bioihbjkbjnl/mcl2 huggingface dataset:
Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test
Condition: Pain
Intervention: 2% Lidocaine jelly; Plain aqueous gel
Intervention description: 2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.; Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: female urethral catheterization; Lidocaine; lubricant; Q-tip test; Q tip test; K-Y jelly; pain perception; straight catheterization

Summary:

      The purpose of this study is to compare the pain perception between lidocaine and plain
      aqueous gel during assessment of postvoid residual volume and the Q-tip test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women who presented to a single urogynecologist's office for an initial
             consultation with a complaint of urinary incontinence and/or pelvic organ prolapse

        Exclusion Criteria:

          -  Being a minor

          -  Pregnancy

          -  Allergy to Lidocaine or aqueous lubricant gel

          -  Any current use of analgesia

          -  Structural abnormalities of the urethra

          -  Active genital Herpes or other vulvovaginal infections or inability to cooperate with
             pain assessment due to mental disorders.
Clinical and Economic Implications of Genetic Testing for Warfarin Management
Condition: Blood Coagulation Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Warfarin
Intervention description: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Intervention MeSH terms: Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coumadine; genotype; genes; Warfarin

Summary:

      The purpose of this study is to explore how knowing genes that individuals inherit from their
      parents can make warfarin dosing more safe and effective. This study is being done to
      determine whether providing doctors with data on the genes their patients inherited and
      warfarin dosing recommendations based on those genes affects the costs and outcomes of care
      and after hospitalization for patients from different ethnic/racial backgrounds, and how
      physicians use this information in decision making.
    

Eligibility criteria:

        Inclusion Criteria:

          -  warfarin-naive patients

          -  ages 18 and older

          -  are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that
             necessitate anticoagulation

        Exclusion Criteria:

          -  patients who are not warfarin-naive

          -  17 years of age or younger
Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation
Condition: Hypertension; Cardiac Transplantation
MeSH terms: Hypertension
Intervention: Aliskiren
Intervention description: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypertension; Cardiac transplantation; Aliskiren; Cyclosporine

Summary:

      The purpose of this study is to evaluate the safety and efficacy of the blood pressure
      medication, aliskiren, in heart transplant patients. In terms of safety, the investigators
      will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood
      levels of the anti-rejection medication, cyclosporine, in these patients. In terms of
      efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart
      transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months or more since cardiac transplant

          -  Clinically stable from a transplant perspective

          -  Maintained on a stable immunosuppressant regimen containing cyclosporine + an
             antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid

          -  Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg
             and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate
             measurements, spaced 2 minutes apart.

        Exclusion Criteria:

          -  Clinical instability from a cardiac transplant perspective

          -  Contraindications to aliskiren therapy

          -  Conditions that may increase the risk of aliskiren adverse effects

          -  Severe hypertension

          -  Concomitant medications known to increase or decrease aliskiren plasma exposure.
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: TIVA NoNarc
Intervention description: patients in both groups receive antiemetic prophylaxis
patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
postop management in both groups is similar in both groups
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bariatric Surgery; TIVA; PONV; non-opioid; OSA

Summary:

      Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after
      surgery and general anesthesia. The results of our observational study indicate that 42.7% of
      patients require medication to treat PONV in the first 24 hours after bariatric surgery
      despite our aggressive perioperative approach with triple prophylaxis. Common risk factors
      for PONV are the use of intraoperative narcotics and anesthetic gases.

      Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a
      reduction of narcotic consumption, desaturations and use of antiemetic medication.

      Our study hypothesis is that different types of anesthetics reduce PONV further.

      Patient would be randomly assigned to receive either our current intraoperative management or
      a narcotic free, total intravenous general anesthetic (TIVA).

      The investigators hope to improve patients' satisfaction by reducing PONV in the
      postoperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients scheduled for bariatric surgery at Flagler Hospital will be included
             after written and informed consent.

        Exclusion Criteria:

          -  Patients will be excluded from the study if they don't consent to participate in the
             study. Patients allergic to any of the study medication will be excluded. Patients
             with second or third degree heart block will be excluded.
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Condition: Wounds
MeSH terms: Wounds and Injuries
Intervention: Lavasept 0.04%; Ringer's Solution
Intervention description: Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.
Dosage Lavasept® 0.04% 50 ml 50ml or as much needed to completely saturate the compress.
Treatment Duration 60 minutes; Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.
Dosage Ringers' solution 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes
Intervention MeSH terms: Polihexanide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute traumatic wounds

Summary:

      The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04%
      when used as an antiseptic agent and to compare these with Ringers' solution in patients with
      acute traumatic wounds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with acute traumatic cut, crush, abrasion, bite or stab wounds Provision of
             voluntary consent to participate in the study, following a full explanation of the
             nature and purpose of the study, by signing the informed consent form approved by the
             Institutional Ethics Committee (IEC) prior to all evaluations

          -  Wounds that are a minimum of approximately 4 cm2 in size

          -  Ability to read and understand the German patient information sheet and informed
             consent form

        Exclusion Criteria:

          -  < 18 years of age

          -  Pregnancy

          -  Immunosuppression

          -  Wounds caused by a burn

          -  Wounds that require treatment of hyaline cartilage, the central nervous system,
             peritoneum, meningae, inner / middle ear or inner eye

          -  Simultaneous participation in another clinical trial

          -  Wounds that require immediate surgical or medical treatment as well patients who are
             critically ill

          -  Patient with a known allergy to the active agent or any of the excipients

          -  Wounds that are >3 cm in depth

          -  Wounds that have not received medical treatment for ≥6 hours

          -  Heavily bleeding wounds

          -  Open fractures, joints or tendons

          -  Wounds of the face
A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: dexamethasone implant
Intervention description: OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant)
      in patients with macular edema associated with branch retinal vein occlusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of macular edema

          -  Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

        Exclusion Criteria:

          -  Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or
             extensive dermal) within 1 month

          -  Intraocular surgery, including cataract surgery, and/or laser surgery of any type
             within 3 months

          -  Any active ocular infection in either eye
Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro); Placebo; Interpersonal Clinical Interaction (ICI)
Intervention description: Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.; Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.; Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
Intervention MeSH terms: Duloxetine Hydrochloride; Venlafaxine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major depressive disorder; MDD; Antidepressant

Summary:

      This study will use measurements of depression symptoms and brain activity to determine what
      factors may influence an individual's response to treatment for depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of unipolar major depression

        Exclusion Criteria:

          -  Substance abuse

          -  Psychotic disorder

          -  History of severe head trauma
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia; Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Human Papillomavirus Vaccine
Intervention description: 0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: inflammatory bowel disease; Crohn disease; ulcerative colitis; Papillomavirus vaccines

Summary:

      The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been
      shown to prevent the transmission of several strains of HPV in young women. Women with
      inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to
      having IBD or due to immunosuppressants used to control IBD. This study will test how well
      women with IBD respond to the Gardasil vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women 9-26 years of age

          2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

        Exclusion Criteria:

          1. Pregnancy

          2. Taking corticosteroids

          3. Allergy to yeast aluminum component of the HPV vaccine

          4. Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label single-arm study will evaluate the efficacy, safety and tolerability of
      methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in
      patients with chronic renal anaemia. Patients will receive methoxy polyethylene
      glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or
      200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose
      adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24
      weeks. The target sample size is 50-100 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >/=18 years of age

          -  Chronic renal anaemia

          -  Haemoglobin concentration between 10 and 12 g/dL at screening

          -  Adequate iron status

          -  Continuous intravenous maintenance short-acting therapy with same dosing interval for
             8 weeks prior to screening

          -  Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

        Exclusion Criteria:

          -  Change in haemoglobin concentration >/=2 g/dL during screening

          -  Transfusion of red blood cells less than 8 weeks prior to screening

          -  Poorly controlled hypertension

          -  Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to
             screening

          -  Active malignant disease

          -  Haemolysis

          -  Haemoglobinopathies
A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
Condition: Total Hip and Knee Arthroplasty
Intervention: Liposomal Bupivacaine; Ropivacaine; Bupivacaine; Clonidine; Ketorolac; Epinephrine
Intervention description: Periarticular injection; Periarticular injection; Included as an element of the Liposomal bupivacaine intervention periarticular injection; Included as an element of both interventions as a standard of care periarticular injection; Included as an element of both interventions as a standard of care periarticular injection; Included as an element of both interventions as a standard of care periarticular injection
Intervention MeSH terms: Ketorolac; Clonidine; Epinephrine; Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study evaluates two routinely used drug combinations for periarticular injection
      following total hip and knee arthroplasty for pain control. One group will receive liposomal
      bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive
      ropivacaine, clonidine, epinephrine and ketorolac.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)

        Exclusion Criteria:

          -  Current use of opioid drugs

          -  Revision surgery

          -  Surgical complication (femoral fracture with implant insertion)

          -  Inability to provide Informed Consent
Validation of a Real-time Urodynamic Measure of Urinary Urgency
Condition: Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin Succinate
Intervention description: Participants take 10mg daily solifenacin succinate for 30 days
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder; Urinary Urgency; Solifenacin; Vesicare(R)

Summary:

      Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more
      bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy
      continues to surround the term 'urgency' and there is no good tool to evaluate the severity
      of urgency. This fact has constrained the performance of clinical research in this field. The
      cause of urinary urgency is not fully understood and may vary from patient to patient.

      Although clinicians regularly obtain measures of bladder sensation during cystometry, little
      attention has been paid to the patient experience of urinary urgency. In this study, the
      researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary
      urgency in women with overactive bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment
             with anticholinergic medication.

          -  Demonstrated detrusor overactivity with or without incontinence during urodynamic
             testing.

          -  Are able to consent and fill out study documents, complete repeated urodynamic
             testing, and follow-up in 4 weeks.

        Exclusion Criteria:

          -  Have been treated with any anticholinergic medication in the previous month.

          -  Have an elevated post -void residual volume as determined during their routine
             clinical care.

          -  Have had a urinary tract infection in the last month, as determined by history.

          -  Have untreated narrow angle glaucoma, by patient history.

          -  Have a known allergy or intolerance to solifenacin, as determined by patient history.