bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the long-term protection against HBV infection in
      adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30
      years ago
    


Intervention name(s): Engerix-B
Intervention type(s): Biological
Intervention description(s): Intramuscular administration of single challenge dose of Engerix-B vaccine in the deltoid region of the non-dominant arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B surface antigen antibody; adult subjects; Hepatitis B; HBV
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by
      optimal pain management protocols. Multimodal analgesia protocols including local
      infiltration anesthesia (LIA) have obtained excellent results in fast-track programs
      involving Total Knee Arthroplasty but further research and data is needed in Total Hip
      Arthoplasty programs.
    


Intervention name(s): 100cc of 2% ropivacaine; Saline Solution; Adrenaline 10mcg/ml
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multimodal analgesia + Local infiltration anesthesia; Multimodal analgesia + Saline solution
Intervention MeSH terms: Epinephrine; Racepinephrine; Ropivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Ultrasound to Evaluate the Quadriceps Muscle Wasting
Condition: Severe Cerebral Pathology
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of
      mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of
      muscle loss. This is a serious pathology associated with high morbidity and mortality.

      Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic
      Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in
      muscle mass. But these tools are not adapted to ICU patients.

      Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not
      expose the patient to additional radiation.

      The objective of this study is to evaluate the correlation between US and CT scan to measure
      quadriceps muscle thickness of ICU patients.
    

Detailed description: 
      As part of the monitoring of the neurological disease, brain CT scans are frequently
      performed. At the same time, an acquisition sequence centered on the quadriceps will follow
      the brain sequences. Up to three brain CT scans coupled with a quadriceps imaging will be
      performed between the day of admission and on the tenth day of hospitalization. An ultrasound
      of the quadriceps will be performed concomitantly. The thickness of the quadriceps is
      measured by an independent operator on CT and ultrasound images.
    

Intervention name(s): CT Scan and ultrasonography
Intervention type(s): Device
Intervention description(s): Up to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: severe cerebral pathology; Ultrasound; thickness of the quadriceps
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
Condition: Mixed Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus
      rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center,
      double-blind, phase 3 study
    


Intervention name(s): Rosuvastatin; Fenofibrate
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 10 mg, qd, po; Fenofibrate 160mg, qd, po
Other intervention name(s): Crestor Tab.; Lipidil supra Tab.
Intervention MeSH terms: Rosuvastatin Calcium; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE
      vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful
      completion of TB treatment with confirmed bacteriologic cure, in preparation for a future
      Phase 2b prevention of TB recurrence trial in the same population.
    


Intervention name(s): Placebo; ID93 + GLA-SE
Intervention type(s): Other; Biological
Intervention description(s): Placebo; ID93 + GLA-SE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis; TB; Pulmonary; Vaccine; Adjuvant
A Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Rifampicin
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, 3 treatment period, fixed-sequence study in healthy
      non-Japanese male subjects, aged 18 to 65 years (inclusive), performed at a single study
      centre. Treatment Period 1 will establish the single dose pharmacokinetic (PK) profile of
      savolitinib. Dosing of daily rifampicin during Treatment Period 2 will result in maximal
      induction of the CYP450 enzymes including CYP3A4. Treatment Period 3 will then establish the
      single dose PK profile of savolitinib under maximum CYP450 induction conditions. Comparison
      of the PK profile of savolitinib between Treatment Period 1 and Treatment Period 3 will
      quantify the effect of CYP450 enzyme induction.
    

Detailed description: 
      The treatment starts with a single dose of savolitinib (Treatment Period 1), followed by a
      washout period at least of 14 days after savolitinib dosing and before the start of Treatment
      Period 2, followed by rifampicin administration for 5 days (Treatment Period 2), and lastly,
      a combination of savolitinib + rifampicin (Treatment Period 3). Overall, all subjects will
      receive 2 single doses of 600 mg savolitinib and 7 daily doses of 600 mg rifampicin. Subjects
      will be resident in the study centre when receiving study drug administrations (savolitinib
      [Treatment Period 1], rifampicin [Treatment Period 2] and savolitinib+rifampicin [Treatment
      Period 3]). Subjects are required to fast overnight before each dosing day. Rifampicin will
      be administered 1 hour before breakfast with 240 mL water. The subjects will need to complete
      high-fat, high calorie breakfast before administration of savolitinib in Treatment Period 1,
      Day 1 (Study Day 1) and Treatment Period 3 Day 1 (Study Day 20).
    

Intervention name(s): Savolitinib; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a single dose on Study Day 1 and Study Day 20. Savolitinib will be administrated after a high fat, high calorie breakfast to reduce the risk of adverse events.; Patients will receive Rifampicin once daily on Study Day 15, 16, 17, 18, 19, 20 and 21. Rifampicin will be administered 1 hour before breakfast.
Other intervention name(s): Rifampin
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Solid tumors; Small-molecule kinase inhibitor
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, open-label, non-randomized study to assess the effects of
      CYP2C8 inhibition using gemfibrozil, and CYP3A4 and CYP2C8 induction using rifampicin on the
      pharmacokinetics of SAR442168 in healthy male participants aged 18 to 45 years.
    

Detailed description: 
      Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days
      for Cohort 2.
    

Intervention name(s): Tolebrutinib; gemfibrozil; rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, taken orally; Tablet, taken orally; Tablet, taken orally
Intervention MeSH terms: Rifampin; Gemfibrozil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant
      to, or have previously failed therapy with, at least one steroid and at least one
      immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The
      protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to
      induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks,
      for approximately an hour each time.
    

Detailed description: 
      A significant number of individuals with Crohn's disease do not find relief with existing
      steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other
      drastic measures for treatment.

      PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors,
      extensively tested, and are stored to be available as needed. Human and animal studies have
      shown that the cells do not require any donor-recipient matching. The cells may have both
      immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate
      specifically to sites of inflammation, so their effects are believed to be local and
      self-limiting rather than systemic.

      Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission
      in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of
      between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in
      each of the steroid, immunosuppressant, and biologic classes.
    

Intervention name(s): Prochymal®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prochymal® IV infusion; Prochymal® Placebo-matching IV infusion
Other intervention name(s): Adult Human Mesenchymal Stem Cells
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's disease; adult stem cell therapy
Exogenous Oxidation of Fructose-glucose Mixtures During Running
Condition: Exercise
Study type: Interventional

Summary: 
      The aim of this study is to characterise exogenous carbohydrate oxidation rates during
      exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and
      glucose-fructose mixtures ingested in hydrogel form.
    


Intervention name(s): Fructose-maltodextrin; Fructose-maltodextrin hydrogel; Glucose-maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fructose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.; Fructose plus maltodextrin in a ratio of 1:1.4, encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution.; Glucose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients
      with primary HER2-positive and HER2-negative breast cancer

      The primary objectives are:

        1. To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;

        2. To evaluate dosimetry of 99mTc-ZHER2:41071;

        3. To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071
           after single intravenous injection:

      The secondary objectives are:

      1. To compare the tumor imaging data with the data concerning HER2 expression obtained by
      immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy
      samples.
    

Detailed description: 
      Overall goal of the project: To determine HER2 expression level in primary breast cancer and
      possibly in axillary lymph node metastases before neoadjuvant targeted (trastuzumab or
      trastuzumab+pertuzumab) therapy.

      Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer.

      The study should evaluate distribution of 99mTc-ZHER2:41071 in patients with primary
      HER2-positive and HER2-negative breast cancer.

      The primary objectives are:

        1. To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;

        2. To evaluate dosimetry of 99mTc-ZHER2:41071;

        3. To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071
           after single intravenous injection:

      The secondary objectives are:

      1. To compare the tumour imaging data with the concerning HER2 expression obtained by
      immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) analysis of biopsy
      samples:

      Methodology:

      Open-label, exploratory, single center study. The subjects will receive a single injection of
      the labelled tracer.
    

Intervention name(s): SPECT
Intervention type(s): Drug
Intervention description(s): One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Other intervention name(s): 99mTc-ZHER2:41071
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: 99mTc-ZHER2:41071; Breast Cancer; HER2 expression
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability,
      pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC)
      injection in participants with mild, moderate, and severe renal impairment compared to
      participants with normal renal function.
    


Intervention name(s): Inclisiran
Intervention type(s): Drug
Intervention description(s): Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
Other intervention name(s): ALN-PCSSC
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      Study design will be a mix of retrospective (older Zeiss microscope previously in use at our
      surgery center) and prospective data collection with the Lumera and Callisto software.

      The Lumera and Callisto software system will be used for all cataract surgeries including
      toric analyses and lens placement.
    

Detailed description: 
      Needs Assessment

      Research on this topic is needed as over 3 million cataract surgeries are performed in the
      United States each year. The number of surgeries performed is growing as baby boomers age.
      Reimbursements continue to decline, necessitating ever improving operating and surgical
      efficiencies in the operating room setting for physicians and small business owners to remain
      financially viable. New governmental regulations dictate that physician payments will be
      related to patient satisfaction and outcomes which may be better provided by newer and better
      surgical technologies.

      The Lumera operating microscope and Callisto software system provide several features that
      may enhance operating room flow including HD video screen and co-observant microscopes that
      can be independently adjusted to help operating room staff anticipate the needs of the
      surgeon. Enhanced retroillumination would be expected to translate into fewer complications
      and more confidence during surgery which could lead to less operating time, phaco energy used
      and improved visual outcomes. The toric alignment assistance device may lead to more accurate
      toric placement and improved visual outcomes after surgery.

      Target audience would include all cataract surgeons both high and lower volume.

      There is currently a dearth of published literature on this technology and its benefits in
      routine cataract surgery. There are no registered similar trials on Clinicaltrials.gov
    

Intervention name(s): Zeiss
Intervention type(s): Device
Intervention description(s): This study proposal will highlight the advanced technology features of the Zeiss Lumera surgical operating microscope which include but are not limited to:
Stereo Coaxial Illumination for improved visualization High resolution video screen/co-observation tool to help OR staff anticipate next steps Integrated toric alignment tool Surgical microscope touch screen Cordless foot control for faster turnover between cases
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        100 patients with visually significant cataracts
Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
Condition: Depression; Post-traumatic Stress Disorder
MeSH terms: Depression; Depressive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 20-subject, dose finding study to examine the use of external trigeminal nerve
      stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD)
      co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant
      medications. Our primary objective is the examination of TNS in this patient population.

      To accomplish our specific aims, the investigators will test the following specific
      hypotheses:

        1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the
           eight-week period.

        2. Subjects will show improvement in ratings of life functional capacity and quality of
           life with TNS.

        3. Subjects will report the TNS treatments to be acceptable in terms of side effects and
           burden of using the device.
    

Detailed description: 
      A total of 20 subjects with Major Depressive Disorder (MDD) co-occurring with Post Traumatic
      Stress Disorder (PTSD), ages 18 to 75 years, will be consented and join this project at UCLA.

      The project will use TNS in under open-label conditions, using the same stimulation
      parameters as have been used in prior studies in MDD by itself and in treatment-refractory
      epilepsy. Subjects will be seen every two weeks during the 8 week study. At the end of the 8
      weeks, the TNS systems will be returned and the adjunctive treatment will end. The co-primary
      endpoints are the changes in depression severity and in PTSD severity from enrollment to the
      week 8 visit.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulator (TENS)
Intervention type(s): Procedure
Intervention description(s): External trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder (MDD); Trigeminal Nerve Stimulation; Post Traumatic Stress Disorder
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of
      exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
    


Intervention name(s): Placebo 0.04 mL twice daily; Placebo 0.04 mL once daily; Placebo 0.08 mL once daily; B - Exenatide 10 mcg twice daily; C - Exenatide 10 mcg once daily; Exenatide 20 mcg once daily
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneously injected, 0.04 mL, twice daily; Subcutaneously injected, 0.04 mL, once daily; Subcutaneously injected, 0.08 mL, once daily; Subcutaneously injected, 10 mcg (0.04 mL), twice daily; Subcutaneously injected, 10 mcg (0.04 mL), once daily; Subcutaneously injected, 20 mcg (0.08 mL), once daily
Other intervention name(s): ACC2993; synthetic exendin-4; ACC2993; synthetic exendin-4; ACC2993; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exenatide; Amylin; Lilly
AcoArt Ⅰ / SFA China
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether DEB is more effective than common PTA
      balloon in long-term vessel patency and inhibiting restenosis.
    


Intervention name(s): drug eluting balloon catheter (trade name: Orchid); common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Intervention type(s): Device; Device
Other intervention name(s): drug eluting dilation catheter; common PTA catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug eluting balloon catheter