bioihbjkbjnl/mcl2 huggingface dataset:
Triple Antigen vs Monoantigen Immunotherapy for Warts
Condition: Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Warts can be resistant to treatment or return despite the use of many therapeutic modalities.
      Combining immunotherapy might contribute to better response rates, particularly in
      recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to
      assess the effectiveness and safety of a triple intralesional immunotherapy combination
      composed of PPD, Candida antigen and MMR versus either agent alone in the management of
      multiple recalcitrant warts.
    

Detailed description: 
      This study included 160 patients with multiple (>3 warts) recalcitrant (at least 6 months
      duration and who did not respond to at least 2 treatment modalities) warts of different
      sites, size and duration, with or without distant warts after approval of the Institutional
      Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one
      of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3
      antigens. Injections into the biggest wart were repeated every two weeks until clearance or
      for a total of five sessions.
    

Intervention name(s): Intralesional antigen immunotherapy
Intervention type(s): Biological
Intervention description(s): Randomized double-blinded comparative effectiveness and safety clinical trial
Other intervention name(s): PPD, Candida antigen, and MMR
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: triple intralesional immunotherapy; Warts; tuberculin purified protein derivative; Candida antigen; Measles-Mumps-Rubella vaccine; combination immunotherapy
Audition After a Lesion and in Migraine. (AuditionPostLesion)
Condition: Migraine Disorders, Brain
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The project studies auditory processing after brain damage (in temporal and/or frontal areas)
      and in migraine. The auditory processes investigated are attention, short-term memory,
      sound-induced emotions. To characterize auditory deficits after brain damage or in migraine,
      neuropsychological assessments are combined with neurophysiological markers
      (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging:
      MRI).
    


Intervention name(s): Neuropsychological tests; Neurophysiological tests
Intervention type(s): Other; Other
Intervention description(s): Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.; Neurophysiological tests consist in the recording of EEG and/or MEG signals while realizing the neuropsychological tests, as well as MRI scanning to characterize the patients' brain lesions and reconstruct the brain sources of surface EEG/MEG signals.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Audition; Stroke; Migraine; Attention; Short-term memory,; Emotions; EEG; MEG
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl
      sustained release) 50/1000mg(25/500mg x 2tablets)
    


Intervention name(s): FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Regional Blocks of Gynecological Surgeries
Condition: Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years
      and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse
      Patients will be divided into three equal groups; group A control group for conventional
      epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre
      spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre
      spinal needle(n=91). Randomization will be done using computer generated number and concealed
      using sequentially numbered sealed opaque envelope.
    


Intervention name(s): Standard Lumbar Epidural Technique; 25G Dural Puncture Epidural Technique; 27G Dural Puncture Epidural Technique
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.; 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.; 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease
Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis
Condition: Sarcoidosis, Pulmonary; Sarcoidosis Lung; Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to determine whether further research is warranted to assess whether
      tofacitinib is an effective steroid sparing treatment for pulmonary sarcoidosis. The primary
      endpoint for this study is a 50% or greater reduction in corticosteroid requirement.
    

Detailed description: 
      Primary Objectives:

      Objective 1: Test the hypothesis that the addition of tofacitinib will allow patients with
      sarcoidosis to have 50% or greater reduction in their corticosteroid requirement without a
      significant decrease in pulmonary function testing, and with a similar quality of life as
      measured by a validated questionnaire (1).

      Objective 2: Test the hypothesis that the addition of tofacitinib will result in
      significantly decreased expression of signal transducer and activator of transcription
      (STAT)-1 dependent gene expression.

      Outline:

      This is a 16-week open-label, interventional, proof of concept, hypothesis-generating study.
      All subjects will receive Tofacitinib 5mg twice daily for 16 weeks. After four weeks on
      Tofacitinib, the corticosteroid will be tapered per a pre-defined protocol; once a reduction
      of 50% has been achieved, any further taper will be per physician discretion. After 16 weeks,
      subjects who meet the primary end-point will be permitted an optional one year open-label
      extension.
    

Intervention name(s): Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial; Spirometry; RNA Sequencing; Laboratory testing; Corticosteroid; Tofacitinib 5mg [Xeljanz] 1 year open-label extension
Intervention type(s): Drug; Diagnostic Test; Genetic; Diagnostic Test; Drug; Drug
Intervention description(s): Tofacitinib 5mg oral table twice daily for 16 weeks; Spirometry testing at baseline, week 4, week 8, week 12, and week 16; RNA sequencing test at baseline and week 16; Laboratory testing at baseline and weeks 2, 4, 8, 12 and 16; Taper corticosteroids starting at week 4; After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension.
Other intervention name(s): Xeljanz; tofacitinib; Pulmonary function test; Blood work; Corticosteroid taper; Prednisone taper; Steroid taper; tofacitinib; Xeljanz
Intervention MeSH terms: Prednisone; Tofacitinib
Intervention model: Single Group Assignment
Intervention model description: Open-label, interventional, proof of concept, hypothesis-generating study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sarcoidosis; Corticosteroid dependent sarcoidosis
Metformin Hydrochloride in Mitigating Side Effects of Radioactive Iodine Treatment in Patients With Differentiated Thyroid Cancer
Condition: Thyroid
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot clinical trial studies how will metformin hydrochloride works in mitigating the
      side effects of radioactive iodine treatment in patients with differentiated thyroid cancer.
      Metformin hydrochloride may reduce the metabolic activity of cancer cell and of surrounding
      supportive tissues.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate if treatment with metformin hydrochloride (metformin) inhibits radioactive
      iodine (RAI)-induced myelosuppression and induces faster recovery of white blood cell count
      to baseline values, the blood counts will be compared in the pre- and post-treatment samples.

      SECONDARY OBJECTIVES:

      I. Assess safety and tolerability of metformin treatment in subjects undergoing RAI treatment
      for differentiated thyroid cancer.

      II. To assess the effect of metformin treatment on symptoms of xerostomia, xerophthalmia and
      dysgeusia as assessed by the Xerostomia Questionnaire (XQ), the modified Vanderbilt Head and
      Neck Cancer Symposium Survey (version 2.0), University of Washington Quality of Life
      Questionnaire, and European Organization for Research and Treatment of Cancer Quality of Life
      Questionnaire (EORTCQLQ)-Head and Neck (H&N)35.
    

Intervention name(s): Metformin Hydrochloride; Radioactive Iodine; Placebo
Intervention type(s): Drug; Other; Other
Intervention description(s): Given Orally; Undergo radioactive iodine treatment; Given orally
Other intervention name(s): 1,1-Dimethylbiguanide Hydrochloride; 1115-70-4; 91485; Cidophage; Dimefor; Glucoformin; Metformin HCl
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of
      ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with
      acne vulgaris.
    


Intervention name(s): dapsone gel
Intervention type(s): Drug
Intervention description(s): Dapsone (ACZONE) 7.5% gel topically once daily.
Other intervention name(s): ACZONE
Intervention MeSH terms: Dapsone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Services and Outcomes for Children With Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Based on the need to characterize and improve early intervention services for minority and
      under-resourced children with ASD, this study translates a manualized and proven training
      model to examine its impact on the use of evidence-based practices (EBP) by early
      intervention providers, and to examine its relationship to child and family outcomes. By
      highlighting the impact of EBP-focused training on participating providers, children, and
      families, findings of the proposed study have the potential to effect significant change in
      the organization and delivery of early intervention services for minority and under-resourced
      children with ASD.
    


Intervention name(s): Provider Education Model (PEM)
Intervention type(s): Behavioral
Intervention description(s): Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Early Intervention; Minority
Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this project is to examine if early exposure to intensive, short-term
      locomotor treadmill training (LT) in young children with neuromotor impairment will help
      develop walking skills earlier, decrease the amount of outside assistance needed (such as a
      walker or crutches) as compared to children with neuromotor impairment who receive
      traditional physical therapy intervention.
    


Intervention name(s): treadmill training
Intervention type(s): Other
Intervention description(s): Home-based treadmill training will be administered to the children in the experimental group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; treadmill training
Study to Assess the Absorption, Metabolism and Excretion of 14C-JNJ-63623872 After a Single Dose in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize the absorption and metabolic pathways
      of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral
      dosing of 14C-JNJ-63623872 in healthy adult male participants.
    

