bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.
Condition: Knee Prosthesis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or
      without adrenaline, in a population of patients undergoing knee replacement.
    

Detailed description: 
      Orthopedic population, especially during a knee surgery, is at risk of significant bleeding
      and blood transfusion in the perioperative period. Tissue damage is associated with the
      activation of a cascade of mechanisms, in which the activation of the fibrinolyse plays an
      important role. This is why anti-fibrinolytic agents are regularly used in this context to
      reduce the perioperative bleeding and the use of blood transfusions.

      In the majority of cases, tranexamic acid, an analogue agent of lysine, is administered by an
      intravenous injection and more recently, by an intra-articular injection.

      Several questions however remain unanswered.

        -  what is the clearance of this substance ?

        -  does an intra-articular resorbtion exist, resulting in a plasmatic rate of the substance
           ? If yes, what is the plasmatic rate ?

        -  Is the intra-articular effect of tranexamic acid predominant compared to its systemic
           effect ?

        -  Does the addition of adrenalin increase the effect of the tranexamic acid by acting on
           its absorption ?

      The efficacy, safety and better administration route of the tranexamic acid remain unknown
      when injected intra-articularly. The goal of this study is to realize the first
      pharmacokinetic study after an intra-articular injection of tranexamic acid, alone of along
      with adrenalin, in a knee neo-articulation.
    

Intervention name(s): Tranexamic Acid; Adrenalin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: tranexamic acid; knee prosthesis; pharmacokinetic profile
Adding Intra-articular Dexmedetomidine to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to
      levobupivacaine for postoperative analgesia in arthroscopic knee surgery.
    

Detailed description: 
      Patients between 18-65 years and with American Society of Anesthesiologists' (ASA) Physical
      Status class I-II, who were scheduled for arthroscopic knee surgery, were enrolled in a
      randomised comparative clinical trial. Blinding or masking began in the preoperative holding
      unit. Exclusion criteria were psychiatric illness, younger than 18 yo, who has analgesic
      treatment before the surgery and known hypersensitivity to relevant drugs. All patients
      received a standard anaesthetic protocol; ECG, heart rate, non-invasive blood pressure,
      oxygen saturation and temperature were monitored. After preoxygenation, general anaesthesia
      was induced with sodium pentothal 4 to 7 mg/kg, 1 mcg/kg fentanyl and neuromuscular block was
      achieved with rocuronium 0.5 mg/kg and trachea was intubated. Anesthesia was maintained with
      desflurane 6% and 50% oxygen in the medical air.

      Randomised patients were achieved dexmedetomidine and levobupivacaine or levobupivacaine
      intra-articularly 10 minutes before medical tourniquet deaerated.

      Postoperative analgesia was maintained with morphine in patient-controlled analgesia.
      Patients postoperative VAS values and analgesic consumptions were recorded in postoperative
      24 hours.
    

Intervention name(s): Levobupivacaine; Dexmedetomidine; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intraarticular; intraarticular 1 ml (100 mcg); intravenously, patient-controlled analgesia
Other intervention name(s): chirocaine 0.5%; precedex, 100mcg/ml; morphine HCL, 10 mg
Intervention MeSH terms: Dexmedetomidine; Morphine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroscopic knee surgery; Dexmedetomidine; Analgesia
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in
      patients with IBS-C.
    

Detailed description: 
      This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in
      patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After
      completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using
      the Interactive Voice Response System (IVRS) during which they will complete daily
      assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS),
      abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from
      the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from
      which change will be determined. Patients who meet all entry criteria will be randomized to
      one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment
      Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue
      the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12,
      patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks
      after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete
      daily IVRS diaries. Patients will then return to the clinical site for a final follow-up
      visit (End of Study Visit). The planned duration of participation in this study will be
      approximately 112 days from signing of informed consent through post-treatment or 145 days if
      30 day washout of a prohibited concomitant medication or stabilization of a medical condition
      is required before Pre-Treatment (up to 148 days, with all windows considered).
    

Intervention name(s): Plecanatide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Trulance
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Endotoxin and Intestinal Flora Before and After Gastric Bypass or Banding in Diabetics
Condition: Obesity, Morbid; Diabetes Mellitus, Type 2; Gastric Bypass
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
Study type: Observational

Summary: 
      This research project is designed to investigate endotoxin (a toxin present in the wall of
      certain kinds of bacteria) levels and the type of bacteria present in the intestine before
      and after Roux-en-Y gastric bypass or gastric banding surgery in patients that meet the
      classification for morbid obesity (body mass index >40 kg/m2) and type 2 diabetes. It is
      known that the type of bacteria present in the intestines of normal weight and obese
      individuals are different, and it is also known that people with obesity and type 2 diabetes
      have higher levels of endotoxin. It has been shown that the bacteria change over the long run
      after Roux-en-Y gastric bypass surgery, but the short-term effects are not known and the
      endotoxin levels after this procedure have never been studied.
    

Detailed description: 
      Evidence exists that (i) morbidly obese, T2D patients undergoing RYGB are highly likely to
      resolve T2D symptoms or dramatically reduce oral and/or insulin requirements, (ii) metabolic
      endotoxemia may incite the pathologic conditions of low-grade inflammation and subsequently
      insulin resistance, obesity and T2D, (iii) significant intestinal microbiologic flora
      differences exist between normal weight and obese/diabetic individuals, and (iv) RYGB alters
      long-term intestinal microbiologic flora. Therefore, it is logical to evaluate short- and
      long-term circulating endotoxin concentrations and intestinal microbiologic flora in context
      with weight loss and restoration of euglycemia to expand our knowledge of the mechanism of
      the benefits observed following RYGB.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Morbidly obese (BMI > 40 kg/m2) patients with T2D
      
Biospecimen description: 
      Serum, urine, stool
    
Keywords: Type 2 Diabetes Mellitus; Gastric Bypass; Gastric Banding; Endotoxin
Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
Condition: Depression; Depressive Symptoms
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Using technology to deliver depression interventions is one way could alleviate the public
      health burden of depression. The study is testing a mobile app intervention program for
      depression that uses cognitive behavioral skills and mindfulness. This study seeks to obtain
      feedback on the intervention and refine the intervention and then test the intervention in a
      larger study. The mobile app intervention called the Meru Health Ascend program consists of
      the app and therapist support via messaging within the app.
    

Detailed description: 
      The Meru Health Ascend program is a guided self-management program that uses a mobile
      application to deliver content of the intervention. A licensed therapist (Meru Health
      employed) provides support to participants as needed and reviews practice logs within the
      app.The 8-week program teaches cognitive behavioral techniques and mindfulness skills with
      the aim of improving the user's mental health. The platform provides informational videos,
      skills practices, group discussion, and messaging with the therapist. The Meru Health program
      enrolls participants in treatment groups that work through the program at the same time and
      can provide support to on another on the discussion board within the app.

      We are conducting two studies in middle aged and older adults with elevated depressive
      symptoms to evaluate the Meru Health Ascend program. In the first study (study 1), we will
      examine the feasibility of the intervention in individuals aged 40 years or older with
      elevated depression symptoms using an iterative case series. Specifically, we will examine
      the usability of app and materials, dropout and reasons for dropout, and user perceptions of
      the program.

      We will then conduct a proof-of-concept study (study 2) using a nonrandomized pre-post design
      to examine whether individuals achieve clinically significant reductions in depressive
      symptoms.
    

Intervention name(s): Meru Health Ascend Program
Intervention type(s): Behavioral
Intervention description(s): Cognitive-behavioral skills, mindfulness
Intervention model: Single Group Assignment
Intervention model description: Study 1: 8 week mobile app based intervention using cognitive behavioral and mindfulness skills Study 2: 12 week mobile app based intervention (8 week intervention+4 weeks focused on sleep and nutrition)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mobile app; middle age adults; older adults
Neural Correlates of Psychodynamic Psychotherapy for Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to see whether we can predict which patients with depression
      will get better when we treat them with psychodynamic psychotherapy. We will use neuroimaging
      (a method of looking at brain activity) in this study. We want to see whether there are
      changes in the brains of patients receiving this type of therapy. We hypothesize that these
      changes may predict how well certain parts of the psychotherapy treatment process works.
    

Detailed description: 
      In this study, we will treat patients with brief psychodynamic psychotherapy. Psychodynamic
      psychotherapy is a type of treatment that may be as helpful as medications in treating
      depression. It focuses on thoughts, feelings, and behaviors as well as both current and past
      relationships. Psychotherapy explores better ways of coping with feelings, expressing needs,
      and interacting with others in order to cope with depression and other life problems.
      Subjects will go to 16 weekly, 45-minute, individual sessions of psychodynamic psychotherapy
      over the course of the study. At five times throughout the study, subjects will come in for
      extra visits, which last approximately 1.5 hours and which include: speaking with a study
      doctor about depressive symptoms, filling out extra questionnaires, and performing positron
      emission tomography (PET)and a Quantitative Electroencephalogram (QEEG). The QEEG is a
      machine that measures the electrical activity of the brain. This task will take approximately
      15 minutes.
    

Intervention name(s): Psychodynamic Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Psychotherapy; Neuroimaging; Subjects with Major Depressive Disorder (MDD)
Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
Condition: Desmoid Tumor
MeSH terms: Fibromatosis, Aggressive; Fibroma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.

      PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see
      how well it works in treating patients with recurrent or refractory aggressive fibromatosis.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the non-progression rate in patients with recurrent or refractory aggressive
           fibromatosis after 3 months of treatment with imatinib mesylate.

      Secondary

        -  Determine the non-progression rate in patients after being treated with this drug for 12
           months.

        -  Determine the toxic effects of this drug in these patients.

        -  Determine the tolerance to this drug in these patients.

        -  Determine the response rate in patients treated with this drug

        -  Determine progression free and overall survival of patients treated with this drug.

        -  Determine the quality of life of patients treated with this drug.

        -  Correlate clinical, biological, and genomic markers with response and long-term stable
           disease in patients treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of
      disease progression or unacceptable toxicity.

      Quality of life is assessed periodically.

      PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
    

Intervention name(s): imatinib mesylate
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: desmoid tumor
Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients
Condition: Sedation Complication; Midazolam; Remimazolam
Study type: Interventional
Phase: Phase 4

Summary: 
      Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the
      advantages of rapid metabolism, quick recovery without injection pain. This study aims to
      compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation
      effect with lower side effects on sedation maintenance period, During the recovery period of
      anesthesia, can Remimazolam Tosilatebe more stable and rapid.
    


Intervention name(s): Fentanyl; Flurbiprofen; Midazolam; Remimazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50ug Fentanyl intravenously; 50mg Fentanyl intravenously; 2.5mg midazolam in 2ml normal saline intravenously; 3mg Remimazolam in 2ml normal saline intravenously
Intervention MeSH terms: Flurbiprofen; Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Remimazolam; Midazolam; Sedation
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
Condition: Hypercholesterolemia
MeSH terms: Liver Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease,
      the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to
      placebo.
    


Intervention name(s): Pravastatin
Intervention type(s): Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bexarotene Amyloid Treatment for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic
      pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and
      removal. The study drug "bexarotene" is an FDA approved anti-cancer agent but is not approved
      for use in Alzheimer's disease. Bexarotene acts as an RXR agonist that has reduced Aβ
      (harmful protein) in the brain in experimental models of Alzheimer's disease.

      This study aims to determine the safety and effect on abnormal proteins found in the brain
      (based on brain scans) of 300 mg of "bexarotene" administered for one month compared to
      placebo (inactive agent).
    


Intervention name(s): Bexarotene; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo
Other intervention name(s): Targretin
Intervention MeSH terms: Bexarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild to Moderate Alzheimer's Disease
Extraluminal Use of the Bronchial Blocker of Univent Tube
Condition: Therapeutic Procedural Complication
Study type: Interventional
Phase: Phase 1

Summary: 
      intends to evaluate the feasibility and security issues of univent bronchial blockers outside
      the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery
      patients.
    

Detailed description: 
      One-lung ventilation is desirable for Several clinical procedures, such as
      thoracic,pulmonary, and cardiac surgery to facilitate lung exposure for these surgical
      procedures by collapsing the lung and most commonly used device is the double-lumen tube
      (DLT) for this surgical procedures.Bronchial blockers (BBs), such as univent tube with an
      bronchial Blocker, has more advantages than the double-lumen tube: no need exchange tube when
      mechanical ventilation is required postoperative, easier insertion,less postoperative sore
      throat (ST) and hoarseness. However, BBs requires more time for placement and more difficult
      to position, especially patients undergoing left-side thoracic surgery. So, this study
      intends to evaluate the feasibility and security issues of univent bronchial blockers outside
      the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery
      patients.
    

Intervention name(s): Extraluminal use of Univent bronchial Blocker; Innerluminal use Univent bronchial Blocker
Intervention type(s): Device; Device
Intervention description(s): Patients assigned to the Extraluminal use of Univent Blocker group were first inserted Univent bronchial Blocker into the glottis via direct laryngoscopy then advanced the Blocker to the target bronchus until slight resistance was encountered.A conventional tracheal tube with appropriate size was intubated via direct laryngoscopy into the appropriate depth, inflating the tracheal tube cuff, and fixing the tube firmly at the patient's mouth with cloth tape .
So the Univent Blocker Extraluminal of the endotracheal tube,then the fibreoptic bronchoscopy was inserted into the tracheal tube and guided bronchial blocker cuff to the target main bronchus under direct vision; Patients in Innerluminal use of Univent Blocker group: When the endotracheal tube had been intubated via direct laryngoscopy, the bronchial blocker was advanced Innerluminal of the endotracheal tube and directed into the right or left mainstem bronchus, then the fibreoptic bronchoscopy was inserted into the tracheal tube. After further pushing and twisting, the bronchial blocker tube will move into the mainstem bronchus under direct vision by FOB.the tracheal tube cuff is inflated with the tube being fixed firmly at the patient's mouth with cloth tape
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Rituximab for Refractory or Relapsed Focal Segmental Glomerulosclerosis or Minimal Change Disease
Condition: Focal Segmental Glomerulosclerosis; Minimal Change Disease
MeSH terms: Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid
Study type: Observational

Summary: 
      Various studies have been conducted to identify effective treatment strategies for primary
      focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the
      light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of
      choice and mycophenolic acid derivatives have been seen as a second line agent. However,
      treatment options in refractory or relapsed cases are still under debate. Recently, rituximab
      has become an alternative in those patients. Therefore, a study based on registry data was
      conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a
      relapsed or refractory primary FSGS or MCD.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with primary focal segmental glomerulosclerosis or minimal change disease who were
        treated using rituximab following resistance to or relapse after at least one set of prior
        therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid
        derivatives.
      
Keywords: focal segmental glomerulosclerosis; minimal change disease; rituximab