bioihbjkbjnl/mcl2 huggingface dataset:
Post-operative Dental Pain Study Comparing Analgesic Efficacy
Condition: Post-surgical Dental Pain
MeSH terms: Toothache
Intervention: Paracetamol 1000 mg; Paracetamol 500 mg; Placebo
Intervention description: Paracetamol 1000 mg; Paracetamol 500 mg; Placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: paracetamol; dental pain; Post-surgical dental pain

Summary:

      GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol
      1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic
      efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The
      duration of the entire study will be approximately 16 weeks. Each subject will have to come
      to the clinic for three visits (Screening, Treatment and Follow up visits).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal
             rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a
             visual analogue scale (VAS) following surgical removal of third molars, of which at
             least one has to be a mandibular partially bony or full bony impaction.
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Intervention: Dotarem®-enhanced MRI; non-enhanced MRI
Intervention description: Single IV administration before MRI exam; non injected MRI
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: contrast-induced nephropathy, creatinemia

Summary:

      Although there is a well documented risk of acute renal failure with the iodinated contrast
      agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity
      remains controversial. The aim of this study was to evaluate the safety profile of gadoterate
      meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of
      patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate
      meglumine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, > or equal 18 years ;

          -  Patient with a known stable renal insufficiency ;

          -  Patient scheduled to undergo an MRI examination to specify a diagnosis ;

          -  Patient able to understand and provide written informed consent to participate in the
             trial ;

        Exclusion Criteria:

          -  Patient with a contra-indication to MRI ;

          -  Patient who has a diagnosis of an hemodynamic instability or acute myocardial
             infarction within 15 days prior the inclusion ;

          -  Patient who needs hemodialysis ;

          -  Patient with known allergy to gadolinium chelates ;

          -  Patient receiving medications known to be nephrotoxic or to cause increases in serum
             creatinine level within 2 weeks before the inclusion ;

          -  Patients planned to either undergo surgery or receive chemotherapy ;

          -  Any condition which, based on the investigator's clinical judgement, would prevent the
             patient from completing all trial assessments and visits ;

          -  Patient under guardianship and/or inability or unwillingness to cooperate with the
             requirements of this trial ;

          -  Patient with newly discovered unstable diabetes.
The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
Condition: Hypertension
MeSH terms: Hypertension; Glucose Intolerance
Intervention: Nebivolol with concomitant losartan or lisinopril; HCTZ with concomitant losartan or lisinopril; Placebo with concomitant losartan or lisinopril
Intervention description: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.; Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.; Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Intervention MeSH terms: Losartan; Lisinopril; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 537.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: nebivolol; BYSTOLIC ™; hydrochlorothiazide; lisinopril; Prinivil (TM); Zestril (TM); losartan; Cozaar (TM); Impaired Fasting Glucose; Impaired Glucose Tolerance; hypertension

Summary:

      This study is being done to see if the blood pressure and metabolic effects of an approved
      drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and
      placebo in hypertensive patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ambulatory outpatients 18-80 years old at screening.

          -  Have a history of hypertension and taking up to 2 medications for high blood pressure.

          -  Qualifying laboratory results confirming impaired fasting glucose or impaired glucose
             tolerance

          -  Vision and hearing (hearing aid permissible) sufficient for compliance with
             questionnaire completion

        Exclusion Criteria:

          -  Have clinically significant respiratory, liver or cardiovascular disease

          -  Presence of coronary artery disease requiring treatment with a beat blocker, calcium
             channel blocker or nitrates

          -  Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study
             entry

          -  Have a history of hypersensitivity to nebivolol, other beta-blockers,
             hydrochlorothiazide, or other sulfonamide-derived drugs.
A Comparison of 5 Low Volume Bowel Preparations
Condition: Bowel Preparation for Colonoscopy
Intervention: MiraLAX; Gatorade; MoviPrep; SUPREP
Intervention description: MiraLAX consumed as described in each arm.; Gatorade consumed as described in each arm.; MoviPrep consumed as described in each arm.; SUPREP consumed as described in each arm.
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1079.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Colonoscopy; Bowel Preparation; MiraLAX; Gatorade; PEG-3350; MoviPrep; SUPREP; Chicago Bowel Preparation Scale; Boston Bowel Preparation Scale

Summary:

      The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and
      SUPREP to see which preparation cleanses the colon best and which preparation is best
      tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years old planning to undergo an elective colonoscopy will be
             eligible for inclusion in our study. We would prefer to exclude as few groups as
             possible since in clinical practice these less well studied groups often need a
             colonoscopy and will need to have a colonoscopy preparation.

        Exclusion Criteria:

          1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.

          2. Patients who are pregnant.

          3. Patients who required multiple day colon preparations (2 days prior and 1 day prior)
             in the past will be excluded.

          4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel
             perforation, toxic colitis or toxic megacolon would not be considered elective
             colonoscopies and are excluded.

          5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will
             need to be excluded due to the magnesium in SUPREP which is contraindicated in
             patients with significant renal disease.
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart; insulin glargine; metformin; glimepiride
Intervention description: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.; Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.; Tablets, 2550 mcg. Administered once daily.; Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Glimepiride; Biphasic Insulins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 480.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, Oceania and South America.

      This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin
      glargine once daily all in combination with metformin and glimepiride in insulin naive
      subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months

          -  Ongoing stable treatment with metformin for at least 2 months

          -  Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue
             for at least 2 months

          -  Insulin naive

          -  HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

        Exclusion Criteria:

          -  Metformin contraindication according to local practice

          -  TZD (thiazolidinedione) treatment for the last 5 months before trial start

          -  Systemic treatment with any corticosteroid 3 months before trial start

          -  Any disease or condition which according to the Investigator would interfere with the
             trial
Evaluation of Two Hand Hygiene Products in ICUs
Condition: Hand Hygiene Effectiveness
Intervention: hand antiseptic with CHG and alcohol; Alcohol hand sanitizer foam
Intervention description: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.; Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day
Intervention MeSH terms: Ethanol; Anti-Infective Agents, Local; Hand Sanitizers
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: antimicrobial; efficacy; hand; hygiene; bacteria

Summary:

      This study will evaluate the immediate antimicrobial efficacy and persistence of two hand
      hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on
      hands using the hand print method. It is hypothesized that the product containing
      Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in
      less bacterial growth on the hand print plates. In addition, environmental monitoring for
      cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas
      using Rodac plates and adenosine triphosphate tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCW willing to participate in the study

          -  HCW willing to use non-Triclosan soap when soap is necessary throughout the study

          -  HCW who will don gloves prior to ICU patient room entry

        Exclusion Criteria:

          -  Use of any CHG -containing products ( liquid hand soap, Sage wipes) on the ICU 72
             hours prior to study initiation and throughout study

          -  HCW with patient bandage or other dressing on palm(s)

          -  Known sensitivity or allergy to CHG or alcohols in hand hygiene products

          -  Known sensitivity or allergy to the following components: Lecithin, Polysorbate
             80,Trypticase Soy Agar, sodium bisulfate, sodium thioglycollate, sodium thiosulfate

          -  History of skin allergies
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
Condition: Allergic Rhinitis; Allergic Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
Intervention: Fluticasone Propionate Nasal Spray; Saline Nasal Spray
Intervention description: two sprays in each nostril once daily; two sprays in each nostril once daily
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal
      spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following
      ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provide written informed consent and signed HIPAA form;

          -  be able and willing to follow all instructions and attend the study visits;

          -  if female and of childbearing potential, be not pregnant, nursing or planning a
             pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to
             use adequate method of birth control

          -  have a positive history of seasonal allergic rhinitis to ragweed;

          -  have a positive skin test reaction to ragweed of within the past 24 months;

          -  manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC

        Exclusion Criteria:

          -  known intolerance or allergy to antihistamines or corticosteroids;

          -  have a compromised lung function at Visit 1;

          -  develop a compromised lung function at Visits 2-6

          -  have any presence of active sinus or nasal infection at any visit;

          -  have experienced an acute upper or lower respiratory tract infection or acute
             sinusitis within 30 days of visit 1;

          -  have significant nasal anatomical deformities or any condition that does not allow
             subject to breathe through the nose (includes, but is not limited to: septal
             deviation, septal perforations, nasal polyps, rhinitis medicamentosa)

          -  have had any nasal surgical intervention in the past;

          -  have a known history of glaucoma

          -  have planned surgery (nasal, ocular or systemic) during the trial period or within 30
             days thereafter;

          -  inability or refusal to discontinue contact lens wear during all visits;

          -  use disallowed medications during the study or appropriate pre-study washout period
A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Intervention: Vitamin D2; Vitamin D2; Placebo
Intervention description: 50 000 IU vitamin D2, one time bolus dose; 100 000 IU vitamin D2, one time bolus dose; Placebo, 1 time bolus dose
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Vitamin D; Hip fracture; Optimal level; Deficiency; Functional muscle strength

Summary:

      The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture
      patients to achieve the optimal therapeutic level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fragility hip fracture patient

          -  Previous Vitamin D supplementation is okay.

        Exclusion Criteria:

          -  Patients with pathological fracture secondary to malignancy or intrinsic bone disease
             (eg. Paget's disease)

          -  Cancer in the past 10 years likely to metastasize to bone

          -  Renal insufficiency (creatinine <30 mls/min)

          -  Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such
             as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the
             last 3 months

          -  Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the
             previous 24 months

          -  Pre-existing bone abnormality

          -  Renal stones in past 10 years
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
Condition: Tinea Corporis
MeSH terms: Tinea
Intervention: Luliconazole Cream 1%; Vehicle Cream
Intervention description: Luliconazole cream will be applied per schedule specified in the arm.; Vehicle cream will be applied per schedule specified in the arm.
Intervention MeSH terms: Luliconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of
      luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to
      17 years of age (inclusive) with tinea corporis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants (or legal guardian/caregiver) with the ability and willingness to sign a
             written informed consent and/or assent (age appropriate).

          -  Participants of either gender must be at least 2 years to less than (<) 18 years of
             age (2 to 17 years, inclusive).

          -  Participants with a clinical diagnosis of tinea corporis characterized by clinical
             evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate
             pruritus).

          -  Participants must be in good general health and free of any disease that in the
             Investigator's opinion might interfere with the study evaluations.

          -  Participants/caregiver must be able to communicate, be able to understand the study
             procedures, and be willing to comply with the study requirements.

        Key Exclusion Criteria:

          -  Participants with active atopic or contact dermatitis in the area to be treated.

          -  Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin
             infection.

          -  Female participants who are pregnant and/or nursing or planning a pregnancy during the
             course of the trial. Participants who test positive for pregnancy after start study
             drug will be discontinued from study drug but will be followed for safety purposes.

          -  Participants who are immunocompromised (due to disease, for example; human
             immunodeficiency virus [HIV] or medications).

          -  Participants who have a recent history of or current drug or alcohol abuse.