bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated change over time in neurocognitive testing in patients receiving statin
      therapy in combination with evolocumab (AMG 145), compared with patients receiving statin
      therapy in combination with placebo.
    

Detailed description: 
      Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in
      select countries (selected based on study start-up timelines) were invited to participate in
      this cognitive function study, 20130385. There was no separate randomization for Study
      20130385; data were analyzed according to Study 20110118 randomized treatment arm.
    

Intervention name(s): Evolocumab; Placebo; Background Statin Therapy
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: High cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia
Diabetes Health Enhancement Program to Improve Health of People With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Management of chronic diseases, such as diabetes, relies upon the health care providers and
      the patients self-care. Self management programs for diabetes that target self-empowerment
      tools have been found to be effective in some studies, but have not typically included
      individuals on Medicaid.

      Our goal for this trial was to observe if patients participating in such a program could
      decrease glycated hemoglobin levels, improve health status and improve self-care practices.
    

Detailed description: 
      Design, Setting and Population: A Phase 3, one year prospective trial, randomized to
      intervention or control (usual care) with Medicaid or dual-Medicare beneficiaries, with
      diabetes, aged 40-85 years old residing in South King County, Washington.

      Intervention: A targeted, multi-component, self-management program incorporating a
      stage-of-change approach to overcome barriers and facilitate life-style behavior changes to
      achieve patient-driven health action plans for nutrition or exercise goals.

      Main Outcome Measures: Glycemic control (HbA1c), physical and mental health, self-care
      practices.

      Recruitment Status: Completed: participants are no longer being recruited; data analysis is
      complete.
    

Intervention name(s): DHEP
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: diabetes; behavioral change; chronic care model; stage of change; Medicaid; Dual eligible; ethnic; self-care
Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of
      bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal
      cancer.
    


Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): Bevacizumab, Capecitabine, Oxaliplatin
Other intervention name(s): Capecitabine, Oxaliplatin
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reirradiation and Erbitux in the HNSCC
Condition: Head and Neck Cancer Squamous Cell
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate in patients with cancer of the throat and
      recurrent inoperable a different modality treatment consisting of radiation continuously for
      5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer,
      called Erbitux ®.

      The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment)
      to improve the antitumor efficacy without additional toxic side effects.
    

Detailed description: 
      We hope with this treatment improved antitumor efficacy without additional toxic side
      effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we
      can not meet the current state of knowledge, which justifies this study.

      The main hypothesis is that this combination of reirradiation and Cetuximab give a relative
      gain of 15% complete response rate.
    

Intervention name(s): Erbitux
Intervention type(s): Drug
Intervention description(s): To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: reirradiation with Erbitux; HNSCC; local recurrent inoperable Squamous Cell Cancer of the Head and Neck
A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY
Condition: Bowel Preparation Before Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this Phase 2 Study was to compare the safety of 3 liter(L) and 4
      liter(L) split dose DCL-101 to split dose 4L GoLYTELY in patients preparing for colonoscopy,
      with secondary objectives to assess tolerability and bowel cleansing efficacy.
    


Intervention name(s): DCL-101 vs Golytely
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Condition: Constipation-predominant Irritable Bowel Syndrome (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456
      in patients with constipation-predominant irritable bowel syndrome.
    

Detailed description: 
      This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative
      study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in
      patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome
      III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after
      oral administration of ASP0456.
    

Intervention name(s): linaclotide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ASP0456
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: irritable bowel syndrome (IBS); linaclotide; constipation; ASP0456
Dezocine for Prevention of Catheter-related Bladder Discomfort
Condition: Catheter Related Bladder Discomfort
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the efficacy of dezocine in preventing the catheter-related bladder
      discomfort (CRBD) in a postanesthesia care unit (PACU).
    

Detailed description: 
      Thirty min before the end of the surgery, patients were randomly assigned to one of the two
      group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1
      mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in
      the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and
      severe.
    

Intervention name(s): Dezocine; Flurbiprofen Axetil
Intervention type(s): Drug; Drug
Intervention description(s): Dezocine (0.1 mg/kg）will be infused during surgery; Flurbiprofen Axetil (1 mg/kg）will be infused during surgery
Other intervention name(s): Dalgan
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil; Dezocine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dezocine; CRBD; General anesthesia; Urinary catheter
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Condition: Mucocutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Mucocutaneous
Study type: Observational

Summary: 
      This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult
      male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide
      semen samples for spermiogram analysis of sperm parameters.
    

Detailed description: 
      This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult
      male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide
      semen samples for spermiogram analysis of sperm parameters. Potential subjects diagnosed with
      mucocutaneous leishmaniasis who are planning to undergo miltefosine treatment will be
      informed about the study and undergo the informed consent process. After obtaining informed
      consent, subjects will be screened over a 28-day period for eligibility by medical history
      including leishmaniasis diagnostics, physical examination, clinical laboratory measurements
      [chemistries: (ALT, total bilirubin, creatinine; hematology: WBC count, hemoglobin, platelet
      count; spermiogram: sperm concentration, total sperm count, semen volume, sperm motility, and
      sperm morphology; hormones: testosterone and FSH]; and medication use in the 28-day period
      before starting treatment. If eligible for the study, the subject will receive miltefosine
      for 28 days at a target dose of approximately 2.5 mg/kg/day. Screening and enrollment into
      the study will continue until at least 55 subjects complete the study and are considered
      evaluable (provide sperm samples per protocol and complete at least 25 of 28 days of
      miltefosine treatment). Chemistries and hematology will be repeated at study Days 14
      (mid-treatment) and 28 (end of treatment). Two semen samples will be collected during
      screening (at least 48 hours apart), at the end of treatment (Days 25-and-28), at 3-months
      after completing treatment. If clinically significant changes spermiogram findings are
      observed at 3 months, one sample will be collected at 6 months. Adverse events (AEs) and
      concomitant medication use will be collected during treatment. Concomitant medication use
      will also be collected at the 3-month visit and in any subject coming back for the 6-month
      visit. A medical history will be taken at the 3-month and 6-month (if conducted) focusing on
      any changes to the urogenital system.
    

Intervention name(s): Miltefosine
Intervention type(s): Drug
Intervention MeSH terms: Miltefosine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        mucocutaneous leishmaniasis patients
      
Keywords: leishmaniasis; miltefosine; spermiogram
Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability,
      pharmacokinetics and pharmacodynamics of single injections of ascending doses of
      investigational drug product Mobilan (М-VM3) administered directly into the prostate of
      patients with prostate cancer.
    

Detailed description: 
      Mobilan is a type V adenovirus carrying TLR5 receptor and its agonist, protein 502s. It's
      mechanism of action involves activation of immune system and extensive mobilisation of
      various immunocytes to administration locus. It's safety and tolerability is currently
      evaluated in first-in-man phase I study in prostate cancer patients. Treatment strategy for
      the disease (radical prostatectomy or active observation) will be determined by the
      Investigator in accordance with routine clinical practice of the hospital.

      Patients will be randomised in cohorts of 4 subjects, where 3 subjects will be administered
      with Mobilan (М-VM3), and one patient will be administered with placebo.

      The dose will be escalated from cohort to cohort, the decision on possible dose escalation
      will be made by Independent Safety Review Board.
    

Intervention name(s): Mobilan (M-VM3); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.; 5% infusion solution of dextrose
Other intervention name(s): Dextrose 5%; Glucose 5%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: prostate cancer; adenovirus; TLR5; immunotherapy
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, placebo-controlled study consisting of both a single ascending
      dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability,
      pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
    


Intervention name(s): PAT-1251; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy
      significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides
      plus GM-CSF-in-adjuvant.
    


Intervention name(s): low-dose IL-2; melanoma vaccine
Intervention type(s): Drug; Biological
Intervention description(s): low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2); six melanoma vaccines given over a 6-week period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: melanoma; vaccine; peptides; adjuvant; immunogenicity; stage IIB, stage III or resected stage IV
QA102 Phase 1 Study in Healthy Young and Older Adult Subjects
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a double masked, randomized, placebo controlled, single and multiple oral dose
      study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral
      doses of QA102 in healthy young and older adult subjects will be evaluated. The study will
      also characterize the pharmacokinetic (PK) profile of QA102 in plasma and urine after single
      and multiple oral doses of QA102. Besides, the metabolite profile of QA102 will also be
      characterized.

      Part 1 will comprise a single dose, sequential cohort design. Part 2 will comprise a multiple
      dose, sequential cohort study. Part 3 will comprise a multiple dose, single cohort study in
      older subjects.
    


Intervention name(s): QA102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of QA102 capsules), oral administration, single dose.
Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration.
Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration.; Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of Placebo capsules), oral administration, single dose.
Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration.
Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Preoperative Vancomycin
Condition: Surgical Site Infection; Vancomycin
MeSH terms: Surgical Wound Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.
    

Detailed description: 
      Background: Vancomycin is used for antibiotic prophylaxis in pediatric surgical patients
      without a complete understanding of plasma and soft tissue pharmacokinetics. Guidelines
      recommend incision within 60 minutes after administration; however, tissue concentrations of
      vancomycin at that early time may not be therapeutic. The Investigators conducted a study of
      plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to
      characterize intraoperative vancomycin pharmacokinetics.

      Patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or
      ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over
      one hour. Skin biopsies were taken at incision and skin closure. Blood samples were also
      collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient
      was still in surgery. Population pharmacokinetic (PK) analysis was performed to characterize
      PK parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin
      concentrations vs. time.
    

Intervention name(s): Administration of Vancomycin
Intervention type(s): Drug
Intervention description(s): Intravenous Vancomycin Administration
Other intervention name(s): Vancomycin Hydrochloride
Intervention MeSH terms: Vancomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for
      the treatment of patients with advanced liver cirrhosis.
    

Detailed description: 
      G-colony stimulating factor(5ug/kg/day)will be administered twice subcutaneously for 3 days
      to three patients with liver cirrhosis. On the day 4th, plasmapheresis will be done to
      collect peripheral blood mononucleated cells

      . And then we are going to infuse the collected peripheral blood mononucleated cells of their
      own through the portal vein of each patients under ultrasonographic guidance.
    

Intervention name(s): G-colony stimulating factor; Infusion of the mobilized monocyte cells
Intervention type(s): Drug; Other
Intervention description(s): G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm.; G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Other intervention name(s): Filgrastim; Filgrastim; leukapheresis
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a
      strategy to deliver comprehensive cervical cancer prevention services in Thailand and the
      Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful
      screening and treatment programs for mothers.
    


Intervention name(s): HPV Vaccine (Gardasil)
Intervention type(s): Biological
Intervention description(s): HPV Vaccine Administration: According to the CDC, Gardasil should be delivered through a series of three intra-muscular injections over a six-month period. The second and third doses should be given two and six months after the first dose. The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines. Providers should consider a 15-minute waiting period for vaccine recipients following vaccination.
FDA's Approval of Gardasil (June 8, 2006) lists the following information on product Formulation: Each 0.5 mL dose of the vaccine contains:
20 mcg of HPV 6 L1 protein 40 mcg of HPV 11 L1 protein 40 mcg of HPV 16 L1 protein 20 mcg of HPV 18 L1 protein 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant) 9.56 mg of sodium chloride 0.78 mg of L-histidine 50 mcg of polysorbate 80 35 mcg of sodium borate water for injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention