bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Simethicone on Screening Colonoscopy
Condition: Adenoma Colon
MeSH terms: Adenoma
Intervention: Simethicone Solution; Polyethylenglycol
Intervention description: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol; Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
Intervention MeSH terms: Simethicone
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 268.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: screening; adenoma detection rate; simethicone

Summary:

      This study is evaluating the effect of adding a high dose of simethicone to the standard
      polyethylene glycol preparation for screening colonoscopy in the quality of the preparation ,
      adenoma detection rate and withdrawal times.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients between the ages of 30-80 scheduled for screening colonoscopy.

          2. Male and female patients

          3. Ambulatory patients

          4. Signed informed consent form

        Exclusion Criteria:

          1. Previous colonic surgery

          2. Patient with mental/physical condition that impairs oral ingestion of preparation

          3. Allergy or hypersensitivity to simethicone

          4. Patients with limited mobility (bedridden patients)

          5. Patients with gastrointestinal obstruction

          6. Patients with gastroparesis
Paracervical Block Versus No Paracervical Block During IUD Insertion
Condition: Analgesia; IUD Insertion
Intervention: Lidocaine; No analgesia; Intrauterine device (IUD)
Intervention description: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.; IUD placement without analgesia.; IUD placement with or without paracervical block with 1% lidocaine.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 52 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the pain level and level of discomfort with
      paracervical block versus no analgesia in women who present to the University of Texas (UT)
      Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and
      the UT Physicians Women's Center- Bellaire for IUD insertion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women of reproductive age who present for an IUD insertion procedure at the University
             of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians
             Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

        Exclusion Criteria:

          -  Women with current pelvic inflammatory disease (PID)

          -  Women who are not good candidates for an IUD

          -  Patients who have a Lidocaine allergy
Bupropion SR Plus Counseling for Smoking Cessation
Condition: Tobacco Dependence; Smoking
MeSH terms: Tobacco Use Disorder
Intervention: Active bupropion + counseling; Active bupropion, No counseling; Placebo medication + counseling; Placebo medication, No counseling
Intervention description: Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.
Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.; Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day.
Counseling: No cessation counseling, only medication checks; Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day.
Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.; Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.
Counseling: No counseling, just medication checks
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation medications; smoking cessation counseling

Summary:

      The purpose of this study was to determine if bupropion plus counseling was more effective
      than bupropion alone or counseling alone in helping smokers quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke 10 or more cigarettes per day

          -  Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)

          -  Motivated to quit smoking (score of 3 on 4-point self-report scale)

          -  Willing to fulfill study requirements

        Exclusion Criteria:

          -  Carbon monoxide breath test score below 9 ppm

          -  Serious psychopathology (bipolar disorder, psychosis)

          -  Center for Epidemiologic Studies Depression Scale CES-D)score over 16

          -  Contraindications for use of bupropion

          -  History of seizure disorder

          -  History of eating disorder

          -  Current heavy drinking

          -  Risk of pregnancy

          -  Current breastfeeding
Glucagon Use in Colonoscopies
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: Glucagon
Intervention description: glucagon (hormone produced by the body)
Intervention MeSH terms: Glucagon
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: glucagon, screening colonoscopy

Summary:

      The investigators believe that glucagon therapy will have a positive impact on key parameters
      of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma
      detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort,
      and patient's willingness to undergo a repeat colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any subject who has already been already cleared for and scheduled to undergo
             colonoscopy at SFGH endoscopy center.

        Exclusion Criteria:

          1. Refusal to give informed consent.

          2. Age <18 or >70.

          3. Prior intra-abdominal surgery

          4. Diabetes

          5. Pheochromocytoma

          6. Insulinoma

          7. Liver disease (Child-Pugh Score >6)

          8. Pregnancy
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Condition: Constipation; Cancer
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: PEG then Senna; Senna then PEG
Intervention description: Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).; Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Intervention MeSH terms: Sennosides
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The primary outcome will be treated as a binomial outcome, expressed as the number of successful trials out of a pre-defined number of trials n = 18. Given this, the primary outcome will be analysed via a generalized mixed effects model. The model will include: (i) fixed effects for treatment, treatment period and their interaction, (ii) fixed effects for the baseline characteristics and (iii) a random patient effect. Including the latter effect in the model will help capture the within-patient correlation among the values of the primary outcome collected in Period I and Period II for the same patient.
All statistical analyses will be conducted using the open-source statistical software package R.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind using a dummy alternate treatment.
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Constipation; Opioids; Cancer; Polyethylene glycol; Sennosides; Opioid Therapy

Summary:

      This is a study to compare the efficacy and tolerability of two laxatives for treatment of
      opioid-induced constipation in adult outpatients with cancer treated at the British Columbia
      Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will
      be randomly assigned to one of two treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient (18 years and above) with diagnosis of cancer.

          2. Patient requires treatment or prevention of constipation.

          3. Patient is able to communicate effectively with staff.

          4. Expected prognosis more than 12 weeks.

          5. On or starting opioid therapy

        Exclusion Criteria:

          1. Patient unable to take oral medication.

          2. Allergy or previous intolerance to PEG or sennosides.

          3. Lactose intolerant.

          4. Contraindication to PEG or sennosides.

          5. Known or suspected bowel obstruction or ileus.

          6. Colostomy or ileostomy.

          7. Inflammatory bowel disease.

          8. Hospitalisation expected within the study period.

          9. Patient unable to complete the study diary in English.
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Intervention: Terconazole Vaginal Suppository; Fluconazole
Intervention description: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days; orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Intervention MeSH terms: Fluconazole; Terconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No

Summary:

      The objectives of this study were to demonstrate comparable safety and efficacy of
      Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with
      severe vulvovaginal candidiasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a
             numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3)
             with a minimum VVC Composite Signs/Symptoms score of 7

          -  Subject completes the informed consent process

          -  Subject agrees to take study medication when scheduled

          -  Subject complies with all clinical trial instructions. Commits to all follow-up visits

          -  Subject agrees to abstain from sexual intercourse from the time of randomization
             through the first seven days immediately following treatment

        Exclusion Criteria:

          -  had any other sexually transmitted disease or gynaecological abnormality requiring
             treatment

          -  had a disease known to predispose to candidiasis such as diabetes mellitus, or were
             receiving antibiotics or corticosteriods

          -  had used antifungal medication in the week before entry; or

          -  were expected to menstruate within seven days of the start of treatment

          -  infected more than one candida species
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Glibenclamide
Intervention description: Sitagliptin 50 mg orally once a day before breakfast for 14 days; Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days
Intervention MeSH terms: Sitagliptin Phosphate; Glyburide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on
      the glucose variability using continuous glucose monitoring (CGM) in Japanese participants
      with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with
      sitagliptin will be superior to treatment with glibenclamide in the change from baseline in
      mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM)
      after 13 days of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese participants with a diagnosis of Type 2 diabetes mellitus

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus or ketoacidosis

          -  History of insulin or thiazolidinedione (including fixed-dose drug combinations
             containing one of these drugs) in the 12 weeks before study participation
Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
Condition: Smoking Cessation
Intervention: Nicotine Replacement Therapy; Smoking Cessation Counseling
Intervention description: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The researchers are testing if counseling alone or counseling plus over-the-counter nicotine
      replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily
      smokers quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  African American adults who are interested in quitting and whose smoking patterns meet
             criteria for non-daily smoking as determined by eligibility screening

        Exclusion Criteria:

          -  Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable
             to complete study procedures as determined by eligibility screening
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AMIODARONE
Intervention description: Assess the effectiveness of different dosing strategies of amiodarone.
Intervention MeSH terms: Amiodarone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a single-center, prospective, randomized, open-label trial of subjects who
      develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky
      Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional
      amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 18 years old or older

          -  Subject must be willing to give written informed consent

          -  Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary
             artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or
             septal defect repair, thoracic aortic replacement surgery, or any combination of these
             procedures

        Exclusion Criteria:

          -  Documented allergy to amiodarone or iodine

          -  History of atrial fibrillation or other heart conduction system abnormality

          -  History of cardiac maze, pulmonary vein isolation, or other procedure affecting the
             conduction system

          -  Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the
             conduction system

          -  Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support

          -  History of pre-existing respiratory system disease requiring oxygen therapy prior to
             admission

          -  History of cirrhosis or other chronic liver diseases

          -  Pregnancy or breastfeeding mothers

          -  Prisoner status
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: High Dose Inactivated Influenza Vaccine; Standard Dose Inactivated Influenza Vaccine
Intervention description: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin; 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 205.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza in Long Term Care Setting; High dose Inactivated influenza vaccine; Standard dose inactivated influenza vaccine

Summary:

      The purpose of the study is to compare the performance of two currently available influenza
      (flu) vaccines. This study will try and determine if the high dose flu vaccine provides
      protection that is the same or better than that of regular dose flu vaccine. Both the regular
      dose and the high dose flu vaccines are approved by the FDA for use in older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Residents of one of the participating LTC sites

          -  65 years or older at the time of consent

          -  require assistance in two or more Instrumental Activities of Daily Living and/or one
             or more Activities of Daily Living as identified by facility staff

        Exclusion Criteria:

          -  Age less than 65 years

          -  Life expectancy less than 6 months

          -  History of allergic reaction to influenza vaccine, its components, or eggs

          -  History of severe allergic reaction to latex

          -  History of Guillian-Barre Syndrome

          -  Actively undergoing chemotherapy

          -  Actively undergoing radiation therapy

          -  Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or
             higher within the past 14 days

          -  Serious current immunosuppression or immunosuppression expected in the next 6 weeks

          -  Any condition that, in the opinion of the investigator,might interfere with the
             evaluation of study objectives
RIGHT: Rhythm ID Going Head-to-Head Trial
Condition: Tachycardia
MeSH terms: Tachycardia
Intervention: VITALITY 2 Implantable Cardioverter Defibrillator; Medtronic Implantable Cardioverter Defibrillator
Intervention description: VITALITY 2 ICD; Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1962.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy
      of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected
      Medtronic ICDs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet current indications for an ICD

          -  Patients who sign and date a Patient Informed Consent form prior to the implant visit

          -  Patients who remain in the clinical care of the enrolling physician in approved
             centers

          -  Patients who are able to tolerate ICD programming as specifically prescribed in the
             study protocol

        Exclusion Criteria:

          -  Patients who are in third degree heart block

          -  Patients whose life expectancy is less than 12 months

          -  Patients who have other cardiac surgeries or procedures planned but not yet performed
             during the duration of the study

          -  Patients who are currently enrolled in another investigational study or registry that
             would directly impact the treatment or outcome of the current study

          -  Patients who are younger than 18 years of age

          -  Patients who are mentally incompetent and cannot sign a Patient Informed Consent form
             or comply with the study

          -  Patients who are pregnant or plan to become pregnant during the study