bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile
Condition: Postoperative Respiratory Condition
MeSH terms: Disease
Intervention: Sugammadex; Neostigmine
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromuscular block; neuromuscular reversal; postoperative conditions; respiratory failure

Summary:

      Suboptimal reversal of neuromuscular blockage after surgery is possibly related to
      unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete
      reversal of neuromuscular block was not possible untill sugammadex was discovered. The
      investigators hyposthesise that reversal with sugammadex leads to favorable postoperative
      respiratory conditions and less pain compared to reversal with neostigmine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years

          -  - BMI < 35

          -  -ASA class I- III

          -  -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

               -  Patients with ability to give oral and written informed consent

        Exclusion Criteria:

          -  Failure to meet the inclusion criteria

               -  -Known or suspected neuromuscular disorders impairing neuromuscular function

               -  -Allergies to muscle relaxants, anesthetics or narcotics

          -  A (family) history of malignant hyperthermia

               -  -Women who are or may be pregnant or are currently breast feeding

               -  -Contraindications for the use of neostigmine

          -  Intestinal obstruction,

          -  COPD GOLD 4

               -  -Abnormal heart rhythm (eg. bradycardia: < 40/min);

               -  -Surgery requiring neuraxial anesthesia / analgesia

               -  -Preoperative cognitive dysfunction or mental disabilities

               -  -Preexistent significant pulmonary disease with preoperative SpO2 < 90%

               -  -Preoperative ICU treatment / intubation (ICU patient);

               -  -Need for postoperative ICU treatment or ventilation;
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Condition: Osteoarthritis; Hip Arthropathy; Shoulder Arthropathy
MeSH terms: Joint Diseases
Intervention: Tranexamic acid (TXA); Normal saline
Intervention description: 1.5g of TXA in 100ml normal saline solution
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tranexamic acid (TXA)

Summary:

      The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in
      decreasing blood loss following both shoulder arthroplasty and primary total hip
      arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system
      within the body. The investigators hypothesize that topical application of TXA prior to
      closure reduces postoperative bleeding as measured by absolute changes in postoperative
      hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic
      acid may reduce the need for transfusions, the rates of hematomas, infections, and length of
      hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Shoulders: All adult patients over the age of 18 scheduled for a primary total
             arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion
             in the study.

        Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty
        will be eligible for inclusion in the study.

        Exclusion Criteria:

          -  allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy
             within 5 days of surgery, history of seizures, renal failure (creatine clearance
             <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or
             pulmonary embolism), significant cardiac history (myocardial infarction, angina,
             stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females
             and < 12g/dl in males).
Spinal Anesthesia in Total Hip Arthroplasty
Condition: Total Hip Arthroplasty
Intervention: Lidocaine; Bupivacaine
Intervention description: Spinal anesthesia administered prior to participant's THA; Spinal anesthesia administered prior to participant's THA
Intervention MeSH terms: Lidocaine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Hip replacement; Total hip arthroplasty; Anterior total hip replacement; Transient neurological symptoms; Spinal anesthesia

Summary:

      Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose
      of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a
      total hip arthroplasty (THA). The objective of this study is to compare the two spinal
      anesthesia treatments in regards to transient neurological symptoms (TNS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips.
             Osteoarthritis will be defined as pain with weight-bearing at the hip articulation
             together with radiographic findings

          -  Indicated for total hip arthroplasty

          -  Agreement to undergo spinal anesthesia for surgery

        Exclusion Criteria:

          -  Patient refusal to undergo spinal anesthesia

          -  Patients with a known history of lumbar or sacral spinal fusion.

          -  Patients with a known history of prostate, urological, or kidney surgery.

          -  Patients who need monitoring of urine output during surgery (including patients with
             confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling
             catheter at the time of surgery).

          -  Current infection at site of injection

          -  Women of child-bearing potential who are on Medicare (child-bearing potential will be
             determined prior to surgery per Anesthesia standard of care)

          -  Hypovolemia

          -  Indeterminate neurologic disease

          -  Allergy or hypersensitivity to the study medications

          -  Currently taking any anti-coagulation medications or coagulopathic

          -  Increased intracranial pressure

          -  Subject is unable to make his/her own decision regarding the informed consent

          -  Subject is unable to read/understand English
Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin pamoate; Leuprolide acetate
Intervention description: Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock; Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.
Intervention MeSH terms: Leuprolide; Triptorelin Pamoate
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: palliative treatment; prostate cancer

Summary:

      The purpose of this study is to compare how subjects feel after receiving injections of two
      different types of GnRH six months apart. One injection is given under the skin of the
      abdomen, and the other one into the muscle of the buttock or thigh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with a diagnosis of advanced prostate cancer for whom treatment with
             triptorelin pamoate or leuprolide acetate is indicated;

          -  At least 18 years of age;

          -  Life expectancy of at least 1 year;

          -  Capable of completing the study questionnaires without assistance.

        Exclusion Criteria:

          -  Patients for whom treatment with triptorelin pamoate or leuprolide acetate is
             contraindicated;

          -  Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing
             hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;

          -  Clinically significant systemic disease or condition that would, in the investigator's
             opinion, lead to undue risk following administration of either triptorelin or
             leuprolide;

          -  History of alcohol/drug abuse within the past year;

          -  History of significant medical problems that may confound the outcome of this study;

          -  Requires concomitant medications that may affect study assessments (e.g., topical
             medications used for pretreatment of injection site pain);

          -  Participated in another investigational drug study within 30 days

          -  Judged by the investigator to be unsuitable for enrollment in this study for any
             reason
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Condition: PCOS
MeSH terms: Anovulation
Intervention: Fiber-Stat
Intervention description: Liquid fiber supplement, 2 tablespoons twice daily.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether 6 months of fiber supplementation will
      improve ovulation in women with polycystic ovary syndrome (PCOS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with PCOS between the ages of 18-45 years and with a body mass index of less
             than or equal to 45

          -  Less than or equal to 8 periods annually

          -  elevated serum free testosterone concentrations

          -  normal thyroid function tests and serum prolactin

          -  exclusion of late-onset adrenal hyperplasia

          -  acceptable health based on interview, medical history,physical examination, and lab
             tests

          -  ability to comply with the requirements of the study

          -  ability and willingness to provide signed, witnessed informed consent

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Clinically significant pulmonary,cardiac
             ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease

          -  high blood pressure

          -  current or recent(within 2 months prior to study entry) injection of any drugs known
             or suspected to affect reproductive function including oral
             contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or
             anti-androgens (spironolactone,flutamide,etc)

          -  documented or suspected history of use of recent (within one year) illicit drug abuse
             or alcoholism

          -  ingestion of any investigational drugs within 4 weeks prior to study onset

          -  pregnancy or lactation(less than or equal to 6 weeks postpartum)
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
Condition: Renal Transplantation
Intervention: Basiliximab; Enteric Coated Mycophenolic Acid (MPA); RAD001; Cyclosporin A (CsA); Corticosteroids
Intervention description: On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group.; A loading dose regimen of 2880 mg/day during weeks 1 and 2 (pre-randomization) were given. During weeks 3 - 6 (pre-randomization), 2160 mg/day were given and during weeks 7 - 24, 1440 mg/day were given if tolerated. Dose reductions due to side effects were possible.; Upon randomization, 3 mg (od) on Day 1, and 3 mg (1.5 mg every 12 hours) on Day 2 was given. Afterwards, the dosage was based on blood trough level (5 - 10 ng/mL).; Dosage was based according to blood level; Dosage was administered according to local standards and administration was optional as per clinical need and the Investigators' discretion. Steroid withdrawal occurred after week 2 (pre-randomization).
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks
      after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well
      tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in
      renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft
      nephropathy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients receiving a primary kidney from a donor aged > 65 years

          -  In the Eurotransplant Senior Program

          -  Recipients of de novo cadaveric kidney transplants

        Exclusion criteria:

          -  Multi-organ recipients (e.g., kidney and pancreas)

          -  Patients receiving a kidney from a non-heart beating donor

          -  Patients who are recipients of A-B-O incompatible transplants

          -  Patients with already existing antibodies against the HLA-type of the receiving
             transplant

          -  Patients who have received an investigational immunosuppressive drug within four weeks
             prior to study entry (Baseline visit 1)

          -  Patients with thrombocytopenia, with an absolute neutrophil count of < 1,500/mm³ or
             leucopenia or hemoglobin < 6 g/dL

          -  Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive

          -  Evidence of severe liver disease

          -  Females at randomization who will be not considered post-menopausal

        Other protocol-defined inclusion/exclusion criteria may apply
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
Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery
Condition: Coronary Artery Bypass Surgery; Elective Surgical Procedure
Intervention: Atorvastatin; Placebo
Intervention description: 40mg/day once daily for two weeks prior to surgery; 1tb/day once daily for two weeks prior to surgery
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Endothelial progenitor cells; Atorvastatin; Coronary surgery

Summary:

      Experimental data have demonstrated favourable effects of statins on endothelial progenitor
      cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present
      prospective randomized controlled trial is to determine the effects of aggressive
      atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial
      progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing elective isolated coronary artery bypass surgery with on-pump
             technique

          -  Written informed consent

        Exclusion Criteria:

          -  Concomitant valve or aortic surgery

          -  Left ventricular aneurysm repair

          -  Re-operation

          -  Emergency surgery

          -  History of myocardial infarction within less than 4 weeks

          -  Hepatic impairment

          -  Chronic renal impairment

          -  Drug related side effects (allergy or hypersensitivity)

          -  Familial Hyperlipidemia

          -  Autoimmune conditions which require steroids
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Exparel; TAP Block
Intervention description: In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.; no intervention will be done to this arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus
      abdominis plane block by assessing the demand of postoperative narcotic, length of hospital
      stay and incidence of postoperative complications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients over the age of 18 years w

          2. Elective laparoscopic colorectal resection.

        Exclusion Criteria:

          1. Patients under 18 years.

          2. Patients unable to provide informed consent

          3. Patients undergoing emergency surgery.

          4. Pregnant women

          5. Severe liver or kidney disease (GFR 15-29 ml/min)
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Condition: Hyperglycemia; Diabetes
MeSH terms: Hyperglycemia
Intervention: insulin glargine; insulin glargine; insulin glargine
Intervention description: Insulin glargine given at 40% of prior stable drip rate.; Insulin glargine given at 60% of prior stable drip rate.; Insulin glargine given at 80% of prior stable drip rate.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: insulin; glargine; intravenous; subcutaneous; hospital; diabetes; glucose; inpatient

Summary:

      The primary objective of this study is to determine the optimal dose of glargine insulin when
      converting from intravenous short-acting continuous insulin infusions in surgical and
      intensive care unit patients using a prospective, controlled, parallel group, randomized
      study design.

      Note: Lantus insulin is the proprietary name for glargine insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting glucose > 100 mg/dl

          -  Patients on surgical services or in intensive care units receiving intravenous insulin

        Exclusion Criteria:

          -  Inability to obtain informed consent from patient or next-of-kin

          -  Allergy to insulin

          -  Participation in another research study

          -  Patients for whom there are "do-not-resuscitate" orders