bioihbjkbjnl/mcl2 huggingface dataset:
Effects of E-cigarette Flavors on Youth TCORS 2.0
Condition: Nicotine Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an examination of the influence of sweet and cooling flavors on the appeal and
      abuse potential of nicotine-containing e-cigarettes among susceptible youth.
    

Detailed description: 
      Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse
      potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate
      the flavor intensity, coolness, sweetness, and irritation experienced using validated rating
      scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will
      participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml
      nicotine salt) during the session; during the session they will be exposed, in random order,
      to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the
      assigned session nicotine concentration.
    

Intervention name(s): Flavoring Agents; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): Flavor of e-liquid - sweet or tobacco; Nicotine level (0, 3, or 12 mg)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
Condition: Ulcerative Colitis in Remission
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug,
      marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool),
      in patients with Ulcerative Colitis in remission, treated for 48 weeks.
    


Intervention name(s): Asacol®; Mesalazine
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg tablets; 400mg tablets
Other intervention name(s): Import Mesalazine; Marketed Mesalazine
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To compare the PK profiles of HLX01 and Rituximab in Chinese patients with moderate to severe
      rheumatoid arthritis.
    


Intervention name(s): HLX01
Intervention type(s): Drug
Intervention description(s): Biosimilar of Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance
Condition: Prediabetic State
MeSH terms: Glucose Intolerance; Prediabetic State
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity
      in patients with impaired glucose tolerance. Secondary purpose of this study was to assess
      changes on metabolic profile, weight and blood pressure.
    


Intervention name(s): Vanadyl sulfate; Magnesium oxide
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 50 mg twice daily orally for a period of 4 weeks; Validation of similar appearance and weight to the intervention component orally 1 unit (<50 mg) twice daily for a period of 4 weeks
Other intervention name(s): Vanadyl sulphate; Vanadyl sulfate hydrate; Vanadyl sulphate hydrate; Calcinated magnesia; Calcined Magnesite; Magnesia
Intervention MeSH terms: Vanadyl sulfate; Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vanadium; insulin sensitivity; impaired glucose tolerance; triglycerides
Aerobic Exercise for Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will evaluate the ability of aerobic exercise (AE) to improve cognition in people
      with schizophrenia. Participants will be randomly assigned to one of two interventions: (1)
      aerobic exercise class (stationary bicycle, or "spin" class) for up to 45 minutes three times
      per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times
      per week for 12 weeks.
    

Detailed description: 
      Schizophrenia (SCZ) is a severe, chronic, and disabling psychotic illness that affects
      approximately 87,000 Veterans. Previous studies have reported improved short-term memory with
      AE, but there in a lack of information on cognitive effects of AE in SCZ. The investigators
      want to determine if twelve weeks of AE training improves cognitive function in Veterans with
      SCZ.
    

Intervention name(s): Aerobic Exercise; Balance and Stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.; Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Exercise; Cognition
Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home
Condition: Premature; Low Birth Weight; Mother-Infant Interaction; Gain, Weight; Depression, Post-Partum; Breastfeeding; Feeding, Breast
MeSH terms: Depression, Postpartum; Body Weight; Birth Weight; Weight Gain
Study type: Interventional

Summary: 
      The objective of this randomized clinical trial will determine the effectiveness of nursing
      intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low
      birth weight infants at home The dyad mother- infant of the control group will receive
      Kangaroo position KP and the dyad mother- infant mothers of the intervention group will
      receive the Kangaroo Baby Massage KBM
    

Detailed description: 
      Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group
      and 34 in control group KP, previous they meet inclusion criteria and accept their
      participation through informed consent. weight gain and Kangaroo position days at home will
      be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental
      self-efficacy and Postnatal depression. Will be secondary outcomes.

      Barnard's mother-child interaction theory supports the study
    

Intervention name(s): Kangaroo Baby Massage
Intervention type(s): Behavioral
Intervention description(s): The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video
Other intervention name(s): Masaje al Bebé Canguro; Nursing intervention KBM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two interventions groups of 34 each, participated in the study. The first group received Nursing intervention Kangaroo Baby Massage KBM at home and the second group received Kangaroo position KP at home, the KBM will start when the infant arrives at home until they leave the kangaroo position. The KP will measure since the baby arrive at home until leave the kangaroo position.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; Kangaroo mother care; low birth weight infant; premature infant; Mother- infant interaction; domiciliary; Nursing; home health nursing; telenursing
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Condition: Total Knee Arthroplasty; Tibiofemoral Kinematics
Study type: Observational

Summary: 
      The objective of this research project is to perform a comparative study on the in vivo
      kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed
      Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and
      downhill walking by means of videofluoroscopy.
    

Detailed description: 
      Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality
      of the joint. To maintain sufficient range of motion, but also not overload the surrounding
      soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is
      thought to be beneficial. In previous studies, it has been shown that the medial condyle,
      described by the centre of the medial condylar sphere, does not move anterioposteriorly
      during progressing joint flexion, whereas the lateral condyle has been observed to translate
      in a posterior direction producing tibial internal rotation with flexion (Freeman and
      Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere
      prosthesis is specifically designed to mimic the healthy kinematics with providing a medial
      pivot.

      The objective of this research project is to perform a comparative study on the in vivo
      kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed
      Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous
      assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and
      subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means
      of skin markers and ground reaction forces during level walking, stair descent and downhill
      walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in
      8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In
      addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile
      Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere
      prosthesis kinematics.
    

Intervention name(s): Observational use of fluoroscopy
Intervention type(s): Radiation
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants fulfilling all of the following inclusion criteria are eligible for the study.
        The presence of any one of the following exclusion criteria will lead to the exclusion of
        the participant.
      
Keywords: Videofluoroscopy; GMK Sphere; GMK PS Fixed Bearing; GMK UC Mobile Bearing
A Study of LY3200327 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at the safety and tolerability of single doses of
      LY3200327 when given to healthy male and female participants either by injection under the
      skin or by drip into a vein. The study will help determine how the drug behaves inside the
      body and how long it takes to disappear from the body. The study will also look for anti-drug
      antibodies and how these may affect how LY3200327 acts in your body.

      The study is expected to last approximately 12 weeks (with screening evaluations up to 4
      weeks prior).
    


Intervention name(s): Placebo (SC); LY3200327 (SC); LY3200327 (IV); Placebo (IV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered IV; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
Condition: Acquired Bleeding Disorder; Trauma
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Contusion; Hemostatic Disorders; Blood Coagulation Disorders; Contusions
Study type: Observational

Summary: 
      This study is conducted in North America. The purpose of this study is to evaluate the
      occurrence and severity of bleeding in brain injury and to identify important safety issues
      following traumatic brain injury.
    


Intervention name(s): activated recombinant human factor VII
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were selected from a speciality practice group (Neurosurgery practices with a
        focus on head trauma. Subjects will have had a mild-to-moderate head injury and require
        hospitalization.
Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney
      transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil,
      therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic
      interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction
      between two drugs is still not well understood. Therefore, an open-label, three period,
      single dose trial is planned to investigate the drug interaction between tacrolimus and
      mycophenolate mofetil.
    

Detailed description: 
      Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil
      1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg
      and tacrolimus 5mg. All subjects have one week of washing period between single dose
      administration. Blood samples are drawn up to 72 hours after drug administration. Single
      nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are
      also investigated. Drug interaction is going to be assessed through the ratio of area under
      the concentration curve of one drug in the presence or absence of another drug.
    

Intervention name(s): Tacrolimus; Mycophenolate mofetil
Intervention type(s): Drug; Drug
Other intervention name(s): Prograf; Cellcept
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer
Rinitis y Sinusitis según la Gravedad Del Asma
Condition: Asthma
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      Based on the evidence for the "common pathway" in asthma presentation, our working hypothesis
      is that asthma severity and lack of control are related to the prevalence and severity of
      nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal
      polyps.
    

Detailed description: 
      Primary objective: To assess the prevalence and severity of rhinitis and rhinosinusitis, with
      or without nasal polyposis, in asthmatic patients depending on severity of their disease.

      Secondary objectives:

      To assess the impact of nasal and sinusal pathology on asthma control.

      To correlate asthma severity to rhinitis and rhinosinusitis.

