bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment
      of migraine headache in order to select a dose range for further studies.
    

Detailed description: 
      This study is set up:

        -  to evaluate the efficacy (headache response at two hours) of a range of intravenous
           doses of COL-144 in order to select a dose range for further evaluation,

        -  to explore the time course and effect of a range of dose levels of COL-144 on features
           of the migraine including: headache response, proportion of participants pain-free,
           headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue
           medication, patient global impression and vomiting

        -  to explore the safety and tolerability of a range of doses of COL-144 in terms of
           adverse events, physical exam, vital signs, laboratory evaluations, and ECGs

        -  to determine key PK parameters for COL-144 and to explore the relationship between the
           PK of COL-144 and the time course and extent of clinical response
    

Intervention name(s): Lasmiditan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as intravenous infusion; Administered as intravenous infusion
Other intervention name(s): LY573144, COL-144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine
The Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound
Condition: Anesthesia; Fasting
Study type: Interventional

Summary: 
      The aim of this work is to evaluate the effect of semi sitting versus supine positions on
      gastric emptying of fluids in children using gastric ultrasound.

      The investigators hypothesize that gastric emptying in children might be faster if the
      patient is in semi-sitting position. This hypothesis could impact the current guidelines for
      peri-operative fasting. Moreover, if this proved effective, could be used for enhancement of
      gastric emptying before emergency operations in non-fasting patient.
    

Detailed description: 
      Dealing with preoperative fasting requires a meticulous balance ensuring patient safety and
      lessening patient's discomfort. Although fasting is a basic requirement for avoiding
      pulmonary aspiration, it is sometimes associated with patient discomfort and hypoglycemia.
      According to the current guidelines for preoperative fasting of children, fasting is required
      for 2-hours, 4-hours, and 6-hours period after ingestion of water, breast milk, and infant
      formula respectively. Limited data is available for the effect of patient positioning on
      gastric emptying. A previous study had reported that gastric emptying of non-nutrient liquids
      was faster in the sitting position compared with the left lateral position . Another study
      showed similar findings after nutritive liquid and solid meals; whilst, a third study had
      reported that gravity has a little effect on gastric emptying.

      In pediatric population the effect of posture on the duration of gastric emptying is not well
      investigated.

      Gastric ultrasound is a valid, accurate, reproducible, non-invasive, bedside test for
      evaluation of the gastric volume. gastric ultrasound has been validated in adults as well as
      children for estimating the volume of gastric contents and evaluating gastric emptying.

      The aim of this work is to evaluate the effect of semi sitting versus supine positions on
      gastric emptying of fluids in children using gastric ultrasound.
    

Intervention name(s): Supine position; Semi-sitting position
Intervention type(s): Other; Other
Intervention description(s): The children will be placed in the supine position after ingestion of a standard volume of clear fluid; The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
Condition: Sexually Active
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are
      unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the
      birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%).
      It has been estimated that if Emergency Contraception (Plan B) was used after every
      contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions
      annually.

      Previous studies have showed the effectiveness of emergency contraception decreases with time
      after intercourse; the sooner it is taken-even if it means a matter of hours-the more
      effective it is in preventing pregnancy. Based on previous studies, it is clear that relying
      on obtaining emergency contraception on the same day or even the day after unprotected
      intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the
      adolescent mystery caller did not have the medication available the day of the call and
      almost all of the pharmacies not stocking the medication would take greater than 24 hours to
      obtain it through their ordering system.

      Thus, the concept of advanced provision of emergency contraception has been proposed to
      assure that the medication can be taken as soon as possible. Although this practice is known
      to be safe and has not shown any association with increased sexual risk or behaviors, it is
      unclear how often/if adolescents will fill a prescription for a medication that is not needed
      at the time of a medical encounter.

      The investigators propose a randomized pilot study (n=60) of a text-messaging intervention
      that aims to increase the rate at which prescriptions for emergency contraception are filled.
      Based on practice norms in the BMC Adolescent Center, sexually active female adolescents
      (ages 13-21) in both the control and intervention groups will be provided a prescription for
      emergency contraception. The intervention group, however, will receive follow-up text message
      on their phone reminding them to fill the prescription.

