bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Olopatadine on Allergic Tear Mediators
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional

Summary: 
      The purpose of the research is to determine which inflammatory substances are involved in
      causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with
      symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances
      released by cells in the affected tissues cause allergic reactions in the eye and elsewhere
      in the body.
    

Detailed description: 
      Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our
      research question is:

      Are there differences in inflammatory mediators and cell surface activation markers in
      patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening
      disease such as Atopic Keratoconjunctivitis (AKC) and will the use of the anti-allergy eye
      drop, PATANOL® (olopatadine hydrochloride) affect these parameters?

      Experimental Design:

      Ocular surface cells (by impression cytology) and tears (via capillary tube) are collected
      from allergic, non-allergic, and AKC subjects undergoing an reaction induced either by
      seasonal allergen or topical allergen provocation (specificity and dose determined via skin
      testing). Ocular surface cells are evaluated for surface activation markers. Tears are
      evaluated for mediator content. Tears are also incubated with peripheral blood eosinophils
      and lymphocytes to see effects on adhesion to conjunctival epithelial cells.
    

Intervention name(s): olopatadine
Intervention type(s): Drug
Intervention description(s): olopatadine one drop in one eye for one week
Intervention MeSH terms: Olopatadine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: tears; conjunctival epithelial cells; olopatadine; eosinophils
A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the
      treatment of Fragile X Syndrome in adolescent and adult males.
    

Detailed description: 
      Fragile X Syndrome is a genetically determined neurological disorder in which affected
      individuals are intellectually handicapped to varying degrees and display a variety of
      associated psychiatric symptoms. Clinically, Fragile X Syndrome is characterized by
      intellectual handicap, hyperactivity and attentional problems, autism spectrum symptoms,
      emotional lability and epilepsy. The epilepsy seen in Fragile X Syndrome is most commonly
      present in childhood, but then gradually remits towards adulthood. Physical features such as
      prominent ears and jaw, and hyper-extensibility of joints are frequently present but are not
      diagnostic. Intellectual handicap is the most common feature defining the phenotype.
      Treatment for the disorder is symptomatic - focusing on the management of symptoms - and
      supportive, requiring a multidisciplinary approach.

      This study will investigate the safety and tolerability of treatment with oral administration
      of NNZ-2566 at 35 mg/kg or 70 mg/kg BID in adolescent or adult males with Fragile X Syndrome.
      The study also will also investigate measures of efficacy during treatment.
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials or 3g in 30mL bottles) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.; Strawberry flavored solution
Other intervention name(s): Strawberry flavored solution 0.5% v/v in Water for Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fragile X disorder; Autism
18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism
Condition: Vascular Parkinsonism
MeSH terms: Parkinsonian Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the
      study. Each evaluable subject involved in this study must fulfill all the inclusion and
      exclusion criteria and each subject will have 3 visits in the study, as one screening visit,
      one imaging visit, and one safety evaluation visit.
    

Detailed description: 
      Study duration is expected to be completed in a period of 3 year. The study will enroll 40
      patients with VP and 20 healthy subjects.

      This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion
      tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task
      functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion
      and exclusion criteria according the subject group, each subject will have 3 visits in this
      study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital
      signs, physical examinations, laboratory examinations and collecting of adverse events.
    

Intervention name(s): 18F-DTBZ
Intervention type(s): Drug
Intervention description(s): During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The compound is labeled with fluorine 18F that decays by positron (β+) emission and has a half life of 109.7 min. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron.
The proposed dose for this study is based on the phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-DTBZ
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess the efficacy and safety of LY3361237 in
      participants with at least moderately active systemic lupus erythematosus (SLE). Study will
      last up to 34 weeks and may include up to 15 visits.
    


Intervention name(s): LY3361237; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autoimmune Disease; BTLA B and T Lymphocyte attenuator; Immune checkpoint; Inhibitory checkpoint agonist antibody; Lupus
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
Condition: Postmenopause
Study type: Interventional
Phase: Phase 3

Summary: 
      Calcitonin has been used for many years for treating osteoporosis in postmenopausal women.
      Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of
      microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent
      vertebral fractures at baseline.This pilot study should provide additional new insights in
      the mode of action of nasal calcitonin, on structural changes as measured by high resolution
      peripheral CT, and on the comparison between weight bearing and non weight bearing bones in
      postmenopausal women.
    


Intervention name(s): Salmon calcitonin
Intervention type(s): Drug
Intervention description(s): nasal salmon calcitonin 200UI/day during 2 years
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal women; bone microarchitecture; peripheral quantitative micro-CT; salmon calcitonin
Subject Satisfaction With AbobutulinumtoxinA Treatment
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA
      treatment.
    

Detailed description: 
      Following signature of informed consent and the screening process, eligible subjects were
      treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region.
      Subjects were re-treated at the Month 6 visit.
    

Intervention name(s): AbobotulinumtoxinA
Intervention type(s): Biological
Intervention description(s): AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Mobility and Attention Capacity in Former Premature Children
Condition: Attention Concentration Difficulty; Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      Attention functions have a major impact on children's social and school behavior. They are an
      important issue for prematurely born children often seen as having learning difficulties and
      being restless, when it could be an adaptative answer to attention disorders. The aim of this
      study is to evaluate attention capacity in former premature children aged 6-7 years old with
      regards to different postures or mobility, for the attention functions of orienting, alerting
      and executive control. The Attention Network Test using reaction time and accuracy to visual
      stimuli will be used to evaluate attention functions in each posture and mobility.
    

Detailed description: 
      Attention functions have a major impact on children's social, school and emotional
      adjustment. They are one of the most common issues for prematurely born children with
      implications in academic and social-behavioral functioning. Prematurely born infants are
      often seen as having excessive mobility or being restless when it could be an adaptative
      answer to attention disorders leading to learning difficulties. Respecting spontaneous
      mobility could improve attention performance in vulnerable children. The aim of the study is
      to evaluate global attention performance of former premature children at the preschool age of
      6 to 7 years. This evaluation will be done in three usual postures or mobility, and for the 3
      attentional functions of orienting, alerting or executive control. They will be compared
      within the prematurely born children group and to term born controls of the same age. The
      Attention Network Test adapted to children by Rueda et al (Neuropsychologia 2004) using
      reaction time and accuracy to visual stimuli will be used to evaluate attention functions.
      Presentation of stimuli through virtual video glasses and collection of answers will be done
      thanks to a specific software.
    

Intervention name(s): speed and accuracy answer to visual stimuli
Intervention type(s): Other
Intervention description(s): A yellow fish swimming over a blue-green background will appear on the screen of virtual glasses. The child will have to give as fast as possible the direction of the fish pushing the left or right button of a computer mouse
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: Attention capacity will be compared in three situations of posture/mobility in a group of prematurely born children, and compared to the same situations in a group of term born children
Masking: None (Open Label)
Primary purpose: Other
Keywords: Prematurely born children; Attention function; Posture; Mobility
Potentiating Rural Investment in Children's Eyecare (PRICE)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of the project is to create, study and advocate for a model that can be adopted by
      the Chinese government to provide spectacles for all children sustainable.
    

Detailed description: 
      Uncorrected refractive error (URE) is the leading cause of visual impairment among Chinese
      children, accounting for 90% or more of poor vision, and Chinese children have among the
      highest rates of myopia in the world. Despite the fact that the problem of URE is safely and
      inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses
      sufficient to provide good vision in rural China.

      PRICE (Potentiating Rural Investment in Children's Eyecare) will use a randomized, controlled
      design across 4 groups of all 138 schools in Yunnan (one of China's poorest provinces) and
      Guangdong (one of the richest) to optimize the model of "free glasses for all with an
      optional upgrade." The selection of free spectacles and cost of the "upgrade" options will be
      varied between groups in order to find the optimal balance between high rates of purchase of
      upgrade glasses on the one hand and good acceptance and wear of free spectacles among those
      selecting them on the other.
    

Intervention name(s): Free Glasses; Upgrade Glasses 1; Upgrade Glasses 2
Intervention type(s): Other; Other; Other
Intervention description(s): Provide free glasses; Provide optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD); Provide optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Myopia Prevalence; Proportion of Purchase of free Spectacles; Proportion of Purchase of update Spectacles; Proportion of Wearing Spectacles
2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the anticaries efficacy for three dentifrices
      (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride
      in a silica base) in a two-year caries clinical study
    


Intervention name(s): 0.32% Sodium Fluoride Dentifrice Toothpaste; 1.5% Arginine Dentifrice; 8.0% Arginine Dentifrice
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Toothpaste; Toothpaste; Toothpaste
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: fluoride; prevention; caries; ICDAS; DMFS; arginine
Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of the management of chronic
      primary insomnia patients by a computer program guidance of behavioral and cognitive
      therapies for insomnia (BCT-I).
    

Detailed description: 
      Chronic insomnia is a common sleep disorder (prevalence = 10%) and a risk identified on the
      physical and mental health. Currently, the treatment involves the prescription of drug
      treatments by general practitioners, which may be unsuitable for the medium term. It is
      better to turn to Behavioral and Cognitive Therapies for Insomnia (BCT-I) in the case of
      primary chronic insomnia. The objective of this study is to evaluate the effectiveness of a
      computer program guidance BCT-I in patients with chronic primary insomnia. This biomedical
      research psychotherapeutic assessment will be randomized, controlled versus psychoeducation
      and conducted in 46 patients with chronic primary insomnia (defined according to Diagnostic
      and Statistical Manual-5) for which a supported by BCT-I is indicated.

      The 46 patients will be randomized into two groups. The subjects in Group 1 will be supported
      by BCT-I online. And the subjects in group 2 will receive psychoeducation. All patients will
      be followed by the research team for three months, during which 3 visits (V0 = pre-selection;
      V1 = visit of randomization and start of the program; V2 = 3 months follow-up visit and end
      of the study) will be performed in the University Hospital Sleep Disorder Unit of
      Montpellier. Patients in Group 1 will conduct BCT-I online at home therapy. Patients in group
      2 will receive a structured 45-minute session information insomnia (psychoeducation = work
      performed daily by clinicians in charge of insomnia problems) to the visit 1. All patients in
      the study will be equipped 2 sensors for the registration of sleep data.

      The primary endpoint will be based on the severity of insomnia measured by the ISI after the
      last online psychotherapy session (3 months) between the 2 groups of patients (BCT-I online
      and without treatment - psychoeducation ). The analyse efficacity to be conducted by
      intention to treat.
    

Intervention name(s): cognitive behavioral therapy online; psychoeducation
Intervention type(s): Other; Other
Intervention description(s): The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password; the psychoeducation is delivered by a doctor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Insomnia; behavioral and cognitive therapies
Vortioxetine vs Sertraline in Mexicans
Condition: Depression; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Depression in patients with type 2 diabetes is often undiagnosed and remains untreated,
      leading to poor therapy adherence and ill health-related outcomes. The aim of study was
      evaluated the effect of vortioxetine versus sertraline in the treatment of depression,
      diabetes-related distress and control metabolic in subjects with type 2 diabetes and
      depression. was included patients who were glycosylated hemoglobin ≥ 7.5%, 18 to 60 years of
      age and written consent . Pharmacological treatment for depression was assigned randomly:
      vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks. Biochemical parameters,
      anthropometric measures and depression symptoms were evaluated before and at the and at the 8
      weeks after antidepressant treatment.
    

Detailed description: 
      The assessment consisted of an extended face-to-face interview. The patients answered a
      structured questionnaire used to collect: sociodemographic characteristics (gender, age,
      education, occupation and marital status) and clinical data (pharmacotherapy, habits,
      consumed of drugs, diabetes complications and comorbidities). Depression was screened using
      Hamilton Depression Rating Scale score ≥ 14 (HAM-D), Center for epidemiologic studies
      depression scale revised in Spanish (CES-DR35), and Problem Areas in Diabetes Questionnaire
      (PAID-V); anthropometrics measurements were evaluated (weight, waist circumference and body
      mass index). Besides, blood samples were drawn for the following biochemical parameters:
      fasting plasma glucose, glycated hemoglobin (HbA1c), cholesterol and triglycerides. Patients
      who gave informed consent and convened inclusion criteria were attended by a psychiatrist.
      The pharmacological management were randomly assigned: vortioxetine (10 mg/day) or sertraline
      (75 mg/day) for 8 weeks, in addition, the patients maintained their established anti-diabetic
      treatment (oral hypoglycemic or insulin). The study ended at the 8th week, subjects were
      attended by psychiatrist and blood samples were drawn for evaluated biochemical parameters
      and the structured questionnaire previously described was applicated.The clinical measures
      and biochemical parameters were done baseline and after 8-week pharmacological treatment.
      Finally the effect of both antidepressants were compared.
    

Intervention name(s): Vortioxetine; Sertraline
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg per day; 75 mg per day
Other intervention name(s): Brintellix; zoloft
Intervention MeSH terms: Vortioxetine; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; Type 2 diabetes Mellitus; vortioxetine; sertraline