bioihbjkbjnl/mcl2 huggingface dataset:
Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of
      the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60
      years in non-endemic country(ies) for dengue.
    

Detailed description: 
      The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The
      primary objective of this trial is to investigate lot-to-lot consistency in terms of
      equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy
      participants in non-endemic country(ies) for dengue.

      The study will enroll approximately 924 healthy participants. Participants will be randomized
      in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo:

        -  TDV 0.5 mL subcutaneous injection OR

        -  Placebo normal saline solution (0.9% NaCl) for injection.

      In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous
      injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in
      participants included in the immunogenicity subset (TDV groups: 176 participants each and
      placebo group: 88 participants) and safety will be assessed in all participants in each
      group.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is 270 days. Participants will make multiple visits to the clinic
      including a final visit at Day 270.
    

Intervention name(s): TAK-003; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TDV subcutaneous injection; TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection
Other intervention name(s): TDV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Intravenous Cannulation In Children During Sevoflurane Induction
Condition: Intravenous Cannulation; Sevoflurane Induction; Child
Study type: Interventional

Summary: 
      The early placement of an intravenous (iv) line in children anesthetized with halothane has
      been shown safe and acceptable compared with later placement. However, there's not well known
      with sevoflurane use (2). The aim of the investigator's study is to determine whether one
      should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120
      s) and waiting until the child receives additional sevoflurane inhalation anesthesia
    

Detailed description: 
      the investigators conducted a prospective randomized study, after obtaining Institutional
      review board approval, which didn't require written parental consent. Children age 1-12
      years, undergoing elective general anesthesia via an inhalation induction were randomized to
      one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or
      120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of
      laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical
      analysis included contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was
      considered significant.
    

Intervention name(s): Intravenous Cannulation (iv placement)
Intervention type(s): Other
Intervention description(s): The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized single blinded parallel group controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sevoflurane; Intravenous Cannulation; anesthesia; child
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Condition: Tinea Capitis
MeSH terms: Tinea; Tinea Capitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily
      in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules
      and pruritus are the primary clinical signs which can be associated with tinea capitis. The
      infection is caused by a relatively small group of dermatophytes in the genera Trichophyton
      and Microsporum.

      Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study
      will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
    


Intervention name(s): Terbinafine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Terbinafine, Tinea capitis, pediatric, antifungal
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
Condition: Paralytic Ileus
MeSH terms: Intestinal Pseudo-Obstruction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have
      traditionally withheld postoperative oral intake until the return of bowel function to
      prevent related complications. Gum chewing can stimulates bowel movement and promotes the
      return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes
      secretion.

      The objectives of this study are to examine effects of adding gum chewing to the conventional
      postoperative feeding regimen on the return of bowel function, its related complications, and
      patients' satisfaction.
    


Intervention name(s): Gum chewing
Intervention type(s): Behavioral
Intervention description(s): Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
Condition: Heart Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and
      mycophenolic acid is associated with a better renal outcome as compared to the standard
      regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while
      both treatments are expected to be comparable with respect to efficacy.
    

Detailed description: 
      This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and
      mycophenolic acid is associated with a better renal outcome as compared to the standard
      regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while
      both treatments are expected to be comparable with respect to efficacy.
    

Intervention name(s): Everolimus (EVR); cyclosporine A (CyA); tacrolimus (TAC); Enteric coated mycophenolate sodium (EC-MPS); mycophenolate mofetil (MMF); Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL); 10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only; 0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only; 180 mg or 360 mg tablet dosed 1440-2280 mg per day; 250 mg or 500 mg tablets with a dose of 1500-3000 mg per day; according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent
Other intervention name(s): Certican, RAD001; Sandimmun Optoral; Prograf; Myfortic; CellCept
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Transplantation; Cardiac Transplantation; CNI-sparing; renal function; CNI; Cyclosporine A; Everolimus; mycophenolic acid
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
Condition: End Stage Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the
      standard treatment Neoral® for a treatment period of 6 months in stable renal allograft
      transplant recipients with respect to drug levels, dosage, and acute graft rejection and
      other adverse events.
    

Detailed description: 
      The introduction of cyclosporine (CsA) into clinical practice resulted in improvements in
      acute renal allograft rejection rate and graft survival in renal transplant patients. Gengraf
      a microemulsion formulation of CsA though granted an AB-rated equivalent to Neoral, because
      of concerns over the use of generic drugs in transplantation, we undertook this study to
      evaluate the clinical efficacy and safety of Gengraf.

      We conducted a multicenter, randomized, open labeled study to establish the equivalence
      between Gengraf and Neoral in stable renal transplant recipients for a treatment period of 6
      months. 6 months post transplant patients with stable graft function and receiving a stable
      dose of neoral were recruited into the study. Eligible patients were randomly assigned to
      remain on Neoral or convert to an equal milligram-for-milligram dose of Gengraf. The primary
      end-point was serum creatinine at 26 weeks.
    

Intervention name(s): Neoral; Gengraf® capsule containing 25mg or 100mg cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): Neoral® capsule containing 25mg or 100mg cyclosporine; Transplant patients who were stable on Neoral were converted to Gengraf
Other intervention name(s): Cyclosporine; Generic Cyclosporine
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplant; Renal allograft rejection; Cyclosporine; Gengraf
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial will explore the safety and effect of autologous ex vivo expanded
      polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent
      onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM
      will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or
      low dose) or placebo.
    


Intervention name(s): CLBS03 Low Dose; CLBS03 High Dose; Placebo
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T1DM; Type 1 Diabetes Mellitus; T regulatory cell; Immunotherapy; Cell therapy; T-Reg
Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find the highest dose of dasatinib that can be safely given
      to a patient when the drug is given in combination with the known anticancer drug paclitaxel.
      Paclitaxel is an established anti-cancer drug, used in the treatment of many cancers, and it
      is an approved treatment for breast cancer. Dasatinib has been approved by the Food and Drug
      Administration for use as a single therapy in another kind of cancer, but its use in breast
      cancer patients, and in combination with paclitaxel is investigational.

      In this study, we will test the safety of dasatinib when given at different dose levels in
      combination with paclitaxel. We want to find out what effects, good and/or bad, it has on the
      patient and on metastatic breast cancer.
    


Intervention name(s): Dasatinib and Paclitaxel
Intervention type(s): Drug
Intervention description(s): A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
Intervention MeSH terms: Paclitaxel; Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast; Cancer; DASATINIB; TAXOL (PACLITAXEL); 08-122
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
Condition: Cognitive Impairment; Aging
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this research is to investigate the impact of overground walking as a part of
      a rehabilitation program on the increase in Brain-derived neurotrophic factor (BDNF) levels,
      decrease in IL-6 levels, decrease in hs-CRP levels, improvement in cognitive function, and
      enhancement of quality of life (QOL) in older people with mild cognitive impairment. These
      findings are anticipated to contribute to the efforts to elevate BDNF levels, cognitive
      function, and QOL while reducing IL-6 and hsCRP levels in the elderly with mild cognitive
      impairment.
    

Detailed description: 
      This research employs a quasi-experimental research design using a Pretest-Posttest Design
      approach. The Pretest-Posttest method is executed by assessing before and after the
      intervention within the same group.

      All research subjects receive the same treatment, which involves participating in an
      overground walking program on a flat surface. The selected research subjects are provided
      with an explanation of the research's objectives and benefits and the exercise and
      examination procedures, then sign the informed consent.

      Research subjects are instructed to walk on a flat surface for a distance of 15 meters, with
      a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is
      achieved during the exercise. After an 8-week post-intervention period, research subjects
      will undergo a follow-up examination.
    

Intervention name(s): Overground Walking
Intervention type(s): Other
Intervention description(s): Walk on a flat surface for a distance of 15 meters, with a duration of 20 minutes, increasing by 5 minutes each week until the target heart rate is achieved during the exercise, for 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Rehabilitation
Drug Combination on Exercise Performance at High Altitude
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is being conducted to determine the effectiveness of using two FDA approved
      medications in concert to reduce the likelihood of sickness due to low oxygen levels and to
      reduce the decrement in physical performance at higher elevations. The investigators
      hypothesize that this drug combination will reduce the symptoms of acute mountain sickness
      and improve exercise performance at high altitude compared to placebo.
    


Intervention name(s): ambrisentan and theophylline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): placebo for comparison group
Intervention MeSH terms: Ambrisentan; Theophylline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: exercise performance
¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This project is based on the contribution that an app can offer for improving knowledge and
      self-management of people with type 1 diabetes.

      The main objective of this study is to assess mySugr app as a tool for empowering people with
      type 1 diabetes.

      The study population are type 1 diabetes people, aged more than 18 years old and with more
      than one year from diagnosis. They will be randomised to standard care or use of mySugr app
      and will be followed-up during 48 weeks.

      Control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the
      possibility of telephone contact and hospital assistance if necessary. Intervention group
      will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3
      and 9 months) and will also have the possibility of telephone contact and hospital assistance
      if necessary.
    


Intervention name(s): mySugr app; Standard care
Intervention type(s): Device; Other
Intervention description(s): mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.; Face-to-face visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes Mellitus, Type 1; Mobile Applications; Telemedicine
Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels
Condition: Prostatectomy
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study is to compare the effect of two surgical techniques (open vs robotic
      assisted) on plasma levels of NGAL (neutrophil gelatinase-associated lipocalin) after radical
      prostatectomy.
    

Detailed description: 
      Patients undergoing radical prostatectomy are at increased risk of acute kidney injury (AKI)
      because of intraoperative bleeding, obstructive uropathy and older age. In particular
      robot-assisted laparoscopic radical prostatectomy (RALP) which is in increasing demand as an
      alternative surgical option for retropubic radical prostatectomy (RRP) is associated with
      postoperative renal dysfunction because pneumoperitoneum during RALP can decrease cardiac
      output and renal perfusion. NGAL may become important for diagnosis of postoperative AKI
      after urogenital oncosurgery.
    

Intervention name(s): NGAL
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        prostatectomy
      
Keywords: NGAL; Prostatectomy; Acute kidney injury
Efficacy of Accelerated Repetitive Transcranial Magnetic Stimulation on Patients With Post-stroke Depression
Condition: Post-stroke Depression
MeSH terms: Stroke; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The FDA approved repetitive transcranial magnetic stimulation (rTMS) for patients with Major
      Depressive Disorder (MDD) in 2008. The conventional rTMS protocol that has been used
      effectively for major depression is 5 days per week for 4-6 weeks. The accelerated rTMS
      protocol involves conducting more than one session per day. In the treatment of post-stroke
      depression (PSD); although the effectiveness of conventional rTMS procedure has been shown in
      many studies, there is limited data on accelerated rTMS protocol in which the number of daily
      sessions is increased. In this study, we aimed to evaluate the efficacy of accelerated rTMS
      treatment on depression symptoms in patients diagnosed with PSD and whose depressive symptoms
      persist despite medical treatment, by comparing it with sham stimulation.

      Question 1: Is accelerated rTMS an effective and reliable method in the treatment of
      post-stroke depression? Question 2: Is accelerated rTMS effective on quality of life,
      functional assessment and motor recovery in patients with post-stroke depression?
    

Detailed description: 
      Objective: Depression is a complication that negatively affects the quality of life and
      functional recovery of stroke patients and is associated with increased physical disability,
      cognitive and social impairment. In addition to being resistant to pharmacotherapy, the
      side-effect profile of the drugs used in the treatment and the increase in stroke recurrence,
      increase the need for new alternatives in the treatment of post-stroke depression (PSD).
      Repetitive transcranial magnetic stimulation (rTMS) is one of the treatment of interest in
      this field. In the treatment of PSD; although the effectiveness of conventional rTMS
      procedure has been shown in many studies, there is limited data on accelerated rTMS protocol
      in which the number of daily sessions is increased. In this study, we aimed to evaluate the
      efficacy of accelerated rTMS treatment on depression symptoms in patients diagnosed with PSD
      and whose depressive symptoms persist despite medical treatment, by comparing it with sham
      stimulation.
    

Intervention name(s): The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Intervention type(s): Device
Intervention description(s): The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available in our center was used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Accelerated rTMS; Repetitive Transcranial Magnetic Stimulation; Post-stroke Depression