bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Condition: Presbyopia; Refractive Errors; Eye Diseases
MeSH terms: Eye Diseases; Presbyopia; Refractive Errors
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with
      Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
    

Detailed description: 
      The primary efficacy variable in this INSIGHT study is the percentage of subjects with at
      least a 3-line improvement.

      The secondary efficacy variable is the percentage of subjects who achieve a 2-line or greater
      improvement from pre-treatment.
    

Intervention name(s): Aceclidine+Brimonidine combination ophthalmic solution; Aceclidine ophthalmic solution; Vehicle Proprietary Ophthalmic Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ophthalmic Solution; Ophthalmic Solution; Ophthalmic Solution
Other intervention name(s): LNZ101; LNZ100; Vehicle
Intervention MeSH terms: Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions; Aceclidine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmaceutical Solutions; Miotics; Ophthalmic Solutions; Near Vision; Eye Drops; INSIGHT
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed to describe the relationship between dose and pharmacokinetic
      parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR
      tablet (12.5 to 37.5 mg) as well as safety profile
    


Intervention name(s): Paroxetine controlled release tablet
Intervention type(s): Drug
Intervention description(s): Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BRL029060/Paroxetine CR; pharmacokinetics; safety
Effect of Timing Progesterone Luteal Support on Embryo Transfer
Condition: Progesterone Luteal Support in ICSI; Embryo Transfer
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to know whether starting progesterone luteal support in intra cytoplasmic
      sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of
      embryo transfer compared with starting luteal support on day of embryo transfer
    

Detailed description: 
      Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded
      of the allocation group.

      A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting
      luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm
      II (66) starting the same P4 dose on day of embryo transfer
    

Intervention name(s): Progesterone 100 IM/day
Intervention type(s): Drug
Intervention description(s): Progesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind Randomized Controlled Trial : the clinicians and the patents were blinded of the allocation group.
A total of 137 embryo transfers (ETs) were randomly allocated into either group A (67 ) starting luteal support as daily intra muscular (IM) injections of 100 mg prontogest on day of egg retrieval, or group B (66) starting the same P4 dose on day of embryo transfer.Transfer technique was blind tactile using Labotect catheter and was considered difficult if the inner ET catheter was blood stained and /or sounding or dilating the cervix was needed. Cervical traction or blood staining of outer sheath did not indicate difficulty
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Effect of Posture Shirts on Posture During Functional Tasks
Condition: Healthy
Study type: Observational

Summary: 
      This study investigates the effect of a posture shirt on posture during functional tasks such
      as office work.
    

Detailed description: 
      Poor posture have historically been blamed for pain and disability in the general population.
      A treatment-strategy that have gain popularity in recent years is the use of a posture shirt
      which is a compressive shirt designed and marketed to the general public and health service
      providers as a way to improve posture and consequently alter muscle activity, reduce
      musculoskeletal pain and discomfort. This study will investigate the effect of posture shirts
      on posture.
    

Intervention name(s): Posture shirt; Compression shirt
Intervention type(s): Device; Device
Intervention description(s): Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort.; Compression shirts are designed for recreational sport activities and can be bought in any local sports store
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy male participants
      
Keywords: Posture; Muscle activity; Posture corrective shirts
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
Condition: Hypercholesterolemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and
      Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with
      hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5
      mg.
    


Intervention name(s): Ezetimibe; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma
Condition: Asthma; Chronic School Absenteeism
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study will establish a multi-disciplinary home visitation team consisting of a medical
      provider and school teacher or staff member, and will evaluate whether a series of visits
      from this team will help decrease school absenteeism among children with asthma.
    