      Boston Medical Center Health Plan will provide prescription fill data regarding the
      prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all
      study participants will be contacted for a follow-up survey.
    


Intervention name(s): Text Message
Intervention type(s): Other
Intervention description(s): Subjects will receive a text message on their personal cell phone on Days 1, 3 and 5 after enrollment reminding them to fill their prescription.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Adolescents; Sexually Active; Unprotected Sex; Emergency Contraception
T Regulatory and Childhood Asthma
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This is an epidemiologic study, examining environmental exposures and affect on immune
      development.
    

Detailed description: 
      This is an epidemiologic study, examining environmental exposures and affect on immune
      development. The study has completed enrollment
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        6-7 yo children of either gender
      
Biospecimen description: 
      blood, PBMC culture supes and nasal lavage
Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      This is a retrospective cohort study that evaluates the postoperative pain findings of a
      consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE).
    

Detailed description: 
      The study was carried out in university hospitals (Istanbul, Turkey). Patients diagnosed
      through bimanual gynecologic examination, gynecologic ultrasound or magnetic resonance
      imaging-confirmed endometrioma and DIE together; who underwent a laparoscopic surgery by a
      team of gynecologists, colorectal surgeons, and a urologist were retrospectively evaluated.
      The data were collected in a specific database and analyzed for postoperative pain outcomes
      through a comparison with preoperative symptoms scored using a visual analogue score (VAS),
      and the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.
    

Intervention name(s): BSGE pelvic pain questionnaire and VAS scores
Intervention type(s): Other
Intervention description(s): Patients were evaluated using the BSGE pelvic pain questionnaire in terms of pre-operative and post-operative pain assessment in order to determine the effects of endometriosis surgery on the quality of life. The patients were asked to indicate their levels of dyspareunia, dysmenorrhea, and chronic pelvic pain on a VAS on the pelvic pain questionnaire.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with endometriosis 65 women whose main symptom was pain and who did not respond to
        medical treatment and underwent endometriosis surgery
      
Keywords: endometriosis
Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Condition: Intermittent Exotropia
MeSH terms: Exotropia
Study type: Interventional

Summary: 
      The main objectives of this randomized trial comparing overminus lens treatment to
      non-overminus (spectacles without overminus or spectacles with plano lenses) are to
      determine:

        -  The long-term on-treatment effect of overminus treatment on distance intermittent
           exotropia (IXT) control score.

        -  The off-treatment effect of overminus treatment on distance IXT control score (following
           weaning and 3 months off treatment).
    

Detailed description: 
      The main objectives of this randomized trial comparing overminus lens treatment to
      non-overminus (spectacles without overminus or spectacles with plano lenses) are to
      determine:

        -  The long-term on-treatment effect of overminus treatment on distance IXT control score.

        -  The off-treatment effect of overminus treatment on distance IXT control score (following
           weaning and 3 months off treatment).

      The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether
      overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing
      overminus spectacles. There have been no rigorous studies that address the following
      important questions related to overminus lens therapy:

        -  Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing
           overminus spectacles (over many months or years)?

        -  Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus
           spectacles are discontinued?

      In November 2019, a protocol amendment discontinued overminus lens treatment and extended the
      study for an additional 18 months after the 18-month randomized trial has ended. The
      objective of the extension study is to compare long-term refractive error between subjects
      originally treated with either overminus spectacles or non-overminus spectacles as part of
      the 18-month randomized trial; treatment is at investigator discretion.
    

Intervention name(s): Overminus treatment; Non-overminus treatment
Intervention type(s): Device; Device
Intervention description(s): spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere; spectacles with full cycloplegic refraction without overminus
Other intervention name(s): Overminus spectacles; Overminus glasses; Overminus therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intermittent Exotropia; IXT; overminus
The Effect of Oral Hyaluronic Acid on the Skin
Condition: Healthy Japanese Subjects
Study type: Interventional

Summary: 
      This clinical trial aims to clarify the effect of hyaluronic acid on skin conditions.
    

