bioihbjkbjnl/mcl2 huggingface dataset:
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Tranexamic acid; 0.9% NaCl solution
Intervention description: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery; 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tumor of ovary; Surgical blood loss; Postoperative blood loss; Preventive therapy; Thromboembolism

Summary:

      The purpose of the study is to determine if a standardized single dose tranexamic acid given
      intravenously immediately preoperatively reduces the perioperative bleeding volume and
      reduces the need of blood transfusion in women undergoing surgery for advanced ovarian
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females ages 18 or older with a pelvic or abdominal tumor suspected or
             histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary
             surgery with the intention of performing optimal cytoreductive radical surgery.

          -  Understand and speak Swedish

          -  Accept participation in the study after written and verbal information and sign
             informed consent.

        Exclusion Criteria:

          -  Allergy to tranexamic acid

          -  Having had tranexamic acid within the recent 30 days

          -  Previous or present episode of thromboembolic events .

          -  Previous or present treatment within the recent 3 months with anticoagulant.

          -  Previous or present known coagulopathy

          -  Myocardial infarction within the previous 12 months or instable angina pectoris which,
             according to the investigator, may increase the risk for complications significantly
             in case of a lowering of the hemoglobin.

          -  Significant renal failure with serum-creatinine > 250 µmol/l.

          -  Severe psychiatric dysfunction or mentally substantially disabled.
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
Condition: Cryptogenic Sensory Polyneuropathy
MeSH terms: Polyneuropathies
Intervention: Nortriptyline; Duloxetine; Pregabalin; Mexiletine
Intervention MeSH terms: Mexiletine; Pregabalin; Duloxetine Hydrochloride; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: CSPN; neuropathy; pain; pain management

Summary:

      The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of
      the University of Kansas Medical Center, is to learn about the safety and effectiveness of
      nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory
      polyneuropathy (CSPN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cryptogenic sensory polyneuropathy.

          -  Likert Pain Score of greater than or equal to 4.

          -  Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or
             similar class of medication for at least 7 days from baseline study visit.

        Exclusion Criteria:

          -  Any medical condition or current medication that would prevent them from taking either
             nortriptyline, duloxetine, pregabalin or mexiletine.

          -  Unable to give consent.

          -  Unable or not willing to comply with the study.

          -  Other causes for polyneuropathy.
Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab 300 mg; Secukinumab 150 mg; Placebo
Intervention description: 150 mg x 2 s.c. injection; 150 mg s.c. injection; Placebo
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study design displays results combined as two or more Arms/Groups. Patients assigned to Placebo arm in Treatment Period 1 (TP1) may have switched to Secukinumab 300mg in Treatment Period 2 (TP2). Summaries by group were performed cumulatively by actual treatment received (as follows) for every visit until Week 16 groups in Treatment Period 1: · Secukinumab 300mg (Group 1) · Secukinumab 150mg (Group 2) · Placebo (Group 3) For entire treatment period, summaries by treatment group were performed cumulatively by the actual treatment received (as follows) for every visit til Week 52, including patients who switched at Weeks 16, 28, 40. For safety variables · Any Secukinumab 150 mg (Group 2) · Any Secukinumab 300mg (Group 1) · Any Secukinumab (Group 3) Hence, participants who received "Placebo" in TP1 were combined with participants who received "Any Secukinumab" in "Group 3" and "Any Secukinumab 300mg" in "Group 1" in TP2. Safety is presented for the ENTIRE period, including TP1 and TP2
Masking: Double (Participant, Investigator)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PsA; ACR; CASPAR; inflammatory arthritis; spondylitis

Summary:

      To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in
      adult patients with active PsA based on the proportion of patients achieving an American
      College of Rheumatology 20 (ACR20) response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female patients at least 18 years of age

          -  Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months
             with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and
             ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

          -  Rheumatoid factor and/or anti-CCP antibodies negative at screening

          -  A target skin psoriatic lesion and a PASI score of 1 or greater

        Exclusion Criteria:

          -  Chest X-ray with evidence of ongoing infectious or malignant process

          -  Patients who ever received biologic immunomodulating agents including those targeting
             TNFα, IL-6 and IL-12/23 investigational or approved
Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
Condition: Trichiasis
MeSH terms: Trichiasis
Intervention: azithromycin; topical tetracycline
Intervention description: oral antibiotic
Intervention MeSH terms: Azithromycin; Tetracycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trichiasis; azithromycin; trichiasis surgery; topical tetracycline

Summary:

      Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of
      blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar
      and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and
      abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a
      multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis.
      Despite this encouraging news, under the best of circumstances the recurrence rate of
      trichiasis following surgery is disappointingly high. The objective of our project is to
      conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment,
      comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in
      Ethiopia with the goal of determining the impact of treatment on rates of trichiasis
      recurrence at one and two years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of trichiasis:

          -  no previous report of trichiasis surgery in at least one eye with trichiasis:

          -  Agreement by at least one other family member accompanying the patient that, if the
             patient is randomized to the family-treatment arm, s/he also would be willing to
             receive antibiotic treatment

          -  Age 18 or older

        Exclusion Criteria:

          -  other household members concurrently participating in the trial

          -  Self-reported pregnancy

          -  Documented allergy to tetracycline

          -  Plans to move out of the region within 1 year.
A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Condition: Kidney Transplantation
Intervention: tacrolimus extended release
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Kidney; Immunosuppression; Transplant

Summary:

      Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day
      dosing regimen. This formulation has the potential to improve compliance. Current dosing
      recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day
      administered once daily in the morning. There are no specifications on appropriate dosing in
      obese patients or on whether to use actual, ideal or and adjusted weight. It will be
      advantageous to understand the pharmacokinetics of this medication in the obese to determine
      the appropriate dosing regimen. In this study, obese patients will be randomized to receive
      tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or
      adjusted body weight (aBW).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is a recipient of a living donor or deceased donor kidney only transplant

          2. Subject is > 18 years of age

          3. BMI≥30 on POD 0

        Exclusion Criteria:

          1. Multi-organ transplant

          2. Subjects taking tacrolimus pre-transplant (i.e. positive crossmatch transplants or
             re-transplants)

          3. Patients undergoing simultaneous sleeve gastrectomy at the time of transplant.
Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia
Condition: Pneumonia, Ventilator-Associated
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Intervention: Aerosolized Tobramycin or Vancomycin; Aerosolized Placebo
Intervention description: Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.; Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.
Intervention MeSH terms: Vancomycin; Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if administering inhaled antibiotics directly into
      the lungs in conjunction with intravenous (IV) antibiotics leads to better outcomes and
      decreased recurrence of ventilator associated pneumonia (VAP) when compared to IV antibiotics
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical Pulmonary Infection Score (CPIS) greater than or equal to 6

          2. Intubated greater than or equal to 48 hours

          3. Screened for possible eligibility

          4. Bronchoscopy and bronchoalveolar lavage (BAL) or combicath performed

          5. Started on empiric intravenous (IV) and inhaled antibiotics after BAL for suspected
             ventilator associated pneumonia (VAP)

          6. > 104 Colony Forming Units (CFU) on BAL

        Exclusion Criteria:

          1. <18 years of age

          2. Pregnant

          3. Human Immunodeficiency Virus (HIV) or on chronic immunosuppressants

          4. Absolute Neutrophil Count <1,000

          5. Allergy to vancomycin or tobramycin

          6. Anaphylaxis to penicillin

          7. Cystic Fibrosis

          8. Previous enrollment

          9. Creatinine >2 mg/dl or doubled within the previous 72 hours
Multimodal Versus Opioid aNalgesia in carDiAc Surgery
Condition: Postoperative Pain; Postoperative Delirium
MeSH terms: Emergence Delirium
Intervention: Dexmedetomidine
Intervention description: The use of multimodal painkillers pre, per and postoperative
Intervention MeSH terms: Lidocaine; Magnesium Sulfate; Pregabalin; Dexmedetomidine; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare standard "Fentanyl - Tramadol - Paracetamol - Oxycodone" regimen to a multimodal
      painmanagement "pregabalin- minimal fentanyl-ketamine-lidocain-dexmedetomidine- paracetamol"
      to determine which therapy provides the most comfort, the fastest extubation time, the least
      pain and the least delirium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing first time cardiac surgery by median sternotomy

          -  Elective surgery or semi-urgent: there needs to be time to provide 1 hour before
             surgery the intake of pregabalin

          -  ≥ 18 years for men

          -  Women who are in menopause

          -  Possibility to communicate with the patient to score pain and comfort

          -  Signed Informed Consent, signed by subject able and willing to provide written
             informed consent for study participation

        Exclusion Criteria:

          -  Urgent surgery

          -  Women who are in premenopause

          -  Hypersensitivity to any of the study medication

          -  In case of direct postoperative revision the patient is NOT excluded.
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum
Intervention: ZULRESSO®
Intervention description: Intravenous infusion of ZULRESSO®.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study was to evaluate whether the safe-use conditions for
      administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ambulatory female ≥18 years of age.

