bioihbjkbjnl/mcl2 huggingface dataset:
A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults
Condition: Encephalitis; Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration
      of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in
      adults.

      Objectives:

      Safety:

        -  Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared
           with a placebo in adult volunteers (≥ 18 to <55 years) without prior Japanese
           encephalitis (JE) vaccination.

      Immunogenicity:

        -  Obtain data on the antibody response in adult volunteers following administration of
           ChimeriVax™-JE

        -  Assess the durability of the immune response in adult volunteers over 60 months
           following one or two doses of ChimeriVax™-JE.
    

Detailed description: 
      Participants will receive ChimeriVax™-JE or diluent on Day 0 and diluent or ChimeriVax™-JE on
      Day 28. A subset of participants in each group will receive a booster dose of ChimeriVax™-JE
      at Month 6. Follow-up visits will occur at 12 and 24 months. Eligible participants will then
      enter the long-term immunogenicity follow-up period with visits at approximately 36, 48, and
      60 months after Day 0. No safety data will be collected in the long-term immunogenicity
      follow-up period.
    

Intervention name(s): Live attenuated Japanese encephalitis virus, then ChimeriVax diluent; ChimeriVax diluent, then Live attenuated Japanese encephalitis virus
Intervention type(s): Biological; Biological
Intervention description(s): ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28; ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.
Other intervention name(s): ChimeriVax™-JE; ChimeriVax™-JE
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; Japanese Encephalitis Vaccines; Adult
Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Condition: Gastritis; Gastroduodenal Ulcer
MeSH terms: Gastritis; Peptic Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal
      Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary
      Intervention.
    


Intervention name(s): ALBIS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastritis; Gastroduodenal Ulcer; Percutaneous Coronary Revascularization; Dual Antiplatelet Therapy
Adrenocorticotropic Hormone in Membranous Nephropathy
Condition: Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH,
      Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous
      nephropathy. Acthar is a hormone that stimulates steroid production from small glands above
      the kidneys. It has direct protective effects on the kidney and is currently approved by the
      FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of
      action are not entirely understood and will be studied in the present trial.
    

Detailed description: 
      Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6
      months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers
      including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory
      B cells will be serially measured to identify predictors of response to therapy.
    

Intervention name(s): ACTHar
Intervention type(s): Drug
Intervention description(s): for 6 months
Other intervention name(s): ACTH; Acthar Injectable Product; Repository corticotropin injection; RCI; Acthar® Gel
Intervention MeSH terms: Adrenocorticotropic Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Membranous nephropathy; adrenocorticotropic hormone; ACTH; proteinuria; glomerulonephritis
HAIC Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.
Condition: HepatoCellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion
      chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with
      large hepatocellular carcinoma staged BCLC A/B.
    

Detailed description: 
      Transarterial chemoembolization (TACE) is the most widely used palliative treatment for
      hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of
      TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those
      with tumor larger than 10 cm. Our previous prospective study also revealed similar results of
      large HCC patients treated with TACE. Recently, the results of our preliminary pilot study
      suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve
      the survivals for HCC with large HCC. Thus, the investigators carried out this prospective
      randomized control to demonstrate the superiority of HAIC over TACE.
    

Intervention name(s): Hepatic arterial infusion chemotherapy; Transarterial chemoembolization; Folfox Protocol; TACE Drug Protocol
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially.; Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.; oxaliplatin,leucovorin and 5-FU; lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)
Other intervention name(s): Folfox for TAI; Drugs for transarterial chemotherapy and embolization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic arterial infusion chemotherapy; Transarterial Chemoembolization; BCLC A/B
Hemodynamic Effects of Intermittent Pneumatic Compression for Sports
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      The aim of this randomized crossover trial is to assess the hemodynamic effects caused by the
      use of 2 distinct intermittent pneumatic compression protocols on athletes.

      The main questions it aims to answer are:

        -  Does intermittent pneumatic compression enhance athletes blood flow?

        -  If yes, what pressure is better to cause this enhancement?
    


Intervention name(s): Intermittent pneumatic compression (AirRelax)
Intervention type(s): Device
Intervention description(s): Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs
Other intervention name(s): High pressure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sports; recovery; intermittent pneumatic compression
Exposure Of Bisphenol Analogues In Chronic Kidney Disease and Dialysis Patients
Condition: Chronic Kidney Diseases; Hemodialysis Complication
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      In this retrospective study, the serum levels of Bisphenol A (BPA) and three BPA analogs,
      namely, bisphenol B (BPB), bisphenol S (BPS), and bisphenol F (BPF), in patients with CKD,
      patients on dialysis therapy and healthy control were investigated to find out if BPA and BPA
      analogs accumulates in patients with chronic kidney disease (CKD), and if hemodialysis
      filters contribute to bisphenol burden in patients on hemodialysis (HD).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with CKD, on dialysis in one center, and age- and gender- matched healthy
        volunteers were enrolled from Shanghai Ninth People's Hospital affiliated to Shanghai
        JiaoTong University.
      
Keywords: bisphenol; human exposure; chronic kidney disease; blood purification
Predicting the Lens Capsular Bag Size Using Pre-operative Biometry
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Aim of this study is to assess whether a high-resolution scan of the crystalline lens before
      surgery may be helpful in predicting post-operative capsule bag diameter.
    

Detailed description: 
      Most of the measurement procedures used in this study are non-invasive and all are used in
      standard routine clinical practice, the benefit/risk ratio appears acceptable.

      However, a capsule tension ring will be used. A CTR is not used routinely, usually only in
      cataract operations in which the lens capsule is not stable enough - in other words, for
      stabilization. The insertion of the CTR is problem-free in most cases. In extremely rare
      cases, however, the lens capsule may be injured. And document complications will be
      collected, report them in a final paper. The CTR used in the study is a standard device and
      CE-marked device. Studies using CTR showed that it is beneficial in difficult cases.

      Gonioscopy after cataract surgery will be performed after 1 week. At this time point the
      wound is already sealed and there appears to be no increased risk to the patient. In the
      first study performed in a similar fashion in 1999 gonioscopy was performed one day after
      surgery.

      Aim of this study is to predict the diameter of the capsular bag using pre-operative optical
      biometry findings.

      This is a prospective, observer-blind and monocentric study that includes patients scheduled
      for cataract surgery. Recruitment will take part on the day of pre-assessment. For each
      patient only one eye will be included.

      In total 50 eyes of 50 patients will be included, of which at least 5 eyes with an axial eye
      length below 22.5mm and 5 eyes with an axial eye length above 25.0mm.
    

Intervention name(s): Biometry
Intervention type(s): Device
Intervention description(s): Lens thickness, lens shape, anterior chamber depth, axial eye length and angle-to-angle will be used as explanatory variables (independent variables) and the size of the capsular bag will be used as main outcome parameter (dependent variable).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: capsular bag
PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System
Condition: Coronary Artery Disease; Intravascular Imaging Device
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were all recommended
      for percutaneous coronary intervention (PCI) optimization in the latest guidelines, however,
      which imaging modality was more suitable as either a diagnostic or guidance tool was still
      unknown. Recently, a novel, well-designed hybrid imaging system was approved for clinical
      use, allowing the accurate co-registration of two imaging modalities and immediate,
      simultaneous image review. For testing each modality in the hybrid imaging system, the
      investigators conducted this prospective, multicentre, non-inferiority trial. In this study,
      all participants achieved hybrid IVUS-OCT imaging after stenting, at meanwhile, patients
      randomly assigned to the IVUS arm were performed control IVUS (OptiCross, Boston Scientific,
      Natick, MA), and patients randomly assigned to the OCT arm were performed control OCT (C7
      Dragonfly Duo, St. Jude Medical, St. Paul, MN). In this study, the investigators evaluated
      the non-inferiority of standalone IVUS versus control IVUS or standalone OCT versus control
      OCT in clinical feasibility using clear stent capture rate (CSCR) and safety using
      perioperative device-related adverse cardiovascular events.
    


Intervention name(s): Intravascular ultrasound; Optical coherence tomography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Hybrid IVUS-OCT and control IVUS were performed after stenting; Hybrid IVUS-OCT and control OCT were performed after stenting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hybrid imaging; Intravascular ultrasound; Optical coherence tomography
Last 3 Months of Life in Home Ventilated Patients
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      To verify with a specific questionnaire, the families' perceived quality of end-of-life care
      and of dying in the last 3 months of life of 168 patients (Chronic Obstructive Pulmonary
      Disease-Amyotrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease-
      others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).
    

Detailed description: 
      Participants: 168 patients' relatives presenting five categories of diseases (Chronic
      Obstructive Pulmonary Disease-Amyothrophic Lateral Sclerosis (ALS)-Restrictive
      disorders-Neuromuscular disease- others) answered to questionnaire.

      Interventions: none Measurements and Main Results: 35 questions grouped in 6 specific domains
      (Control of pain and symptoms (domain 1-D1), awareness of disease (D2), family burden (D3),
      the process of dying (D4), medical troubles including hospitalizations (D5) and technical
      problems linked to MV(D6) were asked after the patient's death to a family member by means of
      a face to face interview. Answers to the binary 35-item questionnaire were distributed into
      just two clusters per each domain.
    

Intervention name(s): survey administration
Intervention type(s): Other
Intervention description(s): application of a family survey on last 3 months of life for their relatives under HMV
Other intervention name(s): caregiver burden
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Home MV patients in the last 3 months of life
      
Keywords: ethics; COPD; end of life; mechanical ventilation; CRF home ventilated patients
Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
Condition: Chlamydia Trachomatis
MeSH terms: Chlamydia Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The present trial is a phase I first in human, double blind, parallel and placebo controlled
      trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant
      system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in
      the United Kingdom.

      Subjects are randomly assigned to one of the following three treatment groups in a ratio of
      3:3:1.

      This trial consisted of 10 visits and 5 telephonic interviews
    


Intervention name(s): CTH522-CAF01; CTH522-Al(OH)3; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration; CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Phase I
Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System
Condition: Relationship Between Calcimimetic and the RAAS
Study type: Interventional

Summary: 
      The aim of this study is to evaluate, in healthy volunteers, the acute modulating effect of
      cinacalcet on the RAAS, the effect of furosemide on parathyroid secretion of PTH and the
      interaction between furosemide and cinacalcet on parathyroid hormone secretion.
    

Detailed description: 
      The clinical trial will be monocentric (Service of Nephrology and Hypertension at CHUV,
      Lausanne) and will include 24 patients. The volunteers will get involved after inclusion
      (Inclusion Visit) in a crossover study over two double-blind periods. The order of the two
      periods (placebo or cinacalcet) will be randomized. Each period comprises 3 days of a
      low-sodium diet (50 mmol of Na+ per day, equivalent to 3 grams of salt/day), followed by an
      investigation day at the hospital during which the subjects will be studied before and after
      exposure to the cinacalcet or placebo. The 2 periods will be separated by a therapeutic
      wash-out lasting 14-28 days. The total length of the study per participant will be 1, max. 2
      months.
    

Intervention name(s): Cinacalcet 60 MG; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): one dose of oral cinacalcet, 60mg; one tablet of placebo
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: calcimimetic agent; RAAS; renin; aldosterone
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell
      response, due to continuous pressure of high viral load. Treatment of chronic HCV patients
      with ASV and DCV will result in a significant drop in HCV viral load. At present, no
      information is available on the immunological effects of treatment with ASV and DCV, nor on
      the early effects of viral load reduction caused by a compound that is thought not to possess
      direct immunomodulatory effects. This information will be crucial for a better understanding
      of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound
      or relapses during, at the end of treatment or during the follow up period.

      Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV
      patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.

      Study design: This is an investigator-initiated single center open label study with one arm
      of 12 patients.

      Study population: Adult chronic HCV patients with genotype 1b, who are previous
      non-responders to the treatment.

      Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and
      once daily a 60 mg DCV for 24 weeks.

      Main study parameters/endpoints:

        1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T
           cells, NK cells and monocytes

        2. Gene expression levels of leukocyte populations before, during and after treatment

        3. Gene expression levels of the type I IFN signaling pathway on whole blood samples

        4. Serum cytokines levels using multiplex platforms
    


Intervention name(s): Daclatasvir; asunaprevir
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg once daily; 100 mg BID
Intervention MeSH terms: Asunaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Immunity
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Condition: Pregnancy
MeSH terms: Gonorrhea; Emergencies
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether providing non-contracepting women with
      gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and
      condoms decreases their risk of becoming pregnant.
    


Intervention name(s): levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
Intervention type(s): Drug
Intervention description(s): levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse
Other intervention name(s): Plan B
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention