bioihbjkbjnl/mcl2 huggingface dataset:
Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Condition: Anterior Cervical Discectomy and Fusion (ACDF)
Intervention: Remifentanil; Ketamine; Dexmedetomidine
Intervention description: Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.; Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.; dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.
Intervention MeSH terms: Dexmedetomidine; Ketamine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will help the investigators learn more about the best way to give anesthesia for
      these kinds of surgery. The investigators will be using 2 different groups of medications
      that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does
      not. The investigators wish to test whether a narcotic free anesthetic will result in an
      overall safer surgery, better patient recovery, and satisfaction. The investigators think
      also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover
      faster after surgery , and consume less pain medicines in the postoperative period.
    

Eligibility criteria:

        Inclusion Criteria

          -  Men and women 18- to 80-years old

          -  ASA 1, 2, 3

          -  1 or 2 levels ACDF

        Exclusion Criteria

          -  ASA 4

          -  Seizure disorders

          -  Chronic narcotic use

          -  Opiate abuse

          -  Major cardiac comorbidity, or significantly elevated blood pressure

          -  Known hypersensitivity to fentanyl analogs, ketamine, or propofol injectable
             emulsions.

          -  Known allergy to eggs, egg products, soybeans, or soy products
MI Varnish for the Prevention of White Spot Lesions
Condition: White Spot Lesion; Orthodontic Treatment
Intervention: MI Varnish; Control group
Intervention description: MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels. This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity. The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients. Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate. In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.; Participants received routine treatment and oral hygiene regimes. No intervention for this group.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 33 subjects were prospectively recruited for the project in the MI Varnish group. These subjects were studied against a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
Masking: Single (Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 10 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Enamel decalcification

Summary:

      The current study aimed to determine if MI Varnish has an effect in preventing the formation
      of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were
      prospectively recruited for the project as the MI Varnish group, with a control group of 29
      orthodontically treated subjects who received routine treatment and oral hygiene
      regimes.Difference in prevention of white spot formation between the control and the study
      groups were evaluated through photographic records and clinical examination by using the
      Enamel Decalcification Index (EDI) scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients seeking orthodontic treatment and receiving routine treatment and oral
             hygiene regimes.

        Exclusion Criteria:

          -  Any medical or dental condition that in the opinion of the investigator could impact
             study results during the expected length of the study;

          -  Patient is currently using any investigational drug or any other investigational
             device;

          -  Patient plans to relocate or move within six months of enrollment.
Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: solifenacin; oxybutynin immediate release
Intervention description: Oral; Oral
Intervention MeSH terms: Solifenacin Succinate; Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solifenacin succinate; Oxybutynin immediate release; Xerostomia; Overactive bladder

Summary:

      The purpose of this study is to compare the safety and efficacy of solifenacin with
      oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 years and older.

          -  Overactive bladder symptoms for greater than or equal to 3 months and as documented in
             a 3-day patient diary following screening and preceding baseline visit: > 1 urge
             episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours
             (average)

        Exclusion Criteria:

          -  Urinary tract infection, chronic inflammation such as interstitial cystitis and
             bladder stones

          -  Clinically significant outflow obstruction

          -  Uncontrolled narrow angle glaucoma, urinary, or gastric retention

          -  Severe renal or hepatic impairment

          -  Chronic severe constipation or history of diagnosed GI obstructive disease

          -  Significant stress incontinence or mixed stress/urge incontinence where stress is the
             predominant factor

          -  Diagnosis or history of neurogenic bladder

          -  History of bladder or pelvic cancer
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Condition: Anesthesia
MeSH terms: Sleep Apnea, Obstructive
Intervention: Sugammadex; Neostigmine
Intervention description: Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).; Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study assesses the efficacy of sugammadex against neostigmine for hastening recovery
      from neuromuscular blockade and optimizing pulmonary function in obese patients with
      obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in
      anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and
      maintaining general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  obese (body mass index [BMI] >30 kg/m2)

          -  diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway
             pressure [CPAP] use)

