bioihbjkbjnl/mcl2 huggingface dataset:
Performance Study of Newly Developed Ostomy Products
Condition: Stoma Colostomy
Intervention: SenSura Mio; Standard Care
Intervention description: Ostomy product - 1 piece closed bag; Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate leakage of a newly developed ostomy product compared
      to standard care in subjects with colostomies. Subjects will be asked to use each test
      product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show
      that the newly developed ostomy product is significantly better to reduce leakage compared to
      standard care.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have given written informed consent.

          2. Be at least 18 years of age and have full legal capacity.

          3. Have experienced leakage under the base plate at least once a week over the last two
             weeks.

          4. Be able to handle the bags themselves or with help from caregiver (e.g. spouse).

          5. Have a colostomy with a diameter between 20 and 45 mm.

          6. Have had their ostomy for at least three months.

          7. Currently use a 1-piece flat product with closed bag.

          8. Use minimum 1 product per day.

          9. Be suitable for participation in the investigation and for using a standard adhesive,
             flat base plate (evaluated by investigator).

        Exclusion Criteria:

          1. Use irrigation during the study (flush the stoma with water).

          2. Currently receiving or have within the past 2 months received radio- and/or
             chemotherapy.

          3. Currently receiving or have within the past month received local or systemic steroid
             treatment in the peristomal area.

          4. Are pregnant or breastfeeding.

          5. Participating in other interventional clinical investigations or have previously
             participated in this investigation.
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Mencevax ACWY
Intervention description: 1 subcutaneous injection.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Meningococcal disease; Meningitidis serogroups A, C,W & Y diseases; Meningococcal vaccine

Summary:

      GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal
      Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to
      collect clinical data in the local target population in order to assess the occurrence of
      rare adverse events after vaccination as per the requirement of Philippines Bureau of Food
      and Drugs Directive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent/guardian can and
             will comply with the requirements of the protocol.

          -  A Filipino male or female > 2 years of age at the time of the first vaccination.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Written informed consent obtained from the subject and/or from the parent/ guardian of
             the subject.

        Exclusion criteria:

          -  Subjects suffering from acute severe febrile illness.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant.

          -  History of chronic alcohol consumption and/or intravenous drug abuse.

          -  Any contraindications as stated on the Prescribing Information.
A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketorolac; Saline
Intervention description: 30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac; 1 ml infiltration 4 ml intraarticular bolus injection of placebo
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total Knee Arthroplasty

Summary:

      The purpose of this study is to determine wether ketorolac is effective in the treatment of
      postoperative pain after total knee arthroplasty
    

Eligibility criteria:

        Inclusion Criteria:

          -  Total knee arthroplasty

          -  Age > 18

          -  Tolerance for study drugs

          -  Written informed consent

        Exclusion Criteria:

        -
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Lanreotide Autogel 120 mg
Intervention description: 120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24
Intervention MeSH terms: Lanreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the efficacy of an extended injection interval schedule
      of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long
      term treatment with octreotide LAR 10 or 20 mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has given written informed consent prior to any study-related procedures

          -  The subject is male or female and is over 18 years of age

          -  The subject must have had documentation supporting the diagnosis of acromegaly, based
             on elevated IGF-1 and/or GH levels

          -  The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six
             months and is biochemically controlled. Control is defined as normal (age and sex
             adjusted) IGF 1 levels for two consecutive measurements (at least two months apart)
             preceding study entry

          -  If the subject is receiving dopamine agonist therapy, treatment should be stable for
             at least four months, and no change in their dopamine-agonist medication is expected
             during the entire study period

        Exclusion Criteria:

          -  The subject has received radiation therapy to the pituitary gland before study entry

          -  The subject has a history of hypersensitivity to lanreotide or drugs with a similar
             chemical structure

          -  The subject has received a growth hormone receptor antagonist (pegvisomant) therapy
             within three months before study entry

          -  The subject has undergone treatment with any other investigational drug in the 30 days
             before study entry or is scheduled to receive an investigational drug, other than
             lanreotide 120 mg, during the course of the study

          -  The subject has received any unlicensed drug within the 30 days prior to the baseline
             visit or is scheduled to receive an unlicensed drug during the course of the study
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Background ARVs; PI; enfuvirtide [Fuzeon]
Intervention description: As prescribed; As prescribed; 90mg sc bid
Intervention MeSH terms: Enfuvirtide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy, safety and tolerability of a new
      investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc
      bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new
      investigational PI will be administered according to the procedures of the early access
      program in which the patient is enrolled. The anticipated time on study treatment is 3-12
      months, and the target sample size is approximately 120 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  seropositive for HIV-1;

          -  enrolled in an early access program for a new investigational PI;

          -  naive to Fuzeon, and the investigational PI;

          -  treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).

        Exclusion Criteria:

          -  females who are pregnant or breast-feeding;

          -  evidence of active, untreated opportunistic infection;

          -  malignancy requiring chemotherapy or radiotherapy.
Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
Condition: Otolaryngeal Cancer
MeSH terms: Delirium
Intervention: Ketamine; Placebo; Electroencephalogram (EEG)
Intervention description: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.; Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.; A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anesthesiology

Summary:

      The goal of this prospective randomized double blinded placebo controlled study is to
      investigate if a single dose of ketamine in addition to standard anesthesia will reduce the
      risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on
      post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will
      be utilized during the surgical procedure to evaluate its potential as a possible predictive
      device for delirium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of otolaryngeal cancer and undergoing surgery with general
             anesthesia

          -  Competent to provide informed consent

        Exclusion Criteria:

          -  Emergency surgery

          -  Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general
             anesthesia)

          -  Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor
             placement

          -  Poor health literacy

          -  Allergy, or have experienced any drug reaction to ketamine

          -  Pregnant or lactating

          -  Currently in active alcohol withdrawal

          -  Taking buprenorphine for chronic pain
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Condition: Single Ventricle Heart Disease After Fontan Surgery
MeSH terms: Heart Diseases; Univentricular Heart
Intervention: Cardiac catheterization
Intervention description: All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 3 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Single ventricle; Fontan; Sildenafil; Pressure-Volume Loops

Summary:

      The study will investigate the cardiovascular effects of sildenafil on patients with Fontan
      circulation. Recent studies suggest that sildenafil may improve exercise in patients with
      Fontan circulation. However, why this occurs is not known. The study will used specialized
      catheters to measure pressure and volume. The measure of pressure and volume leads to more
      detailed analysis of heart function. Patients will receive either sugar pill or sildenafil
      prior to catheterization. It is believed that sildenafil will improve relaxation and
      contraction of the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of a congenital heart defect that leads to single ventricle physiology

          -  Previously performed Fontan surgery

        Exclusion Criteria:

          -  The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization
             of within 1 month of catheterization

               -  Unstable arrhythmia at the time of catheterization

               -  History of unstable arrhythmia within 2 months of catheterization

               -  Venous, arterial or cardiac malformation that precludes the proper placement of a
                  microconductance catheter

               -  Allergy to sildenafil or previous significant adverse reaction to sildenafil
                  (e.g. hypotension)
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Neuropathy, Painful
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: duloxetine hydrochloride; pregabalin; gabapentin
Intervention description: Duloxetine (DLX) once daily (QD), orally (PO); Pregabalin (PGB) orally (PO); Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)
Intervention MeSH terms: Pregabalin; Gabapentin; Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To test the non-inferiority of duloxetine monotherapy as a treatment for the management of
      diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who
      have not had an adequate response to gabapentin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You must have been diagnosed with Diabetic Neuropathic Pain

          -  Patient has an average daily pain score greater than or equal to 4 on an 11-point
             Likert scale, and patient or provider feel that a change from the current gabapentin
             therapy for pain management is warranted

          -  Patient is currently treated with gabapentin greater than or equal to 900
             milligram/day, has been prescribed the current dose for at least 4 weeks, and has been
             at least 80% compliant with dosing, according to patient report

          -  Patient must agree not to change dose of gabapentin between Visits 1 and 2

          -  You must have stable glycemic control

        Exclusion Criteria:

          -  Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or
             greater on question 9 of the Beck Depression Inventory-II (BDI-II)

          -  Current diagnosis or history of hemangiosarcoma

          -  Patients with New York Heart Association Class III or IV symptoms of congestive heart
             failure

          -  Patients with uncontrolled narrow-angle glaucoma

          -  Presence of a current seizure disorder
Superiority Study for Pain Treatment After Cesarean
Condition: Pain
Intervention: Oral Oxycodon; Piritramid
Intervention description: Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.; Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.
Intervention MeSH terms: Pirinitramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain after cesarean; visual analog scale; oxycodon; piritramid

Summary:

      The purpose of this study is to investigate adequate pain treatment for patients after
      cesarean. In this study oral opioids were compared to intravenous opioids as they are
      supposed to provide superior pain control.
    

Eligibility criteria:

        Study participation was offered to all pts. aged > 18 years in labor and delivery for
        elective or unplanned secondary cesarean in the 37th or higher week of gestation.

        Inclusion Criteria:

          -  cesarean in spinal anesthesia,

          -  no history of opioid or metamizol treatment

          -  written consent

          -  ability to use a Patient-controlled analgesia device

        Exclusion Criteria:

          -  cesarean in general anaesthesia

          -  use of peridural catheter for pre-, peri- or post cesarean analgesia

          -  additional post cesarean metamizol use

          -  allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen

          -  chronic use of general anaesthesia

          -  history of known pain syndrome
Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation
Condition: Preparation for Colonoscopy
Intervention: Gatorade/Miralax; NuLytely; Bisacodyl; Placebo
Intervention description: Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.; Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.; Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.; Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy
Intervention MeSH terms: Bisacodyl; Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax
      combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl
      may also be used with the Gatorade and Miralax to see if it helps with the clean out process.
      We are trying to find out if either of these methods is more acceptable to the patient and
      does a better job cleaning out the colon for a colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Patients at least 18 years old planning to undergo an elective colonoscopy.

        Exclusion Criteria:

          1. Patients who are allergic or intolerant to any on the study drugs.

          2. Pregnant patients.

          3. Patients who required multiple day colon preparation in the past.

          4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel
             perforation, toxic colitis or toxic megacolon would not be considered elective
             colonoscopies and are excluded.
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Managed Ventricular Pacing programmed ON/OFF
Intervention description: Device programming
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 630.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pacemaker or ICD replacement

Summary:

      The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable
      cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients implanted with a dual chamber device (including atrial synchronous
             ventricular inhibited [VDD]) for a minimum time duration of 2 years

          -  Planned to be replaced or replaced with a device including the MVP feature

          -  Have had more than 40% ventricular pacing documented with their old device over a
             period of at least 4 weeks before enrollment or device replacement.

          -  Pacing should not be caused by a switch to the single chamber pacing (VVI) mode
             because of battery depletion

          -  Have signed the informed consent

          -  Have no need to change the pacing mode or the atrioventricular (AV) intervals.

        Exclusion Criteria:

          -  Patients with a cardiac resynchronization therapy (CRT) indication

          -  Permanent AF

          -  Permanent AV block

          -  Inability to complete follow-up visits at a study center.

          -  Unwillingness or inability to cooperate or give written informed consent, or the
             patient is a minor, and legal guardian refuses to give informed consent

          -  Planned cardiovascular intervention

          -  Inclusion in another clinical trial that will affect the objectives of this study

          -  Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.