Detailed description: 
      In this study, investigators will evaluate the skin condition before and after the
      intervention. The groups to be compared are two different doses of hyaluronic and a placebo.
    

Intervention name(s): Hyaluronic acid 75 mg/capsule; Hyaluronic acid 50 mg/capsule; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Take 2 capsules per day at any time.; Take 2 capsules per day at any time.; Take 2 capsules per day at any time.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyaluronic Acid; Skin
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4
      dimer to human immunoglobulin Fc.

      In this Double-blind, randomized, placebo-controlled trial, 41 healthy subjects received
      placebo or escalating doses of JY09 on day 1 in the first cohort, and on days 1 and 22 in the
      following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg;
      cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 +
      6.0 mg. The primary endpoints were the incidence of adverse events and serious adverse events
      related to JY09. Secondary endpoints included pharmacodynamics and pharmacokinetics
      parameters, as well as anti-JY09 antibody incidence and titers.
    


Intervention name(s): JY09
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating
      safety and efficacy of donepezil hydrochloride in patients with moderate to severe
      Alzheimer's disease.
    

Detailed description: 
      This study consisted of pre-treatment and treatment phase. Pre-treatment phase was
      approximately 4 weeks including the screening and baseline process. In treatment phase, about
      190 subjects received Donepezil HCl 23 mg once daily for 24 weeks.
    

Intervention name(s): Donepezil HCL
Intervention type(s): Drug
Intervention description(s): Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
Intervention MeSH terms: Donepezil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease
Study of Birth Control Use After Childbirth
Condition: Contraception
Study type: Interventional

Summary: 
      This study is a randomized controlled trial that will evaluate the impact of a brief
      educational script on the method of birth control that women receive at their 6-week
      postpartum visit. The one-minute script ("LARC script") is given to women in the hospital
      during their postpartum admission. It informs patients about long-acting reversible
      contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine
      device. The investigators hypothesize that women who are randomized to receive the LARC
      script will be more likely to report that they are using a LARC method, when queried
      immediately after their six-week postpartum visit.
    


Intervention name(s): LARC Script
Intervention type(s): Behavioral
Intervention description(s): The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Contraception; Contraception behavior; Postnatal care; Health education; Randomized controlled trial
Penn State Hershey Sitting and Health Study
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help
      employees to increase their daily physical activity without compromising work productivity;
      and (b) evaluate the effects of different types of incentives for pedaling the desk-based
      elliptical device on employees' pedaling quantity over a one-month intervention period. The
      study will involve placing a compact elliptical device (provided at no cost by the research
      team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data
      evaluating the effects of the elliptical device on work productivity will be obtained from
      both employees and the employees' supervisors.
    


Intervention name(s): Desk-based pedaling device and pedaling incentives provided
Intervention type(s): Behavioral
Intervention description(s): Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an
      immediate-release formulation when a single dose is administered in adolescents and in adults
      when compared to Children.
    


Intervention name(s): Children's Mucinex® Grape Flavor; Children's Mucinex® Grape Flavor
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation; 1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol
      Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8
      pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure
      and pulse checks at each visit. Patients will have a dilated fundus exam and corneal
      measurements taken at first and last visit.
    


Intervention name(s): BETOPTIC S (betaxolol HCl); Timolol Gel-forming Solution (TGFS)
Intervention type(s): Drug; Drug
Intervention description(s): betaxolol HC); timolol maleate 0.25% and 0.5%
Intervention MeSH terms: Timolol; Betaxolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Glaucoma; Ocular Hypertension
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR.
      Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is
      increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all
      these alterations stimulated a chronic and bad regulated state of inflammation. For this
      porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in
      patients elder than two months old and randomized to received every day a dietetically
      supplement with DHA or placebo, will be done during 12 months. The trial has as a principal
      objective to proved if this long term supplementation could decrease in contrast with
      placebo.
    


Intervention name(s): Docosahexaenoic acid administration: 50 mg/kg/day during 12 months; Placebo: 50 mg/kg/day during 12 months
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment