bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
Condition: Valvular Heart Disease
MeSH terms: Heart Diseases; Heart Valve Diseases
Study type: Interventional

Summary: 
      Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to
      be associated with hemodynamic instability, organ dysfunction and increased postoperative
      morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an
      adjuvant therapy in patients with myocardial infarction or in the patients undergoing
      valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known
      to prevent excretion of lactate and to increase the extraction of lactate after reperfusion
      with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury
      of myocardium after CPB, to improve myocardial contractility, insulin resistance and
      hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to
      the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.
    


Intervention name(s): (Glucose-Insulin-Potassium)GIK group; normal saline group
Intervention type(s): Drug; Drug
Intervention description(s): infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery; same rate of normal saline
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: GIK, valvular heart surgery, lactate
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and
      cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
      killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may
      be effective in treating cancer and blocking the body's immune response. Monoclonal
      antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth
      in different ways. Some block the ability of cancer cells to grow and spread. Others find
      cancer cells and help kill them or carry cancer-killing substances to them. Giving
      chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer
      cells.

      PURPOSE: This phase II trial is studying how well giving doxorubicin together with
      vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y
      90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell
      lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R
           followed by consolidation therapy.

      Secondary

        -  Determine overall survival.

        -  Evaluate relapse-free survival for patients achieving complete or partial response.

        -  Determine the rate of disease progression.

        -  Determine response rate at the end of study therapy.

        -  Assess the toxicities of this regimen.

      OUTLINE: This is a multicenter study.

        -  Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin
           hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and
           prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.

      Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a
      third course of induction therapy.

        -  Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90
           ibritumomab tiuxetan IV on day 0.
    

Intervention name(s): rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate; yttrium Y 90 ibritumomab tiuxetan
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma
A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed to generate data for the investigation of absorption,
      distribution, metabolism and elimination (ADME) processes of pracinostat in humans, as well
      as generating samples for metabolite profiling and structural identification. The mass
      balance recovery of pracinostat following administration of [14C]-pracinostat will be
      assessed, as well as metabolite profiling and identification of pracinostat in healthy male
      subjects. In addition, this study will provide further PK and safety data in healthy
      subjects.
    


Intervention name(s): pracinostat
Intervention type(s): Drug
Intervention description(s): [14C]-pracinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Digital Intervention for HIV Prevention in Black Adolescent Girls
Condition: HIV; Risk Reduction Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate an innovative behavioral HIV prevention
      videogame intervention to bolster motivation and provide skill-building opportunities to
      improve Black adolescent girls' ability to negotiate around risk including advocating for
      partner HIV/sexually transmitted infection (STI) testing, increasing their knowledge and
      awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.
    

Detailed description: 
      This study will develop and evaluate a multiplayer videogame aimed at Black adolescent girls
      with the intent of teaching the ability to negotiate around risk including advocating for
      partner HIV/STI testing, increasing their knowledge and awareness of HIV/STIs, and for
      reducing sexual risk-taking behaviors.

      The intervention will be developed and delivered as a social, multiplayer videogame, a
      compelling context for Black adolescent girls who constantly interact and seek counsel from
      their peers. To this end, the Specific Aims, focusing on Black adolescent girls aged 14-18
      years, are to:

        1. (Phase 1) Translate the culturally and socially-tailored card game One Night Stan to a
           multiplayer videogame called InvestiDate using game design and content experts and focus
           group input from 30 Black adolescent girls.

        2. (Phase 2) Conduct a pilot randomized controlled trial comparing the multiplayer
           videogame InvestiDate (the new adaptation of the One Night Stan intervention) vs. an
           attention/control non-health-related multiplayer videogame with 80 participants
           collecting assessment data at baseline, one, and four months to:

             1. Determine the intervention's acceptability and feasibility by collecting
                quantitative and qualitative data on Black adolescent girls' satisfaction and
                gameplay experience of the intervention.

             2. Determine the preliminary impact of the intervention on knowledge (information),
                intentions/attitudes (motivation), social norms, and behavioral skills as related
                to: i) HIV/STI testing and partner testing and ii) condom use, and iii) sexual risk
                behavior reduction, such as alcohol and drug use.
    

Intervention name(s): InvestiDate; Non-Health Related Video Game
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).; Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Black adolescent girls
A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants
Condition: Healthy Subjects
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the PK and safety after administration of three types of E0302 SR tablets (SR1,
      SR2, SR3) and E0302 IR tablet.
    


Intervention name(s): E0302 SR1; E0302 SR3; E0302 SR2; E0302 IR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): E0302 SR1, oral tablet.; E0302 SR3, oral tablet.; E0302 SR2, oral tablet.; E0302 IR, oral tablet.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: E0302; Healthy Subjects; E0302 SR Tablet; E0302 IR Tablet
Fed Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg
      Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg
      Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under
      fed conditions.
    

Detailed description: 
      An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of
      Single Doses of Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak,
      Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono
      Ltd, UK) in Healthy, Adult Male and Female Subjects Under Fed Conditions.

      During each period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0,
      4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0
      hours after IMP administration.
    

Intervention name(s): Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine); Glucophage® XR 1000 mg Prolonged Release Tablets
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of the Test (T) product was administered orally with 240 mL of water.; One tablet of the Reference (R) product was administered orally with 240 mL of water.
Other intervention name(s): Diaformin ® SR; Glucophage® XR
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Metformin 1000 mg Prolonged Release Tablets; Metformin; Prolonged Release Tablets
Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and
      improve the shoulder function on patients with rotator cuff rupture. Despite the improved
      surgical techniques and decreased failure rate, there are still complications after the
      surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore,
      rehabilitation after the RC repair procedure is crucial for the success of the treatment.
      However, there is no concencus between the post-operative rehabilitation protochol. The aim
      of this study is to compare two different rehabilitation protochols on patients with RC
      repair.
    

Detailed description: 
      Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and
      improve the shoulder function on patients with rotator cuff rupture. Despite the improved
      surgical techniques and decreased failure rate, there are still complications after the
      surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore,
      rehabilitation after the RC repair procedure is crucial for the success of the treatment.
      However, there is no concencus between the post-operative rehabilitation protochol. The aim
      of this study is to compare two different rehabilitation protochols in terms of shoulder
      range of motion, self-reported shoulder function and pain on patients with RC repair.
    

Intervention name(s): Hospitalized rehabilitation; Home-based rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Patients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks; Patients will recive a home program once in a two weeks until the 6. weeks of post-operative period. Then will start to recieve a rehabilitation program ar the clinic once in a week auntil the 12. week of the post-operative period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: shoulder; rotator cuff; exercise
The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients
Condition: Cancer Patients
Study type: Interventional

Summary: 
      This study was conducted as a non-randomized control group experimental study to determine
      the effect of virtual reality glasses on vital signs and state anxiety levels.
    

Detailed description: 
      Purpose This study was conducted as a non-randomized control group experimental study to
      determine the effect of virtual reality glasses on vital signs and state anxiety levels in
      cancer patients receiving chemotherapy for the first time.

      Methods and Sample The population of the study was composed of adult patients admitted to an
      oncology hospital in Ankara province with a diagnosis of stage I-II-III cancer to undergo
      chemotherapy treatment for the first time. The sample of the study consisted of 30 patients
      who were assigned to the intervention and control groups by the stratified sampling method
      (considering such characteristics as age, gender, marital status). The patient identification
      form, Spielberger state anxiety scale, patient opinion form, vital signs follow-up form, and
      virtual reality glasses were used to collect the data.
    

Intervention name(s): Virtual Glasses
Intervention type(s): Device
Intervention description(s): In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel & Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel & Relax is a Paris-Notre Dame museum tour video.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Semi-experimental
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chemotherapy; Virtually Reality; Anxiety; Nursing
The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine differences in lower extremity landing biomechanics
      and real-world physical activity between individuals with patellar tendinopathy compared to
      individuals without patellar tendinopathy,and to determine the acute effects of an isometric
      loading intervention on lower extremity landing biomechanics in individuals with patellar
      tendinopathy.
    


Intervention name(s): Isometric Exercise; Sham Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Other; Other
Intervention description(s): 5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.; 5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.
Other intervention name(s): Therapeutic Exercise; Sham TENS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Exercise; Physical Activity; Biomechanics
Risk Factor Analysis for Developing Metabolic Syndrome in Korean Adults
Condition: Metabolic Syndrome, Atherosclerosis
MeSH terms: Atherosclerosis; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore,
      the investigators intend to the collect the blood sample, laboratory, anthropometric, and
      body composition parameters prospectively to examine the risk factors of metabolic syndrome.
      Furthermore, the investigators will collect the data of carotid IMT and branchial ankle pulse
      wave velocity to clarify the metabolic risk factors of atherosclerosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Apparently healthy people who underwent medical routine check up in Korea University Helath
        Promotion Center.
Assessment of 2012 Bioequivalence Standards for Warfarin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the 2012 bioequivalence statistical criteria for
      warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the Food
      and Drug Administration (FDA).
    

Detailed description: 
      This study is a reasonable starting point to assess the appropriateness of the 2012 FDA
      bioequivalence (BE) statistical criteria for narrow therapeutic index drugs (NTIDs). The idea
      stems from an earlier study conducted in Dr. Benet's lab with the drug furosemide. The
      furosemide study yielded triplicate data that were unable to purely meet the BE statistical
      criteria set forth by the FDA due to the inherent study design. Furosemide is not an NTID to
      be considered by the FDA for BE studies, however. Hence, the investigators have proposed a
      new study to assess the BE statistical criteria with warfarin, an NTID with a draft guidance
      issued by the FDA. By providing the reference product (brand name warfarin) three times to
      each study participant and recording the relevant pharmacokinetic parameters for BE (AUC and
      Cmax), the investigators can make three comparisons between the data (R1 and R2 vs. R2 and
      R3; R1 and R2 vs. R1 and R¬3; R2 and R3 vs. R1 and R3).

      The investigators have three concerns that can be tested here.

        1. Will normal within subject variability potentially lead to inequivalence of the
           reference product using the new NTID BE regulations?

        2. Is it possible that the BE interval could be less than the United States Pharmacopeia
           (USP) content uniformity limits for warfarin?

        3. Provide a comparison of the within-subject variance for the 2.5 ratio comparison.
    

Intervention name(s): warfarin
Intervention type(s): Drug
Intervention description(s): warfarin 10 mg PO x 1
Other intervention name(s): Coumadin; Jantoven
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: warfarin; pharmacokinetics; bioequivalence; healthy volunteer
To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
Condition: Hypoxia; Hypercapnia
MeSH terms: Hypoxia; Hypercapnia
Study type: Interventional
Phase: Phase 2

Summary: 
      A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels
      of patients during endoscopy which have used either the new oral-nasal oxygenating device
      (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of
      oxygen.
    

Detailed description: 
      Hypoxia is common during endoscopy. Following sedation induction, oxygen saturation falls
      moderately in most patients, whilst some drop to unacceptable levels. To monitor such changes
      endoscopic practices routinely use oximeters and capnography.

      TwinGuard is an all-in-one device which incorporates a bite block with the functionality of
      nasal cannula as well as monitoring expired air (carbon dioxide)
    

Intervention name(s): TwinGuard; Standard endoscopic bite block; Standard nasal cannula; CO2 sample line
Intervention type(s): Device; Device; Device; Device
Intervention description(s): A system consisting of an endoscopic bite block that fits together with a nasal cannula. After gastroscopy, the bite block is discarded leaving the patient receiving oxygen in recovery.An optional carbon dioxide sampling device fits with the TwinGuard in endoscopy to monitor expired air.; Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth; Delivers oxygen to the nose. Tubing runs from the nose around the back of the ears and under the chin which then runs to an oxygen source.; Samples expired air from a patients nose. Tubing is connected to a capnograph.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: prevention of hypoxia; prevention of hypercapnia
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Children with cystic fibrosis require increased caloric intake to maintain appropriate
      growth, an important determinant of long-term outcomes. This study seeks to determine the
      feasibility of using a novel therapeutic food to promote weight gain and growth in children
      with cystic fibrosis.
    


Intervention name(s): Cystic Fibrosis Ready to Use Supplemental Food
Intervention type(s): Dietary Supplement
Intervention description(s): Specially formulated for use by children with Cystic Fibrosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment