bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Insulin Glargine Dosing Study
Condition: Diabetes; Surgery
MeSH terms: Diabetes Mellitus
Intervention: Lantus; Insulin; Lantus
Intervention description: Patients in Group 1 will administer 80% of their usual insulin glargine dose.; Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose; Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.
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: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Insulin Glargine; Surgery

Summary:

      The main objective of this study is to compare three strategies of evening insulin glargine
      dosing to preoperative glucose values in patients with diabetes undergoing surgery to
      determine which dosing strategies most often achieves the admission target study values of
      100-179 mg/dl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for Surgical Procedure

          -  Self Management of Diabetes

          -  Currently on Evening Insulin Glargine prescribed by Primary Care Physician

          -  Age 18 or over

          -  Able to Communicate Clearly over the Phone

          -  Pre-screened by Anesthesia Department > 48 hours prior to Surgery

        Exclusion Criteria:

          -  On Glucocorticoid Medication

          -  On Insulin Glargine Dual Dosing or Sliding Scale Regimen

          -  History of Hypoglycemia Unawareness

          -  Pregnancy or Lactating Female

          -  On Insulin Glargine for < 3 months
Resistance Under the Microscope
Condition: Anxiety
Intervention: Lorazepam; NaCl 0.9% (Sodium Chloride)
Intervention description: Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery; Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery
Intervention MeSH terms: Lorazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: quality of life; lorazepam; anxiety; premedication; surgery; Adult patients; Ambulatory Surgical Procedures; Postoperative Period

Summary:

      The purpose of this study is to determine whether lorazepam, which is used to lower
      preoperative anxiety, also improves postoperative recovery.

      This study data will also be used for further research aiming to identify vulnerable patients
      in the day-case surgery setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients > 18 years admitted to the Day-Case Surgery Department Erasmus MC

        Exclusion Criteria:

          -  insufficient command of the Dutch language

          -  ophthalmology surgery

          -  Extracorporeal Shock Wave Lithotripsy (ESWL)-, Gastrointestinal endoscopic
             intervention, Botox-, Abortion and Pain treatment

          -  Use of psychopharmaceuticals

          -  Contra-indication of lorazepam use
Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds
Condition: Diabetic Wound
MeSH terms: Wounds and Injuries
Intervention: NPWT and lyopreserved Stravix; NPWT and cryopreserved Stravix
Intervention description: Subjects will be treated with NPWT and lyopreserved Stravix; Subjects will be treated with NPWT and lyopreserved Stravix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, 2-arm parallel assignment, randomized clinical trial. Stravix will be applied at initial visit with NPWT and will only be reapplied after 4 weeks if wound is not ready for grafting unless debridement is indicated.
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare
      lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a diabetes mellitus

          -  Men/women ≥21 years old

          -  Post-operative foot or ankle wounds sized >4cm2 that have presented for <1 year

          -  ABI ≥0.5 or toe pressures >30 mmHg

          -  Wounds indicated for treatment with NPWT

        Exclusion Criteria:

          -  Active Charcot arthropy

          -  Unable to use NPWT at home

          -  Untreated bone or soft tissue infection

          -  Is pregnant or plans to become pregnant

          -  Is nursing or actively lactating

          -  Developmental disability/significant psychological disorder that in the opinion of the
             investigator could impair the subject's ability to provide informed consent,
             participate in the study protocol or record study measures, including untreated
             schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2
             years.

          -  Active alcohol or substance abuse in the opinion of the investigator that could impair
             the subject's ability to provide informed consent, participate in the study protocol
             or record study materials
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Condition: Anemia
MeSH terms: Anemia
Intervention: Blood and blood products for transfusion
Intervention description: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb >7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if there is a difference in outcomes between
      liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and
      conservative transfusion (transfusing when hemoglobin drops below a set lower value number).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trauma patients admitted to participating hospital with any Orthopaedic injury who
             have been determined to be stable by the Trauma Service (General Surgery) and are no
             longer within the resuscitation phase of initial treatment. This is defined as a
             normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood pressure greater
             than 90 mmHg for greater than 6 hours without fluid bolus or transfusion during that
             time

          -  Age 18-50

          -  Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery

        Exclusion Criteria:

          -  Pregnant ( urine pregnancy test will be done as standard of care)

          -  Prisoner

          -  Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation)

          -  Known cardiac (coronary artery disease, atrial fibrillation, stent placement,
             congestive heart failure), renal (acute or chronic renal insufficiency or failure,
             defined as having Serum Creatinine >1.2 at time of enrollment), liver (Childs C
             cirrhosis) or pulmonary disease (chronic obstructive pulmonary disease, abnormal
             pulmonary function tests or history of poor pulmonary function from any cause
             including acute traumatic conditions such as ARDS)

          -  Unlikely to follow up in the surgeon's estimation

          -  Sickle Cell Anemia

          -  History of cancer

          -  Preexisting weakness, paresthesias, deformities, or other conditions which might
             affect functional outcome in the surgeon's opinion

          -  Spinal cord injury

          -  Patients with burns expected to require operative treatment

          -  COVID positive
The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy
Condition: Gastrointestinal Dysfunction; Alteration of Cognitive Function
Intervention: Midazolam; Meperidine; Remifentanil; Propofol
Intervention description: Dosage adjustment; Dosage adjustment; Dosage adjustment; Dosage adjustment
Intervention MeSH terms: Midazolam; Meperidine; Remifentanil; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cognitive dysfunction; Colonoscopy; Sedation

Summary:

      There are different sedation regimes for lower gastrointestinal system endoscopy which can be
      administered by anesthesiologists and non-anesthesiologists. This study aims to compare the
      effects of propofol/remifentanil combination and midazolam/meperidine combination on early
      cognitive function following lower gastrointestinal system endoscopies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18-65 years of age (ASA I-III risk groups), scheduled for elective
             colonoscopy

        Exclusion Criteria:

          -  Patient refusal

          -  Mini mental test (MMT) score<26

          -  Amsterdam Preoperative Anxiety and Information Scale (APAIS ) score >10

          -  Advanced cardiopulmonary or psychiatric disease

          -  Chronic alcohol abuse

          -  Morbid obesity

          -  Known allergy to study drugs
Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg; Desvenlafaxine Succinate Sustained-Release Formulation 25 mg; Placebo
Intervention description: DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.; DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.; DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 480.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated
      for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation
      (DVS SR)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary Diagnosis of Major Depressive Disorder

          -  Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or
             equal to 14 at baseline

        Exclusion Criteria:

          -  Current psychoactive substance abuse or dependence, manic episode, or a lifetime
             diagnosis of bipolar or psychotic disorder

          -  Potentially violent to others or is at significant risk for suicide

          -  History or current evidence of gastrointestinal disease or history of surgery known to
             interfere with absorption or excretion

          -  Known presence of raised intraocular pressure or history of narrow angle glaucoma
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Thrombosis
Intervention: Optison echocardiography contrast agent
Intervention description: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; stroke; TEE; Left atrial thrombus

Summary:

      The investigators intend to determine if using Optison echocardiography contrast increases
      sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal
      echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo
      contrast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 18 years old

          -  Cognitively sound and able to provide informed consent

          -  Indicated for TEE as a standard clinical procedure for evaluation of cardiac health
             status.

        Exclusion Criteria:

          -  Contraindicated for Optison administration

          -  Known right-to-left or bi-directional cardiac shunts

          -  Hypersensitivity to perflutren, blood, blood products or albumen

          -  Women who are pregnant

          -  Removal of Left Atrial Appendage

          -  Not able to provide informed consent
Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; Exenatide; Dapagliflozin; Exenatide and Dapagliflozin
Intervention description: Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period; Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period; Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period; Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
Intervention MeSH terms: Dapagliflozin; Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Participants will be randomized to one of four groups (20 per group): i) placebo; (ii) exenatide 5 ug subcutaneously; (iii) dapagliflozin (10 mg); and (iv) dapagliflozin 10 mg plus exenatide 5 ug
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Research Design/Plan: After screening, each subject will receive 1 measurements of Endogenous
      Glucose Production [EGP] with prime-continuous Infusion of 3-3H-glucose. After completing the
      EGP measurement each subject will receive a Double Tracer Oral Glucose Tolerance Test [OGTT].

      Methods: Visit 1: Screening. Medical history will be obtained, physical exam performed, and
      pregnancy test performed.

      Visit 2: Endogenous Glucose Production Measurement: The rate of EGP will be measured with
      3-3H-glucose.

      Visit 3: Double Tracer OGTT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in
             good general health as determined by physical exam, medical history, blood
             chemistry-CBC, TSH, T4, EKG and urinalysis)

          -  BMI: 21-45kg/m

          -  HbA1C>7.0% and <10.5%

          -  Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more
             than 3 months)

        Exclusion Criteria:

          -  Health Status: Type 1 Diabetics

          -  Proliferative diabetic retinopathy

          -  Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males,
             or 24 hour urine albumin excretion greater than 300mg/dL

          -  Medication: Subjects taking drugs known to affect glucose metabolism (other than
             metformin and sulfonylurea)
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine; Placebo
Intervention description: Fesoterodine 4mg and 8 mg tablets taken daily.; Placebo sham 4mg and 8 mg tables taken daily.
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 963.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: incontinence OAB urgency nocturia

Summary:

      This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on
      micturition related nocturnal urgency episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening
             bladder diary prior to Start of Placebo run in visit (Visit 2)

          -  Mean number of micturition related urgency episodes >=3 per 24 hours as verified by
             the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency
             episodes are defined as those with Urinary Sensation Scale rating >=3)

          -  Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8
             episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency
             episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in
             the bed time section of the bladder diary)

        Exclusion Criteria:

          -  A known recent history or previous diagnosis of any sleep disorder such as obstructive
             sleep apnea, primary insomnia, periodic limb movement, parasomnia

          -  Nocturia due to other underlying uncontrolled conditions, such as congestive heart
             failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
The Effect of Selenium Supplementation Among Pediatric Patients With Burns
Condition: Burns
MeSH terms: Burns
Intervention: Selenium1; Selenium2; Placebo
Intervention description: 2 ug/kg; 4 ug/kg; IV saline as placebo
Intervention MeSH terms: Selenium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The selenium status of children with major burns is suboptimal which may increase the
      incidence of infection. Se requirements during critical illness are not known. Results from
      this investigation may provide a tool for recommending Se supplements during burn injury.

      The hypothesis of this research is that Se supplementation will restore the depressed Se
      status among children with burn injuries. The secondary hypothesis is that Se status is
      related to the incidence of infection among pediatric patients with burns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 1 and 18 years of age admitted to Shriners Burns Hospital

          -  TBSA burn of > 20%

          -  Existing IV catheter

          -  Enrolled into study within 3 weeks of burn injury

        Exclusion Criteria:

          -  < 1 year or > 18 years of age

          -  < 20% TBSA burn

          -  No existing IV catheter

          -  Pre-existing or acute renal disease (creatine > 1.5 mg/dl)

          -  Pre-existing or acute liver disease (bilirubin > 3)

          -  Pre-existing or acute thyroid disorders

          -  Cancer

          -  AIDS

          -  Pregnancy (as determined by routine admission labs)
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER; Placebo; Paliperidone ER
Intervention description: 1.5 mg tablet once daily for 6 weeks; Once daily for 6 weeks; 6 mg tablet once daily for 6 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of
      paliperidone Extended Release (ER) as compared with placebo when used to treat patients with
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of
             Mental Disorders, Fourth Edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at
             least 1 year before screening

          -  Experiencing an acute episode with a total PANSS score at screening of between 70 and
             120

          -  Are otherwise physically healthy

          -  Agree to at least 8 days of voluntary hospitalization.

        Exclusion Criteria:

          -  Active comorbid DSM-IV axis I diagnosis other than schizophrenia (nicotine and
             caffeine dependence are not exclusionary)

          -  Treatment with antidepressants (unless a subject has been on a stable dosage for at
             least 3 months before baseline) other than monoamine oxidase inhibitors

          -  DSM-IV diagnosis of substance dependence within 6 months before screening evaluation
             (nicotine and caffeine dependence are not exclusionary)

          -  Any medical condition that could potentially alter the absorption, metabolism, or
             excretion of the study medication, such as Crohn's disease, liver disease, or renal
             disease

          -  Relevant history of any significant or unstable cardiovascular, respiratory,
             neurologic (including seizures or significant cerebrovascular), renal, hepatic,
             endocrine, or immunologic disease.