bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
Condition: Blood Loss, Surgical
MeSH terms: Blood Loss, Surgical
Intervention: rThrombin, 1000 IU/mL
Intervention description: rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the safety and immunogenicity of recombinant
      thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin
      grafting in pediatric patients, newborn through 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of newborn through 17 years at time of enrollment

          -  At least 1 skin graft recipient site measuring at least 1% of total body surface area
             (TBSA)

          -  Total initial burn wounds estimated to measure less than 40% of TBSA

          -  Bleeding indicating treatment with rThrombin during the surgical procedure

          -  Females of child-bearing potential must have a negative urine or serum pregnancy test
             within 2 days prior to study-drug treatment

          -  informed consent document signed by legal representative (guardian) and approved by an
             institutional review board/independent ethics committee (IRB/IEC)

          -  Participant has signed an IRB/IEC-approved pediatric assent document, if applicable

        Exclusion Criteria:

          -  Gestational age younger than 36 weeks at birth (for infants younger than 2 years)

          -  Documented active infection at the graft recipient site (participants with resolved
             infections at potential graft recipient sites are not excluded)

          -  Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury

          -  Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous
             malignancies

          -  Presence of antibodies or hypersensitivity to the study drug or any of its components,
             other thrombin preparations, or coagulation factors

          -  Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within
             24 hours prior to study-drug treatment (packed red blood cell transfusions are
             allowed)

          -  History of HIV infection or other immunodeficiency syndrome or is taking
             immunosuppressive or antirejection medications

          -  Medical, social, or psychosocial factors that, in the opinion of the investigator,
             could affect safety or compliance with study procedures

          -  Breastfeeding or being breastfed

          -  Treatment with any experimental agent within 30 days of study enrollment or treatment
Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
Condition: Postoperative Pain; Intra-articular Injection; Dexmedetomidine; Magnesium Sulfate
MeSH terms: Pain, Postoperative
Intervention: Precedex; Magnesium Sulfate
Intervention description: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.; 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.
Intervention MeSH terms: Magnesium Sulfate; Dexmedetomidine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Analgesia; Anesthesia; Arthroscopy; Bupivacaine; Dexmedetomidine; Injections, Intra-Articular; Magnesium; Pain, Postoperative

Summary:

      Arthroscopic meniscus surgeries are the most frequent orthopedic procedures. The objective of
      the study is to compare the effects of intraarticular local anesthetic and adjuvant
      (dexmedetomidine vs magnesium) combinations in postoperative pain and analgesic requirement.
      The investigators' hypothesis is adjuvants added to the local anesthetics decreases the total
      local anesthetic dose, provides more effective pain relief according to local anesthetic
      only, and decreases the postoperative systemic non-steroidal analgesic and opioid doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age >18, <65

          -  scheduled for elective knee arthroscopy under spinal anesthesia

          -  ASA I and ASA II

        Exclusion Criteria:

          -  age <18 and >65

          -  patients who received general anesthesia

          -  diabetes

          -  refusal of the patient

          -  known allergy to the specified drugs
Liposomal Bupivacaine vs Dexamethasone ISB
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Exparel 133 MG Per 10 ML Injection; Dexamethasone
Intervention description: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total); 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      In this study, patients receiving shoulder arthroscopy will receive an interscalene block for
      pain management containing either liposomal bupivacaine and standard bupivacaine or standard
      bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative
      pain and block duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-III

          -  Age 18 years or older

          -  Scheduled for elective outpatient arthroscopic shoulder surgery

        Exclusion Criteria:

          -  History of allergy to local anesthetic, or one of the study medications

          -  Pre-existing neurological deficits

          -  Psychiatric or cognitive disorders that prohibit patients from following study
             protocol

          -  History of drug or alcohol abuse

          -  Chronic opioid use (longer than 3 months)

          -  Chronic pain syndromes

          -  Infection at the site of injection

          -  Patients with severe pulmonary disease

          -  Herniated cervical disc, cervical myelopathy

          -  Contraindication for general anesthesia and/or interscalene nerve block

          -  Pregnancy

          -  Open shoulder arthrotomies.

          -  Non English speakers
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: placebo; Pregabalin
Intervention description: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.; Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pregabalin; postoperative pain; abdominal hysterectomy

Summary:

      This study aims to compare the effect of pre-operative oral pregabalin on post operative
      morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ASA classification 1-2 undergoing abdominal hysterectomy with/without
             salpingo-oophorectomy under spinal anesthesia with intrathecal morphine

          2. Patient can use patient-controlled analgesia (IV PCA)

        Exclusion Criteria:

          1. History of drug allergy to gabapentinoid and related drug

          2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol
             addiction or chronic pain patient

          3. Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and
             Psychiatric disorder
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Condition: Hypertension; Hypercholesterolemia; Angina Pectoris
MeSH terms: Hypertension; Angina Pectoris; Hypercholesterolemia
Intervention: Caduet
Intervention description: One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
Intervention MeSH terms: Amlodipine, atorvastatin drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5
      mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in
      Japanese patients with both of hypertension and hypercholesterolemia, or with both angina
      pectoris and hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with both hypertension and hypercholesterolemia must meet the following (1),
             and the following (2) or (3):

          -  (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2,
             and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)

          -  (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2

          -  (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3
             months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and
             TG < 400 mg/dL at Week -2

          -  Subject with both angina pectoris and hypercholesterolemia must meet the following
             (1), and the following (2) or (3):

          -  (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2,
             and who meet the following criteria; Subjects with well controlled BP value (BP value
             < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris

          -  (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2

          -  (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3
             months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and
             TG < 400 mg/dL at Week -2

        Exclusion Criteria:

          -  Subjects who need three or more multi-antihypertensive therapies to achieve the target
             BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is
             defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.

          -  Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥
             160 mg/dL even though Atorvastatine 10 mg has administrated
Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution
Condition: Surgical Preparation of the Vagina
Intervention: Povidone-Iodine; 4% Chlorhexidine Gluconate
Intervention description: Patients will receive povidone iodine for the surgical preparation of the vagina.; Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
Masking: Single (Participant)
Masking description: Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
Enrollment: 134.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4%
      isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical
      preparations of the vagina. Patients will be randomized to either control (povidone iodine)
      or experimental (chlorhexidine gluconate), and then be given a short survey prior to and
      immediately after surgery, and again 24-48 hours via phone asking them about the presence and
      severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or
      burning with urination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Undergoing hysteroscopy

          2. Gynecologic dilation & curettage

          3. Endometrial ablation

          4. Essure without concomitant laparoscopy

        Exclusion Criteria:

          1. Pregnant

          2. Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or
             anaphylaxis to chlorhexidine gluconate or povidone iodine.
Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
Condition: Schizophrenia; Dual Diagnosis; Schizoaffective Disorder; Psychotic Disorder; Cannabis Abuse
MeSH terms: Marijuana Abuse; Schizophrenia; Psychotic Disorders
Intervention: Clozapine; Treatment as usual
Intervention description: Clozapine up to 550mg per day; Remain on pre-study antipsychotic treatment
Intervention MeSH terms: Clozapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Clozapine; Schizophrenia; Dual Diagnosis; Substance Abuse; Cannabis Abuse

Summary:

      Many individuals with schizophrenia also suffer from marijuana addiction. Clozapine, an
      atypical antipsychotic medication, may prove useful at preventing drug relapse in
      schizophrenic individuals who are seeking treatment for marijuana addiction. The purpose of
      this study is to compare the effectiveness of clozapine, vs. treatment-as-usual with other
      oral antipsychotics at reducing marijuana use in schizophrenic individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statical Manual of Mental Disorders IV (DSM-IV) diagnostic
             criteria for schizophrenia or schizoaffective disorder

          -  Meets diagnostic criteria for marijuana use disorder, as determined by a rating of 3
             or higher on the Drug Use Scale (Abuse or Dependence)

          -  Used marijuana on 5 or more days during the 3 weeks prior to study entry

          -  Taking any oral antipsychotic other than clozapine in the month prior to study entry.
             (Patients may take a second oral antipsychotic medication, if approved by the
             Medication Adjustment Group)

          -  If female, willing to use effective contraception throughout the study

        Exclusion Criteria:

          -  Unable to take clozapine for medical reasons, including previous clozapine-induced
             granulocytopenia, myeloproliferative disorder, white blood cell count less than
             3500/mm3, or history of seizures

          -  Currently taking clozapine

          -  Currently taking other psychotropic medications for the treatment of substance use
             (e.g., disulfiram, naltrexone, acamprosate, inderol, tegretol, topiramate, and
             pramipexole)

          -  Participated in a clinical trial of an investigational drug within 30 days of study
             entry

          -  Currently participating in a psychosocial intervention clinical trial

          -  Has medical or legal problems that may entail a jail or hospital stay during the study

          -  Has a developmental disability that would make study participation difficult

          -  Currently enrolled in a live-in treatment program for substance use disorders

          -  Pregnant or plans to become pregnant during the study
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Condition: Venous Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: Seg. RF Ablation & ClosureFAST catheter; Endovenous Laser
Intervention description: Seg. RF Ablation & ClosureFAST catheter; laser catheter
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Varicose veins, venous reflux, GSV disease

Summary:

      The objective of this post-market study is to compare the post-procedure recovery between two
      types of minimally invasive catheter treatments for venous disease in the Great Saphenous
      Vein.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must provide written informed consent.

          -  Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or
             endovenous laser.

        Exclusion Criteria:

          -  Subjects who require additional treatments in either leg within 30 days before or
             after the study procedure.

          -  Subjects who are participating in another investigational study.
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: olmesartan medoxomil and a CCB; olmesartan medoxomil and a diuretic
Intervention description: olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks; olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Diuretics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Essential hypertension; Combination therapy

Summary:

      The purpose of the study is to test the efficacy and safety of the combination of Calcium
      Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class)
      and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not
      adequately controlled with olmesartan medoxomil alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in
             pre-treatment with olmesartan medoxomil

          -  Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater
             than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan
             medoxomil

        Exclusion Criteria:

          -  Patients with secondary hypertension

          -  Any serious disorder which may limit the ability to evaluate the efficacy or safety of
             the test drugs
High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Condition: Chronic Pain; Low Back Pain; Radiculopathy; Complex Regional Pain Syndrome (CRPS)
MeSH terms: Radiculopathy; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Back Pain; Low Back Pain; Chronic Pain
Intervention: High frequency stimulation; Low frequency stimulation
Intervention description: Implanted pulse generator of a spinal cord stimulator will programmed to deliver high frequency stimulation for pain relief. For our purposes, high frequency stimulation will be defined as 1000 hertz.; Implanted pulse generator of a spinal cord stimulator will programmed to deliver low frequency stimulation for pain relief. Low frequency stimulation will be defined as conventional stimulation pulse generator programming.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Spinal cord stimulation; Chronic pain; Chronic low back pain; Radiculopathy; Complex Regional Pain Syndrome (CRPS); High Frequency stimulation

Summary:

      Study designed to compare the conventional stimulation programming versus the high frequency
      stimulation programming of the spinal cord stimulator for subjects who already have a spinal
      cord stimulator.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be 18 years and older, and younger than 70 years of age.

          2. Subject has had a Precision® spinal cord stimulator system implanted for chronic
             painful condition.

          3. Subject pain scores >5 on NPRS

        Exclusion Criteria:

          1. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that
             would limit study candidate's ability to assess pain

          2. Unstable medical or psychiatric illness

          3. Lifetime history of psychosis, hypomania, or mania.

          4. Epilepsy, or dementia

          5. Substance abuse in the last 6 months

          6. Pregnant or breastfeeding

          7. Not on contraception for those of childbearing age. (Barrier methods, oral
             contraception, hormone injections, or surgical sterilization)

          8. Treatment with investigational drug within 30 days of screening.

          9. Concomitant medication exclusions consisting of medications or herbal agents with
             central nervous system (CNS) effects with exception of episodic use of sedating
             antihistamines