bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Acute Myocardial Infarction Using FDY-5301
Condition: Acute Myocardial Infarction; STEMI
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of
      three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and effectiveness of an experimental drug
      called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused
      by the heart attack. An experimental drug is one that is being tested and is not approved by
      the United States Food and Drug Administration (FDA).

      A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle
      becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization
      procedure to clear the blockage in your coronary artery that caused your heart attack. This
      procedure works well but may not completely prevent some injury to the heart muscle which
      occurs when the blood supply is initially restored to the heart. This is known as
      "reperfusion injury".

      FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in
      this study at about 20 research sites in the United States and Europe. Each subject's
      participation is expected to last about 6 months after receiving the study drug.

      Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups.
      Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive
      a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously)
      during the catheterization procedure. This is a double-blind study so neither the patient nor
      study personnel will know whether the dose is active drug or placebo until the end of the
      study.
    

Intervention name(s): FDY-5301; Placebo
Intervention type(s): Drug; Other
Intervention description(s): FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.; Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to describe candesartan cilexetil antihypertensive effects
      in terms of achieved blood pressure and hypertension control rates and the relationship
      between subject characteristics and antihypertensive efficacy, and between antihypertensive
      therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year
      treatment period in hypertensive children ages 6 to < 17 years; to describe growth in terms
      of height and weight in the study population; to describe change in neurocognition as
      assessed by the Full Scaled IQ score in a subset of study subjects; to determine the
      pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to < 17 years; and
      to describe safety including adverse events and adverse events necessitating study drug
      discontinuation including dose level and dose duration relationships and growth over a 1 year
      period in hypertensive children age 6 to < 17 years.
    


Intervention name(s): candsartan cilexetil
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric hypertension; Hypertension in children
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection
Condition: HBeAg Positive Chronic Hepatitis B Infection
MeSH terms: Infections; Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      During hepatitis B virus(HBV) infection host immune plays important role.Recently there are
      many different antiviral therapy methods.Different antiviral therapy methods showed different
      effector.In order to investigate whether these antiviral therapy methods especially methods
      directly inhibit viral replication have some effect on host immune the investigators designed
      these study. The investigators want to observe the change of host immune during antiviral
      therapy in patients with chronic HBV infection, and analyze the relationship between these
      changes and the antiviral effector of these drugs.
    


Intervention name(s): Telbivudine
Intervention type(s): Drug
Intervention description(s): 600mg,1/d,one year
Intervention MeSH terms: Telbivudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: HBV; Immune; antiviral therapy
A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effects of CKD-506 on signs and
      symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to
      methotrexate.
    


Intervention name(s): CKD-506; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for oral administration; Tablets for oral administration
Intervention MeSH terms: CKD-506
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter
Condition: Deep Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      It has been demonstrated that implantation of inferior vena cava filter was safe and
      effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous
      clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis,
      transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip
      Filter. Although incidence of significant filter tilting (>10°) is not high (13%-16%), severe
      tilting of the Günther Tulip Filter may be associated with difficulty or sometimes
      impossibility of retrieval. It has been reported that a simple technique of keeping tension
      of the delivery system may prevent significant tilting of the transjugular Günther Tulip
      Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip
      Filter from tilting has been reported. The investigators conducted a randomized, controlled
      study to test whether the introducer curving technique is useful to decrease the extent of
      tilting of transfemoral Günther Tulip Filter.
    

Detailed description: 
      The study was designed as a double-blind randomized controlled trial, with research assessors
      and patients intended to be blind to the intervention status. The staff members performing
      the assessment were not involved in implementing any aspect of the intervention. 108 patients
      were randomized to accept curving introducer Günther Tulip Filter and transcatheter
      thrombolysis or straight introducer Günther Tulip Filter and transcatheter thrombolysis. The
      assessments include the tilting angle between the axes of inferior vena cava and Günther
      Tulip Filter after implantation; the tilting angle between the axes of inferior vena cava and
      Günther Tulip Filter before retrieval; the fluoroscopy time of Günther Tulip Filter
      retrieval; the rate of retrieval hook adhering vascular wall; the success rate of retrieval.
    

