bioihbjkbjnl/mcl2 huggingface dataset:
Hemodynamic Assessment in Acute Decompensated Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This study will assess the ability of a novel optical measurement system to determine changes
      in the hemodynamic status of heart failure patients admitted to the hospital with a primary
      diagnosis of acute decompensated heart failure. Patients will be measured with both the novel
      measurement system and reference devices that are FDA-cleared for hemodynamic measurements.
      The measurements from the novel system will be compared to reference variables describing
      hemodynamic and congestive status, including stroke volume, central venous pressure, and
      serum levels of NT-proBNP.
    

Detailed description: 
      This study will assess the ability of a novel optical measurement system to determine changes
      in the hemodynamic status of heart failure patients admitted to the hospital with a primary
      diagnosis of acute decompensated heart failure. Patients will be measured with both the novel
      measurement system and reference devices that are FDA-cleared for hemodynamic measurements.
      The measurements from the novel system will be compared to reference variables describing
      hemodynamic and congestive status, including stroke volume, central venous pressure, and
      serum levels of NT-proBNP.

      All patients enrolled in the study will first provide written informed consent to participate
      and then the research coordinator will check that the subject meets all study inclusion
      criteria and does not meet any of the study exclusion criteria. Enrolled subjects will
      undergo up to six (6) hemodynamic assessment sessions lasting less than 90 minutes each over
      the course of their hospitalization. There will be at least eight (8) hours between
      assessment sessions.

      Each assessment session includes recording of the subject's weight, measurements with the
      reference devices, and measurements with the novel optical system. During the session, the
      subject will be assessed in the supine, sitting, and standing positions. NT-proBNP
      measurements will be done at the start of study participation and the end. A market research
      questionnaire will be administered to the subject following the first measurement session.
    

Intervention name(s): Noninvasive Hemodynamic Measurement System
Intervention type(s): Diagnostic Test
Intervention description(s): Ability of the noninvasive hemodynamic measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects diagnosed with congestive heart failure and admitted to the hospital with a
        diagnosis of acute decompensated heart failure (ADHF).
      
Keywords: CHF; central venous pressure; noninvasive; ADHF; stroke volume
Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of patients with urinary incontinence after prostatectomy using injection of
      autologous adipose-derived mesenchymal stem cells mixed with collagen gel
    

Detailed description: 
      During the implementation of the project, it is planned to develop a method for the treatment
      of men urinary incontinence caused by prostatectomy using injection of autologous
      adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the
      effectiveness of MSCs is due to the following:

        -  the ability of MSCs to stimulate tissue regeneration

        -  positive results of preclinical studies of the method of treatment of urinary
           incontinence in animals.

      In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured
      and then transplanted back to the periurethral area by five point injection in
      rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in
      submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow
      up patients monitoring will occur at 1，3，6 and 12 months after injection.
    

Intervention name(s): Autologous adipose-derived mesenchymal stem cells; Standard treatment according to the Clinical protocols
Intervention type(s): Biological; Other
Intervention description(s): Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space; Standard treatment according to the Clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary incontinence; Prostatectomy
Luteal Phase FSH in the IVF Poor Responder
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty
      conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's
      ovaries and fertilized with sperm in the laboratory. In order to maximize the number of
      oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant
      follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in some cases
      there is a limited response to the stimulation, producing a limited number of oocytes. This
      is called poor ovarian response.

      This study is designed to objectively compare two treatment regimens currently advocated in
      clinical practice, but never compared directly. The purpose is to assess ovarian response to
      starting treatment at the end of the preceding cycle may increase the number of developing
      oocytes.
    


Intervention name(s): follitropin beta; ganirelix acetate
Intervention type(s): Drug; Drug
Intervention description(s): Follitropin beta; Ganirelix acetate
Intervention MeSH terms: Follicle Stimulating Hormone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infertility; in vitro fertilization
Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
Condition: Embolism and Thrombosis of the Radial Artery; Coronary Heart Disease
MeSH terms: Heart Diseases; Thrombosis; Embolism; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Embolism and Thrombosis
Study type: Interventional

Summary: 
      The objective of this study is to determine the rate of radial artery occlusion and vascular
      access site complications following transradial angiogram using a new Terumo (Tokyo, Japan)
      Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.
    

