bioihbjkbjnl/mcl2 huggingface dataset:
IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty
Condition: Pain, Postoperative; Opioid Use
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen; Acetaminophen
Intervention description: Oral acetaminophen, intravenous placebo; Intravenous acetaminophen, oral placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine how well two different methods of administrating
      Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR)
      surgery. The methods of administration are orally, via a pill that is to be swallowed, and
      intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol
      will reduce opioid consumption and opioid-related side effects after THR.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult

          -  Scheduled for an elective primary THA with a participating surgeon,

          -  Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural
             Analgesia (PCEA)

          -  English-speaking

          -  Patients that did not receive pre-operative opioids

        Exclusion criteria:

          -  Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney
             functioning tests.

          -  Hypersensitivity or contraindication to protocol medication

          -  Contraindication for CSE and PCEA

          -  Incapable to provide consent/answer questions in English

          -  Revision or urgent surgery

          -  Receiving Periarticular Injections

          -  History of opioid use

          -  Patients on disability or worker's compensation
CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation
Condition: Kidney Transplantation; Kidney Diseases; Kidney Failure
MeSH terms: Kidney Diseases; Renal Insufficiency
Intervention: Campath; Daclizumab
Intervention description: Monoclonal antibody induction therapy; Monoclonal antibody induction therapy
Intervention MeSH terms: Alemtuzumab; Daclizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney Transplantation; Kidney Disease; Kidney Failure; Graft Rejection

Summary:

      The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years
      has substantially reduced the risk of rejection after kidney transplantation, has allowed the
      development of immuno-suppressive regimens that do not use long-term steroids (steroid
      avoidance), and has improved transplant success rates both in the short and medium term.

      The main new agents used in these modern regimens are the calcineurin inhibitor (CNI)
      tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used
      to provide effective early suppression of the rejection process; these include monoclonal
      antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and
      daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab).

      Although almost all modern immunosuppressive regimens involve one or more of these agents, it
      is not known which is the safest and most effective combination.

      This randomised controlled trial compares two steroid sparing regimens which have been used
      with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit
      over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is
      as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients under the care of the West London Renal and Transplant
             Centre

        Exclusion Criteria:

          -  Patients who are unable to give written informed consent

          -  Simultaneous kidney/pancreas transplant recipients

          -  Non-heart beating deceased donor transplant recipients

          -  Patients who would not be offered Campath-1H induction under our current protocol
             (patients with previous malignancy or with previous exposure to cytotoxic or
             antiproliferative agents)
Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis
Condition: Facial Nerve Injuries; Facial Paresis Associated With Facial Nerve Dysfunction; Facial Asymmetry; Synkinesis
MeSH terms: Facial Nerve Injuries; Facial Paralysis; Paresis; Synkinesis; Facies; Facial Asymmetry
Intervention: OnabotulinumtoxinA Injectable Product; AbobotulinumtoxinA Injectable Product; Incobotulinumtoxin A Injectable Product
Intervention description: Administered to treat facial synkinesis; Administered to treat facial synkinesis; Administered to treat facial synkinesis
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Facial paralysis; Facial synkinesis; Botulinum toxin

Summary:

      The purpose of this study is to compare the effectiveness of three commercially available
      botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported
      outcome measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Facial synkinesis

        Exclusion Criteria:

          -  Previous complication from botulinum toxin neuromodulator injection

          -  Inability to understand or complete the SAQ survey

          -  Inability to participate in follow-up

          -  Pregnancy
Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
Condition: Pain Management
Intervention: Bupivacaine; Dexamethasone
Intervention description: 20 mL of 1.3% bupivacaine; 2 mg dexamethasone
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Opioids are prescribed for moderate to severe pain disorders; however, there are
      contraindications and side effects that are common to all opioids. The investigators
      hypothesize using regional anesthetic during sinus surgery will reduce surgical pain,
      therefore decreasing the need for post-operative opioid medication. The primary of objective
      is to determine if a long-acting local regional anesthetic applied during a surgery will
      reduce post-operative oral opioid usage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Able to sign informed consent form

          -  Able to comply with all study procedures and availability for the duration of the
             study

          -  Able to speak English

          -  Diagnosis of chronic rhinosinusitis

          -  Scheduled to receive functional endoscopic sinus surgery (FESS) at UAB

        Exclusion Criteria:

          -  Current use of opioid medication

          -  Known allergic reactions to components of the study intervention

          -  History of IV drug use or abuse

          -  History of opioid abuse

          -  History of chronic pain disorder

          -  Treatment with another investigational drug or other intervention within 30 days
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: alemtuzumab GZ402673
Intervention description: Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Intervention MeSH terms: Alemtuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1062.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate long-term safety of alemtuzumab.

      Secondary Objectives:

        -  To evaluate long term efficacy of alemtuzumab.

        -  To evaluate the safety profile of participants who received other Disease Modifying
           Treatment (DMT) following alemtuzumab treatment.

        -  To evaluate participant-reported Quality of Life (QoL) outcomes and health resource
           utilization of participant who received alemtuzumab.

        -  To evaluate as needed re-treatment with alemtuzumab and other DMTs.
    

Eligibility criteria:

        Inclusion criteria:

        Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed
        written informed consent form.

        Exclusion criteria:

        Participant participating in another investigational interventional study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Effect of Intraoperative Dexamethasone on Post-op Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: dexamethasone intraocular suspension, 9%; Prednisolone Acetate 1% Oph Susp
Intervention description: single dose intracameral corticosteroid; topical ophthalmic steroid drop
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled prospective study.
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To compare the signs and symptoms of dry eye after cataract surgery between subjects
      randomized to receive intraoperative dexamethasone in addition to the use of a standard
      topical post-op treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing bilateral cataract surgery

        Exclusion Criteria:

          -  central corneal staining with fluorescein and/or a tear film osmolarity of greater
             than 340 in either eye
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Condition: Pulmonary Hypertension; Diastolic Heart Failure; Heart Failure With Preserved Ejection Fraction
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure; Heart Failure, Diastolic
Intervention: Nebivolol
Intervention description: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of
      pulmonary hypertension (PH). Despite the severity of this disease, no established treatments
      exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart
      failure, but not used in patients with PH. Due to some additional properties it possesses,
      the investigators believe nebivolol will improve disease severity in patients with PH
      associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH
      severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (≥ 18 years of age) with World Health Organization Group 2 Pulmonary
             Hypertension (Mean pulmonary artery pressure ≥ 25 mmHg and pulmonary capillary wedge
             pressure ≥ 15 mmHg)

          -  New York Heart Association class II-IV symptoms

          -  Left ventricular ejection fraction (LVEF) ≥ 45%

        Exclusion Criteria:

          -  Other causes of heart failure other than diastolic dysfunction, such as restrictive
             cardiomyopathy or infiltrative cardiomyopathy

          -  Women who are pregnant or nursing

          -  Liver cirrhosis,

          -  Primary valvular disease

          -  Acute coronary syndrome

          -  Causes of PH other than that of heart failure, such as: chronic thromboembolic PH,
             sickle-cell disease, or sarcoidosis

          -  Severe bradycardia or greater than 1st degree heart block

          -  Decompensated heart failure

          -  Current use of a third generation beta-blocker (nebivolol, carvedilol, or labetalol)
             or high dose of any beta-blockers (greater than 100 mg daily of metoprolol, or
             equivalent)
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Condition: Healthy
Intervention: Medline Pediatric Face Masks; KC Childs Mask
Intervention description: Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.; KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatric Face Masks; children

Summary:

      Compare the fit of two pediatric face masks in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4 to 12 years of age

          -  conscious

        Exclusion Criteria:

          -  able to wear a mask

          -  no previous allergic reactions to face masks
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: DNR:; Ara-c
Intervention description: DNR：45mg/m2 d1-3; DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 1 Year
Maximum age: 14 Years
Healthy volunteers: No
Keywords: ara-c; As2O3; pediatric; acute

Summary:

      Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low
      relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining
      ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C
      in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the
      relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at
      presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively)
      in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to
      an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role
      of the Ara-C remains controversial. And there are very limited data reported on children with
      APL so far.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute Promyelocytic Leukemia (APL)

        Exclusion Criteria:

          -  > 14
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
Condition: Pre-Eclampsia; HELLP Syndrome; Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia; HELLP Syndrome
Intervention: Acetaminophen; Ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen
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: Accepts Healthy Volunteers

Summary:

      NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure
      over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the
      setting of preeclampsia have not been well studied. This study aims to assess the effect of
      avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with
      preeclampsia with severe features. Eligible women will be randomized to receive either
      acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies
      for pain control although ibuprofen has better pain control than acetaminophen. The primary
      outcome will be duration of postpartum severe-range hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ability to give informed consent

          -  diagnosis of a "severe" hypertensive disorder of pregnancy:

          -  preeclampsia with severe features

          -  chronic hypertension with superimposed preeclampsia with severe features

          -  HELLP syndrome: hemolysis, elevated liver function tests, low platelets

          -  eclampsia

          -  not yet delivered or less than 6 hours after delivery

        Exclusion Criteria:

          -  current incarceration

          -  serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury

          -  AST (aspartate aminotransferase) >200 unit/L

          -  ALT (alanine aminotransferase) > 200 unit/L

          -  known allergy or sensitivity to NSAIDs or acetaminophen

          -  delivery > 6 hours prior to enrollment

          -  chronic kidney disease

          -  chronic liver disease

          -  prior liver transplant

          -  chronic infectious hepatitis

          -  gastritis

          -  gastro-esophageal reflux disease (GERD)

          -  peptic ulcer disease

          -  bleeding disorder

          -  provider feels that participation is not in the best interest of the patient
A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin 11.25 mg
Intervention description: Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the benefit of immediate hormonal treatment after
      Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To
      reach this target, the trial will compare a group of patients treated with triptorelin at 8
      weeks after the surgery and for a duration of 9 months (3 injections) versus another group
      (called "active surveillance group") who will be not receiving triptorelin. Both groups will
      be followed every 3 months to monitor any sign of disease progression during a minimum of 36
      months
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically confirmed adenocarcinoma of the prostate

          -  Radical Prostatectomy with curative intent performed no more than 8 weeks before
             randomisation

          -  High risk criteria of disease progression, defined as follows:

        Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or
        Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score)

          -  Post-RP PSA levels ≤0.2 ng/mL at 6 weeks

        Exclusion Criteria:

          -  Evidence of lymph nodes or distant metastasis

          -  Positive margins

          -  Evidence of any other malignant disease, not treated with a curative intent

          -  Had surgical castration