bioihbjkbjnl/mcl2 huggingface dataset:
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the efficacy and safety for steroid non-resistant
      MG patients in a double blind, placebo controlled study.
    


Intervention name(s): tacrolimus; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tacrolimus; Myasthenia Gravis
A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2
      receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric
      oxide (FeNO) is a non-invasive airway inflammation marker.

      In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose
      study, the duration of action of fluticasone furoate (FF) will be determined by monitoring
      the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in
      asthmatic subjects.

      Subjects who meet the eligibility criteria will participate in the following two treatment
      periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will
      be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be
      followed by a 21-day monitoring/washout period before crossing over to the next treatment
      period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored
      up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).
    


Intervention name(s): Fluticasone furoate (FF) (100 mcg); Vilanterol (VI) (25 mcg); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): First blister strip contains FF blended with lactose, 100 mcg per blister; Second blister strip contains vilanterol blended with lactose and magnesium stearate, 25 mcg per blister; Matching placebo will have two blister strips, identical in appearance to the inhaler containing active study medication; one containing lactose and the second strip containing lactose and magnesium stearate
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone furoate/vilanterol; Asthma; fraction of exhaled nitric oxide; cross-over
Interactive Computer Treatment for Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will develop an interactive computer-based version of cognitive behavioral therapy
      (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.
    

Detailed description: 
      Panic disorder (PD) is a highly prevalent and debilitating condition. Unfortunately, many
      people with PD go untreated because of the high cost and low availability of treatment.
      Research shows that CBT is an effective treatment for PD. When administered as a self-help,
      computer based treatment, CBT may provide a less expensive, more engaging treatment for PD.

      Participants in this study will be randomly assigned to receive computer based treatment,
      book based treatment, or no treatment for 10 weeks. After these 10 weeks, symptoms of anxiety
      and depression will be measured with patient interviews, scales, and questionnaires.
    

Intervention name(s): Computer Based Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and
      non-interference of concomitant routine vaccines by MenACWY in an infant age group.
    


Intervention name(s): MenACWY-CRM; DTaP-IPV/Hib; HBV; PCV; MMR
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.; IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.; IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.; IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.; Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
Other intervention name(s): Combined diphtheria, tetanus toxoid, acellular pertussis and inactivated polio vaccine containing Haemophilus influenzae type B vaccine; Pentacel; Hepatitis B virus vaccine; Engerix-B; Heptavalent Streptococcus pneumonia vaccine; Prevnar (PCV-7); Prevnar 13 (PCV-13); Measles, mumps, and rubella vaccine; M-M-R II
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MenACWY conjugate vaccine in infants; Meningococcal vaccine in infants; MenACWY
Skin Sensitization Test (Modified Draize-95 Test)
Condition: Skin Sensitisation
Study type: Interventional

Summary: 
      Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for
      a Blue Non Sterile Powder Free Nitrile Examination Gloves. To evaluate whether residual
      chemical additives at a level that may induce type IV allergy in the unsensitized general
      user population are present in a finished rubber containing medical device.
    

Detailed description: 
      1. To evaluate whether residual chemical additives at a level that may induce Type IV
           allergy in the unsensitized general user population are present in a finished rubber
           containing medical device.

        2. To meet requirements for claim: This product demonstrated reduced potential for
           sensitizing users to chemical additives as described in Guidance for Industry and FDA
           Staff - Medical Glove Guidance Manual9. Supporting Test Data: A negative skin
           sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human
           subjects.
    

Intervention name(s): NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE
Intervention type(s): Device
Intervention description(s): Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Intervention model: Single Group Assignment
Intervention model description: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina
Condition: Vasospastic Angina
MeSH terms: Angina Pectoris; Angina Pectoris, Variant
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted in accordance with the local regulation of New Drug Application.
      Overall duration of this trial will be 3 years after approval of MFDS.

      Each subject will participate around 26 weeks, which include the 24 weeks treatment period
      and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks
      treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn
      subjects with other reason also have 2 weeks follow up period.
    

Detailed description: 
      A Multicenter, One group, Open-label Study. Cilostazol will be treated for additional 24
      weeks to the subject who had completed 021-KOA-1301i study. PletaalÒ(Cilostazol) is taken
      100mg oral tablets bid during 2 3weeks after dosing of PletaalÒ(Cilostazol) 50mg oral tablets
      bid during 1 week. The dose can be adjusted by investigator's discretion during the study and
      the detailed method is described in the Protocol. Subject who has 2 or more chest pain at 4th
      week will be withdrawn from the study (But, subjects who show 50% or more of chest pain
      decrease compared to 1st week would not be withdrawn.). Subjects who participated in this
      trial will have 2 weeks follow-up after study completion.
    

Intervention name(s): Cilostazol
Intervention type(s): Drug
Intervention description(s): Oral, Bid, 24 weeks
Other intervention name(s): Pletaal
Intervention MeSH terms: Cilostazol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment for vasospastic angina
Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The aim of this study is to determine if videocapillaroscopy could be used as an objective
      and reliable method to assess psoriasis severity and to document improvement during treatment
      by measuring changes in vascular features.
    

Detailed description: 
      This is a single-center, prospective, observational study that will recruit subjects from
      Northwestern University to examine the degree of improvement of psoriatic plaques during
      systemic therapy treatment. Thirty patients with a confirmed diagnosis of "active" psoriasis
      treated with a single systemic agent will be recruited from the Northwestern Medical Faculty
      Foundation Dermatology clinic. The study population will include 15 patients receiving
      adalimumab and 15 patients receiving methotrexate.

      Eight visits will be completed for each subject: visit 0 (baseline) and visits 1-8 (week 2,
      4, 6, 8, 12, 16 and 24). At the baseline visit, after informed consent is obtained, a
      capillaroscopic examination will be performed to assess for evidence of characteristic
      vascular alterations. If such changes are present, the remainder of the baseline visit will
      be completed. This includes gathering personal information (age, race, gender etc.), clinical
      history (time of first diagnosis, presentation site, treatment used, biopsy results if
      previously performed, etc.) and past medical history (including current and previous
      medications). At each of the subsequent visits (visit 1-8), any changes to medical history
      and/or medications will be obtained and recorded. At each of the eight visits, a dermatologic
      physical examination, including PASI and PGA scores will be performed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single
        systemic agent will be recruited from the Northwestern Medical Faculty Foundation
        Dermatology clinic. The study population will include 15 patients receiving adalimumab and
        15 patients receiving methotrexate.
      
Keywords: videocapillaroscopy, psoriasis, systemic agent
Improving the Quality of Asthma Care Using the Internet
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It is important for people with asthma to become involved in their asthma care and
      management. This study will evaluate an interactive Web site that provides tailored feedback
      and information to asthma patients and encourages them to ask their doctor specific questions
      about their asthma care.
    

Detailed description: 
      Asthma is a common cause of illness and lost productivity, including missed days of work and
      school, in the United States. It is important for people with asthma to become involved in
      their treatment and care. Previous studies have shown that encouraging people to ask their
      doctor for various medical tests and treatments improves preventive care (e.g., cancer
      screenings), but more research is needed on the effect this can have on asthma management.
      This study will involve an interactive Web site that will ask patients questions about their
      asthma symptoms and medications and provide suggestions and feedback on the types of
      questions patients may want to ask their doctors. By asking questions about their asthma care
      and increasing communication with their doctor, patients may experience improved quality of
      asthma care and better asthma control. The purpose of this study is to evaluate the impact of
      the interactive Web site on asthma control and other measures of asthma management.

      This 12-month study will enroll people with asthma. Participants will be randomly assigned to
      either the Asthma Feedback group or the Preventive Feedback (control) group. Both groups will
      log in to the study Web site at least once a month for 12 months and before all doctor
      visits. After logging in to the Web site, participants in the Asthma Feedback group will
      answer a series of questions about their asthma care. They will then receive information and
      feedback on the types of questions they should ask their asthma care provider during their
      next office visit. Participants in the Preventive Feedback group will answer questions and
      receive information and feedback regarding preventive services (e.g., cancer screening,
      cholesterol screening) that they should discuss with their primary care provider. At baseline
      and Months 6 and 12, all participants will complete online questionnaires regarding their
      asthma and overall health. Study researchers will review participants' medical records and
      insurance claims data at the end of the study.
    

Intervention name(s): Asthma Feedback
Intervention type(s): Behavioral
Intervention description(s): All participants will log in to the study Web site at least once a month and before all doctor visits. They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Observational

Summary: 
      The purpose of this study is to develop indices predicting response to pre-operative
      chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is
      very important for the ultimate outcome of osteosarcoma patients. Conventional methods such
      as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like
      osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT
      findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict
      chemotherapy response in osteosarcoma.
    

Detailed description: 
      We will conduct a prospective trial to verify the validity of indices utilizing TGF-b1,
      NF-kB, PET/CT, and MRS for predicting response to neoadjuvant chemotherapy in osteosarcoma
      patients. We assume that changes in plasma TGF-b1 levels, PET/CT and magnetic resonance
      spectroscopy (MRS) findings during the period of neoadjuvant chemotherapy as well as the
      initial nuclear NF-kB expression status of tumor biopsy specimen either alone or in
      combination may predict a chemotherapeutic response determined by histopathologic necrosis
      fractions of tumors removed. To test this, we will obtain TGF-b1 levels, PET/CT and MRS
      findings at diagnosis and at follow-up (after first and second/third chemotherapy cycle).
      Tumor will then be removed. Chemotherapy regimen comprised of various combination of
      cisplatin, adriamycin, and high-dose methotrexate, ifosfamide, and etoposide. Indices derived
      from TGF-b1, PET/CT, MRS predicting greater than 90% necrosis fractions will be sought
      utilizing statistical methods.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        osteosarcoma patients hospitalized to National Cancer Center, Korea
      
Biospecimen description: 
      NF-kB expression status will be determined on initial biopsy and surgically removed tumor
      specimen.
    
Keywords: osteosarcoma; transforming growth factor-beta 1; nuclear factor-kappa B; positron emission tomography/computed tomography; magnetic resonance spectroscopy; predicting response to neoadjuvant chemotherapy
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive
      therapy in patients with refractory partial onset-seizures.
    


Intervention name(s): USL255; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Epilepsy; partial onset seizure; adjunctive therapy
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Rotavirus disease is the most common cause of gastroenteritis and dehydration in young
      children worldwide. The global public health burden has prompted the development of a human
      rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This
      pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety
      data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of
      the first dose.
    

Detailed description: 
      The study consists of two groups of children to be recruited in different centers in India.
      One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or
      placebo will be administered starting at 8-12 weeks of age, according to a two dose schedule
      (0, 1 months schedule). The study will consist of three visits. A 8-day (Day 0 - 7) follow-up
      period will be observed for general symptoms solicited in the study. A 31-day (Day 0 - 30)
      follow-up will be observed for other unsolicited symptoms. Serious adverse events (SAEs) will
      be followed-up throughout the study. A stool sample will be collected from the child at any
      point during the study if he/ she develops any GE.
    

Intervention name(s): Live attenuated human rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
The Effects of Creative Dance Therapy on Motor and Executive Functions in Children With Dyslexia
Condition: Dyslexia; Dance Therapy; Motor Skills; Executive Function
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      Although some benefits of dance have been described for motor and cognitive skills, the
      effects on individuals with dyslexia are unclear. The purpose of this study was to
      investigate the effects of creative dance training on the motor and executive skills of
      children with dyslexia.
    

Detailed description: 
      Although some benefits of dance have been described for motor and cognitive skills, the
      effects on individuals with dyslexia are unclear. The purpose of this study was to
      investigate the effects of creative dance training on the motor and executive skills of
      children with dyslexia.

      The randomized controlled trial was conducted between August 2019 and December 2020 in the
      Occupational Therapy Department of Hacettepe University. The sample consisted of 51 children
      with dyslexia aged 8-10 years. While 26 of the participants received routine literacy
      training, the other 25 also received creative dance training three times a week for 4 weeks.
      Motor functions were assessed using the "Bruininks-Oseretsky Motor Competence 2 Test- Short
      Form", and executive functions were assessedusing the "Executive Function and Occupational
      Routines Scale".
    

Intervention name(s): Creative Dance Therapy
Intervention type(s): Other
Intervention description(s): After completion of the initial assessments, the intervention group received 3 sessions per week of creative dance training for 4 weeks (12 sessions), with each session lasting approximately 40 minutes. The creative dance training took place in a 40-square-metre mirrored hall with a tatami mat on the floor. The training was conducted individually for each child in the IG. Different children's songs were selected for each session in harmony with the rhythm of the dance movements. In each session, 10 minutes of warm-up movements and 20 minutes of creative dance training were conducted, accompanied by songs. Meanwhile, materials such as spiky and heavy balls, ribbons, rhythm sticks and holihop were included in the application.
The creative dance training was planned by diversifying the 8 movement models (breath, tactile, core-distal, head-tail, upper-lower, body side, cross lateral and vestibular) of "Brain Dance", which is a part of creative dance (Gilbert, 2002,2015).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment