bioihbjkbjnl/mcl2 huggingface dataset:
ProvodineTM Decreases Hand Contamination
Condition: Hand Hygiene
Intervention: Provodine Hand Sanitizer
Intervention description: Intervention with Provodine
Intervention MeSH terms: Hand Sanitizers
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Anesthesia providers will serve as their own controls
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 22 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hand hygiene; Provodine; Hand contamination

Summary:

      The purpose of this study is to see whether Provodine, an FDA approved product, provides
      long-lasting protection on the hands of staff who provide anesthesia for patients. If this
      product does provide long-lasting protection, it could be used for hand hygiene in the
      operating room and it could help prevent infections after operations. Fifteen anesthesia
      providers (15 main operating room [MOR] and 5 ambulatory surgery center [ASC]) who agree to
      participate will participate in the pre-intervention and intervention periods. During the
      pre-intervention or baseline period, the investigators will do bag broth cultures of
      anesthesia providers' hands just before the start of their first case of the day . The
      participants will then rinse and dry their hands to remove the culture medium. The
      investigators will also obtain cultures after the first case of the day, and after the second
      case. During the intervention period (ProvodineTM; usual hand hygiene practice), the
      investigators obtain hand cultures from the same anesthesia providers at the beginning of the
      day. The participants will then then do a hand scrub with ProvodineTM. The investigators will
      obtain a second hand culture at this point and participants will rinse and dry their hands to
      remove the culture medium and then apply a small amount of ProvodineTM as a hand rub. The
      investigators will obtain cultures after the first case of the day, and after the second case
      of the day. If participants are still providing anesthesia to their second case 6 hours after
      they applied ProvodineTM, the participants will apply a small of ProvodineTM amount as a hand
      rub at this time.

      For anesthesia providers in the ASC, the investigators will use the same protocol with the
      following exception. Because cases are likely to be shorter, the investigators will obtain
      the final cultures after the last case of the day or after the case that ends closest to 6
      hours after ProvodineTM was applied in the morning.
    

Eligibility criteria:

        Inclusion Criteria:

        - Must be an anesthesia provider at The University of Iowa Hospitals and Clinics

        Exclusion Criteria:

        - Are not an anesthesia provider at The University of Iowa Hospitals and Clinics
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tedizolid PO; Tedizolid IV
Intervention description: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.; Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
Intervention MeSH terms: Tedizolid; Oxazolidinones
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The proposed study is designed to characterize the pharmacokinetics of intravenous and oral
      tedizolid in patients with Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CF based on positive sweat chloride or known CF mutation

          -  Age > 17 years

          -  Able to spontaneously expectorate sputum

        Exclusion Criteria:

          -  Any clinically significant laboratory abnormalities

          -  Presence of an ongoing acute pulmonary exacerbation

          -  Pregnancy

          -  Serious past allergy to linezolid or tedizolid

          -  No alcohol, nicotine, or caffeine-containing products during the study period
Prevention of Persistent Opioid Use in Mothers
Condition: Opioid Use; Postpartum Disorder; Chronic Pain Syndrome
MeSH terms: Puerperal Disorders; Chronic Pain
Intervention: Gabapentin; Placebo
Intervention description: Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.; Placebo to match gabapentin
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.
Enrollment: 78.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Our previous work has identified the group of women at risk for prolonged pain, opioid use
      and poor functional recovery after childbirth. The optimal intervention to mitigate this risk
      is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative
      pain compared to placebo to improve post-partum recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Delivery within 5 days, able to provide informed consent, English speaker

        Exclusion Criteria:

          -  Opiate use disorder
Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Condition: Healthy Volunteers
Intervention: Pitavastatin (NK-104); Lopinavir/ritonavir
Intervention description: pitavastatin (NK-104) 4 mg once daily (QD); lopinavir/ritonavir 800 mg/200 mg
Intervention MeSH terms: Ritonavir; Lopinavir; Pitavastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or female volunteer aged 18 to 45 years, inclusive.

          -  Subject has a body mass index of 18 to 30 kg/m2, inclusive.

          -  Subject has normal hematology, serum chemistry, and urinalysis test results

          -  Subject is able and willing to abstain from alcohol, grapefruit, caffeine, or caffeine
             containing products for 4 days before Day 1 until after completion of this study.

          -  Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of
             study drug.

        Exclusion Criteria:

          -  Subject has had any surgery of the gastrointestinal tract likely to affect drug
             absorption, distribution, metabolism, or excretion.

          -  Subject has had a previous allergy or intolerance to treatment with pitavastatin or
             lopinavir/ritonavir.

          -  Subject has a history of drug or alcohol abuse.

          -  Subject has had a clinically significant illness within 4 weeks before the first dose
             of study drug.
Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Donepezil HCL
Intervention description: Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 45 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Alzheimer's disease

Summary:

      This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating
      safety and efficacy of donepezil hydrochloride in patients with moderate to severe
      Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female aged 45 to 90 years

          2. Patients have eligible conditions of dementia diagnosis listed in DSM-IV

          3. Diagnosed as a probable Alzheimer's Disease patient according to NINCDS-ADRDA criteria

          4. At the timing of screening, MMSE less than or equal to 20 AND CDR greater than or
             equal to 2 OR GDS greater than or equal to 4

          5. Patients, who have been taking stable donepezil 10 mg for 3 months or longer before
             the start of the study (screening visit), are evaluated as eligible to take donepezil
             23 mg by investigator

          6. Patients who have not received any other medications for AD such as AChE inhibitors at
             least for 3 months prior to the screening visit excluding donepezil hydrochloride
             (However, concomitant use of memantine is allowed if taken at stable dose that are
             less than or equal to the approved dose range for at least 3 months prior to
             screening)

          7. Medicines for cerebral activation such as Gingko Biloba is allowed to be taken if the
             patient has received it as stable dose for 3 months prior to the screening visit

        Exclusion Criteria

          1. Patients who have been participated in any other clinical trial 3 months prior to the
             screening visit

          2. Patients who are having any severe psychiatric disorder or schizophrenia

          3. Patients who are having a neurological disorder other than AD which affect the
             subject's cognition or ability to assess the cognition
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
Condition: Infections, Fungal
MeSH terms: Mycoses
Intervention: voriconazole
Intervention description: Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
Intervention MeSH terms: Voriconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Voriconazole; Magnetic Resonance Spectroscopy

Summary:

      To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance
      doses over 3 days and compare it to the amount of voriconazole in the plasma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be willing and able to provide informed consent.

          -  Subjects must be willing and able to be confined at the Clinical Research Unit as
             required by the protocol.

        Exclusion Criteria:

          -  Subjects with any condition affecting drug absorption.
To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
Condition: Hypertension; High Blood Pressure
MeSH terms: Hypertension
Intervention: Amlodipine 5mg/Valsartan 80 mg; Valsartan
Intervention description: Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.; For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.
Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks
Intervention MeSH terms: Amlodipine; Valsartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; valsartan; amlodipine; high blood pressure

Summary:

      The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg
      amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood
      pressure in Taiwanese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants over 18 years of age with hypertension defined as sitting systolic blood
             pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90
             mmHg and 120 mmHg.

          -  High risk participants ( defined as having: (diabetes mellitus, chronic renal disease,
             Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD
             equivalents including carotid artery disease, peripheral arterial disease (PAD),
             abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood
             pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80
             mmHg and 120 mmHg.

        Exclusion Criteria:

          -  Known or suspected secondary hypertension

          -  Known New York Heart Association (NYHA) functional class IV Heart Failure

          -  History of myocardial infarction, transient ischemic attack or cerebrovascular
             accident within the preceding 3 months

          -  Clinically significant valvular disease

          -  Women who are pregnant, intend to become pregnant or are breastfeeding

          -  Participants who have severe medical condition(s) that in the view of the Investigator
             prohibits participation in the study

          -  Participants who have hypersensitivity to the investigational/ reference drug or any
             of the components in the formulation.

          -  Other protocol-defined inclusion/exclusion criteria may apply
Sexual Absorption of Vaginal Progesterone
Condition: Infertility; Pregnancy
MeSH terms: Infertility
Intervention: Crinone vaginal progesterone gel; Placebo vaginal gel
Intervention description: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.; Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Initial assignment randomized, then crossed over to the other treatment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Assisted reproductive technology; Infertility; Progesterone; Vaginal gel; Luteal-phase support

Summary:

      The purpose of this study is to determine if sexual intercourse lowers serum progesterone in
      women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their
      male sexual partners. We hypothesize, based on previous estrogen studies done by our group,
      that intercourse will interfere with absorption of vaginal progesterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active 18-40 year old heterosexual couple

          -  Subject willing to take Mircette birth control pills for at least one cycle (one pack)

          -  Willing to have intercourse at the defined times (at least weekly within a 3 week
             interval, and draw blood within 10 hours of intercourse)

          -  IRB signed informed consent

        Exclusion Criteria:

          -  Undiagnosed vaginal bleeding

          -  Contraindication to oral contraceptives

          -  Liver dysfunction or disease

          -  Known sensitivity to Crinone

          -  Known or suspected malignancy of the breast or genital organs

          -  History of or active thrombophlebitis or thromboembolic disorders

          -  Use of condoms during intercourse

          -  Male erectile or ejaculatory dysfunction
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
Condition: Caries
MeSH terms: Dental Caries
Intervention: Silver Diamine Fluoride (SDF)
Intervention description: No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet
Intervention MeSH terms: Fluorides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Caries; Cavity; Silver Diamine Fluoride (SDF); HOMINGS

Summary:

      The study will compare bacteria levels in cavities before and after silver diamine fluoride
      (SDF) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy adult participants 18 years of age and older.

          -  At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the
             gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft
             active carious lesions exposing dentin).

        Exclusion Criteria:

          -  Adult participants who suffer from serious life-threatening medical diseases that
             interfere with basic daily self care activities.

          -  Patients taking antibiotics within the last two weeks.

          -  Patients using chlorhexidine or fluoride mouth washes within the last two weeks.

          -  Pregnant or breastfeeding women.

          -  Teeth with arrested (hard) cervical or root caries lesions.

          -  Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are
             mobile.
Knee Injection RCT
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Ketorolac Tromethamine Injection; Methylprednisolone Acetate Injection; Hylan G-F 20
Intervention description: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine; One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine; One knee injection of Hylan G-F 20 (Synvisc-One)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Ketorolac; Ketorolac Tromethamine; Prednisolone hemisuccinate; Prednisolone phosphate; Hylan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Injection; Ketorolac

Summary:

      Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of
      knee osteoarthritis (OA) compared to steroids and viscosupplementation.

      Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective
      study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in
      the nonsurgical management of symptomatic OA compared to injections with corticosteroids and
      viscosupplements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic
             evidence of joint space narrowing and 2) are interested in knee injections for pain
             relief.

        Exclusion Criteria:

          -  Prior injections into the same knee within the past 6 months,

          -  Pregnant and/or lactating women,

          -  Inflammatory joint disease including rheumatoid or psoriatic arthritis,

          -  Concurrent use of anti-rheumatic drugs,

          -  Allergy or hypersensitivity to the study medications,

          -  Patients on an active pain management contract,

          -  Patients with insurance that requires pre-certification for any of the study drugs,

          -  Inability to make own decisions regarding the informed consent,

          -  Inability to read and/or understand English,

          -  Patients who are unable to return for follow-up or be reached by phone.
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Condition: Post-Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]
Intervention description: 150mg po monthly for 3 years; 100mg po monthly for 3 years
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 719.0
Sex: Female
Healthy volunteers: No

Summary:

      This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg
      or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed
      Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly,
      or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and
      calcium. The anticipated time of study treatment is 2+ years, and the target sample size is
      500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  successful completion of Bonviva study BM16549, with at least 75% compliance;

          -  ambulatory.

        Exclusion Criteria:

          -  malignant disease diagnosed within the previous 12 years (except basal cell cancer
             that has been successfully removed);

          -  breast cancer diagnosed within the previous 22 years.