bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
Condition: Migraine; Vascular Headaches
MeSH terms: Migraine Disorders; Vascular Headaches; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the effectiveness and safety of topiramate
      compared with placebo in the prevention of migraine attacks in children (12 to 17 years of
      age).
    

Detailed description: 
      This is an outpatient, randomized, double-blind, placebo-controlled study to evaluate the
      effectiveness of 2 dosages of topiramate (50 and 100 milligrams/day) compared with placebo in
      the prevention of migraine attacks in children 12 to 17 years of age. The study is composed
      of 3 phases: pretreatment, double-blind treatment for 4 months (16 weeks), and posttreatment.
      During the study, patients will maintain headache and medication records to document the
      following: occurrence and duration of headaches; severity of headache pain; whether or not
      the headache is pulsating or aggravated by physical activity; associated symptoms, such as
      nausea, vomiting, photophobia, phonophobia, abdominal pain; and medication taken to relieve
      headache pain or symptoms. Assessment of efficacy include the percent reduction in the
      frequency of monthly migraine attacks over the last 12 weeks of the double-blind treatment
      phase compared with prospective BL period. In addition, the percent reduction in (a) average
      monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over
      the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase
      will be assessed. Safety assessments include the incidence of adverse events, measurement of
      vital signs (pulse, blood pressure, oral temperature), results of pregnancy tests, physical
      and neurologic examinations, clinical laboratory tests (hematology, biochemistry, and
      urinalysis), and monitoring for visual or ocular disturbances, heat intolerance, renal or
      urinary disturbance, depression and rash. The study hypothesis is that the percent reduction
      in frequency of monthly (28-day) migraine attacks (using the 48-hour rule) from the
      prospective baseline period (pretreatment phase) to the last 12 weeks of the double-blind
      phase will be significantly better for the topiramate groups than for the placebo group.
      Topiramate tablets (25 milligrams) or placebo, beginning at 25mg once daily (Week 1),
      increasing to twice daily total of 50mg or 100mg (Week 4). Maximum dosage of topiramate (or
      placebo) continues for next 12 weeks. Dosage may be reduced once at investigator's
      discretion.
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Topiramate; Migraine; Migraine headache; Migraine prevention; Pediatric
Application of New Technologies and Tools to Nutrition Research
Condition: Obesity; Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The overall objective of the research is to develop new methods for studying the link between
      diet, health and disease.
    

Detailed description: 
      The enquiry consists of two part. A metabolomic biomarker discovery study followed by a
      randomised controlled trial of moderate dietary induced weight loss.

      A cohort of moderately overweight men and women will undergo a metabolomic study follow by
      randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week
      period. This intervention will improve the volunteer's body composition and reduce their risk
      of developing diabetes.

      Extensive tests will be conducted before and after the dietary intervention using emerging
      technologies with current state-of-the-art methods. These tests will monitor the numerous
      physiological adaptations that have occurred on a gene, cell, organ and organismic level.

      The study will, therefore, aim for a scientific breakthrough by developing a series of novel
      biological "markers" that can accurately determine an individual's health status.
    

Intervention name(s): Metabolomic and Energy Intake Restriction
Intervention type(s): Behavioral
Intervention description(s): Metabolomic inquiry followed by a 12 week energy intake restriction. This study is part of a very large European study called EPIC. Only the results by Lee et al. 2016 have been presented here. The results of the study published by Cheung 2017 are from a different study. therefore the entries for the results are correct. For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option. In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately. Unfortunately no different NCT number is available.
Other intervention name(s): Energy restriction diet; Metabolomic
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Obesity; Metabolites
A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM)
      receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in
      three time intervals
    


Intervention name(s): Empagliflozin
Intervention type(s): Drug
Intervention description(s): drug
Intervention MeSH terms: Empagliflozin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Ventricular Remodeling
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the effect of macitentan on right ventricular and hemodynamic properties
      in patients with symptomatic pulmonary arterial hypertension. Patients are treated with
      macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and
      Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and
      Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each
      patient can participate in no sub-study or in one sub-study. The sub-studies are: (1)
      metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the
      RHC); (3) Echo sub-study.
    


Intervention name(s): Macitentan
Intervention type(s): Drug
Intervention description(s): All patients take open-label macitentan 10mg o.d.
Other intervention name(s): ACT-064992
Intervention MeSH terms: Macitentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension
Intra-arterial Thrombolysis for Severe Recent Central Retinal Vein Occlusion
Condition: Central Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Interventional
Phase: Phase 1

Summary: 
      Central retinal vein occlusion (CRVO) is a common cause of vision loss, typically affecting
      individuals during the fifth through seventh decade of life. Eyes with severe CRVO have a
      poor visual prognosis because current treatments address only secondary complications of CRVO
      without treating its cause. Intra-ophthalmic artery injection of a small dose of t-PA (clot
      busting medicine), also called intra-ophthalmic artery thrombolysis, may reopen the central
      retinal vein-and address the cause of the disease- without exposing the subject to the risks
      of systemic thrombolysis. Our project aims to evaluate the safety and efficacy of
      intra-ophthalmic artery thrombolysis in subjects with CRVO.
    

Detailed description: 
      1. Study hypothesis: Injection of t-PA, a thrombolytic drug (clot busting medicine)into the
           ophthalmic artery (the blood vessel feeding the eye), in patients with recent severe
           central retinal vein occlusion, may reopen the central retinal vein and improve retinal
           blood flow, which may in turn improve visual acuity and prevent the long-term
           complications of the disease.

        2. Experimental intervention: An outpatient procedure during which the ophthalmic artery is
           selective catheterized (with a small plastic tube called a microcatheter introduced from
           the artery of the leg) and infused with t-PA during two hours.
    

Intervention name(s): Tissue Plasminogen Activator
Intervention type(s): Drug
Intervention description(s): Intra-ophthalmic artery injection of 2 mg t-PA over 10 minutes followed by 10 mg t-PA over 2 hours
Other intervention name(s): intra-arterial thrombolysis
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: central retinal vein occlusion; macular edema; vision loss; relative afferent papillary defect
A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged
      dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect
      how much Avibactam and Ceftazidime enters the blood. Part B investigates how much Avibactam
      (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given separately
      or together intravenously.
    

Detailed description: 
      A Phase I, 2-Part, Open-Label, Pharmacokinetic and Drug-Drug Interaction Study of CAZ104
      (Avibactam and Ceftazidime in Healthy Subjects)
    

Intervention name(s): CAZ104; Avibactam; Ceftazidime
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Ceftazidime; Avibactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; open label; ceftazidime; pharmacokinetics; urinary tract infection; intra-abdominal infection
Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Condition: Laser Assisted Liposuction
Study type: Interventional

Summary: 
      Multi-center, prospective, open-label, single arm study. The study aims to evaluate the
      safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife
      system. The study will include twenty (20) eligible subjects, that are willing to undergo
      abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of
      this study group should also be eligible for facial fat grafting. Follow up visits to
      evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.
    


Intervention name(s): LipoLife system
Intervention type(s): Device
Intervention description(s): Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Youth Health and Social Media
Condition: Sleep; Physical Activity; Family and Household; Computer, Attitude to; Adolescent Behavior
Study type: Interventional

Summary: 
      The purpose of this study is test the American Academy of Pediatrics (AAP) Family Media Use
      plan among teens and their parents through a randomized intervention and assess impact on
      outcomes including family media rules and health behavior outcomes.
    

Detailed description: 
      For this study there will be three time points of data collection and participant contact by
      Qualtrics:

      Time 1: Baseline

      Participants (teen and parent dyads) will be randomized into one of two tracks:

      Track A: Family Media Use Plan intervention Track B: Awareness intervention (delayed start
      intervention)

      The track A group will complete a survey regarding technology rules, tech use, and health
      behaviors, as well as the Family Media Use Plan embedded into the survey. Track B group will
      only complete the baseline survey.

      Time 2: Follow Up Survey: 4-6 weeks after baseline

      Track A group will complete a follow-up survey similar to the baseline with additional
      follow-up questions around their use of the family media use plan.

      The track B group will complete a similar survey and receive the Awareness Intervention,
      providing resources available regarding youth and media use .

      Time 3: Follow Up Survey: 3-4 months after baseline

      All participants will be asked to complete their corresponding tracks (track A or track B)
      survey again to understand use media use and health behaviors change over time.

      Track A or B designated questions are labeled within each uploaded survey.
    

Intervention name(s): Family Media Use Plan; Media Use Resources Awareness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A tool developed by the American Academy of Pediatrics that engages teens and parent to discuss internet safety ideas and develop rules around technology use together.; Resources offered to parents and teens that include tools and publicly available resources for safe technology use among teens
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Track A will be our intervention group receiving the Family Media Use intervention Track B will serve as control group at Time 2, and then receive an awareness intervention at that time to compare that intervention at Time 3 to Track A at Time 2
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: internet; social media; family rules
Enhanced Magnifying Endoscopy for Diagnosis of Early Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      When performing screening endoscopy, small focal gastric lesions are frequently encountered.
      Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging
      (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to
      enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of
      gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been
      proposed in the recognition of early gastric cancer (EGC).

      This study is based on the hypothesis as follow:

        1. The microvascular structure could be clearly observed with magnifying endoscopy enhanced
           by narrow-band imaging (ME-NBI).

        2. The microsurface architecture could be clearly observed with magnifying endoscopy
           enhanced by acetic acid-indigocarmine mixture (ME-AIM).

        3. Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE),
           has higher sensitivity and specificity for the differential diagnosing small focal
           gastric lesions.
    

Detailed description: 
      Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for
      inclusion. WLE without magnification was performed first in eligible patients. Based on an
      assessment of the shape (such as flat, depressed or elevated) and color (pale or reddened),
      small focal gastric lesions were identified and included for evaluation by experienced
      endoscopists. When such a lesion was detected during non-magnifying observation with WLE, the
      mode was then changed to ME-NBI for observation of microvascular pattern and ME-AIM for
      observation of microsurface pattern subsequently. All endoscopic images of the whole
      procedure were recorded in digital filing system for later evaluation. To avoid possible
      selection bias and to maintain the quality of the study, all images of each endoscopic
      modality (including WLE, ME-NBI, ME-AIM), which were arranged randomly on one slide and
      displayed independently of the images of other endoscopic modality, were evaluated by 4
      skilled endoscopists, who were not access to the clinical and pathological data. The general
      consensus was established for an assessment of each lesion. Two forceps biopsy specimens were
      taken from each lesion and pathological diagnosis were used as the criterion standard for
      cancer diagnosis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible
        for inclusion.
      
Biospecimen description: 
      Biopsy of gastric lesions
    
Keywords: Stomach Neoplasms; early gastric cancer; magnifying endoscopy; narrow band imaging; acetic acid; indigocarmine
Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of
      a single bolus dose of propofol in obese patients and to extract a time to peak effect
      (t-peak) from the estimated model parameters.
    

Detailed description: 
      Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows
      rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp)
      or at the site of effect (Ce).

      To characterize the time profile of propofol effect an additional parameter, the
      equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in
      the pharmacokinetic (PK) model.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 μg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS>75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 > 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anaesthetics iv; propofol; pharmacokinetics; pharmacodynamic
Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic
Condition: Dissociative Disorders; Schizophrenia
MeSH terms: Schizophrenia; Dissociative Disorders; Conversion Disorder
Study type: Interventional

Summary: 
      We propose a prospective multicenter study, whose originality lies in the inclusion of the
      naive child and adolescent population. Its purpose is to evaluate the incidence of adverse
      events related to the use of l antipsychotic drugs in children and adolescents with no
      history of taking such drugs.

      The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years,
      (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days
      without taking antipsychotic before or with a history of antipsychotic over a maximum period
      of three consecutive months and discontinued for at least 6 months.

      Therapeutic monitoring during the 12 month study period will include clinical assessments and
      laboratory testing. These assessments will be performed before treatment (at inclusion), and
      at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.
    

Detailed description: 
      a prospective multicenter study, whose originality lies in the inclusion of the naive child
      and adolescent population
    

Intervention name(s): Rispéridone, aripiprazole, olanzapine
Intervention type(s): Other
Intervention description(s): Study:
We propose a prospective, interventional multicenter study.
Method:
Both in and out patients may be included in the study Patients will be recruited over a period of 24 months. They will be followed up for 12 months. Each patient will receive one year of therapeutic monitoring after the introduction of the antipsychotic drug.
The therapeutic monitoring will include clinical, electrocardiographical, and laboratory assessments. These assessments are performed at baseline (before prescribing treatment) and at 1 month (M1), at 3 months (M3), 6 months (M6), 9 months (M9), and at 12 months (M12) after the first prescription of the antipsychotic drug.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting
      study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment
      visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and
      safety assessments are performed over a 3-hour period.
    


Intervention name(s): Pilocarpine Ophthalmic; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser; Vehicle ophthalmic solution administered with the Optejet microdose dispenser
Other intervention name(s): MicroLine
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment