bioihbjkbjnl/mcl2 huggingface dataset:
LYmphangiogenesis FacTors in Heart Failure States
Condition: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Heart failure often causes fluid to accumulate in the body, leading to congestion and
      swelling. However, some people who have had heart failure for a long time seem to have very
      little congestion or swelling, even when the heart failure is poorly treated. The
      investigators think that this is because lymphatic vessels are able to grow and remove fluid
      to prevent congestion. The investigators do not know how lymphatic vessels grow. This study
      will investigate the blood levels of various proteins to try to figure out how the lymph
      vessels of people with long-standing heart failure might grow.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All Inpatient and Outpatient individuals undergoing clincially-indicated right heart
        catheterization.
      
Biospecimen description: 
      plasma or serum
    
Keywords: Lymphangiogenesis; Heart Failure
Muscle Relaxants on Efficacy of LMA Insertion
Condition: Anesthesia Intubation Complication
MeSH terms: Muscle Hypotonia
Study type: Interventional

Summary: 
      The use of laryngeal mask airway (LMA) is increasing in pediatric anesthesia because it
      provides lesser direct mechanical stimulation of the airway due to being placed above the
      larynx. However, LMA insertion can be more difficult in children than in adults due to their
      unique characteristics of pediatric airway. Neuromuscular blocking agents, so-called, muscle
      relaxants have long been used to facilitate insertion of airway devices. But there are pros
      and cons for the efficacy of muscle relaxants in LMA insertion, and most studies were
      investigated in adults.
    


Intervention name(s): rocuronium; saline
Intervention type(s): Drug; Drug
Intervention description(s): After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg rocuronium is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues.; After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg saline is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues
Other intervention name(s): Rocuronium bromide; 0.9% normal saline
Intervention MeSH terms: Bromides; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized parallel prospective non-inferiority study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: laryngeal mask airway; children, preschool; muscle relaxant
Subcostal TAP Block For Percutaneous Nephrolithotomy
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Study type: Interventional

Summary: 
      Percutaneous nephrolithotomy (PCNL) is a minimally- invasive procedure for removing kidney
      stones. The small incision of PCNL is performed medially from the posterior axillary line
      according to stones location. Despite the small skin incision patients suffer from
      postoperative pain due to visceral pain and intercostal nerve injury. The aim of this study
      is to evaluate the perioperative analgesic effect of subcostal transversus abdominis plane
      (TAP) block performed prior to PCNL procedure.

      Primary outcome of our study was Morphine consumption at 48th hour after the surgery.
      Secondary outcomes were perioperative fentanyl consumption; postoperative Verbal Analog Scale
      and additional analgesic drug requirement.
    

Detailed description: 
      Patients who were scheduled for elective percutaneous nephrolithotomy were randomized into
      two groups: Group TAP and Group IV. General anesthesia was induced with propofol 2 mg/kg,
      fentanyl 1 mcgr/kg and rocuronium 0,6 mg/kg and maintained with sevoflurane 2% in 40%:60%
      oxygen/air mixture and fentanyl 0,5 mcgr/kg and rocuronium 10 mg, if necessary. Unilateral
      Transversus abdominis plane block was performed with total of 30 ml volume of local
      anesthetic solution (20ml Bupivacaine 0,125% and 10ml Lidocaine 1%) after intubation but
      before surgery to the Group TAP patients. Paracetamol 1 gr, iv was given to the Group IV 20
      minutes before the end of the surgery. Also 100mg Tramadol,iv was administered 20 minutes
      before the end of the surgery to the both groups. Morphine iv patient controlled analgesia
      was applied to both groups. Perioperative fentanyl consumption; postoperative Verbal Analog
      Scale, morphine consumption and additional analgesic drug requirement were determined. Data
      of perioperative complications and adverse effects were also collected. Chi square with Yates
      correction and Mann Whitney U tests were used for statistical analysis.
    

Intervention name(s): Subcostal transversus abdominis plane block
Intervention type(s): Procedure
Intervention description(s): Ultrasound guided Subcostal transversus abdominis plane block is performed after anesthesia induction and endotracheal intubation , to the side where kidney stone is. A composition of 10 ml Lidocaine %1 plus 10 ml physiologic saline solution plus 10 ml Bupivacaine %0,5 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: percutaneous nephrolithotomy; subcostal transversus abdominis plane block; pain; paracetamol; tramadol; morphine; nephrolithiasis; lidocaine; bupivacaine
Escalating Ketamine Doses and Pre-emption
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Ketamine affects postoperative pain when administered intravenously immediately before,
      during or at the end of surgical procedures. We assessed the effects of multiple and
      escalating doses of ketamine administered many hours before surgery on postoperative pain and
      analgesia consumption.
    


Intervention name(s): Ketamine; ketamine; ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS); ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group; ketamine injected IM 17-18, 11-12, and 3-4 hours before surgery (5, 10 and 25 mg, respectively) (K3), and the second group received NS
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Preemption, ketamine, escalating, dose, pain, analgesia
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg
      tablet of lecozotan.
    


Intervention name(s): lecozotan SR
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Compare Bioavailability of RO7239361 After Subcutaneous Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected
      into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
    


Intervention name(s): RO7239361
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 4

Summary: 
      This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics
      effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and
      survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV)
      RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil
      kinetics data will be collected for all subjects up to Day 10 of the study. Following the
      last study visit on Day 10, all subjects will attend two further safety follow-up visits on
      Day 28 and Day 56.
    


Intervention name(s): placebo; tocilizumab [RoActemra/Actemra]
Intervention type(s): Drug; Drug
Intervention description(s): Single i.v. infusion; Single 8 mg/kg i.v. infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Study type: Interventional

Summary: 
      Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart
      from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).
    

Detailed description: 
      Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart
      from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)

      Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids
      etc)

      Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to
      the organ so that liberation of protective mediators occurs. The liberated mediators have
      favorable effects not only upon the myocardium, but it extend to protect other organs against
      inflammatory activation; ischemia reperfusion injury

      Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and
      mortality

      Aim of the work:

      Is to validate the impact of Sevoflurane versus ischemic & Sevoflurane PC upon postoperative
      inotropic score in adult patient undergoing open heart surgery
    

Intervention name(s): A pharmacologic cardiac preconditioning (Sevoflurane); B ischeamic preconditioning
Intervention type(s): Drug; Procedure
Intervention description(s): A Patients are anaesthetized by Sevoflurane more than 1 mac.; B ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Myocardial Preconditioning, inotropic score
Clinical Trial to Evaluate ANT-1401 in Crow's Feet
Condition: Lateral Canthal Lines; Crows Feet
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral
      Canthal Lines.
    


Intervention name(s): ANT-1401; Vehicle
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder
      Treatment.
    

Detailed description: 
      Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial
      support in combination with BP1.3656 to reduce alcohol consumption. The study will be a
      multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups
      to evaluate the effectiveness and the safety of BP1.3656.
    

Intervention name(s): BP1.3656 low dose; BP1.3656 intermediate dose; Placebo; BP1.3656 high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, once daily oral administration at the low dose; Tablet, once daily oral administration at the intermediate dose; Tablet, once daily oral administration; Tablet, once daily oral administration at the high dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Therapeutic Vaccination in Treated HIV Disease
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The central premise of our program is that durable control of HIV in the absence of
      antiretroviral therapy ("remission") will require the generation of de novo potent and
      sustained HIV-specific CD8+ cell responses that target evolutionarily conserved epitopes. Our
      program is inspired by the recent success of VGX-3100 (Inovio), a DNA therapeutic vaccine for
      HPV that leads to histopathologic regression of pre-malignant lesions in people and is
      associated with a potent, sustained boost to HPV-specific CD8+ T cell populations. A closely
      related multi-clade gag/pol/env DNA vaccine administered with an IL-12 DNA plasmid (PENNVAX,
      Inovio) has been studied for HIV prevention and is known to be both safe and highly
      immunogenic. In a randomized placebo-controlled study we will compare the immunogenicity and
      anti-reservoir activities of gag/pol DNA versus gag/pol/env DNA (both administered with
      IL-12). We will determine for the first time in established HIV disease whether presence of
      env in a DNA vaccine blunts T cell responses to more conserved Gag-specific and Pol-specific
      epitopes. We will also determine if Env-specific responses (which will presumably be mediated
      by antibodies and antibody-dependent cellular cytotoxicity, or ADCC) have a measurable effect
      on reservoir.
    


Intervention name(s): PENNVAX-GP; INO-6145; INO-9012; CELLECTRA® 2000
Intervention type(s): Biological; Biological; Biological; Device
Intervention description(s): PENNVAX®-GP is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag, Pol and Env proteins.; INO-6145 is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag and Pol proteins.; The IL-12 DNA adjuvant (INO-9012) consists of a single plasmid containing a dual promoter system for expression of both the IL-12 p35 and p40 genes necessary for production of the active heterodimeric (p70) IL-12 protein.; Electroporation (EP) is a technology in which an electrical field is applied to increase the permeability of cell membranes and thereby enhance the uptake of drugs, vaccines, or other agents into target cells. This technology has been used in the last decade in both therapeutics and vaccinations. EP is currently being used to deliver cancer vaccines and therapeutics as well as in gene therapy. The expression levels are increased by as much as 3 orders of magnitude over plasmid injection alone.
Other intervention name(s): HIV DNA vaccine; HIV DNA vaccine; IL-12 DNA adjuvant; Electroporation device
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HIV Vaccine; Electroporation
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous
      (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric
      participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in
      Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment
      cycle and 14 days of follow-up for a total of 17 days.
    

Detailed description: 
      Upon completion of Cycle 1, participants were given the option to exit the study and be
      considered completed, or to continue on study therapy for up to 2 more (optional) 17-day
      cycles of chemotherapy where fosaprepitant was administered and additional safety data
      collected.
    

Intervention name(s): Fosaprepitant Dimeglumine; 5-HT3 antagonist; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).; All participants received an oral 5-hydroxytryptamine (serotonin; [5-HT]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.; Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
Other intervention name(s): EMEND for injection®; MK-0517
Intervention MeSH terms: Dexamethasone; Fosaprepitant; Aprepitant; Serotonin 5-HT3 Receptor Antagonists
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the results from two methods used to determine the
      renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at
      which appreciable amounts of glucose appear in the urine) in untreated patients with type 2
      diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg
      once-daily canigliflozin for 8 days.
    

Detailed description: 
      This is an open-label (patients will know if they are receiving treatment and the identity of
      the treatment) study that will compare renal threshold of glucose (RTG) values obtained by 2
      different methods: an established method (ie, the stepwise hyperglycemic clamp method) and a
      new method (the mixed meal tolerance test [MMTT] method). The RTG is defined as the lowest
      plasma glucose concentration at which appreciable amounts of glucose appear in the urine.
      Each method for determining the RTG value will be performed in untreated patients with type 2
      diabetes mellitus (T2DM) and in patients with T2DM who are treated with canagliflozin 100 mg
      once daily for 8 days. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is
      currently under development to lower blood sugar levels in patients with T2DM. Patients will
      not take study drug (canagliflozin 100 mg overencapsulated tablets) in Part 1 of the study.
      In Part 2 of the study, patients will take study drug once daily on Study Days 1 through 8.
    

Intervention name(s): Canagliflozin
Intervention type(s): Drug
Intervention description(s): One 100 mg capsule taken orally (by mouth) on Days Days 1-8
Intervention MeSH terms: Canagliflozin
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Canagliflozin; Renal threshold for glucose; Pharmacodynamics
Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy
Condition: Blood Loss, Surgical; Uterine Myoma
MeSH terms: Leiomyoma; Myofibroma; Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 3

Summary: 
      A total of 200 women for elective abdominal myomectomy were randomly allocated into two
      groups.

      100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®)
      through the rectal route prior to surgery and 100 were in control group, in which no drug was
      administered.
    

Detailed description: 
      After getting approval from hospital's ethical committee, patients eligible for the study
      were recruited in the study according to the selection criteria. Before surgery, after taking
      informed written consent, patient's detailed history including demographics, parity & BMI was
      recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing
      myomectomy were randomly divided into 2 groups using lottery method. In experimental group
      Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug
      was administered.

      The surgical procedural elements, the surgeon or surgeons performing the procedure and the
      use of antibiotics as well as anesthetic agents was standardized to remove any bias.
      Intraoperative blood loss was recorded by a single trained doctor and calculated using visual
      scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood
      collected in suction bottle.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): 400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy
Other intervention name(s): Prosotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other