s): Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%; Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%
Intervention type(s): Drug; Drug
Intervention description(s): 1 drop (6.5 μL) for 3 doses with 5-minute intervals; 1 drop (28-34 μL) for 3 doses with 5-minute intervals
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tropicamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: microdrops; mydriasis; dilating drops; phenylephrine; tropicamide; retinopathy of prematurity; ROP; screening
Intra and Postoperative Outcomes With 3 Injectors
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This randomized clinical trial compares subjective performance during Intraocular lens (IOL)
      implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL
      implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision
      using one of three injectors :

      Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector
      (Autosert). Further, the investigators also looked at incision integrity by comparing ingress
      of trypan blue from the ocular surface into the anterior chamber.
    

Detailed description: 
      In this randomized, clinical trial, three types of injectors were compared :

        1. Manual, screw type injector (Monarch III)

        2. Manual, plunger type injector (Royale, ASICO)

        3. Motorized injector (Autosert, Alcon)

      Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed
      using a D cartridge and one of three injectors which was decided in a randomized fashion.

      The investigators evaluated incision enlargement at following points : at the end of
      phacoemulsification, and then, at the end of IOL implantation The investigators also looked
      at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week,
      and 1 month after surgery anterior segment OCT morphology was also studied.

      further, the surgeon was asked to subjectively grade the ease of implantation with each
      injector
    

Intervention name(s): Intraocular lens implantation; Autosert Injector; Royale Injector; Monarch III Injector
Intervention type(s): Procedure; Device; Device; Device
Intervention description(s): Intraocular lens implantation; Motorised injection device for intraocular lens implantation; Manual, plunger type injection device for intraocular lens implantation; Manual, screw type injection device for intraocular lens implantation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Intraocular lens implantation
Preventing Youth Soccer Injury
Condition: Injuries; Sports Injury; Sports Injuries in Children
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      A study is proposed to test whether adding additional referees to youth soccer matches may
      reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games
      will be randomly assigned to have either one or three referees and videotaped. The videotaped
      games will then be watched to record risk-taking behavior by players, referee decisions, and
      other factors relevant to potential injury.
    


Intervention name(s): 3 referees present; 1 referee present
Intervention type(s): Behavioral; Other
Intervention description(s): We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.; We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: youth soccer injury
A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      This study is being done to collect data on the potential use of a sponge on a string device
      as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy
      controls.
    

Detailed description: 
      This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of
      determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm
      sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal
      irritation and DNA yield, using a randomized factorial design pilot trial. Participants will
      first undergo the sponge on a string test followed by clinical endoscopy. Following
      completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen
      for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity
      configuration selected from Phase 1. Study procedures, testing and follow up will be the same
      as Phase 1.
    

Intervention name(s): Biopsy; Biospecimen Collection; Endoscopic Procedure; Swallowable Sponge Cell Sampling Device
Intervention type(s): Procedure; Procedure; Procedure; Device
Intervention description(s): Undergo biopsy; Undergo collection of blood sample; Undergo endoscopy; Undergo swallowable sponge cell sampling assessment
Other intervention name(s): BIOPSY_TYPE; Bx; Biological Sample Collection; Biospecimen Collected; Specimen Collection; Endoscopic Examination; Endoscopy; Cytosponge; Swallowable Sponge; Swallowable Sponge Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Barrett's; esophagus; reflux; esophageal adenocarcinoma
Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study
Condition: Depressive Symptoms; Anxiety Disorders
MeSH terms: Depression; Anxiety Disorders
Study type: Observational

Summary: 
      Therapies delivered via technology have been developed to improve accessibility, however,
      there is limited research regarding messaging therapy in particular, and none that we know of
      utilizing a longitudinal effectiveness design. The aim of this study was to investigate the
      overall effectiveness of messaging therapy, identify any contributors to its effectiveness,
      and to evaluate a dosage effect for this type of treatment.
    


Intervention name(s): psychotherapy via asynchronous message
Intervention type(s): Behavioral
Intervention description(s): Behavioral psychotherapy delivered by asynchronous message using the Talkspace application
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals seeking psychotherapy services through digitally-mediated application who
        present with and are diagnosed with a depression and/or anxiety related disorder.
      
Keywords: technology; messaging psychotherapy; depression; anxiety; telehealth
Time to Eugonadal Range, Time to Steady State and Drying Time
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal
      testosterone range after initial testosterone gel 2% application, time to steady state after
      after initiation of testosterone gel 2%, and drying time after application of testosterone
      gel 2%.
    

Detailed description: 
      Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel
      2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After
      Fortesta Application
    

Intervention name(s): testosterone gel 2%
Intervention type(s): Drug
Intervention description(s): 40 mg testosterone gel 2%
Other intervention name(s): EN3350
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone deficiency; hypogonadism
Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
Condition: Substance-Related Disorders; Depressive Disorder; Anxiety Disorder
MeSH terms: Substance-Related Disorders; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Adolescent substance abuse results in significant negative outcomes and extraordinary costs
      for youths, their families, communities, and society. Moreover, rates of psychiatric
      comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual
      diagnosis are more than twice as costly to treat compared to those with no comorbidity. The
      applicant principal investigator recently completed a pilot project funded by the National
      Institute on Drug Abuse focused on developing and piloting a psychosocial treatment
      specifically for youth presenting for outpatient treatment with co-occurring substance use
      and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the
      experimental group exhibiting significantly less substance use and more rapid reductions in
      anxiety and depressive symptoms compared to the control group. The proposed research is a
      randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment
      for Adolescents; OPT-A) to an "active placebo" on key clinical indices from pre-treatment
      through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance
      protocol, and therapist training protocol developed and successfully tested in the pilot
      study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of
      co-occurring substance use and internalizing problems. The following outcomes will be
      evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and
      consumer satisfaction. The intervention addresses one of the more prevalent and most
      challenging, costly, and understudied presenting problems among adolescent outpatients. If
      successful, this research could provide a considerable contribution in the treatment field
      for youth with co-occurring substance use and internalizing disorders.
    


Intervention name(s): OutPatient Treatment for Adolescents (OPT-A); Treatment As Usual
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to analyze the sensitivity of blood pressure to oral
      salt intake. Matched male and female participants will be selected as normal weight,
      overweight, and obese.

      Participating subjects will have a first visit with blood pressure measurement and a blood
      sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6
      grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.
    


Intervention name(s): sodium chloride; Methylcellulose crystalline
Intervention type(s): Other; Other
Intervention description(s): sodium chloride 500mg; Methylcellulose 37 ml
Keywords: Blood pressure
A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the bioequivalence of the hormones norgestimate,
      norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets,
      formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by
      dry process, in healthy women.
    

Detailed description: 
      This is a Phase 1, single-dose, open-label (a medical research study in which participants
      and researchers are told which treatments the participants are receiving, "unblinded"),
      randomized (the study medication is assigned by chance), single-center and a 2-way crossover
      (method used to switch participants from one study group to another in a clinical trial)
      study in healthy women. The study consists of 3 parts: Screening phase, Treatment phase and
      end-of-study or withdrawal. Treatment periods will be separated by a wash out period of at
      least 10 days. The duration of participation in the study for an individual participant will
      be approximately 7 weeks. All participants will be randomly assigned in a 1:1 ratio to 1 of 2
      possible treatment sequences and receive both of the following treatments: 1 oral tablet
      formulated by wet process or dry process, whereas each tablet contains norgestimate 250
      microgram (mcg) and ethinyl estradiol 35 mcg. The primary endpoint of the study will be
      assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process); Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
Intervention type(s): Drug; Drug
Intervention description(s): Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by wet process will be orally administered on Day 1 of Period 1 or Period 2.; Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by dry process will be orally administered on Day 1 of Period 1 or Period 2.
Other intervention name(s): Cyclen; Tri Cyclen; Cilest; Tri-Cilest; Ortho Cyclen; Ortho Tri Cyclen
Intervention MeSH terms: Moxifloxacin; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norgestimate; Norgestrel; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Norgestimate; Ethinyl estradiol; Norgestrel; Norelgestromin; Ortho cyclen; Phase 1; Healthy Women
Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Background:

      - This study is designed for people who need a standard, non-research invasive coronary
      angiogram to find out if they have heart disease. Researchers want to take a computed
      tomography (CT) scan of people s hearts before their procedure to see if this less invasive
      test can also diagnose coronary artery disease.

      Objectives:

      - To learn if a new way to view CT pictures is able to accurately diagnose coronary artery
      disease.

      Eligibility:

      - People age 55 and older who need a coronary angiogram.

      Design:

        -  Participants will be screened with their medical records.

        -  Participants may give a blood sample.

        -  Participants may have a CT scan of the heart with and without contrast. The CT scan will
           not interfere with their medical care.

        -  Participants blood pressure and heart rhythm will be monitored before, during, and after
           the CT scan. They may have an electrocardiogram.

        -  Before the scan, participants will have an intravenous catheter put into their arm. It
           will be used to inject contrast.

        -  Participants may take a beta blocker to slow their heart rate.

        -  Participants may take nitroglycerin under their tongue. It will enlarge their heart
           blood vessels and improve picture quality. It may cause a flushing sensation or
           headache.

        -  Participants will lie on their back on a padded table. The table slides into a large,
           donut-shaped machine. An x-ray tube will move around their body, taking pictures. They
           will be asked to hold their breath for 5 seconds at a time.

        -  Participants will be called 30 days after their angiogram. They will answer questions
           about their health, hospital visits, or medical treatments.
    

Detailed description: 
      Coronary calcium can impair the accurate evaluation of the coronary arteries with coronary
      computed tomography angiography (CCTA). A novel approach to potentially overcome this
      limitation is coronary calcium subtraction, where areas of calcification identified on a
      non-contrast scan are removed from the contrast enhanced images.

      .
    

Observational model: Case-Only
Time perspective: Prospective
Keywords: Cardiac; Computed Tomography; Coronary Artery Disease
Neuropsychological Outcome After Cardiac Arrest
Condition: Heart Arrest, Out-Of-Hospital; Hypoxia-Ischemia, Brain; Cognition Disorders; Psychological Distress; Fatigue; Insomnia
MeSH terms: Brain Ischemia; Hypoxia-Ischemia, Brain; Heart Arrest; Out-of-Hospital Cardiac Arrest; Ischemia; Hypoxia; Cognition Disorders
Study type: Observational

Summary: 
      This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial
      (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of
      controlled hypothermia after out-of-hospital cardiac arrest (OHCA).

      This study is designed to provide detailed information on cognition after OHCA and its
      relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim
      is to utilize this information to validate a neurocognitive screening battery used 6 months
      after OHCA in the TTM2-trial.

      Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform
      a standardized neuropsychological assessment including performance-based tests of cognition
      and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio,
      a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest
      will be recruited and perform the same test battery. Group differences at 7 and 24 months
      will be analyzed per cognitive domain (verbal, visual/constructive, short-term working
      memory, episodic memory, processing speed, executive functions). Results of the OHCA
      survivors on the TTM2 neurocognitive screening battery will be compared with
      neuropsychological test results at 7 months time.
    


Intervention name(s): Neuropsychological assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Standardized neuropsychological battery consisting of the following tests and questionnaires: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Vocabulary, Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency, WAIS-IV Block Design, WAIS-IV Matrix Reasoning, WAIS-IV Digit Span, Wechsler Memory Scale - Third Edition (WMS-III) Spatial Span, Rey Auditory Verbal Learning Test (RAVLT), WMS-III Logical Memory, Brief Visuospatial Memory Test-Revised (BVMT-R), Trail Making Test (TMT) A & B, D-KEFS Color Word Interference Test, Behavioral Assessment of the Dysexecutive Syndrome Dysexecutive Questionnaire (BADS DEX), Multidimensional Fatigue Inventory (MFI-20), Minimal Insomnia Symptom Scale (MISS), Hospital Anxiety and Depression Scale (HADS).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OHCA survivors at TTM2-sites participating in this study. Survivors are invited to partake
        in this study at the regular six-month follow-up of the TTM2-trial.

        The cohort of MI patients acting as controls are recruited and assessed at one
        participating site per country through quality registers.
      
Keywords: Neuropsychology