Detailed description: 
      This is a Phase 1, open-label (all people know the identity of the intervention), single dose
      study in 6 healthy adult male participants to characterize the absorption, metabolism and
      excretion of 14C-JNJ-63623872. The total study duration will be approximately of 16 days per
      participant. The study consists of 3 parts: Screening (that is, 28 days before study
      commences on Day 1); open-Label Treatment Phase(that is, Day 1); and Follow-up (that is, up
      to Day 16). All the eligible participants will receive 14C-JNJ-63623872 at a dose level of
      600 milligram. Participants will enter the study site on Day -1 and stay at the study site at
      least until Day 8. Urine, feces, whole blood samples, plasma, nasal mucus and saliva samples
      will be collected up to Day 8. Unchanged JNJ-63623872 will be determined in plasma and, if
      feasible, in saliva. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-63623872
Intervention type(s): Drug
Intervention description(s): Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.
Other intervention name(s): 14C-JNJ-63623872
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-63623872; 14C-JNJ-63623872
Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
Condition: Phase 1 Study, Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared
      with those of DWP14012 tablet B in healthy subjects.
    


Intervention name(s): DWP14012 Tablet A; DWP14012 Tablet B
Intervention type(s): Drug; Drug
Intervention description(s): DWP14012 10mg; DWP14012 40mg
Intervention MeSH terms: Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3819469 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study. In Part A, the main purpose is to evaluate the safety and
      tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a)
      [Lp(a)] levels. How the body processes the study drug and the effect of the study drug on
      blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and
      tolerability of LY3819469 as well as how the body processes the study drug in Japanese
      participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B,
      respectively.
    


Intervention name(s): LY3819469; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress
      which aggravates airway and systemic inflammation. Previous studies suggested that dietary
      factors such as ample consumption of antioxidants might have beneficial effects in lung
      function in COPD patients.

      The investigators' primary aim is therefore to investigate prospectively whether a
      nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and
      vegetables, would significantly affect lung function decline in COPD patients compared to a
      free diet.

      Methods: This is a 3-year prospective study, incorporating a run-in period of six months and
      outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit
      120 patients with COPD. At baseline and at each visit all patients were evaluated for
      respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will
      be randomized either to a diet based on increased consumption of foods containing
      antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet,
      control group (CG).

      The investigators hypothesize that the results from the study will suggest that a diet rich
      in antioxidants may be associated with improvement in lung function in COPD patients. In this
      respect dietary interventions should be considered in the management of COPD.
    


Intervention name(s): Diet rich in antioxidants
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary intervention based on diet with increased consumption of foods containing antioxidants such as fresh fruits, fruit juices and vegetables. Patients are advised by a physician and a specialist nurse during regular scheduled outpatient clinic visits to increase fresh fruit /fruit juices/vegetable consumption of at least one portion per day compared to baseline and to maintain this regime throughout the study period.
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung function; Chronic obstructive pulmonary disease; Antioxidants
Abbott Sensor Based Glucose Monitoring System Paediatric Study
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used
      at home by children with diabetes.
    


Intervention name(s): FreeStyle Libre Flash Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Diabetes Mellitus; Sensing Technology
Improving Asthma Outcomes in an Urban Pediatric Population
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Little is known about how ED-based programs can help to reduce pediatric ED visits for
      asthma. The current study evaluated a novel intervention in which the ED itself became the
      site of highly individualized, comprehensive follow-up asthma care. It sought to determine if
      such an intervention could decrease subsequent unscheduled visits for asthma while improving
      asthma quality of life.
    

Detailed description: 
      Prospective, randomized clinical trial of a single visit to a specialized emergency
      department-based asthma follow-up clinic occurring 2-15 days after emergency department care
      for an acute exacerbation. All patients were followed for 6 months. Analysis was by
      intention-to-treat with adjustment for baseline differences. Our primary hypothesis was that
      this intervention would decrease subsequent unscheduled visits (both to EDs and other sources
      of urgent care) for asthma over a six-month follow-up period. We further hypothesized that
      the intervention would decrease hospitalizations for asthma, improve compliance with an
      individualized medical plan and with trigger control, increase scheduled primary care
      practitioner (PCP) visits for routine asthma care, and decrease asthma symptoms while
      improving asthma quality of life (QOL).
    

Intervention name(s): Emergency Department based asthma follow-up clinic
Intervention type(s): Behavioral
Intervention description(s): The clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains:
Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching.
Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings.
Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; emergency department; compliance; randomized clinical trial