          -  scheduled for surgery requiring general anesthesia and neuromuscular blockade

        Exclusion Criteria:

          -  history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction

          -  history of difficult tracheal intubation

          -  history of adverse reaction to anesthesia

          -  history of adverse reaction to rocuronium, sugammadex, and/or
             neostigmine/glycopyrrolate
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Condition: Focal Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
Intervention description: Gabapentin: up to 3.600 mg/d
Lamotrigine: up to 400 mg/d
Levetiracetam: up to 3.000 mg/d
Pregabalin: up to 600 mg/d
Oxcarbazepine: up to 2.400 mg/d
Tiagabine: up to 30 mg/d
Topiramate: up to 400 mg/d
Zonisamide: up to 500 mg/d
Intervention MeSH terms: Topiramate; Pregabalin; Lamotrigine; Zonisamide; Gabapentin; Levetiracetam; Tiagabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: epilepsy antiepileptic biotherapy

Summary:

      Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs
      (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and
      topiramate, used as first-choice combination therapy (bitherapy) in patients with focal
      epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older.

          -  Diagnosis of focal epilepsy.

          -  Previous failure of one or more AEDs used in monotherapy.

          -  Background treatment with an antiepileptic drug.

          -  The investigator has considered that the patient must start treatment with some of the
             seven new AEDs in combination therapy: lamotrigine, levetiracetam, gabapentin,
             oxcarbazepine, pregabalin, tiagabine and/or topiramate.

          -  History of seizures in the patient in the past 3 months.

          -  The patient or legal guardian must be able to understand the characteristics of the
             study and fill in the seizure diaries.

          -  Written informed consent.

        Exclusion Criteria:

          -  Inability to comply with the study requirements.

          -  Diagnosis of generalized epilepsy or inability to establish if focal or generalized.

          -  Presence of serious or uncontrolled systemic disease, serious psychiatric disease or
             progressive neurological disease.

          -  History of alcoholism, drug addiction, or abuse of medicines in the past two years.

          -  Psychogenic seizures in the two years prior to inclusion in the study.
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Topicort® (desoximetasone) Topical Spray, 0.25%
Intervention description: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Intervention MeSH terms: Desoximetasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the potential of Topicort® (desoximetasone)
      Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary
      objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event
      profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 7 years and older must have provided written assent accompanied by
             written informed consent from patient's representative

          -  Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface
             area (excluding face and scalp)

          -  Physicians Global Assessment score of 3 or 4 at baseline

        Exclusion Criteria:

          -  Has other dermatological conditions that may interfere with clinical assessments

          -  Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance
             that would compromise patient safety or study results

          -  History of an adverse reaction to Cortrosyn™ or similar test reagents

          -  Chronic infectious disease, system or organ disorder or other medical condition that
             would place patient at undue risk by study participation
Menopur Mixed Protocol
Condition: Infertility
MeSH terms: Infertility
Intervention: Bravelle; Menopur
Intervention MeSH terms: Menotropins; Follicle Stimulating Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Assisted Reproductive Technology

Summary:

      The objective of this study was to compare the fertilization rate between the combination of
      Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered
      subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART).
      Additionally the study assessed subjects' ability to mix and store the combination of Menopur
      and Bravelle and to assess safety of the Menopur and Bravelle combination.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Infertile pre-menopausal female subjects

          -  Documented history of infertility (eg., unable to conceive for at least 1 year, or 6
             months for women ≥36 years of age, or women with bilateral tubal occlusion or absence,
             or subjects who require donor sperm).

          -  Subject's male partner with semen analysis that was at least adequate for
             intracytoplasmic sperm injection (ICSI) within 6 months prior to the subjects
             beginning down-regulation with gonadotropin-releasing hormone (GnRH)-agonist. Partners
             with severe male factor requiring invasive or surgical sperm retrieval or donor sperm
             could have been used.

          -  Anti-mullerian hormone (AMH) > 1 ng/mL and < 3 ng/mL at screening.

          -  Eligible for in-vitro fertilisation (IVF) or ICSI treatment.

        Main Exclusion Criteria:

          -  Oocyte donor or embryo recipient; gestational or surrogate carrier

          -  Previous IVF or assisted reproductive technology (ART) failure due to a poor response
             to gonadotropins. Poor response was defined as development of ≤ 2 mature follicles or
             history of 2 previous failed cycle cancellations prior to oocyte retrieval due to poor
             response.

          -  Inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous
             ART attempts.

          -  Subject's male partners with obvious leukospermia (>2 million white blood cells
             [WBC]/mL) or signs of infection in semen sample within 2 months of the start of
             subject's pituitary down-regulation. If either of these conditions existed, the male
             was to be treated with antibiotics and retested prior to subject's pituitary
             down-regulation.

          -  Undergoing blastomere biopsy and other experimental ART procedures.

          -  Body mass index (BMI) of ≤18 and ≥32 kg/m^2
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Condition: Hepatic Carcinoma
MeSH terms: Neoplasm Metastasis; Carcinoma, Hepatocellular; Recurrence
Intervention: Huaier Granule
Intervention description: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1044.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Huaier Granule;; After radical hepatectomy;; Prevention of Recurrence and Metastasis;; Safety.

Summary:

      To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and
      metastasis of hepatocarcinoma after radical hepatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: ≥ 18 and ≤ 75 years, both male and female;

          -  Radical hepatectomy has been performed for hepatocellular carcinoma;

          -  The hepatocellular carcinoma has been confirmed by pathological examination;

          -  Barcelona clinic liver cancer(BCLC) stage A or B;

          -  Not receiving any preoperative anticancer drug;

          -  The liver and kidney function satisfies the following conditions within 15 days after
             surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic
             transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin≤2ULN, serum creatinine
             <1.5 ULN;

          -  Other laboratory tests meet the following requirements within 15 days after surgery
             (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, absolute neutrophil
             count>1.0×109/L;

          -  The expected survival time ≥ 12 weeks;

          -  The subjects volunteer to sign the informed consent.

        Exclusion Criteria:

          -  Hepatocellular carcinoma patients who received non-radical hepatectomy;

          -  Non-hepatocellular carcinoma patients;

          -  Those with Child-Pugh C;

          -  Pregnant or lactating women;

          -  Those with active bleeding due to various reasons;

          -  Those with HIV infection or AIDS-associated diseases;

          -  Those with severe acute and chronic diseases;

          -  Those with severe diabetes;

          -  Those with serious infectious diseases;

          -  Those who can not take drugs by oral route;

          -  Drug abusers or those with psychological or mental diseases that may interfere with
             study compliance;

          -  Conditions that are considered not suitable for this study investigators
Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Placebo; Solifenacin Succinate
Intervention description: Oral Administration; Oral Administration
Intervention MeSH terms: Solifenacin 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: 768.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Overactive Bladder

Summary:

      Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without
             difficulty

          -  History of OAB symptoms for ≥ 3 months

          -  An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without
             incontinence) per 24 hours as documented in a 3-day micturition diary

          -  Subjects are bothered by symptoms as reflected by PPBC ≥3

        Exclusion Criteria:

          -  Evidence of chronic urologic inflammation such as interstitial cystitis and bladder
             stones; uncontrolled narrow angle glaucoma; urinary or gastric retention

          -  Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or
             evidence of a urinary tract infection at Baseline Visit (Visit 2)

          -  Significant stress incontinence or mixed stress/urge incontinence where stress is the
             predominant factor as determined by the investigator

          -  History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in
             parameters and considered clinically significant by the investigator

          -  History of diagnosed gastrointestinal obstruction disease

          -  Subject has a known diagnosis or history of carcinoma (including prostate cancer)
             except non metastatic basal or squamous cell carcinoma of the skin that has been
             successfully treated or previous pelvis radiation within the past five years

          -  Known or suspected hypersensitivity to solifenacin succinate, any components, or other
             anticholinergics