bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Bone Turnover With Increased Incretin Hormone Exposure
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: sitagliptin; Placebo
Intervention description: sitagliptin 100mg daily; 1 pill daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 diabetes; sitagliptin; Januvia

Summary:

      The purpose of this study is to determine if the use of sitagliptin increases bone formation
      and reduces bone turnover in postmenopausal women with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (as defined by age >55 years old or amenorrhea for >1years)

          -  Type 2 DM currently not on diabetes-specific medication(s) or treated with monotherapy
             of metformin or a sulfonylurea. Patients treated with insulin monotherapy will also be
             eligible if the total daily dose of insulin is <10units.

          -  Hemoglobin A1c (HbA1c) of 6.5-9.0%

        Exclusion Criteria:

          -  Use of an incretin mimetic (i.e. exenatide), a DPP-4 inhibitor (i.e. sitagliptin,
             saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to
             the study will not be eligible

          -  Known osteoporosis or patients treated with an osteoporosis-specific medication
             (bisphosphonate, teriparatide) or estrogen (including Selective Estrogen Receptor
             Modulators (SERMs)) or those who anticipate imminent treatment with one of these
             medications will be excluded from the study

          -  Chronic kidney disease (calculated GFR <30 ml/min) or a disease known to affect bone
             turnover (i.e. Paget Disease, Osteogenesis Imperfecta, HIV) will be excluded from the
             study.

          -  History of pancreatitis
Treatment Response in Dialysis Anaemia
Condition: Anaemia; Haemodialysis
MeSH terms: Anemia
Intervention: Iron sucrose; Erythopoietin stimulating agent
Intervention description: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl; Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Haemodialysis; Anaemia; Iron; Erythropoeitin stimulating agents

Summary:

      Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two
      current possible treatments for anaemia which are iron and erythropoietin stimulating agents
      (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and
      haemoglobin, but these markers are known to be inaccurate. The current clinical protocol
      therefore tends towards overuse of both agents which can be associated with toxicity, and the
      reliance on these markers prevents retrospective assessment of treatment responsiveness. This
      study is designed to investigate the factors which predict which agent would produce a better
      response. Patients with a fall in haemoglobin will be given treatment with either iron or an
      increased dose of ESA as they are currently, but allocated at random rather than by poorly
      performing biochemical markers. The iron treated and ESA treated groups can then be analysed
      for factors which predict response in o
    

Eligibility criteria:

        Inclusion Criteria:

          -  All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will
             be eligible for inclusion if they have been on dialysis for more than 3 months

        Exclusion Criteria:

          -  Patients with a bone marrow disorder, active infection or active malignancy will be
             excluded as these are non-renal causes of anaemia. Patients unable to give informed
             consent will also not be included within the study.
Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
Condition: Post-operative Pain Control
MeSH terms: Pain, Postoperative
Intervention: acetaminophen/codeine vs acetaminophen/oxycodone
Intervention description: pain medications
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to Group 1 or Group 2
Masking: Double (Participant, Investigator)
Masking description: Randomization was accomplished by the pharmacy and the medication bottles were not labeled.
Enrollment: 200.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Photorefractive Keratectomy; Post-operative Eye Pain; Refractive Surgery

Summary:

      Photorefractive keratectomy (PRK) is a refractive error correction procedure that helps
      eliminate or reduce the dependence on corrective lenses. An important aspect of PRK is
      post-operative pain management. Post-operative pain can be significant in the first three to
      five days and is typically controlled utilizing various modalities including narcotic pain
      medication. Simple observation suggests a difference in the post-operative pain levels of
      patients utilizing the more potent oxycodone- versus the less potent codeine-containing
      acetaminophen preparations. There have been no studies performed to explore any differences
      in perceived pain comparing these two medications when used following PRK. This study is
      designed to answer this question by means of a pain survey conducted in the first five days
      post-op. This may help better manage similar patients in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  M/F >21 years of age (PRK is not done on anyone under the age of 21 at this surgery
             center)

          -  Have met all criteria for bilateral PRK

        Exclusion Criteria

          -  Patients who do not meet the criteria for refractive surgery

          -  Patients receiving LASIK

          -  Patients known to have an allergy to either of the study pain medications

          -  Patients receiving refractive surgery on only one eye

          -  Pregnant women, children, military basic trainees, prisoners and detainees

          -  Subject has used narcotics in the last 6 months
Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)
Condition: Adverse Reaction to Spinal Anesthetic; Maternal Care for Cervical Incompetence
MeSH terms: Uterine Cervical Incompetence
Intervention: Chloroprocaine; Bupivacaine; Fentanyl; Saline
Intervention description: Administered as a single injection or continuously through an indwelling catheter - 50 mg; A dextrose Solution is usually given as an injection - 9 mg (1.4 ml); 15 mcg Fentanyl will be included int he spinal anesthetic in both groups; Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml
Intervention MeSH terms: Fentanyl; Bupivacaine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chloroprocaine; cervical cerclage; spinal anesthesia; Bupivacaine

Summary:

      This study aims to determine whether or not spinal anesthesia with the local anesthetic drug,
      chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in
      faster discharge from the post-anesthesia care unit after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I and II women

          -  18-45 yrs old

          -  Singleton pregnancy

          -  Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia

          -  Height 150 - 180 cm

          -  BMI ≤ 40 kg/m2.

        Exclusion Criteria:

          -  Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g.,
             multiple sclerosis, spinal stenosis, central or peripheral neuropathy)

          -  Pre-existing/chronic back pain

          -  Ester local anesthetic allergy, PABA allergy

          -  History of atypical cholinesterase (CP is metabolized by cholinesterase)
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Condition: Anterior Ischemic Optic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Ischemia
Intervention: Diagnostic procedures
Intervention description: The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Non-arteritic Anterior Ischemic Optic Neuropathy; NAION; PDE5 inhibitors; vardenafil; Levitra; sildenafil; Viagra; Tadalafil; Cialis; acute vision loss; vision loss; blurred vision; optic neuropathy; erectile dysfunction.

Summary:

      The primary objective of this study is to determine whether the use of PDE5 inhibitors
      (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NAION onset within 45 days before entry to the study

          -  NAION onset definable by the subject within a 2 calendar day window

          -  Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year
             prior to enrollment in the study

          -  Age 40 years or older

        Exclusion Criteria:

          -  History of multiple sclerosis or optic neuritis

          -  Evidence of temporal arteritis

          -  History of vasculitis or collagen vascular disease

          -  Previous history of NAION
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Condition: Ureteral Patency
Intervention: Pyridium; Sodium Fluorescein; Mannitol; Normal Saline
Intervention MeSH terms: Mannitol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to
      identify the opening of the ureters to ensure that they are working correctly. Historically,
      indigo carmine, an intravenous medication that dyes the urine blue, has been used to help
      visualize the opening of the ureters with cystoscopy which is a camera placed inside the
      bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus,
      investigators need to evaluate other methods for assessing ureteral patency. Ideal
      alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are
      readily available and are easy to use.

      Examples of such agents currently being used to evaluate the ureters, include oral pyridium,
      IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by
      either dyeing the urine a different color such as pyridium and sodium fluorescein, or by
      having a different viscosity to urine such as mannitol. This study will compare three methods
      of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium
      fluorescein, and pyridium.
    

Eligibility criteria:

        Inclusion Criteria:

        - Planned cystoscopy

        Exclusion Criteria:

          1. Women who are pregnant

          2. Women with contraindications to pyridium, sodium fluorescein or mannitol:

               1. Intra-operative administration of nitric oxide, prilocaine and sodium nitrite

               2. Anuria

               3. Women with creatinine greater than 1 or Cr Cl < 50ml/minute

               4. Known allergy to pyridium, sodium fluorescein or mannitol.

          3. Women with a known urologic anatomical anomaly
Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
Condition: Foot Dermatoses
MeSH terms: Skin Diseases; Foot Dermatoses
Intervention: Loceryl NL + Cosmetic varnish; Loceryl NL 12 weeks; Loceryl NL 15 months
Intervention description: Loceryl NL + Cosmetic varnish once/week for 12 weeks; Loceryl NL once/week for 12 weeks; Loceryl once/week for additional 15 months
Intervention MeSH terms: Amorolfine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Masking description: Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized.
15 months of treatment with Loceryl NL alone had an open study design
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis; antifungal

Summary:

      The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail
      Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment
      of mild to moderate toenail Distal Subungual Onychomycosis.

      The second objective of this study will be photographic follow-up of clinical improvement and
      cure after the initial treatment period of 12 weeks, for 15 additional months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1
             great toenail chosen as a Target nail

          -  Subjects must have maximum of 50% of nail distal edge involved

          -  Subjects with positive mycological results (direct microscopy and culture) of the
             Target nail for dermatophytes or Yeast (including Candida) at Screening

        Exclusion Criteria:

          -  Subjects with clinically important abnormal physical findings at the
             Screening/Baseline visit

          -  Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail
             unit

          -  Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
Condition: Hepatitis C; Transplantation Disease Transmission
MeSH terms: Hepatitis C
Intervention: Sofosbuvir/Velpatasvir; Sofosbuvir/Velpatasvir/Voxilaprevir
Intervention description: Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.; Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.
Dosage: 400mg/100mg/100mg daily for 12 weeks.
Intervention MeSH terms: Sofosbuvir; Velpatasvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Healthy volunteers: No

Summary:

      In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with
      livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be
      given to the study subjects shortly after transplant to protect them from developing the
      problems HCV can cause to the liver.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a
             potential suitable living donor or for simultaneous liver kidney transplant;

          -  HCV non-infected at the time of transplant. Subjects who were previously HCV infected
             but who have had documented SVR12 are eligible to participate;

          -  Agree to use two methods of birth control during the study;

          -  Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface
             antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or
             minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.

        Exclusion Criteria:

          -  Donor and/or recipient HIV infection

          -  Subject pregnant or nursing

          -  Donor and/or recipient Hepatitis B surface antigen positive

          -  Kidney-pancreas transplant

          -  Single organ liver recipients who received hemodialysis for more than 7 days prior to
             liver transplantation

          -  Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized
             with panel reactive antibody > 80%; for single organ kidney transplant, subjects with
             advanced liver fibrosis (Knodell stage 3) or cirrhosis

          -  Individuals being treated with and needing to continue rifabutin, rifampin,
             carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum
             perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton
             pump inhibitors (See Concomitant Medications).

          -  Individuals treated with amiodarone within 42 days of organ transplant.
Smoking Tobacco and Drinking Study
Condition: Smoking; Heavy Episodic Drinking
Intervention: Tobacco Status Project Intervention; Tobacco Status Project + Alcohol Intervention; nicotine patch
Intervention description: 90 days of Facebook messaging, weekly live sessions targeting tobacco use; 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use; 14-day supply of nicotine patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco; Cigarettes; Alcohol; Cessation; Intervention; Young adults; Internet; Social media

Summary:

      This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use
      and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use.
      Both groups will be offered a nicotine patch starter kit. The primary outcome is verified
      7-day point prevalence abstinence from smoking at 3, 6, and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  read English

          -  between 18 and 25 years of age

          -  indicate they use Facebook "most" (≥ 4) days per week

          -  have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette
             per day on 4 or more days of the week

          -  have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past
             month.

        Exclusion Criteria:

          -  do not read English

          -  are not between 18 and 25 years of age

          -  indicate they do not use Facebook "most" (≥ 4) days per week

          -  have not smoked ≥100 cigarettes in their lives and currently smoke at least 1
             cigarette per day on 4 or more days of the week

          -  have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the
             past month.
Antibiotics During Intrauterine Balloon Tamponade Placement
Condition: Obstetric Complication; Postpartum Hemorrhage; Postpartum Endometritis
MeSH terms: Postpartum Hemorrhage; Endometritis; Hemorrhage
Intervention: CeFAZolin 1000 MG; Clindamycin 900 MG in 6 ML Injection
Intervention description: Cefazolin 1000 mg every 8 hours for 3 doses; Clindamycin 900 mg every 8 hours for 3 doses
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, randomized controlled trial
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bakri; Intrauterine balloon tamponade; Antibiotics

Summary:

      The goal of this study is to identify whether antibiotics given at the time of placement of
      an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis.
      The investigators hypothesize that antibiotics given at the time of intrauterine balloon
      tamponade will reduce the likelihood of postpartum endometritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Able to give consent

          -  Gestational age > 24 weeks

          -  Postpartum

          -  Placement of an IBT within the last 2 hours with plans for it to remain in situ for at
             least 2 hours

          -  Primary obstetrician amenable to proceeding with either method of management during
             the study period.

        Exclusion Criteria:

          -  Age < 18 years old

          -  IBT removed within 2 hours of placement

          -  Chorioamnionitis

          -  Insufficient documentation of demographics, delivery outcomes, or peripartum events
             including postpartum hemorrhage, infectious outcomes