bioihbjkbjnl/mcl2 huggingface dataset:
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Mindfulness Based Stress Reduction; Stress Management Education
Intervention description: 8 week course; 8 week course
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This
      study measures the efficacy of two different approaches to reducing anxiety and stress. One
      approach uses education, nutrition, exercise, and time management training, and another uses
      mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress
      reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that
      the two approaches will reduce anxiety in individuals with GAD in different ways. We will
      measure changes in stress hormones associated with these changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with generalized anxiety disorder

          -  medically healthy

        Exclusion Criteria:

          -  substance abuse

          -  history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive
             Disorder, PTSD

          -  use of certain types of psychotherapy, meditation training, yoga

          -  pregnant or lactating women
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Condition: Post-operative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant 80 mg Oral Capsule; scopolamine transdermal; Total intravenous anesthesia; Dexamethasone; Ondansetron; Reglan; Ondansetron; Compazine; Sugammadex; Propofol; dexmedetomidine; Fentanyl; Sevoflurane; Desflurane
Intervention description: aprepitant 80 mg orally one hour prior to scheduled surgery; scopolamine transdermal patch one hour prior to scheduled surgery; Maintenance of anesthesia without the use of inhaled anesthetics.; Dexamethasone 8 mg intraoperatively; Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.; Postoperatively scheduled Reglan; Postoperatively scheduled ondansetron; Postoperatively as needed compazine for breakthrough PONV; Reversal with sugammadex; Intravenous anesthesia will be maintained through IV propofol; maintenance of anesthesia in the intervention arm; intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance; inhalational anesthesia; inhalational anesthesia
Intervention MeSH terms: Dexamethasone; Fentanyl; Scopolamine; Dexmedetomidine; Ondansetron; Aprepitant; Metoclopramide; Prochlorperazine; Propofol; Sevoflurane; Desflurane; Butylscopolammonium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bariatric Procedure

Summary:

      Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and
      vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses
      on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and
      aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The
      investigators hypothesize that the intervention group will experience a reduction of
      nausea-related prolonged hospital stay and significantly improve patient-reported quality of
      recovery from surgery and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (18 years and older) undergoing LSG

        Exclusion Criteria:

          -  Allergy to medications delineated in the protocol (muscle blockade, anesthetics,
             reversal agents)

          -  Inability to provide informed consent

          -  History of chronic nausea and emesis requiring medication

          -  Poorly controlled diabetes (HgA1c>9 mg/dl),

          -  History of previous bariatric or gastro-esophageal surgery
Negative Beta Glucan in ICU Patients
Condition: Candidemia
MeSH terms: Candidemia
Intervention: Anidulafungin
Intervention description: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Intervention MeSH terms: Anidulafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: candidemia; intensive care unit; 1,3 beta-D-glucan

Summary:

      This is a prospective study aimed at testing a strategy of early initiation of an antifungal
      agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis.
      Score system have been developed to identify groups at very high risk for the development of
      candidemia/invasive candidiasis in the ICU. These scoring system have used clinical
      information with or without data on Candida colonization, and have shown reasonable
      correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of
      1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The
      incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at
      higher risk for candidemia, and despite the fact that these tests may give false-positive
      results, their negative predictive value could be of great help.

      Therefore, the objectives of this study are:

        1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop
           invasive candidiasis/candidemia;

        2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly
           negative blood cultures and 1,3 beta-D-glucan in the serum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the ICU for >2 days AND

               -  Systemic antibiotics on days 1-3 of ICU OR

               -  Central venous catheter on days 1-3 of ICU

          -  AND at least 2 of:

               -  Total parenteral nutrition on days 1-3 of ICU

               -  Any dialysis on days 1-3 of ICU

               -  Major surgery in the 7 days before admission in the ICU

               -  Pancreatitis in the 7 days before admission in the ICU

               -  Use of corticosteroids for at least 3 days in the 7 days before admission

               -  Use of other immunosuppressive agents in the 7 days before admission in the ICU

          -  In addition, the patient must have at least one of the following:

               -  Fever (axillary temperature >37.5 oC)

               -  Hypothermia (axillary temperature <35 oC)

               -  Hypotension

               -  Unexplained acidosis

               -  Unexplained elevation in C-reactive protein

        Exclusion Criteria:

          -  Antifungal for >3 days

          -  Allergy to an echinocandin
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Condition: Contraception; Postpartum Depression; Lactation
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Depot medroxyprogesterone acetate; Depot medroxyprogesterone acetate
Intervention description: Postpartum administration of DMPA (prior to hospital discharge); Delayed administration of DMPA (4-6 weeks postpartum)
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum contraception; Contraceptive continuation; Breastfeeding; Postpartum depression; Progestins

Summary:

      The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after
      delivery to find out whether the timing of postpartum administration of DMPA (prior to
      hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of
      breastfeeding among women who plan to breastfeed their infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment

          -  Planning to deliver at Magee-Womens Hospital and to breastfeed

          -  Plans to use DMPA for postpartum contraception for at least 6 months

          -  Willing and able to provide informed consent in English and to comply with study
             protocol

        Exclusion Criteria:

          -  Intolerance of irregular vaginal bleeding

          -  Severe coagulation disorder

          -  Severe liver disease (LFTs >2x upper limits of normal at time of randomization)

          -  Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with
             breast lesions; active varicella; active, untreated tuberculosis; antineoplastic,
             thyrotoxic, or immunosuppressive medications; concern that the infant may have
             galactosemia

          -  History of breast cancer, reduction or augmentation surgery

          -  History of severe clinical depression

          -  Multiple gestation
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
Condition: Neuromuscular Block; Renal Transplant Donor of Left Kidney; Renal Transplant Donor of Right Kidney; Surgery
Intervention: Rocuronium; No additional Rocuronium
Intervention description: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.; No additional rocuronium is administered after tracheal intubation.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Laparoscopic donor nephrectomy; Early quality of recovery

Summary:

      Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the
      consequences of postoperative pain and analgesia consumptions. The investigators' goal is to
      establish the relationship between the use of deep neuromuscular blockade (NMB) during
      laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the
      investigators designed a trial in which patients scheduled for living donor nephrectomy are
      randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will
      be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.
    

Eligibility criteria:

        All adult individuals, who are scheduled for living kidney donation.

        Inclusion Criteria:

          -  obtained informed consent

          -  age over 18 years

        Exclusion Criteria:

          -  insufficient control of the Dutch language to read the patient information and to fill
             out the questionnaires

          -  chronic use of analgesics or psychotropic drugs

          -  use of NSAIDs shorter than 5 days before surgery

          -  known or suspect allergy to rocuronium of sugammadex

          -  neuromuscular disease

          -  indication for rapid sequence induction

          -  deficiency of vitamin K-dependent clotting factors, coagulopathy or active use of
             coumarin derivates.

          -  Peri-operative use of fusidic acid or flucloxacillin

          -  Severe renal impairment (creatinine clearance <30ml/min)

          -  Morbid obesity (BMI>35 kg/m2)
A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: mirabegron; solifenacin
Intervention description: oral; oral
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: mirabegron; solifenacin

Summary:

      The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on
      therapy in patients with OAB treated with solifenacin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female: postmenopausal OAB outpatient

          -  Male: OAB outpatient who did not wish to have children at all

          -  Patient had been treated with solifenacin at a stable dose once daily for at least 4
             weeks prior to the study

          -  Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3
             score ≥2 points

        Exclusion Criteria:

          -  Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or
             patients with benign prostatic hyperplasia, or lower urinary tract obstruction

          -  Patient had serious heart disease (myocardial infarction, cardiac failure,
             uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver
             disease, kidney disease, immunological disease, lung disease, etc. or patient had
             malignant tumor (except for malignant tumor that has not been treated for at least 5 y
             before the start of the screening period with no risk of recurrence)

          -  Patient had received surgical therapy that may affect the urinary tract function
             within 24 weeks before the start of the screening period
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine 8mg; Fesoterodine 4mg; Placebo
Intervention description: Oral, 1 tablet per day, 12 weeks duration, 8mg/day; Oral, 1 tablet per day, 12 weeks duration, 4mg/day; Oral, 1 tablet per day, 12 weeks duration
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2012.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to confirm if 8mg of fesoterodine is more effective in reducing
      overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to
      assess if the higher dose reduces the overall effect of overactive bladder on the subject's
      daily life more than the lower dose. The study also assesses the side effects and safety of
      the two doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence
             episodes per 24 hours and minimum of 8 micturitions per 24 hours.

        Exclusion Criteria:

          -  Other concurrent and concomitant medication or disease that could put the subjects at
             additional risk or interfere with the study results.
Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery
Condition: Pain
Intervention: Intrathecal morphine; Placebo
Intervention description: 5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg; Saline intrathecal given in the same manner as the intervention groups.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomized into 2 groups. The placebo group will receive intrathecal saline. The morphine group will receive intrathecal morphine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All patients will receive intrathecal intervention and will not know which group they are assigned to. The provider performing the procedure and collecting the data will also be blinded to the intervention assignment.
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized clinical trial in patients undergoing robotic myocardial
      revascularization with intraoperative extubation. Patients will be randomized into placebo or
      intrathecal morphine groups to assess postoperative pain scores and patient satisfaction.
      Patients will also be assessed for side effects from the intervention.
    

Eligibility criteria:

        Inclusion Criteria:

        • patient undergoing elective robotic myocardial revascularization without anticipated use
        of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.

        Exclusion Criteria:

          -  Emergency surgery

          -  Preoperative use of inotropes/IABP

          -  Preoperative use of opoids

          -  Ejection fraction less than 40%

          -  Anticipated use of cardiopulmonary bypass

          -  Previous cardiothoracic surgery

          -  Anticipated postoperative tracheal intubation

          -  severe pulmonary disease

          -  morbid obesity (BMI >35 kg/m2)

          -  severe hepatic impairment

          -  severe renal dysfunction (creatinine > 1.5)

          -  any contraindication to intrathecal injection (patient refusal, difficult patient
             anatomy, pre-existing coagulopathy, morphine allergy)
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Bevacizumab; dexamethasone intravitreal implant
Intervention description: intravitreal, 1.25mg., monthly; 0.7mg, intravitreal every 4 months
Intervention MeSH terms: Dexamethasone; Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetic macular edema; DME

Summary:

      The investigators hypothesize that a combination treatment with Avastin and Ozurdex will
      result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18 years or older

          -  Type 1 or type 2 diabetes

          -  BCVA score of >24 and <78 letters

          -  Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT
             CST) >250microns

        Exclusion Criteria:

          -  Anti-VEGF intravitreal treatment in last 4 weeks

          -  Intravitreal steroid treatment in the last 8 weeks

          -  PRP or Focal laser in last 4 months

          -  Active iris neovascularization
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
Condition: Type 2 Diabetes
Intervention: dapagliflozin; Placebo
Intervention description: SGLT-2 inhibitor for the treatment of type 2 diabetes
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a single center, prospective, randomized, placebo -controlled, parallel design and
      double blind study to evaluate oxidative stress, inflammation and hypertension markers and
      mediators before and after treatment with dapagliflozin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 20-80 years inclusive.

          -  Type 2 diabetes

          -  BMI ≥30 kg/m2

          -  Subjects on statins, ACE inhibitors, ARBs, thiazolidinediones and -antioxidants will
             be allowed as long as they are on stable doses of these -compounds and the dosage in
             not changed during the course of study. -Patients will be evenly distributed between
             the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.

          -  HbA1c ≤ 8.0%

        Exclusion Criteria:

          -  Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.

          -  Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and
             -hypertriglyceridemia.

          -  Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery
             bypass, surgery or coronary angioplasty) in the previous 3 months.

          -  Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver
             -function defined as:

          -  aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or -alanine
             aminotransferase (ALT) >3x ULN

          -  Total bilirubin >2.0 mg/dL (34.2 µmol/L)

          -  Positive serologic evidence of current infectious liver disease including Hepatitis B
             viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody

          -  (liver function tests more than 3 times the upper limit of normal)

          -  Renal impairment (serum eGFR <60 ml/min)

          -  Any other life-threatening, non-cardiac disease

          -  Uncontrolled hypertension (BP > 160/100 mm of Hg)

          -  Congestive Heart Failure class III or IV.

          -  Use of an investigational agent or therapeutic regimen within 30 days of study

          -  Participation in any other concurrent clinical trial

          -  pregnant or breastfeeding patients

          -  Volume depleted patients. Patients at risk for volume depletion due to co-existing
             conditions or concomitant medications, such as loop diuretics