bioihbjkbjnl/mcl2 huggingface dataset:
Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?
Condition: Neuromuscular Block
Intervention: Sugammadex; Rocuronium
Intervention description: Reversal of deep neuromuscular block; Maintenance of deep neuromuscular block
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: deep neuromuscular block; sugammadex; stability of anesthesia; suppression of EMG activity; PQRS; General Anesthesia; Quality of Recovery

Summary:

      The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular
      block throughout the entire surgical procedure followed by sugammadex reversal, would
      suppress EMG activity and result in improved anesthetic stability by reducing the variability
      of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the
      anesthetic drugs propofol and remifentanil required to maintain an adequate level of
      anesthesia (BIS between 40 and 60).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ASA I-III

          -  Between 18 - 80 years old

          -  Scheduled for routine cervical surgery

          -  Minimum duration of surgery is 90 minutes and performed with total intravenous
             anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the
             neuromuscular relaxant rocuronium

          -  Patients that are able to and do provide a signed informed consent form

        Exclusion Criteria:

          -  Patients with neuromuscular diseases and severe cardiac and respiratory pathologies

          -  Contra indication for any of the drugs used

          -  Not able to complete the baseline PQRS test.

          -  Indication to perform tracheal intubation using fibroscopy

          -  Patients who are pregnant or nursing
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.
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism
Intervention: androgel; androgel 10g; placebo
Intervention description: androgel 5g; androgel 10g; placebo
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 49.0
Sex: Male
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: DM type 2; Hypogonadism; Testosterone; AndroGel

Summary:

      This is to study the effect of replacing testosterone on different inflammatory cells in type
      2 diabetics with low testosterone levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males with age 35-75 years inclusive.

          -  Evidence of hypogonadism: low free testosterone.

          -  Type 2 Diabetes

          -  People on stable doses of cholesterol lowering medications, blood pressure medications
             and multi-vitamins are allowed.

          -  If currently on testosterone replacement,testosterone treatment will be held for 8
             weeks.

          -  BP under control even if on medication.

        Exclusion Criteria:

          -  Coronary event or procedure in previous past 4 wks.

          -  High PSA

          -  H/O prostate cancer

          -  Hepatic or renal disease

          -  Participation in any other concurrent clinical trial

          -  Any other life- threatening , non cardiac disease.

          -  Uncontrolled BP

          -  Congestive heart failure

          -  High hemoglobin

          -  Use of investigational agent or therapeutic regimen within 30 days of study.
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Condition: Urinary Incontinence; Urgency Urinary
MeSH terms: Urinary Incontinence; Enuresis; Inflammation
Intervention: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine
Intervention description: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
Intervention MeSH terms: Solifenacin Succinate; Tolterodine Tartrate; Fesoterodine; Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Urinary Incontinence; Urgency Urinary; Anticholinergic Treatment; Urinary Microbiome

Summary:

      Urinary incontinence (UI) is a very common condition affecting women of all ages. The
      objective of this pilot study is to better understand the urinary microbiome and associated
      inflammatory markers in blood and urine in women with urgency UI. The study will assess how
      inflammation may affect response to standard of care anticholinergic medication treatment for
      urgency urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)

          -  English speaking

          -  Willing to take anticholinergics for at least 6 weeks

          -  Willing to complete UDI-6 and voiding diary at baseline and 6 weeks

          -  Willing to give urine and blood for study at baseline and 6 weeks

        Exclusion Criteria:

          -  Have taken anticholinergic medication within the last month

          -  Have taken antibiotics within the last month

          -  Urinary Tract Infection (UTI) in the last three months

          -  Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)

          -  Immunological deficiencies

          -  History of sexually transmitted disease (STD)

          -  Lack of consent

          -  Not ambulatory (e.g. uses a wheelchair)
PREvention of VENous ThromboEmbolism Following Radical Prostatectomy
Condition: Prostate Cancer; Venous Thromboembolism; Lymphocele After Surgical Procedure; Deep Venous Thrombosis; Pulmonary Embolism
MeSH terms: Lymphocele; Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Subcutaneous Heparin
Intervention description: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.
Intervention MeSH terms: Heparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, single-institution, multi-surgeon, stratified randomized controlled trial. Randomization will be stratified into four groups by procedure approach (open or robotic) and whether patients elect to undergo a screening 30-day lower extremity Duplex (ultrasound or no ultrasound). Patients will then be randomized, within each of the strata, to the two arms (subcutaneous heparin versus no subcutaneous heparin).
Masking: Single (Outcomes Assessor)
Enrollment: 501.0
Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis
      (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of
      IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy
      (RP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18-100 years of age with histologically confirmed prostate cancer of any stage
             undergoing RP

          -  Patients who would have otherwise been eligible to receive routine post-RP care

        Exclusion Criteria:

          -  Active treatment for VTE

          -  Patients judged by patients' urologist, primary care doctor, or in the preoperative
             evaluation center (PEC) to be unsafe to forgo pharmacologic prophylaxis or systemic
             anticoagulation postoperatively (whether or not patients are on systematic
             anticoagulation for indications other than VTE)

          -  Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy)

          -  Epidural analgesia

          -  Spinal anesthesia

          -  Participation in a different trial that increases a patient's risk of VTE
Ketamine and Propofol for Upper Endoscopy
Condition: Anesthesia
Intervention: Ketamine; Propofol
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 3 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: Ketamine; Propofol; Children; Pediatrics; Upper endoscopy

Summary:

      The purpose of this study is to examine the dose-response relationship of ketamine in
      combination with propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3-13 years

          -  Receiving general anesthesia for upper endoscopy

        Exclusion Criteria:

          -  Known or possible difficult airway

          -  BMI > 35

          -  Weight < 10 kg

          -  Sedative premedication required

          -  Known contraindication to ketamine or propofol
Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
Condition: Sezary Syndrome; Pruritus
MeSH terms: Sezary Syndrome; Pruritus; Syndrome
Intervention: Aprepitant; Placebo
Intervention description: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.; Placebo will be given orally for a total of 7 days.
Intervention MeSH terms: Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sezary Syndrome; Pruritus; Aprepitant; Neurokinin-1

Summary:

      The purpose of this randomized, double-blinded, placebo-controlled study is to test the
      hypothesis that administration of aprepitant will decrease the severity of pruritus in
      patients with Sèzary Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known Sezary Syndrome

          -  Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale > 4.

          -  Age 18 through 80 years of age.

          -  Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to
             study participation.

        Exclusion Criteria:

          -  Known hepatic impairment (defined as liver function tests >3 times the upper limit of
             normal).

          -  Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing).

          -  Concurrent use of pimozide, terfenadine, astemizole, or cisapride.
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Dapsone 7.5 % gel
Intervention description: Dapsone gel 7.5% applied once daily to truncal acne
Intervention MeSH terms: Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the
      trunk
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects of any race and at least 12 years of age.

          -  Female subjects of childbearing potential must have a negative urine pregnancy test at
             Baseline and practice a reliable method of contraception throughout the study.

          -  Truncal acne IGA score of 3.

          -  Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

        Exclusion Criteria:

          -  Female subjects who are pregnant , breast feeding or are of childbearing potential who
             are not willing to use a reliable method birth control.

          -  Subjects who have an allergy or sensitivity to any component of the test medication.

          -  Subjects who have not complied with the proper wash out periods for prohibited
             medications.

          -  Evidence of recent drug or alcohol abuse.

          -  Skin disease /disorder that might interfere with the diagnosis or evaluation of
             truncal acne.

          -  Exposure to an investigational drug within 30 days of the Baseline visit.

          -  Medical condition that contraindicates the subject's participation in the study.

          -  History of poor cooperation, non-compliance with medical treatment or unreliability.
Glycemia in Diabetic Elders Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Standard Treatment; Incretin-Based Treatment
Intervention description: traditional drugs only; incretin-based drugs
Intervention MeSH terms: Metformin; Dipeptidyl-Peptidase IV Inhibitors; Incretins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients
      conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology
      Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen
      base solely on traditional drugs, a regimen including newer drugs will achieve glycemic
      target faster and induce less hypoglycemia, weight gain, and other side effects, over the
      short run.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetics diagnosed for at least 6 months

          -  Patients ages ≥ 65 years and older

          -  Active patients in the Bay West Endocrinology practice

          -  Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0%
             and 12%

          -  Eligible for randomization to either treatment group

          -  Patients willing to follow either treatment arm including regimen using one or more
             injectables

          -  Patients to have an English Reading Level of Grade 6 or above

          -  Patients residing at home

        Exclusion Criteria:

          -  Unwilling to use a regimen that may contain using one or more injections

          -  Using short acting insulin prior to the study

          -  Using GLP-1 in past 10 weeks

          -  History of hypoglycemia unawareness or episodes needing emergency intervention

          -  End-stage renal disease

          -  Dementia

          -  Blindness

          -  Terminal illness
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation; Catheter Ablation
MeSH terms: Atrial Fibrillation
Intervention: Protamine Sulfate
Intervention description: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.
Intervention MeSH terms: Protamines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; catheter ablation; protamine sulfate; anticoagulation reversal

Summary:

      The objective of this study is to evaluate the safety, efficacy and efficiency of rapid
      anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT)
      monitoring in patients undergoing catheter based ablation of atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial
             fibrillation or atrial flutter (left atrial).

          -  Age ≥ 18 year

          -  Patients who are mentally and linguistically able to understand the aim of the trial,
             comply with the trial protocol, verbally acknowledge the risks, benefits, and
             alternatives in this trial.

        Exclusion Criteria:

          -  Previous intolerance or allergy to heparin products.

          -  Current or prior administration of protamine products

          -  History of femoral access site complications including hematoma, AV fistula,
             pseudoaneurysm, aneurysm.

          -  Known lower extremity venous thrombosis.

          -  Coagulopathy or blood dyscrasias.

          -  Active malignancy.

          -  Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul)

          -  Planned use of vascular closure device
Treatment of GLP-1 for Diabetic Bariatric Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Semaglutide (1 Mg Dose); Placebo
Intervention description: Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery; Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bariatric Surgery; Semaglutide

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

Eligibility criteria:

        Inclusion Criteria:

          1. Candidates for Roux-en-Y Gastric Bypass Surgery with an established diagnosis of Type
             2 diabetes requiring insulin treatment for glycemic control

          2. Ability to provide informed consent before any trial-related activities

        Exclusion Criteria:

          1. Prior metabolic surgery procedure

          2. Use of GLP-1 analogues for diabetes treatment at the time of recruitment

          3. Known or suspected allergy to semaglutide or the excipients in semaglutide, or related
             products.

          4. Contraindications to semaglutide which include a personal or family history of
             medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome-2 (MEN-2)

          5. Previously randomized for participation in this trial.

          6. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate
             contraceptive measures.

          7. Type 1 diabetes