Detailed description: 
      Based on previously reported studies the rates of radial artery occlusion using a standard 6
      Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath
      Slender by Aminian et al (see reference in the citations), the rate of radial artery
      occlusion was reported 0.88%.

      This study will be a prospective randomized, single-blinded (patient-blinded) study,
      comparing the rate of radial artery occlusion and vascular access site complications between
      the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in
      patients undergoing transradial coronary catheterization.

        -  The study will enroll patients who will undergo elective or emergency coronary
           angiography and/or percutaneous coronary intervention (PCI) via transradial approach at
           the University of Ottawa Heart Institute.

        -  A baseline clinical vascular & ultrasound assessment will be performed prior to the
           procedure to document patency of the radial artery.

        -  Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath
           Slender versus the currently used 6 Fr. sheath.

        -  The standard angiogram/ PCI will be performed as per usual practice.

        -  Following the angiogram, clinical vascular assessment as well as an ultrasound will be
           performed prior to discharge.

        -  At 30 days follow up the patient will come back for clinical and ultrasound assessment
           of radial artery patency and access site vascular complications.
    

Intervention name(s): Glidesheath Slender; standard 6- French radial sheath
Intervention type(s): Device; Device
Intervention description(s): testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
Other intervention name(s): Glidesheath Slender, Terumo, Tokyo, Japan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: transradial coronary angiography; radial artery occlusion; coronary heart disease; Glidesheath Slender
Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation
Condition: Acute Mechanical Ventilatory Failure
MeSH terms: Hypoventilation
Study type: Interventional

Summary: 
      The indications for mechanical ventilation (MV) include excessive work of breathing, with or
      without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge
      because it is based on criteria understudied, often subjective and observer-dependent.
      Despite several studies, to our knowledge has never been done before is the precise
      definition of the optimal range of ventilatory support. Novel and recognizable diagnostic
      techniques will be applied. No single parameter of the breathing pattern has good accuracy
      for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of
      muscle relaxation may have good accuracy for the adjustment of ventilatory support.
    

Detailed description: 
      Use of excessive pressure support
    

Intervention name(s): Variation of the level of pressure support during the mechanical ventilation
Intervention type(s): Procedure
Intervention description(s): The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2
      mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and
      activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up
      visits are also required periodically through day 43. Study procedures involve taking blood
      samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
    


Intervention name(s): Single Ascending Dose Cohorts GS-9620; Multiple Ascending Dose Cohorts GS-9620
Intervention type(s): Drug; Drug
Intervention description(s): This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.; This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Intervention MeSH terms: Vesatolimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis; Hepatitis C; Chronic HCV; HCV; Treatment Naive; Gilead; GS-9620
Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This is a multi-site study to examine error-related brain activity (i.e., the error-related
      negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated
      by two years. The study examines the degree to which error-related negativity can predict
      anxiety prospectively over two years, and whether a computerized game that alters attention
      to threat can alter error-related negativity and trajectories of anxiety.
    

Detailed description: 
      Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed.
      Adolescents will be evaluated at baseline using event-related potentials, self-report, and
      interview-based measures. The error-related negativity will be evaluated immediately (it
      takes less than 5 minutes to process and score a single subjects' error-related negativity ),
      and adolescents with good error-related negativity data (~90%, based on scorable
      error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16
      session) adaptive attention bias modification (N=180) or control condition (N=180) or a
      waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be
      asked to complete two 20-minute sessions per week. Participants will be assessed immediately
      at post, using the same measures from the baseline assessment. All participants will complete
      a 2-year follow-up lab visit using the same measures from the baseline assessment.
    

Intervention name(s): Attention Bias Modification
Intervention type(s): Other
Intervention description(s): A computer game is used to facilitate attention away from threatening words.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adolescents are randomized to either a game that trains attention away from threat (attention bias modification), a game that trains attention but unrelated to threat (control condition), or a wait list group.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
Condition: Respiratory Syncytial Virus (RSV)
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the administration of single ascending
      intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in
      adults 60 years or older who are healthy or who have stable, chronic underlying medical
      conditions.
    

Detailed description: 
      A phase 1a, first time in human, double-blind, randomized, placebo-controlled, cohort
      escalation study evaluating the safety and tolerability of a single ascending intramuscular
      dose of RSV sF or MEDI7510 or placebo.

      Approximately 146 participants will be enrolled at 3 US study centers and randomized in a 5:1
      ratio by cohort as described below:

      Cohort 1: RSV sF 20 microgram (mcg) (n=20) or placebo (n=4) Cohort 1a: MEDI7510 (20 mcg RSV
      sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or
      placebo (n=4) Cohort 2: RSV sF 50 mcg (n=20) or placebo (n=4) Cohort 2a: MEDI7510 (50 mcg RSV
      sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or
      placebo (n=4) Cohort 3: 80 mcg RSV sF (n=20) or placebo (n=4) Cohort 3a: MEDI7510 (80 mcg RSV
      sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or
      placebo (n=4)
    

Intervention name(s): Placebo; RSV sF 20 mcg; MEDI7510 (20 mcg RSV sF); RSV sF 50 mcg; MEDI7510 (50 mcg RSV sF); RSV sF 80 mcg; MEDI7510 (80 mcg RSV sF)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.; Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus (RSV); MEDI7510
Lithium Drug-Drug Interaction Study With Lurasidone HCl
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and
      Lurasidone HCl.
    

Detailed description: 
      To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered
      alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when
      coadministered with steady state lithium 600 mg BID.
    

Intervention name(s): Lurasidone HCl
Intervention type(s): Drug
Intervention description(s): lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD).
Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID).
On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast.
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Lithium DDI with Lurasidone HCl; Male/Female, Schizophrenia Patients
A Comparative Study Minisling Versus Transobturator (TOT)Sling
Condition: Female Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot
      with minisling.
    

Detailed description: 
      eligibility criteria was : female stress urinary incontinence
    

Intervention name(s): Mini-sling; Transobturator
Intervention type(s): Procedure; Procedure
Intervention description(s): The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.; Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
Other intervention name(s): Mini-sling Ophira™; Transobturator Sling Unitape™
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urodynamic Stress urinary incontinence; Minisling; Ophira™; Unitape™
Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study
Condition: Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      This is a prospective randomized multicenter study which purpose is to determine whether
      triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the
      incidence of surgical wound infections.
    


Intervention name(s): triclosan coated suture for surgical wound closure; regular sutures for surgical wound closure
Intervention type(s): Procedure; Procedure
Intervention description(s): triclosan coated suture for surgical wound closure
Intervention MeSH terms: Triclosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: surgical wound infection; triclosan-coated suture
Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA)
      approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase
      PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of
      other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and
      Humulin-R in order to determine if it improves the absorption of these insulins to more
      closely mimic the body's natural increase in insulin in response to a meal.
    

Detailed description: 
      Participants received all 4 interventions in the same order.

      Dose-finding visits were conducted to identify the appropriate dose of Humalog and Humulin-R.
      For each Humalog dose-finding visit, a total of 24 U of rHuPH20 was injected SC per unit of
      Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL)
      rHuPH20 (at final concentration of 91 U/mL of Humalog). For each Humulin-R dose-finding
      visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a
      mass concentration of 20.0 μg/mL rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
    

Intervention name(s): Humalog; Humulin-R; Recombinant human hyaluronidase PH20 (rHuPH20); Liquid meal
Intervention type(s): Drug; Drug; Drug; Other
Other intervention name(s): Insulin lispro; Humulin; Recombinant human insulin; HYLENEX; PH20; Ensure
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Recombinant Hyaluronidase; Type 1 Diabetes Mellitus; Humalog; Humulin R; rHuPH20; Hylenex