bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients
Condition: Hyperglycemia in Critically Ill Patients
MeSH terms: Hyperglycemia; Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves
      lives. However, this is difficult to do in the ICU and carries risks of lowering the blood
      sugar too much. In addition, the best way to achieve this control is not known. Many strict
      nomograms that provide a standardized approach for nurses have been developed and validated,
      including one here at SMH. However, these nomograms cannot apply to all patients at all
      times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the
      bedside constantly, are very familiar with their patient's needs, and have decades of
      experience in titrating medication doses without a nomogram to achieve a pre-determined
      response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside
      nurse has bought into the importance of the concept of tight glucose control and have been
      introduced to the nomogram here at SMH, their experience and intuition may be more adaptable
      to the changing needs of the patient than an inflexible paper nomogram. This study will
      compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse
      directed) in order to determine whether the nomogram should continue to be used.
    


Intervention name(s): Nursing judgement; Nomogram
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L; A preprinted order outlining a nomogram with instructions for how insulin infusion should be changed based on measured glucose values and how frequent the glucose checks should be
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intensive insulin therapy; glucose control; nurse directed; nomogram directed
Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia Patients
Condition: Aplastic Anemia; Drug Effect
MeSH terms: Anemia; Anemia, Aplastic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, phase II study to compare the efficacy of eltrombopag
      combined with tacrolimus to eltrombopag alone in Chinese subjects with refractory or relapsed
      aplastic anemia. The safety would also be evaluated. Patients would be randomized to receive
      eltrombopag alone or eltrombopag combined with tacrolimus. Treatment with eltrombopag will be
      started at 25 mg/day and increased by 25 mg/day every 2 weeks according to the platelet count
      up to 150 mg/day, or the best response was achieved. Tacrolimus will be given at 1mg bid with
      the target trough concentration of 4-10 ng/mL throughout the study. The hematological
      response rate and safety will be recorded and compared at 3, 6 months and 1 year after
      starting the study treatment (Week 13, 26 and 52).
    


Intervention name(s): Tacrolimus; Placebo (for Tacrolimus)
Intervention type(s): Drug; Drug
Intervention description(s): Tacrolimus will be given at 1mg bid with the target trough concentration to be 4-10 ng/mL.; placebo will be given at 1mg bid.
Other intervention name(s): experimental; control
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, two stage, double-blind, placebo-controlled
      administration study comprising 200 healthy participants.
    

Detailed description: 
      This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled
      study comprising 200 participants. Eligible subjects will be randomized to receive one of the
      following administrations (as two single IM injections with an interval of 21 days between
      each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg - 64
      subjects.

      Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS
      (Placebo)twice - 32 subjects. Participants from administrations A and B will be further
      immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.

      Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose
      - 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with
      50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once with
      50% of TIV dose - 24 subjects
    

Intervention name(s): Multimeric-001, 500 mcg; Adjuvanted PBS; PBS and TIV 15%; PBS and TIV 50%
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days.; Adjuvanted PBS was administered twice with an interval of 19-23 days.; PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered.; PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered.
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HAI; Influenza; prime; boost; immune response; seroconversion; universal; vaccine
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
Condition: Complete Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional

Summary: 
      A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's
      procedure in treatment of complete rectal prolapse to ass both efficacy and complications
    

Detailed description: 
      A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's
      procedure in treatment of complete rectal prolapse to ass both efficacy and complications.

      Follow up is scheduled for 18 months to evaluate recurrence, continence state and
      complications
    

Intervention name(s): Laparoscopic ventral mesh Rectopexy; Delorme's procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic fixation of rectum to sacral promontory using mesh; Transanal excision of rectal mucosa and plication of muscle layer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema
Condition: Heterogeneous Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other
      than the upper lobes, as determined by high resolution computed tomography (HRCT), could have
      a positive response to valve treatment.
    


Intervention name(s): Intra-bronchial valve (Spiration IBV)
Intervention type(s): Device
Intervention description(s): Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
Other intervention name(s): Spiration IBV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrabronchial valve; heterogeneous emphysema; non-upper lobe
Joint Effort Study
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability
      and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile
      application) aimed at supporting university-level students into taking action on their
      cannabis use. The two main objectives of the proposed study are:

        1. To assess the acceptability of the Joint Effort mobile application in terms of uptake,
           engagement and intervention appreciation.

        2. To document the feasibility of the study processes in terms of online recruitment rate,
           adherence to online data collection methods, and attrition rate.
    


Intervention name(s): Joint Effort; Brief normative feedback and standard information
Intervention type(s): Other; Other
Intervention description(s): The Joint Effort intervention is available in the form of an iPhone mobile application (running on iOS 13 and 14) in French language. It aims to support young adults in school who have used cannabis in the past month into taking action on their cannabis use.; The brief normative feedback is based on the frequency of cannabis use use. Participants will also be offered basic reliable non personalized information on lower-risk cannabis use in the form of official public websites.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Gastric pH in Critically Ill Patients
Condition: Critically Ill Patients; Indication for Stress Ulcer Prophylaxis
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill
      patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor
      antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is
      unknown, whether proton pump inhibitors are more effective in increasing gastric pH than
      H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.
    

Detailed description: 
      Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between
      7 and 15cm below the lower esophageal sphincter.
    

Intervention name(s): esomeprazole; ranitidine
Intervention type(s): Drug; Drug
Intervention description(s): 40mg once daily; 50mg every h hours
Intervention MeSH terms: Esomeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Arterial Oxygen Parameters on Antioxidant Parameters
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational [Patient Registry]

Summary: 
      We aimed to measure the changes in your blood values caused by different but safe oxygen
      values used by us during your heart surgery under laboratory conditions.
    

Detailed description: 
      Hyperoxia is often preferred due to the risk of tissue hypoxia that may develop in cardiac
      surgery. It is thought that with hyperoxemia, ischemia reperfusion damage increases,
      microcirculation is impaired and tissue oxygenation is impaired.Oxidative damage occurs in
      cases of increased oxidative stress and impaired antioxidant balance.It was aimed to
      investigate oxidative damage by recording modified albumin and thiol disulfide in blood
      simultaneously by recording arterial oxygen levels at determined times during cardiac
      surgery.
    

Intervention name(s): taken venous sample
Intervention type(s): Diagnostic Test
Intervention description(s): Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        128 patients scheduled for cardiac surgery
      
Keywords: cardiovascular surgery; antioxidant; tiyol-disülfid homeostasis; ischemia modified albumin
Sun Protection Factor Assay (343/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521; SPF Control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-104); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Mobile Self Management and Support for Adolescents and Young Adults With Cancer
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional

Summary: 
      This study is the user testing phase of a mobile application intervention which will be
      designed to promote positive coping skills, illness resilience, and social support, and to
      serve as a complement to patient-physician interactions in adolescents and young adults (AYA)
      with sarcoma. User testing will be conducted with a prototype of the app. Participants will
      be AYA ages 13-25 with sarcoma (N=16). Study participation involves the AYAs downloading and
      using the app for 30 days. During the 30 days, participants will interact with the app by
      inputting their current mood, receiving supportive feedback from the app, reading messages,
      and doing brief activities (such as relaxation activities, etc.). Participants will also
      participate in an online focus group focused around the user experience. Before and after the
      30 days of user testing, participants will complete a few brief questionnaires about their
      behavior, how their symptoms affect their life, and how they receive support from others.
      These questions will take around 20 minutes to complete at each administration.
    


Intervention name(s): Pocket Coach for AYA with Cancer
Intervention type(s): Behavioral
Intervention description(s): The Pocket Coach for AYA with Cancer is a psychosocial intervention to be delivered through a mobile platform. Intervention content is based on Mindfulness Based Stress Reduction (MBSR) and the Resilience in Illness Model [Dr. Joan E. Haase et al] and includes modules on relaxation, mindfulness, cognitions, and self-compassion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have
      antibodies among children seeking medical care for non-Covid-19 related conditions.

