bioihbjkbjnl/mcl2 huggingface dataset:
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to better understand how the study drug works when
      people use it to treat atopic dermatitis.
    

Detailed description: 
      To evaluate adherence to topical therapy using adherence data collected by the MEMS cap
      (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD)
      and the impact of a return visit.
    

Intervention name(s): tacrolimus ointment
Intervention type(s): Drug
Intervention description(s): tacrolimus ointment to be applied twice daily to affected areas during duration of study
Other intervention name(s): Protopic Ointment
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atopic dermatitis; eczema
MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS Study
Condition: Contraception
Study type: Observational

Summary: 
      The study is designed as non interventional to observe the continuation rate and the patient
      satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system)
      inserted for contraception over the period of 12 months under real life condition in
      India.The study will begin after the study approval by ethics committee.All Indian women aged
      between 18-49 years who are initiating LNG IUS therapy for contraception will be included in
      study after taking the informed consent.Patients will be observed for upto 12 months.The
      study involves general examination of patients, collection of data like medical history,
      previous contraceptive use,concomitant medication etc.The study is planned to enroll 600
      subjects from multiple study centers spread across India. The study data will be analyzed
      with appropriate statistical methods.
    


Intervention name(s): Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
Intervention type(s): Drug
Intervention description(s): Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study subjects will be enrolled from multiple sites like women's hospitals, tertiary
        care institutes, Family planning clinics and gynaecological consulting centres.
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label, extension trial designed to evaluate the long-term safety over 12
      months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia.
      Patients recruited into this trial were those who had successfully completed the double-blind
      study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they
      received during the double-blind study.
    

Detailed description: 
      The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was
      typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6,
      9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within
      one month after stopping study drug treatment.

      Primary:

      The primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets
      taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study
      TNX-CY-F202 (NCT01903265)

      Secondary:

      The secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken
      daily at bedtime to control symptoms of fibromyalgia
    

Intervention name(s): TNX-102 SL
Intervention type(s): Drug
Intervention description(s): TNX-102 SL 2.8 mg taken daily at bedtime.
Other intervention name(s): cyclobenzaprine HCl
Intervention MeSH terms: Cyclobenzaprine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TNX-102 SL; bedtime; sublingual; 12-month; long term safety; long term efficacy; Fibromyalgia
Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain
Condition: Progressive Supranuclear Palsy; Alzheimer Disease; Healthy Volunteers
MeSH terms: Alzheimer Disease; Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as
      [18F]UCB-K), a tau targeted PET radioligand.
    

Detailed description: 
      The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as
      [18F]UCB-K), a tau targeted PET radioligand.

        -  To characterize [18F]MNI-952, a PET radioligand for imaging tau.

        -  To visually and quantitatively assess brain uptake and pharmacokinetics of [18F]MNI-952,
           a PET imaging marker for tau pathology in individuals with Progressive Supranuclear
           Palsy (PSP) or Alzheimer's disease (AD) and compare with healthy volunteers (HV).

        -  To evaluate the safety of a single injection of [18F]MNI-952.

        -  To compare the distribution of tau (using [18F]MNI-952) and Aâ (using florbetapir) in AD
           subjects.
    

Intervention name(s): [18F]MNI-952; [18F]Florbetapir
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will undergo PET imaging using [18F]MNI-952, a PET radioligand for imaging tau.; Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-952.
Other intervention name(s): [18F]UCB-K
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PSP; AD; HV
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
Condition: Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by
      Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for
      all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface
      antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and
      anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.
    


Intervention name(s): Quinvaxem; Quinvaxem/Tritanrix
Intervention type(s): Biological; Biological
Intervention description(s): A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at Weeks 6, 10 and 14; A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at Weeks 6, 10 and 14
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity
Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      An open label, randomized controlled trial of single vs. multiple treatments of praziquantel
      in intestinal African schistosomiasis in Côte d'Ivoire

      This study aims to determine the efficacy of repeated (up to four times) praziquantel
      treatment against S. mansoni infection in school-age children from Côte d'Ivoire using the
      traditional Kato-Katz thick smear technique, but also with more accurate and non-invasive
      antigen- and DNA-detection methods.
    


Intervention name(s): 4x Praziquantel; 1x Praziquantel
Intervention type(s): Drug; Drug
Intervention description(s): Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.; One praziquantel treatment (40 mg/kg) at baseline
Other intervention name(s): Biltricide; Biltricide
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schistosomiasis; Schistosoma mansoni; Bilharzia
Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
Condition: Alzheimer Disease; Cognition Disorders
MeSH terms: Alzheimer Disease; Cognition Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled,
      36-month study comparing the length of time of progression from mild cognitive impairment
      (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs.
      placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a
      treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40
      countries for Alzheimer's disease to date, including all 15 member states of the European
      Union, New Zealand, Argentina, Brazil and Mexico.

      Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo.
      Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day)
      for the majority of the study. At every regular visit scheduled every three months, patients
      will be given basic efficacy and safety assessments. These assessments will include
      evaluation of adverse events, vital signs, activities of daily living, and clinical staging
      scales to determine if the subject may have converted to dementia.
    


Intervention name(s): Rivastigmine
Intervention type(s): Drug
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Mild cognitive impairment; Alzheimer's disease; Memory; Cholinergic agents; Cholinesterase inhibitors
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to determine the effect of teriflunomide on the frequency of
      relapses in patients with relapsing multiple sclerosis (MS).

      Secondary objectives were:

        -  to evaluate the effect of teriflunomide on the accumulation of disability as measured by
           Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic
           Resonance Imaging [MRI] and patient-reported fatigue;

        -  to evaluate the safety and tolerability of teriflunomide.
    

Detailed description: 
      The study period per participant was approximatively 128 weeks broken down as follows:

        -  Screening period up to 4 weeks,

        -  108-week double-blind treatment period (approximatively 2 years)*,

        -  16-week post-treatment elimination follow-up period.

      '*' Participants successfully completing the week 108 visit were offered the opportunity to
      enter the optional long-term extension study LTS6050 - NCT00803049.
    

Intervention name(s): Teriflunomide; Placebo (for teriflunomide)
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet
Oral administration; Film-coated tablet
Oral administration
Other intervention name(s): HMR1726
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing Remitting; Secondary Progressive; Progressive Relapsing
Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy
Condition: Other Infantile Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South
      Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral
      palsy in children.
    


Intervention name(s): Botulinum Toxin Type A(Botox®); Botulinum toxin type A(Botulax®)
Intervention type(s): Drug; Drug
Intervention description(s): Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units; Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Other Infantile Cerebral Palsy
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
Condition: Anemia in Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics
      (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage
      renal disease (ESRD) receiving hemodialysis
    


Intervention name(s): JTZ-951
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End-stage Renal Disease; Hemodialysis; Pharmacokinetics
Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering
      from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be
      at the origin of a reinforcement of anorectic behavior which might alter medical care. The
      objective of this study is to identify neural correlates of self-recognition in Anorexia
      Nervosa. Patients are hypothesized to activate the self-recognition network when seeing
      images of a fatter body shape than their own.
    

Detailed description: 
      Patients suffering from Anorexia Nervosa and control subjects (matched by age and study
      level) are recruited in medical care facilities in Lille's Metropolis. They are asked to
      identify their body shape when being presented with 3 different stimuli, i.e.real (RBS),
      estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or
      functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to
      identify modifications in the self body-recognition network.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched
        by age and study level
      
Keywords: Anorexia nervosa; functional MRI (fMRI); self body-shape recognition
Nutrition to Relieve IBS Constipation
Condition: Irritable Bowel Syndrome; Constipation
MeSH terms: Irritable Bowel Syndrome; Constipation
Study type: Interventional

Summary: 
      Rationale: Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people.
      To date, no adequate treatment is available. This is partially due to the heterogeneity of
      the patients and the complicated pathology in which not all mechanisms are understood. Based
      on results of in vitro screening within the IBSQUtrition project, we selected promising
      dietary supplements for validation of their potential beneficial effects on stool pattern in
      IBS-Constipation (IBS-C) patients.

      Objective: The primary objective is to determine the effects of a 4-week intervention with
      either a prebiotic supplement or a probiotic supplement on stool pattern (including stool
      frequency, consistency, and volume) in IBS-C patients. The secondary objective is to
      determine the effects if this intervention on GI complaints and quality of life in IBS-C
      patients.

      Study design: A double-blind, randomized, placebo-controlled trial will be conducted with
      three parallel intervention arms Study population: 180 adult (18-70 yrs) IBS patients with a
      constipation-predominant subtype Intervention: A 4 week run-in period will be followed by a
      4-week intervention period with three parallel arms: 1) prebiotic supplement, 2) probiotic
      supplement, and 3) Placebo supplement, during which the study participants consume the
      respective supplement twice per day.

      Main study parameters/endpoints: The primary study parameter is stool pattern: stool
      frequency, stool consistency; and stool volume. The secondary study parameters are
      gastrointestinal complaints, Quality of Life, and HADS.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Study participants have to invest about 14.5 hours of their time in this study
      mainly to complete several questionnaires (short daily questionnaire, longer questionnaires
      at three occasions), which is conveniently all possible from home. They have to comply to
      consume a supplement twice daily for four weeks. At two time points they have to collect
      their stool for five consecutive days. There are limited risks for the study participants.
    


Intervention name(s): Probiotic supplement; Prebiotic supplement; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Use of a probiotic sachet; Prebiotic sachets; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prebiotic; Probiotic
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg
      Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical
      Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg
      METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500
      mg tablet) in healthy adult subjects administered under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets; 5 mg/500 mg METAGLIP™ Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 5 mg/500 mg, single-dose fasting; 1 x 5 mg/500 mg, single-dose fasting
Intervention MeSH terms: Metformin; Glipizide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Pharmacokinetics of Two Different Formulation of Voriconazole
Condition: Fungus Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 4

Summary: 
      A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different
      Formulation of Voriconazole 200 mg Tablets in Healthy Adult Subjects.
    


Intervention name(s): Vaway FC Tablets 200mg (Voriconazole); VFEND FC Tablets 200mg (Voriconazole)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Voriconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder
Condition: Open Bite
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      This study evaluated the efficacy of rapid molar intruder (RMI) in treating anterior open
      bite in the mixed dentition. The study sample consisted of 40 patients who had a skeletal
      anterior open bite. The sample was allocated randomly into two groups: the RMI group and the
      control group. The skeletal, dentoalveolar and soft tissue changes occurring after treatment
      were assessed by using lateral cephalometric images.
    

Detailed description: 
      Many appliances have been used to treat skeletal anterior open bite (AOB) malocclusion, such
      as removable appliances, extra-oral appliances (vertical chin cup and vertical head gear),
      fixed appliances, Orthognathic surgery and functional appliances. Treatment with these
      appliances produces soft and hard dentofacial tissue changes. Many studies have been carried
      out in order to study these changes.

      In this study, the investigators treated AOB using RMI. Patients were divided into two groups
      to evaluate the efficacy of RMI.

      RMI group: Rapid molar intruder was applied. Control group: Untreated control group. In order
      to evaluate the changes occurring, lateral cephalometric images were taken in both groups at
      the beginning of the treatment (T1) and after 9 months of the first cephalograms (T2).
    

Intervention name(s): Rapid molar intruder
Intervention type(s): Device
Intervention description(s): The rapid molar intruder was applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior open bite; Rapid molar intruder; Mixed dentition