Intervention name(s): curving introducer Günther Tulip Filter; straight introducer Günther Tulip Filter
Intervention type(s): Device; Device
Intervention description(s): The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark) The amplitude of introducer curvature was 5°-15° less than the angle between the inferior vena cave axis and the approached iliac vein axis and the distance between the vertex of the curved angle and the hook of the filter was 2-4cm less than the distance between the level of the renal vein confluence and the furcation of inferior vena cave.; The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Filter Tilt; Preventional efficiency; Günther Tulip filter; Transfemoral Approach
Absorbable or Non Absorbable Sutures in Hand Surgery
Condition: Wound Complication Hand Surgery
Study type: Interventional

Summary: 
      After all surgical procedures, the skin must be closed with some form of stitch, in
      healthcare called suture. According to the tradition of hand surgery, sutures that must be
      removed by caregivers, ie non-resorbable thread, have been used extensively, and the
      frequency of complications in the form of wound rupture and infection is low. For many
      procedures, however, it can be an advantage to avoid removing the stitches, as it is both
      painful for the patient and time-consuming and resource-consuming for both the patient and
      the healthcare system. You can then use a thread that the body itself breaks down and
      absorbs, ie resorbable suture. In the project, we will compare resorbable and non-resorbable
      suture with the primary outcome of superficial infection in the surgical area sometime day
      1-20 after surgery. Secondary outcomes are the occurrence of wound rupture, pain VAS (Visual
      Analog Scale) when changing 2 weeks postoperatively, patient satisfaction VAS at 2 weeks and
      time spent in minutes for changing at 2 weeks postoperatively. The project will include all
      consecutive patients> 18 years of age who are operated on at the hand surgery clinic
      Södersjukhuset for elective or emergency surgery that do not meet the exclusion criteria. The
      project will include 270 patients.
    


Intervention name(s): Skin closure
Intervention type(s): Procedure
Intervention description(s): Skin closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer.

      PURPOSE: This research study is looking at tumor samples from women who have undergone
      chemotherapy for breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To identify gene sets for risk of recurrence using molecular profiling in samples from
           women with lymph node-positive or high-risk lymph node-negative breast cancer on
           clinical trial ECOG-E2197.

      Secondary

        -  To define a set of significant genes as prognostic markers of recurrence.

        -  To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical
           trial with gene sets determined in this study.

        -  To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial.

        -  To compare the prognostic value of selected genes with gene sets determined in this
           study.

      OUTLINE: This is a multicenter study.

      Samples are used in molecular profiling by applying a custom panel of breast cancer-related
      genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay,
      immunohistochemistry, and other studies.
    

Intervention name(s): RNA analysis; microarray analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E2197
      
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission
Condition: HIV
Study type: Interventional

Summary: 
      Violence against women (VAW), the most extreme manifestation of the unequal power balance
      between women and men, is a major global public health concern. One of the most common forms
      of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of
      women reported having experienced physical and/or sexual intimate partner violence (IPV) in
      their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence
      has also linked IPV and HIV risk.

      This study is a cluster randomized controlled trial assessing the impact of a community-based
      intervention focused on Intimate Partner Violence and HIV delivered in the context of the
      Ethiopian coffee ceremony, a culturally established forum for community discussion and
      conflict resolution. Villages will be randomly assigned to one of 4 study arms (3
      intervention and one control arm): 1) Women only participate in the intervention, 2) Men only
      participate, 3) Both men and women (couples) participate, 4) Women and men receive the
      control intervention comprising a short informational session on violence reduction.
    


Intervention name(s): Intervention to reduce IPV and HIV
Intervention type(s): Behavioral
Intervention description(s): The Ethiopian traditional coffee ceremony will be used as an entry point for a community based intervention to provide information, change behaviour around IPV and improve gender equity and intra-couple relations. The coffee ceremony is a culturally established forum for community discussion and conflict resolution and an integral part of Ethiopian life. The intervention will involve regular coffee ceremonies, during which approximately 20 members of the community will participate in education and discussions centred on gender issues, sexuality, communication and conflict resolution, HIV/AIDS and its link with violence, as well as HIV/AIDS prevention. Each coffee ceremony will be moderated by a female or male facilitator trained in participatory learning, moderation, HIV/AIDS prevention, counselling, and gender issues. The intervention will involve 14 two-hour session per group of participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gender; Physical Violence; Sexual Violence; HIV; AIDS; Prevention; Community Intervention; Ethiopia; Intimate Partner Violence
Social Media Use of Psoriasis Vulgaris Patients: Multicenter, Survey Work
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      Psoriasis Vulgaris is a chronic, recurrent, inflammatory and hyperproliferative skin disease.
      Joint involvement is common along with skin involvement. However, metabolic diseases, such as
      cardiovascular diseases can be accompanied by many systemic diseases, chronic and repetitive
      due to the quality of life and psychological status of patients can affect. For this reason,
      patients carry out various research on their diseases on social media and follow programs on
      these issues in other media such as television and radio. However, there is no study on how
      much patients are interested in these publications, how much they trust them, and how they
      reach and organize information via social media. The aim of the study will be to clarify how
      and how patients with Psoriasis Vulgaris use social media to obtain information about the
      diagnosis and treatment of their disease, the interaction of patient groups with each other,
      and how often social media is used, especially in which group of patients.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        psoriasis vulgaris patients
Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck
Condition: Head and Neck Neoplasms
MeSH terms: Neoplasms; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study will be to determine the safety and tolerability of intratumoral
      M4N. Patients suffering from cancer of the head and neck that is recurrent after primary
      treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is
      a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for
      three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor
      volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4
      weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated
      for 6 weeks, and finally, 8 weeks.
    

Detailed description: 
      Study data collected will include pre-study demographics and measurements, treatment
      compliance, efficacy determined by tumor measurements, M4N levels in blood for
      pharmacokinetics, serum and biochemical determinations, hematology determinations, and
      patient vital signs.
    

Intervention name(s): M4N
Intervention type(s): Drug
Intervention description(s): Dose escalation study of M4N administered intratumorally on days 1, 8 and 15. Dose escalated in cohorts on three weeks schedule to a target of 20 mg/cm3 tumor volume.
Other intervention name(s): Tetra-O-Methyl Nordihydroguaiaretic Acid or EM-1421
Intervention MeSH terms: Masoprocol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol
Condition: Surgery Related to Lower Extremity Under Spinal Anesthesia
Study type: Observational

Summary: 
      Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent
      bolus of sedative frequently results in inappropriate sedation which comes with various side
      effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use
      target-controlled infusion(TCI) to provide proper sedation without serious side effects.

      In this study, the investigators try to find the appropriate propofol target concentration
      with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol
      target concentration and side effects.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who have lower extremity surgery under spinal anesthesia at Gangnam Severance
        Hospital
Use of Ultrasound in Lower Extremity Blocks.
Condition: Regional Anesthesia
Study type: Interventional

Summary: 
      Nerve "freezing" injections of the leg are very useful in providing anesthesia and pain
      relief for knee and ankle surgery. However, current nerve "freezing" techniques are "blind".
      As a result, they are not always successful and may cause complications, albeit infrequent.

      The objective of the current study is to determine any advantage in performing these
      "freezing" injections under direct ultrasound guidance, to "visualize" the nerves. We feel
      that by developing this technique, it will allow us to perform these procedures with greater
      success and fewer complications.
    

Detailed description: 
      This study is a randomised controlled trial. Its objective is to compare results and
      complications between two techniques of nerve localisation for nerve blocks of the lower
      limb. We have developed a real-time, image guided approach to nerve blocks of the lower
      extremities in three locations: the femoral nerve in the groin and the sciatic nerve in the
      buttock and/or popliteal fossa. We have used ultrasound imaging to locate and asess the
      nerves of the lower extremities and to use it as a real-time guidance for performance of
      lower extremity blocks in patients undergoing orthopaedic procedures. The results of our
      previous study will be presented as a case series reporting anatomical appearance of the
      nerves studied, time for block performance and success rates. In this study we aim to compare
      these parambeters between standard and ultrasound techniques of lower extremity block, to
      show any advantage.
    

Intervention name(s): Ultrasound
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
A Study of 1592U89 in HIV-Infected Children
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months
      until 14th birthday) with advanced HIV infection who have few treatment options available.
      The study also examines the effect 1592U89 has on the levels of HIV in the blood.
    

Detailed description: 
      This is an open-label, non-randomized study. All patients will be treated with 1592U89.
      Additionally, since optimal therapy usually includes the combined use of 2 or more
      antiretroviral agents in advanced patients, other novel antiretroviral therapies may be
      accessed through commercial means or via compassionate use programs. NOTE: 1592U89 should not
      be administered as a single new agent added to a failing treatment regimen.
    

Intervention name(s): Abacavir sulfate
Intervention type(s): Drug
Intervention MeSH terms: Abacavir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; CD4 Lymphocyte Count; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; abacavir