      The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not
      been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the
      level of immunity in this population which could inform further decisions about covid-19
      vaccine strategies for children
    

Detailed description: 
      Enrolled participants will have a survey about demographic information, history of previous
      suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status.
      For participants aged less than 12 months, participants' mothers' status of Covid-19
      vaccination and/or previous infection will be recorded. Participants will then complete
      serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens
      collected/stored for routine laboratory tests on the date of enrollment. The study will
      characterize the prevalence of antibody positivity in this population and assess whether
      there is a correlation between demographic characteristics and antibodies levels.
    

Intervention name(s): SARS-CoV-2 IgG Antibody testing
Intervention type(s): Diagnostic Test
Intervention description(s): IgG Antibody testing for previous exposure to SARS-CoV-2
Intervention MeSH terms: Antibodies; Immunoglobulin G
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In-patient or out-patient children aged from 0 to 18 years old, who have not have not been
        previously diagnosed and are presumed/confirmed COVID-19 negative, have blood specimens
        collected for routine biochemistry tests.
      
Keywords: SARS-CoV-2; Seroprevalence; IgG Antibodies; Children; Vietnam; Covid-19
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the relative bioavailability of
      BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)
      compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),
      both in the fasting state. All 42 subjects entered are planned to be included in this
      comparison.

      The secondary objective is to investigate the relative bioavailability of BI 10773 /
      linagliptin fixed dose combination tablet after administration of a standardised high fat,
      high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin
      fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the
      42 subjects entered 18 subjects are planned to be included in this comparison.

      An additional objective is to investigate the relative bioavailability of a second
      formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation
      A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet
      (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned
      to be included in this comparison.
    


Intervention name(s): BI 10773/linagliptin; BI 10773/linagliptin; BI 10773/linagliptin SID; BI 10773/linagliptin FDC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): medium single dose of BI 10773/linagliptin FDC (Formulation A1); medium single dose of BI 10773/linagliptin FDC (Formulation A3); medium single dose of mono components BI 10773/linagliptin; medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
Intervention MeSH terms: Linagliptin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Condition: Diabetes; Hypertension; Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and
      death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United
      States. The purpose of this study is to prevent progression of kidney disease among patients
      with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that
      simultaneously address medication management and modifies multiple risk factors through a
      combination of patient self-monitoring, behavioral therapies and education to optimize
      adherence and self-efficacy. Additional goals are to improve control of cardiovascular
      disease risk factors and reduce cardiovascular events and death.

      We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will
      have less progression, or a smaller decrease in kidney function, after 3 years when compared
      to the education control group.
    

Detailed description: 
      A randomized, controlled trial to slow DKD progression:

        1. Using an innovative telehealth approach that is potentially scalable with demonstrable
           efficacy in reducing antecedents of kidney disease, including poor blood pressure,
           glucose, and lipid control

        2. Enrolling demographically diverse patients from local primary care clinics to allow
           applicability of our results to the general US population within existing delivery
           systems; and

        3. Targeting patients with moderate DKD (estimated glomerular filtration rate between 45-90
           ml/min/1.73m2 with evidence of diabetic nephropathy) and uncontrolled HTN (blood
           pressure ≥140/90 mm Hg), accounting for about 20% of all patients with diabetes who
           disproportionately suffer from end-stage renal disease (ESRD), cardiovascular events,
           and death.
    

Intervention name(s): Pharmacist telehealth intervention
Intervention type(s): Behavioral
Intervention description(s): A tailored intervention with medication management and behavioral components. The behavioral modules may include, diet, exercise, weight, tobacco use, medication management, side effects, diabetes education, DKD/ HTN/ CVD risk and knowledge.Based on the patient's responses to a series of questions, there will be a provision of tailored feedback to reinforce evidence-based behavior for disease and lifestyle management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research