bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the safety and immunogenicity of a single dose of
      Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
      (SP284) to support registration of the product in Japan.

      Primary Objective:

        -  To describe the seroprotection rate [% of subjects with serum bactericidal assay using
           baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y
           and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of
           age

      Secondary Objectives:

        -  To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years
           of age

        -  To describe the immune responses to meningococcal antigens (serogroups A, C, Y and
           W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.
    

Detailed description: 
      All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135)
      Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity
      assessment and safety monitoring post-vaccination.
    

Intervention name(s): Meningococcal polysaccharide diphtheria toxoid conjugate
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Menactra®, SP284
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Meningococcal conjugate Vaccine; Menactra®
68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for
      identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the
      association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and
      compare 68Ga-THP-PSMA PET/CT with other imaging procedure.
    


Intervention name(s): 68Ga-Labeled PSMA; Non-labeled PSMA
Intervention type(s): Drug; Drug
Intervention description(s): All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.; Patient will be injected with microdose (<100 ug) of THP-PSMA
Other intervention name(s): 68Ga-THP-PSMA; THP-PSMA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 68Ga-THP-PSMA; PET/CT
Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare renal function of immunosuppressive regimens with
      different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low
      dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
    


Intervention name(s): Everolimus; Myfortic; Sandimmun Optoral; Simulect®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen; 1 tablet containing 180 mg or 360 mg
Dosing schedule:
Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day); 1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level; Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4
Other intervention name(s): Certican; Enteric Coated Mycophenolate Sodium; Cyclosporine A; Basiliximab
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Everolimus; mycophenolate; CNI-free; kidney transplantation
Effects of Sea Buckthorn Oil on Mucous Membranes
Condition: Mucous Membranes
Study type: Interventional

Summary: 
      Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous
      membranes
    


Intervention name(s): Sea buckthorn oil; Placebo oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sea buckthorn; mucous membrane; dryness; metabolic syndrome; vaginal atrophy
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Condition: Mandibular Fracture
MeSH terms: Mandibular Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      In condylar fracture surgery, reduction is the most difficult step and the key factor which
      determined the postoperative outcome. Therefore, the aim of this study is to develop a new
      instrument, which the investigators call condylar redactor, to assist the surgeon to reduct
      the condylar segments effectively.
    

Detailed description: 
      In this prospective cohort study, it involved condylar fractures patients who were received
      surgical treatment from January 2014 to June 2016. Patients in the experimental group were
      treated with the condylar reductor, and patients in the control group were treated with the
      traditional surgical instruments. The primary outcome variable was reduction time and
      reduction rate. The continuity correction X2 and test student t test were used.
    

Intervention name(s): Condylar reductor
Intervention type(s): Device
Intervention description(s): A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Tear Dynamics After Restasis Treatment in Dry Eye Patients
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Observational

Summary: 
      Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months
      and during 6-month follow-up after discontinuation of study treatment.
    

Detailed description: 
      Using an imaging device name optical coherence tomography to image the tear volume in dry eye
      patients before and after Restasis treatment.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        dry eye patients more than 18 yrs old
      
Keywords: dry eye; Optical coherence tomography
Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
Condition: Uterus Leiomyosarcoma; Soft Tissue Leiomyosarcoma
MeSH terms: Leiomyosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when
      metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin,
      ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first
      line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft
      tissue.

      The trabectedin is a new cancer drug that has obtained marketing authorization after failure
      of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It
      has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.

      This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin
      in first-line treatment of uterine or soft tissue leiomyosarcoma.
    


Intervention name(s): Doxorubicin; Trabectedin
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/m²; 1,1 mg/m²
Other intervention name(s): Adriamycin; Yondelis®
Intervention MeSH terms: Doxorubicin; Trabectedin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Gabapentin From Nerpentin 600 mg (Test ) F.C.T (Aman Pharma ,Egypt.) and Gabapentin From Neurontin 300 mg (Referance ) H.G.C. ( Pfizer Egypt)
Condition: Healthy
Study type: Interventional

Summary: 
      This study is conducted with the aim to investigate whether any differences concerning the
      rate and extent of absorption exist between the test and the reference product, Test product
      was Nerpentine 600 mg Film coated Tablet (Aman Pharma) Reference Product was Neurontin 300 mg
      Capsule.(Pfizer) The comparative bio availability of the two formulations was evaluated based
      in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug
      concentrations in blood.

      Study was open-label, randomized, crossover, with 02 treatments, 02 sequences and 02 periods,
      under fasting conditions. one tablet from test product 600 mg against two capsules ( 2*300 mg
      ) reference product.

      Study population was 34 subjects , males ,adults between 18-55 years.
    


Intervention name(s): Gabapentin; Neurontin
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 600 mg Gabapentin; 2 capsule contains 2*300 = 600 mg Gabapentin
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized single oral dose, open-label, two-way, two-periods, UN-replicated crossover design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharma Guide; Gabapentin; Neurontin; Mostafa Kaboah
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety
      of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total
      trial duration per subject is approximately 58 weeks.
    


Intervention name(s): liraglutide; placebo; liraglutide; placebo; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The primary objective of the study was to assess the bioequivalence between the test product
      (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair
      HFA [albuterol sulfate] Inhalation Aerosol 90mcg per actuation) under fasting conditions.
      Bioequivalence would be demonstrated if the 90% confidence interval for the ratios of
      geometric means for AUC(0-t), AUC(0-inf), and Cmax between test products and reference
      products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.
    

Detailed description: 
      A single-dose, randomized, open-label, two-period, two-sequence, two-treatment,
      single-centre, two-way crossover bioequivalence study of Albuterol Sulfate inhalation aerosol
      108mcg per actuation (equivalent to 90mcg of Albuterol) and Proair HFA (albuterol sulfate)
      Inhalation Aerosol 90mcg per actuation was carried out under fasting conditions in healthy
      adults, aged 20-60 years. For each period, 60 subjects were planned to receive a single dose
      of albuterol inhalation aerosol (2 puffs) according to the pre-determined randomization
      scheme. Venous blood of each subject was drawn 22 times over the period of 24 hours. Plasma
      samples were collected and analysed for albuterol concentrations by LC-MS/MS. For each
      subject, there were 2 dosing periods, separated by a 14-day washout period. During the study,
      standardized meals were provided to all subjects when institutionalized.
    

Intervention name(s): Albuterol Sulfate Inhalation Aerosol 108mcg per actuation; Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
Intervention type(s): Drug; Drug
Intervention description(s): MDI, 2 puffs, single dose, fasting; MDI, 2 puffs, single dose, fasting
Other intervention name(s): Albuterol 90mcg/puff; Albuterol 90mcg/puff
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effect of this CR program on the improvement of
      myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in
      AMI patients.
    

Detailed description: 
      The effect of early short-term home-based cardiac rehabilitation (CR) program on left
      ventricular function in acute myocardial infarction (AMI) patients is not clear yet.
    

Intervention name(s): entailing an early home-based CR program; enter the usual care program
Intervention type(s): Behavioral; Other
Intervention description(s): enter the early outpatient phase of CR program. The progressive exercise training of this phase was performed without supervision after their discharge. The CR program consisted of a five-minute warm-up period (stretching), a twenty-minute aerobic exercise (walking or trotting, gymnastics), and a five-minute cooling-down period (stretching); enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cotton Sock in Pediatric Patients With Leg-foot Splint
Condition: Flat Foot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The post-operative treatment of pediatric patients operated for the correction of flat foot,
      sees today the use of preformed leg-foot splint (Walker) as an alternative to the application
      of plaster casts. The change of the immobilization system has led to the appearance of
      problems of tolerability in particular in the skin. The problems persist also after placing a
      polyurethane foam dress at the heel in the immediate postoperative period. The aim of this
      study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in
      children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous
      lesions.
    


Intervention name(s): cotton sock; Elastic Compression Wraps
Intervention type(s): Other; Other
Intervention description(s): Application of a cotton sock in the immediate postoperative period before applied the Walker; Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of
      BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)
    


Intervention name(s): BMS-986177; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of BMS-986177 and multiple doses of Rifampin; Single dose of BMS-986177 and multiple doses of Rifampin
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Renal dysfunction in the context of liver transplantation is a major issue, with difficult
      patients' management and determining a worsened prognosis.

      Physiopathologically pretransplant renal dysfunction is dependent on multifactorial causes,
      including hypoperfusion-derived functional renal insufficiency, hepatorenal syndrome or
      interstitial parenchymatous insufficiency. On top, intra- or post-transplant events,
      including hypoperfusion or calcineurin inhibitors nephrotoxicity may aggravate this
      situation.

      At present MELD criteria favours allocation of organs to patients suffering from renal
      insufficiency, so at least 30% of the investigators liver transplant patients suffer from
      some degree of renal impairment pretransplant.

      After liver transplant impaired renal function tends to recover partially or completely,
      unless advanced parenchymatous lesions are significantly involved as a major cause of renal
      dysfunction.

      In this context, calcineurin inhibitors avoiding or sparing protocols may help in the
      recovery from renal insufficiency, improving long-term prognosis. The use of anti-CD25
      antibodies is a good option, but provides a limited antirejection prophylaxis, limiting the
      use of these antibodies to a reduced cohort of liver transplant patients.

      Polyclonal antibodies might provide an advantage in management of liver transplant patients
      with renal insufficiency, without increasing acute rejection episodes of the allograft
      efficacy and security evaluation of low nephrotoxicity immunosuppression, based on the use of
      ATeGe, in liver transplant candidates with pre-transplant renal dysfunction.

      The aim of this study is to evaluate the efficacy and security use of immunosuppression based
      on ATeGe in liver transplant recipients with pre-transplant renal dysfunction.
    


Intervention name(s): ATeGe-Fresenius
Intervention type(s): Drug
Intervention description(s): Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal insufficiency; Liver transplant; Acute rejection; Infections; Hepatitis C recurrence
Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
Condition: Macular Pucker; Macular Cyst
MeSH terms: Epiretinal Membrane
Study type: Observational

Summary: 
      To evaluate the visual acuity, macular thickness, morphological changes after cataract
      surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were
      also investigated.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The general medical history of the patients was evaluated preoperatively. Comprehensive
        ophthalmological examinations including BCVA measurements and funduscopic examinations were
        performed at each visit. SD-OCT (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA) was used to
        measure the central macular thickness (CMT) and structural changes preoperatively, and at 1
        day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively
      
Keywords: macular edema; pseudophakic cystoid macular edema; macular pucker; internal limiting membrane peeling; pars plana vitrectomy