bioihbjkbjnl/mcl2 huggingface dataset:
Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control
Condition: Internal Derangement of Knee
Intervention: 0.25% Bupivacaine; Normal Saline
Intervention description: 10cc, single dose, US guided injection; 10cc, single dose, US guided injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: infrapatellar nerve; saphenous nerve; knee arthroscopy; nerve block

Summary:

      The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve
      blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving
      long term outcome scores after knee arthroscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned knee arthroscopy with soft tissue intervention

          -  age 18+

          -  English speaking

        Exclusion Criteria:

          -  contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy

          -  knee arthroscopy with planned bony intervention
Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Tolterodine ER; Placebo
Intervention description: One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.; A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Double-blind; Placebo-controlled; frequency; urgency; web-based; incontinence; methodology; ediary; safety; efficacy; tolerability ER; overactive bladder

Summary:

      To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in
      subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative
      web-based trial design
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and 21 years or older

          -  Overactive bladder symptoms (subject-reported) for at least 3 months

          -  Be resident in the United States of America and have access and be able to use a
             computer with internet access throughout the duration of the study

        Exclusion Criteria:

          -  Clinically significant hepatic, renal or neurological condition such as stroke (with
             residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.

          -  History of cystitis, continence, urogenitalcancer or radiation

          -  Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are
             intending to become pregnant within 28 days after the completion of the trial.
A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro Premix; Insulin Glargine; Insulin Lispro
Intervention description: Participant dependent dose, administered subcutaneously for 24 weeks; Participant dependent dose, administered subcutaneously for 24 weeks; Participant dependent dose, administered subcutaneously for 24 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin, Isophane; Biphasic Insulins; Isophane insulin, insulin lispro drug combination 50:50
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Metabolic Diseases; Diabetes Mellitus, Type 2; Glargine; Diabetes Mellitus; Insulin LISPRO; Insulin

Summary:

      The purpose of the study is to compare the effects on overall glycaemic control of two
      insulin intensification therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with type 2 diabetes mellitus

          -  Have been receiving twice-daily premixed insulin therapy with or without metformin
             and/or alpha-glucosidase inhibitors, for at least six months prior to study entry

          -  Have Haemoglobin A1c (HbA1c) >7.0% and <12.0%

        Exclusion Criteria:

          -  Within the last 3 months prior to entry into the study, are taking any non-permitted
             glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic
             medications

          -  Are pregnant or intend to become pregnant during the course of the study, or are
             sexually active women of childbearing potential not actively practicing birth control
             by a method determined by the investigator to be medically acceptable.

          -  Are women who are breastfeeding.

          -  Have an irregular sleep/wake cycle (for example, participants who sleep during the day
             and work during the night).

          -  Do not regularly consume three meals per day.

          -  Have a body mass index >35 kilogram per square meter (kg/m^2).

          -  Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry
             into the study.

          -  Have cardiac disease with a functional status that is Class III or IV

          -  Have a history of renal or liver disease

          -  Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90
             days for more than 14 days (accumulated).
Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: glucose monitoring before and after HepaGam B administration; HepaGam B (Hepatitis B Immune Globulin (HBIG))
Intervention description: Glucose monitoring before and after HepaGam B administration. Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.; Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis B immune globulin; HBIG; HepaGam B; orthotopic liver transplant

Summary:

      HepaGam B Hepatitis B Immune Globulin (HBIG) solution contains 10% maltose, which could
      possibly interfere with the measurement of glucose levels when using glucose non-specific
      tests. The purpose of this study is to determine whether use of HepaGam B HBIG shows an
      increase in glucose levels in the body using non-specific glucose monitoring, as well as
      specific glucose monitoring. The sponsor believes that this medication will not cause a
      significant increase in glucose levels in the body when measured by glucose non-specific
      tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  written informed consent

          -  HBsAG positive candidates for HBV related liver transplant to be placed on HepaGam B
             therapy for the prevention of HBV recurrence in both the acute phase (immediately post
             operative) and the long term maintenance phase

          -  at least 18 years of age

        Exclusion Criteria:

          -  unable or unwilling to provide written informed consent

          -  concomitant administration of other maltose containing products such as dietary
             supplements, dietary aids, IVIG, external peritoneal dialysis solution in both arms

          -  concomitant administration of corticosteroids in the long term maintenance phase

          -  pregnancy, as determined by a pregnancy test administered after consent has been
             signed
Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy
Condition: Hunter Syndrome; Mucopolysaccharidosis II; MPS II
MeSH terms: Mucopolysaccharidosis II; Mucopolysaccharidoses; Syndrome
Intervention: Idursulfase
Intervention description: Solution for intravenous infusion, 0.5 mg/kg weekly
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Hunter syndrome; hunters syndrome; hunter's syndrome; hunter disease; hunters disease; hunter's disease; MPS II; MPSII; MPS2; MPS 2; mucopolysaccharides; lysosomal storage disease; lysosomal storage disorder; chronic ear infection; enlarged adenoids; mps symptoms; mps diagnosis; mps ii therapy; MPS II treatment; ert treatment; elaprase; idursulfase; iduronate sulfatase; iduronate 2 sulfatase; enzyme replacement therapy; hunter syndrome treatment; hunter's syndrome treatment; hunter syndrome therapy; hunter's disease treatment; mps society

Summary:

      The objective of this study is to determine the safety of once weekly dosing of idursulfase
      0.5 mg/kg administered by intravenous (IV) infusion for male Hunter syndrome patients ≤ 5
      years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a diagnosis of Hunter syndrome based upon biochemical criteria either
             documented in their medical history or established at Screening:

               1. A deficiency in iduronate-2-sulfatase (I2S) enzyme activity of ≤ 10 % of the
                  lower limit of the normal range as measured in plasma, fibroblasts, or leukocytes
                  (based on normal range of measuring laboratory)

                  AND

               2. A normal enzyme activity level of one other sulfatase as measured in plasma,
                  fibroblasts, or leukocytes (based on normal range of measuring laboratory).

          -  The patient is 5 years of age and under.

          -  The patient is male.

          -  The patient's parent(s), or patient's legal guardian must have voluntarily signed an
             Institutional Review Board approved informed consent form after all relevant aspects
             of the study have been explained and discussed with the patient's parent(s), or the
             patient's legal guardian.

        Exclusion Criteria:

          -  The patient has received treatment with another investigational therapy within 30 days
             prior to enrollment.

          -  The patient has clinically relevant medical condition(s) making implementation of the
             protocol difficult.

          -  The patient has previously received idursulfase.

          -  The patient has known hypersensitivity to any of the components of idursulfase.

          -  The patient has had a tracheostomy.
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Halobetasol Topical Foam
Intervention description: Foam
Intervention MeSH terms: Halobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects
      aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the
      potential to suppress the adrenal glands and the degree to which the drug is absorbed into
      the bloodstream.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject is male or non-pregnant female and is 12 to less than 18 years of age

          -  Subject has provided written informed assent and was accompanied by the parent or
             legal guardian at the time of assent/consent signing

          -  Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10%
             Body Surface Area (BSA)

          -  Subject has an Investigator's Global Assessment (IGA) score of at least three (3 =
             moderate) at the Baseline Visit

        Key Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis

          -  Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to
             an unacceptable risk by study participation

          -  Subject has had prolonged exposure to natural or artificial sources of ultraviolet
             radiation

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study

          -  Subject is currently enrolled in an investigational drug or device study
Immunologic Response to FluMist vs. Flucelvax
Condition: Influenza, Human; Immune Response
MeSH terms: Influenza, Human
Intervention: FluMist live attenuated influenza vaccine; Flucelvax inactivated influenza vaccine
Intervention description: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.; Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 465.0
Sex: All
Minimum age: 4 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate immunologic response to different types of influenza
      vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized
      controlled trial (RCT), that will assess immune response in about 440 participants (about 220
      per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine
      given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza
      vaccine).
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 4-21 years;

          -  has prior vaccination history available (which can be determined based either on
             medical record review or through state registry review);

          -  plans to receive the current seasonal influenza vaccination at one of the recruiting
             sites

        Exclusion Criteria:

          -  unable or unwilling to completed required study activities, including informed
             consent, randomization to vaccine, and bloodwork;

          -  has already received influenza vaccine for the current season;

          -  has a known immunocompromising condition or is on an immunosuppressing medication
             (e.g., high dose steroids >10 days);

          -  is known to be pregnant;

          -  has a history of severe allergy to eggs or to influenza vaccine or any of its
             components
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone plus Adapalene; Clindamycin/benzoyl peroxide plus Adapalene
Intervention description: Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.; Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dapsone; Adapalene; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 286.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      A study comparing the topical application of Aczone® plus Differin® versus Duac® plus
      Differin® in patients with severe facial acne (facial acne vulgaris).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe facial acne (acne vulgaris)

        Exclusion Criteria:

          -  History of significant anemia or hemolysis

          -  History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous
             colitis, antibiotic-associated colitis)

          -  History of lupus, rosacea, or seborrheic dermatitis
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Condition: Diaper Rash
MeSH terms: Diaper Rash
Intervention: 0.25 % Miconazole Nitrate Ointment
Intervention description: Topical Application
Intervention MeSH terms: Miconazole; Clotrimazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Maximum age: 15 Months
Healthy volunteers: No
Keywords: Diaper dermatitis complicated by candidiasis

Summary:

      The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate
      ointment in newborns and infants with a yeast infection in the diaper area causes the yeast
      to become resistant to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female neonate or infant up to 1 year of age with Fitzpatrick Skin Type I-VI

          -  Clinical evidence of diaper dermatitis and a positive KOH result for pseudohyphae
             and/or budding yeast at baseline visit

          -  Overall Diaper Dermatitis Severity Index score at baseline visit of 4-8 (must include
             an overall clinical grade of at least 2 for erythema)

          -  Wear commercially available diapers day and night for at least 7 days prior to
             enrollment and during the course of the 2 year study

          -  Caretaker must complete informed consent process

        Exclusion Criteria:

          -  Known sensitivity to any component of the formulation

          -  No other skin conditions that may confound the evaluation of the drug efficacy or
             tolerability

          -  Known sensitivity to skin care toiletry products or diapers

          -  History of HIV positive

          -  Chronic illnesses that require systemic medication that may confound the evaluation of
             study drug efficacy or tolerability (antibiotic therapy is not included)

          -  Treatment with a prescription product for diaper dermatitis or other skin condition 7
             days prior to enrollment
Recovery and Analgesia After Surgery for Gynecological Cancer
Condition: Gynecological Cancer
Intervention: Epidural; Intrathecal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare epidural analgesia and intrathecal analgesia for
      explorative laparotomy through a middle-line incision for gynecological cancer in a fast
      track program to se if there is any difference in recovery. Length of stay is analyzed
      together with self-rate quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with gynecological cancer (suspected or verified) planned for explorative
             laparotomy through a middle-line incision with a curative purpose.

          -  WHO performance status < 2.

          -  American Society of Anesthesiologists class 1-2.

          -  Women that understand and can express themselves in Swedish.

          -  Women that after verbal and written information accept participation in the study and
             have signed an informed consent.

        Exclusion Criteria:

          -  Women where surgery is expected to include part/s, other than the abdominal surgery,
             where intrathecal or epidural analgesia is not expected to be effective

          -  Women with contra indications for intrathecal or epidural anesthesia.

          -  Women who are physically disabled and therefore nor expected to be mobilized on the
             day after surgery in the same way as non-disabled.

          -  Women with a mental retardation that makes it impossible to fill in the relevant
             questionnaires or makes it impossible to understand the meaning of participation, or
             if it is ethically doubtful to include the woman.

          -  Women with psychiatric or mental disorder that according to the responsible physician
             makes it unsuitable to participate in the study .