          2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by
             the investigator.

          3. Participant agrees not to be the primary caregiver of any dependents during the
             infusion and must be accompanied by another adult (other than the home healthcare
             provider) during interactions with their child(ren).

          4. Participant has no history of sleep apnea or any clinically significant respiratory
             conditions.

          5. Participant agrees to refrain from the use of central nervous system depressants, such
             as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.

          6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the
             judgement of the investigator.

          7. Participant's home is suitable and has necessary provisions for administration of
             ZULRESSO® and meets the following criteria:

               -  safe environment for the home infusion provider staff.

               -  access to a working telephone.

               -  electricity and grounded electrical outlets.

               -  running water.

               -  access to back-up emergency services (911 service or ambulance availability).

               -  sanitary environment.

          8. Participant agrees to stay at home until the end-of-study visit has been completed,
             except for a medical emergency.

          9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the
             start of the ZULRESSO® infusion.

        Exclusion Criteria:

          1. Participant has end stage renal failure.

          2. Participant has known allergy to progesterone or allopregnanolone or any excipients in
             the brexanolone injection.

          3. Participant is currently at risk of suicide, as judged by the investigator, or has
             attempted suicide associated with the current episode of PPD.
The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis
Condition: Type 2 Diabetes
Intervention: Liraglutide; Placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the mechanisms underlying the effect of incretin therapy on
      lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of
      liraglutide on hepatic de novo lipogenesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes treated with a lifestyle or metformin (any dose)

          -  waist circumference > 88 cm in women and > 92 cm in men

          -  BMI 27-40 kg/m2

          -  triglycerides between 1.0 - 4.0 mmol/L

          -  LDL < 4.5 mmol/l

        Exclusion Criteria:

          -  Type 1 diabetes

          -  Apo E2/2 phenotype

          -  ALT/AST > 3x ULN

          -  GFR < 60 ml/min, clinically significant TSH outside normal range

          -  Lipid-lowering drugs other than statins within 6 months

          -  Current treatment with pioglitazone, insulin, sulphonylureas, gliptins, glinides,
             SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day)

          -  Blood pressure > 160 mmHg systolic and/or > 105 diastolic

          -  History of pancreatitis or stomach / other major bleeding, thyroid neoplasia,
             persistent hypothyroidism or persistent hyperthyroidism

          -  Any medical condition that puts the patient in the risk of dehydration

          -  Concurrent medical condition that may interfere with the interpretation of efficacy
             and safety data during the study.

          -  Females of childbearing potential who are not using adequate contraceptive methods

          -  Subjects who have experienced side-effects previously from GLP-1 agonists

          -  Non-compliance or withdrawal of consent

          -  Any information or clinical event described in liraglutide SPC that is a
             contraindication for the use of liraglutide
Tobacco Use Treatment in Cancer Patients
Condition: Smoking, Cigarette
Intervention: Nicotine Replacement Therapy; Referral to AHEC/Quitline
Intervention description: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.; Participants will be referred to local AHEC/Quitline for treatment
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking, Cancer, Treatment

Summary:

      Tobacco use among cancer survivors reduces the effectiveness of cancer treatments, increases
      the risk for additional primary cancers, and increases mortality. Implementation of tobacco
      treatment for cancer patients is challenging, but may be improved substantially with
      clinically-efficient and sustainable solutions to accurately identify tobacco users, direct
      them to evidence-based treatment, and provide demonstrable outcomes for stakeholders.

      At UF Health Cancer Center (UFHCC), patient access and utilization of tobacco use treatment
      are sub optimal. Further, UFHCC has a largely rural catchment area with a high burden of
      tobacco-related disease and mortality. To address this research-to-practice gap using a
      mixed-methods approach to assess the relevant contextual factors at UFHCC and evaluate the
      feasibility of implementing a multi-level intervention to increase tobacco treatment
      utilization and improve health outcomes.

      This study uses a mixed methods approach and will inform the design of a pragmatic clinical
      trial to improve the delivery of tobacco use treatment services to cancer patients. Guided by
      a conceptual model that emphasizes patient, provider, and organizational characteristics, the
      study team will identify factors that influence the implementation process at the UFHCC. The
      ultimate goal of the proposed research is to provide new knowledge to facilitate the
      widespread adoption, implementation, and dissemination and sustained utilization of
      evidence-based tobacco use treatments in cancer care settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  UF Health cancer patients, 18 years and older, who are current smokers.

        Exclusion Criteria:

          -  Patients with unstable medical or psychiatric illness or

          -  Patients with a use disorder for illicit drugs.