bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma; Transformed Follicular Lymphoma; Primary Mediastinal Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Observational [Patient Registry]

Summary: 
      This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19
      for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector
      persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).
    

Detailed description: 
      Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T
      treatment ( NCT03258047) and will be followed for 5 years post treatment from the last
      treatment. They will be monitored for safety and efficacy with the primary treatment
      protocols for the protocol defined duration. This long-term following up study allow an
      interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection
      of such long term effects of CAR-T cell therapy will help to further define the risk-benefit
      profile of CAR-T Therapies.
    

Intervention name(s): CD19 CAR-T Expressing IL7 and CCL19
Intervention type(s): Biological
Intervention description(s): A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        39 patients meet including and excluding criteria criteria
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal
      is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1
      infected patients receiving antiretroviral treatment.
    


Intervention name(s): Placebo; Bryostatin 1 (10ug/m2); Bryostatin 1 (20ug/m2)
Intervention type(s): Other; Drug; Drug
Intervention description(s): Group 1: Placebo (sodium chloride 0.8 %) at single dose; Group 2: Bryostatin 1 (10ug/m2) at single dose; Group 3: Bryostatin 1 (20ug/m2) at single dose
Intervention MeSH terms: Bryostatin 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV reservoir; Bryostatin
An Exploration of the Impact of Gene Therapy on the Lives of People With Haemophilia and Their Families
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      This study programme aims to examine the real-world experience and impact of gene therapy in
      a diverse community of people and families affected by haemophilia who have been or will be
      exposed to gene therapy.
    

Detailed description: 
      This is a prospective observational multiple cohort qualitative research study to be
      conducted among diverse groups within the haemophilia community whose lives may have been
      impacted by gene therapy.

      The study is designed to allow English-speaking patients and their families to tell their own
      life stories through narrative accounts. The narratives represent a true sharing of
      experiences and offer insight into how these patients and families cope with haemophilia.
    

Intervention name(s): Qualitative interview
Intervention type(s): Other
Intervention description(s): Qualitative semi structured interview
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with haemophilia and a member of their family
      
Keywords: Haemophilia, Gene Therapy, Quality of Life
Betamethasone Dosing Interval - 12 or 24 Hours?
Condition: Preterm Delivery
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine if there may be a benefit to the newborn if
      betamethasone is given 12 hours apart instead of 24 hours apart.
    

Detailed description: 
      Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks
      of pregnancy. It is very advantageous in preventing or decreasing the many problems these
      small babies may face if born early. Betamethasone makes breathing easier for them, also
      decreases the chance of them bleeding in the head and makes their chances of survival better.
      This medicine is used routinely in pregnancy but the best timing between doses in not well
      established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the
      medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark,
      despite the doctors best efforts to try and delay delivery, and therefore miss the
      opportunity for the 2nd dose.
    

Intervention name(s): dosing of Betamethasone
Intervention type(s): Drug
Intervention MeSH terms: Betamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Betamethasone for preterm labor; Preterm delivery; Infant Respiratory Distress Syndrome
Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for
      fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for
      bedtime use. The present trial is designed to assess the safety and tolerability of 3
      different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine
      designed to result in increased dosage precision and decreased potential for morning
      grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg
      SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C
      with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
    


Intervention name(s): TNX-102 SL Tablets at 2.8 mg; TNX-102-B SL Tablets at 2.8 mg; TNX-102-C SL Tablets at 2.8 mg; Cyclobenzaprine tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.; 1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.; 1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.; 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Monitoring Of Scratch Via Accelerometry In Children
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis
      platforms would provide quantitative and qualitative knowledge regarding the action of
      scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. The overall
      aim of this research is to validate the use of sensor technology and digital measures to
      quantitatively and qualitatively evaluate scratch and sleep in AD patients, and specifically
      in this study in children ages 2 to 11 years. To evaluate this experimental paradigm, the
      investigators propose using wearable accelerometers, a sleep sensor, PSG, videography and
      associated traditional patient-reported outcome measures/clinical outcome assessments
      (PRO/COA) in patients/caregivers with AD in a well-controlled in-laboratory and at-home
      study.
    

Detailed description: 
      To assess the feasibility of quantifying scratch and sleep in children with Atopic Dermatitis
      (AD), children, age 2 to 11 years, with AD will be recruited. The subjects will complete
      specific questionnaires related to itch, sleeping habits and AD and continuously wear two
      wrist worn accelerometry devices. The EarlySense Sleep Monitor will also be placed underneath
      the mattress to measure additional sleep related activities.

      The study will be comprised of two overnight sleep laboratory site visits. The clinic visits
      will be followed by a continuous ~48 hour in-home environment assessment period (defined as
      the subject's daily routine environment). During the sleep lab site visit, the subject and
      accompanying parent(s)/guardian(s) will sleep overnight at the facility. The subject will be
      video-recorded during the in-sleep lab visit, wear the wrist accelerometry devices, use the
      sleep sensor and complete assessments (Depending on age, parent/guardian may complete some
      assessments). Upon the completion of sleep lab activities the subjects will then continue to
      wear the wrist accelerometry devices, utilize the sleep sensor and complete Patient Reported
      Outcome/Clinical Outcome Assessments (PRO/COA) assessments during the 48 hour in-home
      assessment. At the conclusion of the in-home portion of the assessment, the subject will
      return the device/s and assessments to the facility and undergo brief assessments/interview.
    

Intervention name(s): Wrist Actigraphy Devices; Sleep Monitor; Polysomnography; Videography
Intervention type(s): Device; Device; Device; Device
Intervention description(s): A watch-like wearable sensor; Remote Sensor; Sleep Monitor; Thermal Camera
Other intervention name(s): GENEActiv Watch; EarlySense
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with atopic dermatitis
      
Keywords: Wearable devices; Scratch; Sleep
An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy
Condition: Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      Up to 50% of postmenopausal women frequently suffer from atrophic vaginitis or vaginal
      atrophy with symptoms including vaginal dryness, irritation, burning, itching or discomfort.
      Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier,
      and less elastic due to lack of estrogen. In addition, vaginal atrophy is associated with an
      increased pH, which creates an environment more susceptible to infections.

      Menopausal hormone therapy is a common treatment for vaginal atrophy. However, menopausal
      hormone therapy has been shown to coincide with an increased incidence of breast cancer,
      heart attack and stroke. Some women experience adverse reactions such as uterine bleeding,
      perineal pain, and breast pain with menopausal hormone therapy. Many women are also reluctant
      to initiate estrogen treatment, due to a general negative view of menopausal hormone therapy
      in the society. There are also many contraindicated conditions like undiagnosed vaginal
      bleeding, thromboembolic disease, breast cancer, other estrogen-sensitive cancers, or liver
      disease. Women suffering from vaginal atrophy and presenting with these conditions have
      extremely limited options for effective therapy.

      Oxytocin is a peptide hormone, normally released into the circulation via the pituitary.
      Oxytocin has been shown in vitro to exert positive effects on the proliferation of human
      vaginal mucosal cells from postmenopausal women. Local application of oxytocin, in the form
      of a vaginal gel, Vagitocin, has been investigated in previous studies on postmenopausal
      women, as a new effective and safe option for the treatment of vaginal atrophy. Vagitocin
      appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal
      growth, reducing symptoms of vaginal atrophy and increasing the patients' wellbeing and
      quality of life. Overall, treatment with Vagitocin was safe and well tolerated by the
      subjects in the studies.

      In this study, the clinical efficacy of Vagitocin as a potential treatment for postmenopausal
      women suffering from moderate to severe symptoms of vaginal atrophy, vaginal
      irritation/itching and vaginal discomfort and/or pain associated with sexual activity will be
      explored. In addition, the dose relationship and lowest effective dose of Vagitocin will be
      investigated.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Vagitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atrophy; Pathological Conditions, Anatomical; Oxytocin; Oxytocics
Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This is an open-label, clinical pharmacology study to investigate drug-drug interaction in
      patients with RA.
    


Intervention name(s): MRA(Tocilizumab)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kinetics of IgE Memory B Cells, Plasmablasts and Plasma Cells After Whole Lung Allergen Challenge in Mild Asthmatics
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the time course of B cell activation after
      allergen challenge, and more specifically measure the M1 prime related biomarkers.
    

Detailed description: 
      M1 prime is a segment of IgE found only in the membrane form of IgE and not on soluble IgE
      found in serum. Membrane IgE (and M1prime) is expressed on IgE-switched B cells, IgE-memory B
      cels, and IgE-plasmablasts. Depletion of IgE-switched B cells and plasmablasts will reduce
      IgE-producing cells and serum IgE, and may be a target for treatment of allergic asthma. A
      humanized antibody targeting M1 prime is being developed by Genentech, Inc., as a potential
      therapeutic for asthma.

      Currently, the efficacy of MEMP1972A is being assessed in an allergen challenge study in mild
      asthmatics (MOP4843g). Extensive biomarker samples have been incorporated in that study to
      characterize the mechanism of action (MOA) as well as the kinetics of the MOA of MEMP1972A,
      which are poorly understood at this time. Furthermore, samples for the B cell enriched
      peripheral blood flow cytometry and bone marrow aspirates to evaluate the kinetics and MOA of
      MEMP1972a are collected only 24 hr after allergen challenge due to visit and sample volume
      limitations. It is known that maximal B cell responses are expected ~7 days after allergen
      stimulation. Therefore, the purpose of this research study will be to characterize the time
      course of B cell activation after allergen challenge, and more specifically measure the M1
      prime related biomarkers.
    

Intervention name(s): Bone Marrow Aspiration; Tonsil Biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): 3 per study; Optional upon completion of study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Allergen Challenge; B cell activation; M1 prime related biomarkers
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in
      patients with type 2 diabetes mellitus
    


Intervention name(s): Cilostazol; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol 200 mg/day; Aspirin 100 mg/day
Intervention MeSH terms: Aspirin; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of three consecutive
      lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
    

Detailed description: 
      The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero
      cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants.
      The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000
      healthy infants have revieved the vaccines and no unexpected severe adverse reactions were
      reported. According to the requirement of SFDA (China), the sponsor should also provide the
      evidence for the consistency of three consecutive lots of EV71 Vaccines before the
      application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety
      of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to
      conduct.
    

Intervention name(s): three consecutive lots of EV71 vaccine; placebo
Intervention type(s): Biological; Biological
Intervention description(s): inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval; placebo, two doses, 28 days interval
Other intervention name(s): Vaccine groups; Control group
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: 71 vaccine; HFMD; consistency of three consecutive lots; immunogenicity
Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up
Condition: Endodontically Treated Teeth; Permanent Molars
MeSH terms: Tooth, Nonvital
Study type: Interventional

Summary: 
      Background: A real challenge faces practitioners in dealing with permanent molars in young
      patients starting from proper selection of endodontic treatment system till the type of final
      coronal restoration. For permanent molars in young age patients, which system should be
      followed to guarantee better performance and enhance the integrity of such weakened teeth?
      The question most commonly asked.

      Purpose: To evaluate two-year clinical performance of endocrowns as permanent restorations
      for endodontically treated molars in young age.
    

Detailed description: 
      Endodontic treatment will be done for all patients using ProTaper Next rotary files and iRoot
      SP sealer. Then patients were randomly divided into two groups;

      Gr 1: Conventional group (CG), the coronal cavity will be restored directly with bulk-fill
      nanohybrid composite restorations.

      Gr 2: Endocrown group (EG), the coronal cavity will be restored with IPS e.max CAD endocrown
      restorations.

        -  First step: Endodontic treatment protocol will be used as the following:

             1. Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary
                files for instrumentation and 17% EDTA gel for lubrication.

             2. Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer.

        -  Second step: Endocrown restoration protocol will be used as the following:

             1. Occlusal Butt joint design for Endocrown preparation.

             2. Putty-wash technique for taking impression.

             3. IPS e.max CAD for Endocrown construction.

             4. G-CEM self-adhesive resin cement for Endocrown cementation.

        -  Follow up visits: The patients will be recalled every 6 months for evaluation.

        -  Evaluation methods:

             -  Endodontic treatment evaluation: The outcome will be evaluated clinically and
                radiographically.

             -  Endocrown restoration evaluation: The outcome will be evaluated clinically in terms
                of; marginal adaptation, marginal discoloration and surface alteration.
    

Intervention name(s): Control group; Endocrown group
Intervention type(s): Other; Other
Intervention description(s): ProTaper Next rotary system and iRoot SP sealer with composite restorations.; ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Endocrown,; Monoblock restoration,; Endodontically treated teeth; Young age