bioihbjkbjnl/mcl2 huggingface dataset:
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: liposomal bupivacaine; Placebo
Intervention description: Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.; Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: retropubic suburethral sling; stress urinary incontinence; liposomal bupivacaine

Summary:

      The purpose of the study is to determine if the administration of liposomal bupivacaine at
      the completion of a suburethral sling procedure will result in decreased postoperative pain
      compared to no injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than 18 years of age

          -  Planning for outpatient surgical treatment of stress urinary incontinence with
             placement of a retropubic suburethral sling under general anesthesia

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Allergy to bupivacaine

          -  History of drug/alcohol abuse

          -  Severe cardiovascular, hepatic, renal disease, or neurological impairment

          -  Long-acting opioid within 3 days or any opioid use within 24 hours before surgery

          -  Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory
             drugs (NSAID)

          -  Administration of an investigational drug within 30 days before study

          -  Chronic pain syndromes

          -  Daily NSAID/opioid use

          -  Patients having concomitant procedures or not undergoing general anesthesia
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept , Methotrexate; Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Intervention description: Etanercept: 25 mg twice weekly over 16 weeks, SC
Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO; Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Etanercept; Methotrexate; Leflunomide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy of etanercept with usual
      disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe
      rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA

          -  Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA

          -  Active RA at time of screening and baseline

        Exclusion Criteria:

          -  Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha
             inhibitors, or other biologic agents

          -  Concurrent treatment with a DMARD, other than MTX, at screening

          -  Receipt of any DMARD, other than MTX, within 3 months before screening
Treatment of GLP-1 for Diabetic Bariatric Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Semaglutide (1 Mg Dose); Placebo
Intervention description: Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery; Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bariatric Surgery; Semaglutide

Summary:

      This study is for patients that are diabetic, and require insulin for glycemic control, and
      going through the bariatric surgery process. This is a prospective study that is trying to
      determine if the introduction of a semaglutide increases the remission rates of diabetes
      post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Candidates for Roux-en-Y Gastric Bypass Surgery with an established diagnosis of Type
             2 diabetes requiring insulin treatment for glycemic control

          2. Ability to provide informed consent before any trial-related activities

        Exclusion Criteria:

          1. Prior metabolic surgery procedure

          2. Use of GLP-1 analogues for diabetes treatment at the time of recruitment

          3. Known or suspected allergy to semaglutide or the excipients in semaglutide, or related
             products.

          4. Contraindications to semaglutide which include a personal or family history of
             medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome-2 (MEN-2)

          5. Previously randomized for participation in this trial.

          6. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate
             contraceptive measures.

          7. Type 1 diabetes
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hyperglycemia
Intervention: Pramlintide; Exenatide; Insulin
Intervention description: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months; Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months; Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
Intervention MeSH terms: Exenatide; Pramlintide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: type 1 diabetes; Symlin; Byetta; CGMS iPro

Summary:

      The main purpose of the study is to determine the effects of 16 weeks of adjunctive
      pramlintide or exenatide use on glycemic control in Type 1 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 12 to 21 years.

          2. HbA1C less than 9%

          3. Subjects must be on intensive insulin management

          4. Tanner stage greater than or equal to 3

          5. Having Type 1 Diabetes for at least one year

          6. Type 1Diabetes defined by ADA criteria and having at least one of the following
             antibodies a. Anti-GAD (glutamic acid decarboxylase) b. Anti-islet cell 512 (ICA512)
             c. Anti-insulin

          7. Willing to give consent.

        Exclusion Criteria:

          1. Type 2 diabetes.

          2. Having any other chronic condition except hypothyroidism stable on medications.

          3. On chronic medications that may affect glucose excursions.

          4. Anemia as defined as Hb less than 9 gm/dl.

          5. Abnormal amylase, lipase or creatinine (twice normal).

          6. Abnormal Liver function tests(three times above normal)

          7. Unsupportive family environment as determined by clinicians and/or social workers.

          8. Pregnant or lactating mothers
Tumor Gene Expression in Women With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Dexamethasone; Placebo
Intervention description: 20 MG OF DEXAMETHASONE OR PLACEBO; Placebo saline
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: Subject has intraabdominal disease either proven or strongly; suspected to be ovarian or primary peritoneal cancer

Summary:

      The study objective is to compare changes in expression of glucocorticoid-induced genes that
      may be involved in cell survival signaling in the tumors of ovarian cancer patients before
      and after an intraoperative dose of 20mg dexamethasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has intraabdominal disease either proven or strongly suspected to be ovarian
             or primary peritoneal cancer, and will be undergoing surgical debulking.

          -  Subject is not allergic to dexamethasone, and there is no obvious medical
             contraindication to dexamethasone.

          -  Subjects with diabetes requiring drug therapy are excluded.

          -  Subject is not currently receiving glucocorticoid therapy

          -  Nasal steroids (e.g. Flonase) are permitted

          -  Subject understands that this protocol does not have therapeutic intent

          -  Preoperative serum albumin at least 3.0 mg/dL

          -  Negative serum or urine pregnancy test in women of childbearing potential

          -  Signed informed consent

        Exclusion Criteria:

          -  Males do not get ovarian cancer and therefore will not be included in this trial.

          -  Patients of all ethnic backgrounds are eligible and will be encouraged to enroll.
             However we do not expect differences based on ethnicity, and this small study will not
             therefore be powered to make conclusions about ethnic differences in induction of
             GR-regulated genes with dexamethasone.
Novartis Everolimus Transition
Condition: Graft Dysfunction; Interstitial Fibrosis
MeSH terms: Lung Diseases, Interstitial; Fibrosis
Intervention: Everolimus; Standard of Care
Intervention description: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus; Tacrolimus, mycophenolate mofetil and steroids
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Everolimus; Graft dysfunction; Interstitial fibrosis

Summary:

      Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids
      in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone
      will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age and able to give informed consent.

          2. Received a first or repeat cadaveric (including ECD) or living donor renal transplant.

          3. Patient has stable graft function, defined as no change of greater than 40% of
             baseline serum creatinine and no acute rejection during the past month.

          4. Currently receiving tacrolimus, mycophenolate mofetil and prednisone as their
             immunosuppression regimen

        Exclusion Criteria:

          1. Biopsy proven acute rejection episode that occurred within the past month.

          2. Malignancy within the past 3 years, except for non-melanoma skin cancer.

          3. Currently enrolled in an investigational drug trial.

          4. Woman of child bearing potential not utilizing an effective form of birth control.

          5. Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or
             serum fasting triglycerides >500 mg/dL.

          6. Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram
             of creatinine.

          7. WBC < 2,000 cells/mm3

          8. Platelets < 75,000 cells/mm3

          9. Patients who have received an organ transplant other than a kidney.

         10. Patients with a history of biopsy proven FSGS, MPGN, or PGN.
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Amantadine Hydrochloride, USP; Amantadine Hydrochloride, USP; Placebo
Intervention description: amantadine tablets 100 mg. BID for 4 weeks; amantadine 200 mg. tablets BID for 4 weeks; tablets BID, for 4 weeks
Intervention MeSH terms: Amantadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective disorder; paliperidone ER; risperidone Consta; prolactin; hyperprolactinemia

Summary:

      The purpose of this study is to show that amantadine might help to reduce the side effect of
      the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High
      level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be
      developed in patients treated with the paliperidone ER or risperidone Consta.

      High level of prolactin might stimulate breast development, might decrease sexual desire
      (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels,
      decreases side effects, and improves psychiatric symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Age 18-65 years

          -  Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform
             disorder

          -  Well established compliance with out-patient medications including paliperidone ER or
             risperidone Consta for 3 months

        Exclusion Criteria:

          -  Current substance or alcohol abuse

          -  Significant medical illness

          -  Women who are pregnant, breastfeeding, or who are unwilling or unable to use an
             effective form of birth control during the entire study

          -  Subjects treated with more than one antipsychotic drug
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab
Intervention description: Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Idiopathic Urticaria; CIU; Urticaria; Chronic Hives; Xolair

Summary:

      This study looks at changes in cell proteins in people with chronic hives treated with
      omalizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic urticaria (hives) for more than 6 weeks.

          -  No improvement with standard doses of antihistamines (loratadine 10 mg daily,
             desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or
             levocetirizine 5 mg daily)

        Exclusion Criteria:

          -  Taken any oral steroids for 1 month prior to beginning the study.

          -  Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine,
             cyclosporine, methotrexate) for 1 month prior to beginning the study.

          -  Physical urticaria as a primary diagnosis.

          -  Known allergic precipitant of urticaria such as foods.

          -  Urticarial Vasculitis.

          -  Anemia.

          -  Asthma.

          -  Serum Immunoglobulin E (IgE) >700 IU/ml.

          -  Women of childbearing potential not using contraception method(s), as well as women
             who are pregnant and/or breastfeeding.

          -  Known sensitivity to omalizumab or this class of drug.

          -  Use of any other investigational agent in the last 1 month.

          -  Untreated intercurrent illness.
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Entresto
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study intends to measure the effects of valsartan/sacubitril compared to baseline
      standard medical heart failure therapy on reverse remodeling using echocardiographic
      endocardial surface analysis techniques to assess changes in ventricular volume, function,
      and shape.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females aged ≥18 years

          2. Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤
             Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)

               -  NT-proBNP ≥ 600 pg/mL OR

               -  NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12
                  months

          3. Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent
             to enalapril ≥ 10 twice a day (BID) for at least 4 weeks

          4. Stable and optimized on a beta-blocker for at least 4 weeks

          5. Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks

        Exclusion Criteria:

          1. History of angioedema

          2. estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 at screening

          3. Serum potassium > 5.2 mmol/L at screening

          4. Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) <
             100 mmHg at screening

          5. Current acute decompensated heart failure

          6. History of severe pulmonary disease

          7. Active malignancy

          8. Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and
             angiotensin receptor blockers (ARB)
Acetaminophen and Post Circumcision Pain Control
Condition: Pain; Circumcision
Intervention: Acetaminophen
Intervention description: Infants will receive 15 mg/kg of acetaminophen.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 11.0
Sex: Male
Minimum age: 10 Hours
Maximum age: 36 Hours
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infant pain; Acetaminophen; Circumcision

Summary:

      Infants do not routinely receive acetaminophen for pain control after circumcision. This
      study will determine if acetaminophen is effective at controlling infant pain after
      circumcision using nerve block and oral dextrose. Infants will undergo the routine
      circumcision procedure, and half will be randomly selected to receive half acetaminophen
      immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,
      respiratory rate, oxygen saturation), the neonatal infant pain scale (NIPS), and salivary
      cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated
      pain scoring system based on the appearance of the infant. A reduction in NIPS for those
      infants who receive acetaminophen versus nothing will be the primary outcome to determine if
      the study is significant.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery
        who's parents are requesting circumcision. Eligibility includes

          1. Apgar score at 5 minutes >7

          2. birthweight greater than 2.4 kg

          3. Age of at least 10 hours

          4. At least one void.

        Exclusion Criteria:

          1. Newborns of substance abusing mothers.

          2. Newborns with any contraindications to routine circumcision, anatomical or
             hematologic.
Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Condition: Anterior Cruciate Ligament Reconstruction
MeSH terms: Hemarthrosis
Intervention: Tranexamic Acid
Intervention description: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of the proposed study is to evaluate the effects of administering intravenous
      tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction
      with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and
      post operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

        -PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

        Exclusion Criteria:

          -  Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects,
             dementia, etc.)

          -  Younger than 18 years of age

          -  Any patient considered a vulnerable subject

          -  Have bleeding or clotting disorder

          -  Preoperative anticoagulation therapy

          -  Abnormal coagulation profile

          -  Renal disorder or insufficiency

          -  Sickle cell disease