Intervention name(s): Home Visit; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will consist of a series of home visitations to chronically absent students with co-morbid asthma. These visits will consist of a home environment evaluation, medication adherence and knowledge assessment, distribution of home environmental allergen reduction items such as mattress and pillow encasements, as well as review and reinforcement of any asthma action plans or care plans provided by patient's primary care physicians or medical home.; Standard care will refer to the procedures carried out by the school district to address students with chronic absenteeism. This includes parent-teacher and parent-school administrator meetings and communications and may also include home visits carried out by classroom teachers or student support center staff.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a randomized wait-list control trial. Participants will be randomized to the intervention or control arm for the study observation period. At the conclusion of the observation period, the control group will receive the intervention.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Home Visit; School Absenteeism
Effect of Abdominal Obesity on Lipoprotein Metabolism
Condition: Obesity; Dyslipidemia; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance; Dyslipidemias; Obesity, Abdominal
Study type: Interventional
Phase: Phase 3

Summary: 
      Abdominal obesity is strongly associated with dyslipidemia, which may account for the
      associated increased risk of atherosclerosis and coronary disease. Weight reduction is
      suggested to be a preferred and effective first-line strategy to correct lipid abnormalities,
      particularly in overweight/obese subjects. This improvement may be related to the effect of
      reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully
      demonstrated.

      Hypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and
      raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as
      well as decreasing HDL apoA-I, respectively.
    

Detailed description: 
      We examined the mechanism of the effect of weight loss through dieting on LDL and HDL
      metabolism in abdominally obese men. LDL apoB-100 and HDL apoA-I kinetics were studied using
      a primed-constant infusion of 1-[13C]-leucine in a controlled, dietary intervention trial of
      16 weeks duration in middle-aged, obese men with the metabolic syndrome. Isotopic enrichment
      in apoB and apoA-I was measured by gas chromatography-mass spectrometry and fractional
      turnover rates estimated using multi-compartmental modelling.
    

Intervention name(s): Weight loss by dietary restriction
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipoprotein metabolism; Cardiovascular disease; Obesity
Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression
Condition: HIV
MeSH terms: Viremia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot
      clinical trial.

      Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the
      PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same
      approach.

      The aim of the study is to compare the virological efficacy of the etravirine-based regimen
      with standard PI-containing regimen.
    

Detailed description: 
      Etravirine is a second generation non-nucleoside analogue reverse transcriptase inhibitor
      (NNRTI) approved by the U.S. Food and Drug Administration (FDA) in January 2008 and by the
      European Medicines Agency in September 2008 for clinical use in adults with incomplete
      virologic suppression and resistance to previous NNRTI and other antiretroviral classes.

      A question that has not been explored is whether subjects with sustained undetectable HIV-1
      RNA-levels experiencing antiretroviral-related toxicity can safely switch their current PI to
      etravirine. This treatment strategy could allow improvements in tolerability and lipid
      profile and would permit an easy posology (400 mg dissolved in water every 24 hours). We
      designed a proof-of-concept study to test the efficacy and safety of switching from a
      Protease Inhibitor (PI) to etravirine in subjects with viral suppression as an antiretroviral
      strategy of simplification therapy, based on the high antiviral potency, low toxicity,
      together with its easy posology (in water dissolution).

      Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the
      PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same
      approach.

      The primary endpoint would be the percentage of patients who maintain virological suppression
      at week 48.
    

Intervention name(s): Etravirine 400 mg dissolved in water every 24 hours; Continue with the same antiretroviral regimen
Intervention type(s): Drug; Drug
Intervention description(s): Switch from the PI to Etravirine 400 mg dissolved in water every 24 hours; Continue with the same antiretroviral regimen
Other intervention name(s): ETV; CNT
Intervention MeSH terms: Anti-Retroviral Agents; Etravirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Active Comparator; Placebo Comparator; Sham Comparator; No intervention; Other; Treatment Experienced
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the feasibility of a clinical informatics system-based approach to lung
      cancer screening. Patients of a large academic medical center who may qualify for lung cancer
      screening will be sent an electronic invitation to complete an online lung cancer screening
      decision aid.
    

Detailed description: 
      The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose
      chest CT scans for lung cancer screening in patients who meet specific criteria. However,
      many individuals who meet these criteria do not realize they qualify for screening. This
      study will determine the feasibility of using a clinical informatics approach to
      systematically identify potential candidates for LDCT screening, reach out to them via the
      patient portal, and use a web app to provide them with a personalized LDCT screening decision
      aid and facilitate the ordering of screening tests.
    

Intervention name(s): Decision Aid Invitation
Intervention type(s): Behavioral
Intervention description(s): electronic invitation to complete web-based decision aid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study explores the effects of an eight-week exercise intervention for adolescents with
      Down syndrome on home exercise compliance. As well, to observe changes in fitness including
      muscular strength, endurance and aerobic capacity. Finally to observe any changes in mood,
      behavior and quality of life.
    

Detailed description: 
      Adolescents with Down syndrome will participate in an eight-week, center-based exercise
      intervention. Participants will undergo an hour of exercise intervention each week. During
      this time, participants will be working with a team consisting of a physician, physical
      therapy student volunteers, and clinical research coordinators. Exercises will focus on
      strength and endurance of all major muscle groups, while ensuring proper technique and form
      is used. They will also receive instruction on how to continue the exercise program at home.

      Prior to starting, and at the end of eight sessions, all exercise participants will undergo
      testing procedures for anthropometric, strength and flexibility measurements. This data will
      be collected as part of clinically evaluating the impact of the program on each participant.
      In addition to the exercise program (and clinical assessments of fitness), DSFit participants
      will complete study measures of behavioral functioning as well as scales of depression and
      anxiety. Participants in the DSFit study will also complete a weekly exercise log during the
      intervention and for a follow-up period afterwards.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exercise; Fitness; Overall wellbeing
Home Remineralization of White Spot Lesions With Two Different Toothpastes.
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      The aim of the study is to compare white spot lesions before, during and after treatment with
      New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and
      Colgate toothpaste with 1450 ppm of fluoride. The timeline will consider the study begin, 15
      days, 30 days and 90 days after the beginning of the study. The following indices will be
      recorded: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a
      satisfaction questionnaire.
    

Detailed description: 
      The aim of the study is to compare white spot lesions before, during and after treatment with
      two different toothpastes for home oral care. Patients who agree to sign the informed consent
      will be randomly assigned to two different groups:

        -  Trial Group will use New Biorepair Advanced Sensitive toothpaste containing micro
           crystals of hydroxyapatite;

        -  Control Group will use Colgate toothpaste with 1450 ppm of fluoride.

      At the baseline, professional oral hygiene will be performed. The following indices will be
      recorded at the study begin and at the following 15, 30 and 90 days: BEWE Index, Schiff Air
      Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
    

Intervention name(s): Biorepair toothpaste; Colgate toothpaste
Intervention type(s): Other; Other
Intervention description(s): Use of New Biorepair Advanced Sensitive for home oral care.; Use of Colgate toothpaste for home oral care.
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remineralization; hydroxyapatite
RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors
Condition: if Aortic Stiffness; Myocardial Wall Strain
Study type: Observational

Summary: 
      Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer,
      occurring at a significantly younger age than in the general population. The increased
      incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and
      mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover,
      understanding of the mechanisms by which cancer treatment could influence the occurrence of
      latent cardiovascular events is unavailable. Our group and others have established
      independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in
      middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes,
      cardiac death, and congestive heart failure. The goal of this application is to show that
      childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health
      have increased aortic stiffness, when compared to healthy adolescent and young adult age
      mate. Studies are designed to determine if MRI measures of cardiovascular function differ
      between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and
      adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The
      investigators propose that MRI markers responsible for cardiovascular events represent new
      clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Childhood cancer survivors, adolescent/young adults with no cancer history and newly
        diagnosed cancer patients
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      Partial thickness burns are a common, painful injury requiring a great deal of resources in
      their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to
      remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to
      silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain
      control and resources required to deliver care.
    


Intervention name(s): water-soluble therapy; silver sulfadiazine
Intervention type(s): Drug; Drug
Intervention description(s): The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis; The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test if the investigational medication ABT-089 is a safe and
      effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): ABT-089; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take up to two 40 mg tablets once daily for 8 weeks.; Subjects will take one or two placebos once daily for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment