bioihbjkbjnl/mcl2 huggingface dataset:
LEO 29102 Cream in the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with
      vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment
      regimen in mild to moderate atopic dermatitis patients.
    


Intervention name(s): LEO 29102; Elidel®
Intervention type(s): Drug; Drug
Intervention description(s): comparison of different dosages of drug; comparison
Intervention MeSH terms: Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Heweizhixie capsuleTherapy on Patients With Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in
      patients with diarrhea.
    

Detailed description: 
      The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in
      patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea
      Primary Outcome Measure:Percent of subjects with treatment Success

      Secondary Outcome Measures:

      Number of unformed stools passed per 24 h period Time (hours) from first intake to the last
      unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of
      subjects with AE.
    

Intervention name(s): Heweizhixie capsule
Intervention type(s): Drug
Intervention description(s): 3 #, Tid, Oral for 3 days
Other intervention name(s): Changdaoqing capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether erenumab is safe and well tolerated
      in healthy adults and migraine patients. As part of the secondary objectives, this study will
      be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple
      subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize
      the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple
      SC doses in healthy adults and migraine patients.
    


Intervention name(s): Erenumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Other intervention name(s): AMG-334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine
Study of Colorectal Cancer Screening Options
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The investigators propose to evaluate Guardant Health's commercially available colorectal
      cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC
      screening.
    

Detailed description: 
      The investigators propose to evaluate Guardant Health's commercially available colorectal
      cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC
      screening.

      Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who
      are non-adherent after receiving stool test outreach, who have an upcoming clinical
      appointment, and who are offered a commercially available colorectal cancer blood test versus
      usual care (i.e. reminder to complete stool testing during their clinical appointment).

      Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the
      test (based on available test performance characteristics) and willingness to obtain/offer
      the test on an on-going basis, based on qualitative interviews; assess preliminary rates of
      follow-up colonoscopy completion (after an initial abnormal test result) among participants
      allocated to the blood test vs. usual care condition.
    

Intervention name(s): GuardantSHIELD Blood Test
Intervention type(s): Diagnostic Test
Intervention description(s): The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colon Cancer Screening
Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Condition: Osteo Arthritis Knee; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will investigate if mindfulness training via a smartphone mobile app is effective
      in improving OA-related knee pain.
    

Detailed description: 
      The investigator's primary aim in this study is to determine if regular use of a mindfulness
      application improves pain outcomes in adults with knee osteoarthritis. The investigator's
      secondary aim is to determine if self-reported Healthcare-Related Quality of Life (HRQoL)
      scores predict response to mindfulness treatment in OA. The investigators hypothesize that
      the use of an mHealth intervention for mindfulness training may be an effective adjunct
      treatment of chronic knee osteoarthritis pain; specifically, that regular use of a
      mindfulness application will result in a statistically significant reduction in pain outcomes
      and improvement in physical function as determined by the KOOS scoring system. The
      investigators also hypothesize that those with lower baseline self-reported HRQoL scores are
      more likely to see a greater improvement in their pain and function with use of a mindfulness
      application than those with higher baseline scores.
    

Intervention name(s): Intervention -- "Headspace" mindfulness application; Control -- "My Water Balance" application
Intervention type(s): Device; Device
Intervention description(s): Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials", "Pain Management", and "Physical Health" Session Packs.; My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of Continuous Heart Rate Monitoring in Healthy Participants
Condition: Healthy
Study type: Interventional

Summary: 
      The main purpose of this study in healthy participants is to find out whether a heart rate
      monitor will accurately pick up changes in heart rate caused by 2 different medications
      (pseudoephedrine and metoprolol), on the background of daily activities. Participants will
      wear a patch heart rate and activity monitor on the chest for the entire study. The study
      will last about 36 days and may include up to seven visits to the study center.
    


Intervention name(s): Propranolol; Pseudoephedrine; Wearable Biosensor Patch Device
Intervention type(s): Drug; Drug; Device
Intervention description(s): Administered orally.; Administered orally.; Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.
Intervention MeSH terms: Propranolol; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study was set up to assess the effects of different doses of aspirin when compared with
      placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out
      (rest period) in between, in people with type-2 diabetes and high cardiovascular risk.
      Specifically, its effects on different factors which are thought to contribute to diabetes
      such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess
      glucose in the blood), oxidative stress (effects from accumulation of by-products of
      metabolism), endothelial function (function of lining of blood vessels) and inflammation were
      studied.
    


Intervention name(s): Aspirin; Aspirin; Aspirin; placebo tablet
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Aspirin 75mgs/day orally for 2 weeks.; 300mgs/day orally for 2 weeks; aspirin 900mgs QID orally for 2 weeks; placebo tablet with lactose and excipients.
Other intervention name(s): acetyl salicylic acid; acetyl salicylic acid; acetyl salicylic acid
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: diabetes; aspirin; oxidative stress; insulin resistance; endothelial function; inflammation; photoplethysmography; dysglycaemia
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate
      Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron
      Deficiency Anemia.
    


Intervention name(s): Ferrous (II) Glycine Sulphate Complex; Polyferose; Placebo to Ferrous (II) Glycine Sulphate Complex; Placebo to Polyferose
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.; Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.; Administered orally with water.; Administered orally with water.
Other intervention name(s): Ferro Sanol Duodenal; Nifirex
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ferrous (II) Glycine Sulphate Complex; Polyferose; Ferro Sanol duodenal; Niferex; Iron Deficiency Anemia
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
Condition: Alport Syndrome
MeSH terms: Nephritis, Hereditary; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and
      efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2
      portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of
      the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180
      patients.
    

Detailed description: 
      This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and
      efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2
      portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of
      the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180
      patients.

      Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients
      in the Phase 3 cohort will be randomized 1:1 to either bardoxolone methyl or placebo and
      randomization will be stratified by baseline albumin to creatinine ratio (ACR). Patients
      randomized to placebo will remain on placebo throughout the study, undergoing sham titration.

      All patients in the study will follow the same visit and assessment schedule. Following
      randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks
      1, 2, 4, 6, 8, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days
      3, 10, 21, 31, 38, and 45. Patients will not receive study drug during a 4-week withdrawal
      period between Weeks 48 and 52. They will re-start treatment at Week 52 at the same dose they
      received at Week 48 and will continue study drug treatment through Week 100. Patients will
      also be scheduled to be assessed at an in person follow up visit at Week 104, four weeks
      after the end of treatment.

      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Placebo Oral Capsule; Bardoxolone Methyl
Intervention type(s): Drug; Drug
Intervention description(s): Capsule containing an inert placebo; Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
Other intervention name(s): RTA 402
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alport Syndrome; Bardoxolone methyl; CDDO-ME; RTA 402
tES With Random Noise Stimulation Applied to Children With Brain Injury
Condition: Brain Injury; Motor Skills Disorders
MeSH terms: Brain Injuries; Wounds and Injuries; Motor Skills Disorders
Study type: Interventional

Summary: 
      50 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50%
      females will participate in an interventional study in two groups: placebo and experimental
      group.

      Placebo group will only receive traditional treatment with physiotherapy and the Experimental
      or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.
    

Detailed description: 
      In this Interventional Study with Double Blind Assignment to Placebo and Experimental Group,
      Gross Motor Function Measure (GMFM) and Neurophysiological are the parameters measured with
      EEG amplifier before and after 30 sessions.

      Work hypothesis is that the tRNS Group will present better motor functionality after 30
      sessions of 30 minutes of duration of electrical brain stimulation administered during
      physiotherapy exercises 2 days per week than the Group that only receives treatment with
      physiotherapy during 30 minutes 2 days per week without tRNS.
    

Intervention name(s): Transcranial Random Noise Stimulation; Physiotherapy
Intervention type(s): Device; Other
Intervention description(s): A special Helmet supply weak electrical currents in the head; Standard of care physiotherapy aimed to the motor impairment the subject presents
Other intervention name(s): tRNS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: QEEG; ERP; tRNS; Brain injury; Motor Impairment; Transcranial Brain non-invasive stimulation; electroencephalogram
Latino Youth Agricultural Study
Condition: Pesticide Safety
Study type: Interventional

Summary: 
      This project implements and evaluates a promotora-based intervention targeted at adolescent
      farm workers. The goal of the project is to determine the effectiveness of each intervention
      in promoting increased knowledge and practice of pesticide safety behaviors.
    

Detailed description: 
      This project implements and evaluates a promotora-based intervention targeted at adolescent
      farm workers. The intervention will be delivered to two different treatment groups: 1)
      adolescent only, adolescents receive the adapted adolescent version of La Familia Sana
      program and 2) family enhanced, adolescent and mother both receive the La Familia Sana
      program. In addition, there will be a control group where adolescent farmworkers will not be
      exposed to any pesticide safety program. Our project will:

        1. Determine if a promotora-based intervention targeting pesticide safety in the workplace
           is effective in increasing knowledge about safety behaviors among Latino adolescents
           engaged in farm work.

        2. Delineate variation by group among adolescents' knowledge about safety behaviors.

        3. Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes
           after intervention between all groups.
    

Intervention name(s): Safety Education Program
Intervention type(s): Behavioral
Intervention description(s): this is a pesticide safety education program
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Latino Youth
Neuropsychological Prognosis Factors of Smoking Cessation
Condition: Smoking Cessation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The low overall effectiveness of available smoking cessation treatment so far, indicate the
      need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a
      highly heterogeneous population. Identification of individual characteristics that predict
      success in smoking cessation is highly desirable to allow designing more specific strategies
      in order to enhance success in quitting tobacco.The main objective of this study is to assess
      whether the presence of certain neuropsychological deficits found before the initiation of
      smoking cessation is associated with a greater relapse rate.The secondary objectives concern
      how neuropsychological performance are involved in motivation and craving in the whole sample
      of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological
      factors associated with agood or poor prognosis for success and provived more specific and
      therefore more effective care.
    

Detailed description: 
      This is a prospective multicenter study. Patients will be recruited to anti tobacco
      consultations in the Montpellier and Clermont-Ferrand University Hospitals. The initial
      assessment includes a clinical assessment of smoking history, Axis I disorders history,
      motivation to quit and craving, a neuropsychological assessment : NART, RVIP task, trail
      Making Test, Stroop, Iowa gambling task, Hayling test, N back, verbal fluency. Then patients
      will be reviewed 3 times in 6 months. These visits include: CO level and cigarette
      consumption since the last visit, cessation strategy (medication, observance … ), tobacco
      craving questionnary, withdrawal symptoms, abstinence.

      The primary endpoint will be smoking abstinence objectified by the rate of carbon monoxide
      measured at each visit. Subjects who emerge from the study prematurely, especially patients
      lost to follow will be considered as failures in the statistical analysis.
    

Intervention name(s): neuropsychological assessment
Intervention type(s): Behavioral
Intervention description(s): The main criterion of evaluation of the smoking abstinence will be made by the measure of the rate of carbon monoxide (CO) in the expired air between the study start and during the study until 6 months after inclusion.
The secondary criteria of evaluation are criteria of neuropsychological order, namely the performances in the tests listed: result of NART test,Continuous Performance Test (CPT), Trail Making test, Stroop test, Iowa gambling task. (IGT), Hayling test, N back test, fluence verbal test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Smoking; Neuropsychology; Abstinence; Prognosis; Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders
Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using
      oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily
      regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent
      asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative
      for Asthma (GINA) guidelines 2011.
    


Intervention name(s): VR506
Intervention type(s): Drug
Intervention description(s): VR506 inhalation powder delivered via a new dry powder inhaler device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Children's Deep Neck Infections at the Montpellier Hospital
Condition: Deep Neck Infections
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      To descride the clinical presentation, diagnosis, management and complications of children
      with a deep neck infection. A retrospective chart review was conducted at the Montpellier
      hospital in France. All children aged less than 18 years who had been admitted with a
      diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal
      abscesses between January 2015 and December 2017 were included. The investigators collected
      the demographic, biological, radiological data and treatment received of the patients to the
      admision. The results of the bacteriological samples were collected. The investigators
      compared our results to those of the 10-year cohort. The investigators wish to compare the
      duration of hospitalization and the duration of the fever enter the group treated by alone
      antibiotic and the group treated by antibiotic and surgical drainage
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children hospitalized for acute pharyngeal infection
      
Keywords: cervical phlegmon; tonsillar abscesses; retropharyngeal or parapharyngeal abscesses; medical and chirurgical treatment; Bacteria in deep neck infections