      To compare the potential association between chronic rhinosinusitis, with and without nasal
      polyposis, and asthma severity, and to detect radiographic differences, markers of atopy, and
      pulmonary function.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hospitals in Spain and Latin America
Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies
Condition: Blood Cancer; Leukemia
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To measure how frequently and to what degree a complication of transplant cell acute graft
      versus host disease (GvHD) occurs.
    

Detailed description: 
      This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell
      transplant (HCT), which has provided excellent overall survival for patients with relapsed
      lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly
      patients with hematologic malignancies.
    

Intervention name(s): Cyclosporine; Anti-thymocyte globulin (ATG); Mycophenolate mofetil (MMF); Filgrastim; Total Lymphoid Irradiation (TLI)
Intervention type(s): Drug; Drug; Drug; Drug; Radiation
Intervention description(s): Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL; 1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT; Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.; Donors mobilized with 16 µg/kg/day filgrastim.
As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day; 0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.
Other intervention name(s): Cyclosporin; Cyclosporin A; Thymoglobulin; CellCept; Neupogen; Granulocyte-colony stimulating factor (G-CSF; GCSF); colony-stimulating factor 3 (CSF-3)
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Lenograstim; Cyclosporins; Thymoglobulin; Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to document the immunogenicity and safety of a booster dose of
      IMOJEV administered at least 12 months after the primary dose.

      Primary objective:

        -  To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a
           booster dose of IMOJEV administered at least 12 months after primary vaccination with
           IMOJEV.

      Exploratory objectives:

        -  To describe the safety profile of a booster dose of IMOJEV® .
    

Detailed description: 
      Participants who previously participated in Study JEC12 (NCT01396512) and were primed with
      IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose.
      Participants were assessed for immune response before and on Day 28 after the booster dose
      and were monitored for safety through Day 28 post-vaccination for non-serious adverse events
      (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's
      participation in the study was approximately 6 months.
    

Intervention name(s): IMOJEV
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Subcutaneous
Other intervention name(s): Japanese Encephalitis Chimeric Virus Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese encephalitis; Japanese encephalitis chimeric virus vaccine; IMOJEV®
TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional

Summary: 
      To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell
      and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for
      peripheral blood stem cell transplant in relapsed lymphoma.

      Assess incidence of acute Graft Versus Host Disease (GVHD), chronic GVHD, graft failure rate,
      treatment related mortality rate, progression free survival and overall survival of patients.

      The stem cell product will be processed using an investigational Miltenyi cell selection
      device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that
      are more likely to cause GVHD.
    


Intervention name(s): Fludarabine Phosphate; Mesna; Cyclophosphamide; Total nodal irradiation; T Cell-Depleted Hematopoietic Stem Cell Transplantation; Allogeneic Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation; Mycophenolate Mofetil; Tacrolimus; Rituximab
Intervention type(s): Drug; Drug; Drug; Radiation; Biological; Procedure; Procedure; Drug; Drug; Biological
Intervention description(s): Fludarabine will be administered by IV over approximately 30 minutes for 4 days.; Given IV over 24 hours starting prior to cyclophosphamide; Given IV for 2 days; Undergo total lymphoid irradiation; Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant; Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant; Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant; Given PO; Given PO or IV ONLY if graft cell content is over 1 x 10^5 cells/kg ideal BW of the patient; Given IV ONLY if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient
Other intervention name(s): HSC; HSCT; MMF
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Rituximab; Fludarabine; Fludarabine phosphate; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory
      blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female
      subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API)
      sources of eslicarbazepine acetate (ESL)
    

Detailed description: 
      Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory
      blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female
      subjects. The study consisted in 2 periods separated by a wash-out of at least 7 days between
      doses. To demonstrate the bioequivalence (BE) between two active product ingredient (API)
      sources [current API source - marketed formulation (MF) versus new API source -
      to-be-marketed (TBM)] of eslicarbazepine acetate (ESL)
    

Intervention name(s): BIA 2-093; BIA 2-093
Intervention type(s): Drug; Drug
Intervention description(s): MF - Marketed formulation; TBM - to-be-marketed
Other intervention name(s): ESL, Eslicarbazepine acetate; ESL, Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment