bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Lidocaine Administration Techniques
Condition: Pain
Intervention: lidocaine; lidocaine
Intervention description: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection; 1% lidocaine subcutaneous injection alone
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: procedural

Summary:

      The objective of our study is to determine if technique of lidocaine administration can
      decrease pain perception.

      Hypothesis: There will be a significant difference in pain perception between patients who
      are given lidocaine on the skin surface prior to subcutaneous injection and patients who are
      given only subcutaneous injection by standard approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients refered to the University of Chicago Medical Centers Procedure Service
             for a planned medical procedure requiring local injection of lidocaine.

        Exclusion Criteria:

          -  Patient who lack decisional capacity to consent

          -  Patients who lack the ability to answer questions in english using pain scales
Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Condition: Arthropathy of Hip
MeSH terms: Joint Diseases
Intervention: Vecuronium 0.1 mg/kg; Vecuronium 0.2mg/kg
Intervention description: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.; Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Intervention MeSH terms: Bromides; Vecuronium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: The anesthesiologist will NOT be blinded, but the orthopedic surgeon performing the hip replacement surgery will be.
Enrollment: 116.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: neuromuscular blockade; sugammadex

Summary:

      During many surgeries, increased muscle tension makes it harder for the surgeon to expose the
      site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as
      Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction,
      blocking their action and producing muscle relaxation. This muscle relaxation allows easier
      retraction of muscle tissues and manipulation of structures in the wound. Improved surgical
      conditions are likely to result in improved patient outcomes. While increased depths of NMB
      have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal
      procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To
      address this, we propose to study the effect of NMB depth on surgical conditions during total
      hip replacement (THR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Physical status 1-3

          -  age 50-75

          -  English speaking

          -  able to provide informed consent

          -  BMI equal to less than 30

          -  non-emergent THR by anterolateral minimally invasive non-cemented total hip
             arthroplasty

        Exclusion Criteria:

          -  Revision surgery

          -  Bilateral THR

          -  ASA 4+

          -  age less than 50 or greater than 75

          -  BMI greater than 30

          -  unable to provide informed consent

          -  women taking oral contraceptives (Sugammadex used for reversal interferes with their
             efficacy

          -  contraindications to general inhalation anesthesia (such as malignant hyperthermia)

          -  contraindications to NMB (known allergy to NMB)

          -  chronic kidney disease
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Data Collection
Intervention description: No study treatment was administered as part of this study
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 662.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Cladribine; High Disease Activity

Summary:

      The objective of this study was to collect data both retrospectively and prospectively in
      order to evaluate the long-term outcomes, durability of effect, and real-world treatment
      patterns following treatment with Cladribine Tablets or placebo in participants with multiple
      sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and
      CLARITY/CLARITY-EXT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with relapsing remitting multiple sclerosis (RRMS) randomised in
             CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=)
             1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo

          -  Participants with their first clinical demyelinating event randomised in ORACLE MS
             clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo

          -  Participants who has sign informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form and this protocol

        Exclusion Criteria:

          -  Participants who has any uncontrolled disease state other than MS, that in the
             Investigator's opinion, constitutes an inappropriate risk or a contraindication for
             participation in the study or that could interfere with the study objectives, conduct,
             or evaluation

          -  For study participants at selected sites where MRI assessment will be conducted
             following exclusion criteria will apply to MRI assessments only:

          -  Female study participants who are pregnant

          -  Participants who are taking Cladribine Tablets as part of another study at the time of
             the start of this study
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Lifestyle intervention
Intervention description: Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; lifestyle change; weight management; control of glycemic in HbA1C and FPG

Summary:

      This study was aimed to achieve of long-term weight loss in T2DM patients by use of
      comprehensive lifestyle changes program, providing patients with structured diet, exercise
      plan, group behavioral support and group education. Additionally the study was designed to
      establish reduction of the body weight leads to the improvement of glycemic and lipid
      metabolism, and also reducing blood pressure level. The study was also directed to show that
      lifestyle changes program in T2DM patients can lead to decreasing of hospitalization rate and
      healthcare consumption. In order to demonstrate a change from standard of care, data were to
      be collected from a parallel cohort from the same centers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent. Written informed consent must be obtained before any
             assessment is performed.

             •≥ 18 years

          -  Type 2 diabetes

          -  The Body Mass Index is from 28 to 40 kg/m^2

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation.

          -  Type 1 diabetes

          -  Proliferative retinopathy

          -  Renal impairment: serum creatinine >1.5 mg/dL, creatinine clearance < 40 ml/min and/or
             proteinuria

          -  The lack of ability to perform the physical exercises due to the orthopedic or
             cardiovascular disorders

          -  Chronic alcoholism, acute alcoholic intoxication
Evaluation of Diaphragm Movement After an Interscalene Block
Condition: Phrenic Nerve Paralysis
MeSH terms: Paralysis
Intervention: liposomal bupivacaine; bupivacaine
Intervention description: Experimental; Active comparator
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the movement of the diaphragm after an interscalene
      block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine.
      This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using
      liposome bupivacaine in an interscalene block, using ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients age 18 years and older who are scheduled for shoulder surgery with
             interscalene block and remain in the hospital for more than 24 hours that are being
             randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.

        Exclusion Criteria:

          -  Non English speaking patients.
Stress Testing and Cardiac Magnetic Resonance
Condition: Coronary Disease
MeSH terms: Coronary Disease; Coronary Artery Disease
Intervention: regadenoson
Intervention description: Subjects in open label group will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus) as contrast.
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coronary Disease; Stress Testing; Lexiscan (regadenoson); Cardiac Magnetic Resonance Imaging

Summary:

      The purpose of this study is to better define the role of a comprehensive stress MRI (which
      includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar
      imaging) in medical practice and in patient health management. Information gathered from the
      healthy volunteers that participate in this study will be compared to information from the
      coronary artery disease patients in this study in order to help further our understanding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected coronary artery disease

          -  Symptoms of possible coronary artery disease

        Exclusion Criteria:

          -  Acute ST-elevation myocardial infarction

          -  Second or third degree AV block

          -  Severe Renal Disease (Glomerular Filtration Rate (GFR) <30cc/min or hemodialysis)

          -  Contra-indications to MRI (i.e. Implantable Cardioverter Defibrillator (ICD),
             pacemaker, aneurysm clip, etc)

          -  Hemodynamic instability

          -  Inability to provide informed consent

          -  Severe claustrophobia

          -  Pregnancy

          -  Age <18 years
Subcuticular Suture for Cesarean Skin Incision Closure
Condition: Complications; Cesarean Section; Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Surgical Wound
Intervention: poliglecaprone 25 suture; polyglactin 910 suture
Intervention description: cesarean delivery incision closure with poliglecaprone 25 suture; cesarean delivery incision closure with polyglactin 910 suture
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 550.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: wound complications

Summary:

      A comparison of the type of suture used for cesarean skin incision approximation and the
      subsequent rate of wound complications has not been widely studied. Investigators seek to
      compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in
      Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication
      rates (SSI, hematoma, seroma, wound separation).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age of 37 completed weeks or greater based on their estimated due date
             calculated from last menstrual period or early ultrasound.

          -  Patients participating will be undergoing either:

               -  Scheduled cesarean delivery

               -  Non-emergent cesarean delivery

        Exclusion Criteria:

          -  Urogenital tract infection within 2 weeks prior to surgery

          -  Chronic oral or injectable steroid use (> 2 weeks)

          -  Emergency cesarean delivery (need to deliver immediately due to a maternal or fetal
             indication)

          -  Vertical skin incision

          -  Active participation in another research study
Double-Blind Placebo-Controlled CIN Trial
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Intervention: Iopamidol 300 (Contrast); Placebo (Normal Saline)
Intervention description: Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan; Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CT, iodinated contrast, contrast-induced AKI, kidney injury

Summary:

      This double-blinded placebo-controlled study will examine the incidence and significance of
      contrast-induced acute kidney injury following IV iodine-based contrast material
      administration in subjects with stage IIIB or stage IV chronic kidney disease.

      Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to
      evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive
      either weight-based low-osmolality iodinated contrast material or saline. The primary outcome
      measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inpatients scheduled for CT scan of abdomen and/or pelvis

          -  Had surgery in the last 4 weeks

          -  Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each
             other, with most recent within 5 days of CT)

          -  Suspected infection or fluid collection in abdomen and/or pelvis

        Exclusion Criteria:

          -  Pregnant

          -  Severe Allergy (anaphylaxis) to contrast

          -  Dialysis in last 7 days

          -  Received intravascular iodinated contrast in last 48 hours

          -  CT of abdomen and pelvis in last 7 days shows no fluid collection

          -  Prisoners

          -  CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg,
             renal stone CT) the administration of intravascular contrast
Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Condition: Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Healthy
MeSH terms: Schizophrenia; Psychotic Disorders; Mood Disorders
Intervention: Memantine; Placebos
Intervention description: To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.; To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced
      early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory
      processing fidelity (APF) and auditory learning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of schizophrenia OR schizoaffective-depressed OR healthy subjects

          -  ages 18-50 for all subjects

          -  double barrier contraception for all subjects

          -  not pregnant for all subjects

        Exclusion Criteria:

          -  DSM-IV Axis I or II Diagnosis for for healthy subjects

          -  MEM or amantadine for patients

          -  current substance abuse for all subjects

          -  current recreational drug use for all subjects

          -  history of other significant medical illness (e.g. cancer, diabetes, heart disease,
             HIV, seizures) for all subjects

          -  open head injury or closed head injury with loss of consciousness > 1 min for all
             subjects

          -  hearing or visual impairment for all subjects

          -  pregnancy for all subjects

          -  dementia for all subjects

          -  mental retardation for all subjects
Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: 30 ml of 0.2% ropivacaine; 15 ml of 0.2% ropivacaine; 100 mcg clonidine; High-frequency linear ultrasound transducer
Intervention MeSH terms: Clonidine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 125.0
Sex: All
Minimum age: 16 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Femoral Nerve Block; Adductor Canal Block

Summary:

      This study will examine the potential differences between femoral nerve blockade (FNB) and
      adductor canal blockade (ACB) for pain control and quadriceps muscle activation for patients
      following anterior cruciate ligament (ACL) reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males & Females ages 16-30 yrs

          -  Undergoing ACL reconstruction by Co-Investigator (Walter Lowe)

          -  Receiving peri-operative FNB or ACB

        Exclusion Criteria:

          -  Not enrolled within the COFAKS study

          -  Receiving intrathecal nerve blockade or no blockade
Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
Condition: Minimal Change Disease
MeSH terms: Nephrosis, Lipoid
Intervention: tacrolimus; prednisolone
Intervention description: tacrolimus0.05mg/kg bd (levels 6-12ng/ml); Prednisolone 1mg/kg maximum 60mg od
Intervention MeSH terms: Prednisolone; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nephrotic minimal change tacrolimus prednisolone

Summary:

      The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus
      prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR)
             > 100units), secondary to minimal change disease.

          -  Age over 18.

        Exclusion Criteria:

          -  Hepatitis B, hepatitis C or HIV infection.

          -  Untreated infection.

          -  Females who are pregnant, breast feeding, or at risk of pregnancy and not using a
             medically acceptable form of contraception.

          -  Patients who have been treated with immunosuppression over the last 18 months.

          -  Patients who have had more than 3 relapses of nephrotic syndrome within 5 years.

          -  Any condition judged by the investigator that would cause the study to be detrimental
             to the patient.
Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
Condition: Moderate-severe Pain
Intervention: Ages 7-11; ages 12-17
Intervention description: Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.; Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; pain indication; controlled release morphine

Summary:

      Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine
      sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 7-17 with moderate to severe pain requiring around the clock treatment with
             an opioid analgesic.

          -  Be an experienced opioid user, defined as any subject treated with opioid therapy,
             equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days
             immediately prior to first day of dosing.

        Exclusion Criteria:

          -  Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in
             past year.

          -  Hypersensitivity to morphine, naltrexone.

          -  A life expectancy (assessed by investigator) of less than 6 months or is no longer
             capable of taking medication orally.

          -  Undergone surgery within 3 days prior to the first day of dosing.