bioihbjkbjnl/mcl2 huggingface dataset:
Promiseb Topical Cream for Cradle Cap
Condition: Cradle Cap; Infantile Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: Promiseb Topical Cream; Bland emollient
Intervention description: topical non steroidal cream, twice daily; Eucerin cream twice daily
Intervention MeSH terms: Emollients
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 30 Days
Healthy volunteers: No
Keywords: Cradle Cap; Infantile seborrheic Dermatitis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in
      cradle cap.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of cradle cap

          -  Must be at least 30 days old

          -  Must be in good health as determined by investigator

          -  Naive to prior cradle cap therapy (may have used mineral, olive oils)

        Exclusion Criteria:

          -  Known food, topical product or medicinal allergies.

          -  Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap

          -  Weighing less than 7 lbs
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: moroctocog alfa (AF-CC) (ReFacto AF); Laboratory tests
Intervention description: Providing moroctocog alfa (AF-CC) as test article for use during this study.; Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Hemophilia A

Summary:

      The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and
      other Factor VIII products.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients greater than or equal to 12 years of age with severe hemophilia A
             (FVIII:C less than 1%).

          -  Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII
             replacement products.

          -  Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII
             replacement products.

          -  Serum albumin greater than or equal to the lower limit of normal (LLN).

          -  Platelet count greater than or equal to 100,000/µL.

          -  Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized
             ratio (INR) less than or equal to 1.5.

          -  HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load
             less than 200 particles/µL.

        Exclusion Criteria:

          -  Presence of any bleeding disorder in addition to hemophilia A.

          -  A positive FVIII inhibitor, according to the local laboratory, at screening; or any
             Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the
             testing laboratory.

          -  Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI])
             during the screening period.

          -  Prior exposure to moroctocog alfa (AF-CC).

          -  Known hypersensitivity to hamster protein.
Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock
Condition: Sepsis; Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: drotrecogin alfa (activated)
Intervention MeSH terms: Drotrecogin alfa activated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will evaluate the vasopressor requirement, hemodynamic response and measures of
      tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa
      (activated) compared to patients not receiving drotrecogin alfa (activated).
    

Eligibility criteria:

        Inclusion:

          -  18 years of age or older with a diagnosis of septic shock

          -  presence of a pulmonary artery catheter (or central venous catheters)

          -  requiring vasopressor support despite adequate fluid resuscitation

          -  an intravenous steroid administered for septic shock, except for those patients who
             were tested and are responders to a corticotropin stimulation test, or patients who do
             not receive a steroid due to the clinical judgment of the treating physician, based on
             an alternate assessment (e.g. normal baseline cortisol).

        Exclusion:

          -  Onset of first-sepsis induced organ dysfunction is greater than 24 hours from the time
             of informed consent

          -  Baseline measurements of pulmonary artery occlusive pressure (PAOP) < 12 mmHg or a
             central venous pressure (CVP) < 8 mmHg

          -  Patient requires continuous oxygen therapy by face-mask

          -  The presence of an advanced directive to withhold life-sustaining treatment, with the
             exception of a directive to withhold chest compressions only

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry

          -  Weight > 200 kg

          -  Are moribund (not expected to survive 24 hours)

          -  Are pregnant or are lactating and the milk is to be ingested by the infant (pregnancy
             status must be verified by urine or serum testing)

          -  Have not completed written informed consent signed by the patient or the patient's
             legal representative.
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Resorption
Intervention: Teriparatide 40-mcg subcutaneous injection; Denosumab Injection; Alendronate Oral Tablet
Intervention description: One-time Denosumab injection; weekly alendronate for 8 weeks
Intervention MeSH terms: Denosumab; Alendronate; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: osteoporosis; postmenopausal; denosumab; teriparatide; alendronate; Forteo®; Prolia®

Summary:

      The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis
      medications when combined with teriparatide.
    

Eligibility criteria:

        Inclusion Criteria:

        Must satisfy A and B and C below:

        A. Women aged 45+

        B. Postmenopausal

        C. Osteoporotic with high risk of fracture

        Exclusion Criteria:

          -  History of significant hepatic, renal, cardiovascular, malignant disease, or
             conditions with impaired immune system

          -  Current alcohol or substance abuse

          -  Major psychiatric disorders

          -  Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia

          -  Known congenital or acquired bone disease other than osteoporosis

          -  Current use or past use in the past 12 months of oral bisphosphonates

          -  Current use or use in the past 3 months of estrogens, selective estrogen receptor
             modulators, or calcitonin

          -  Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months

          -  Any current or previous use of strontium or intravenous bisphosphonates

          -  Sensitivity to cell-derived drug products or teriparatide

          -  Extensive dental work involving dental extraction or dental implant within the past 2
             months or in the upcoming 2 months

          -  Inability to sit upright for 30 minutes

          -  Esophageal abnormalities
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Condition: Metabolic Syndrome; Bipolar Depression; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome; Bipolar Disorder
Intervention: Pioglitazone
Intervention description: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of
      bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who
      experience a partial or full response will have the option of continuing in an acute
      continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the
      safety and tolerability of pioglitazone during the acute continuation period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be male or female between the ages of 18 and 70

          -  Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of bipolar
             disorder (type I, II, or NOS)

          -  Currently depressed as confirmed by the MINI-Plus at the screening visit

          -  Currently receiving treatment with an anti-manic drug

          -  Meets criteria for metabolic syndrome or insulin resistance

        Exclusion Criteria:

          -  Pregnancy or breast feeding

          -  Unstable or inadequately treated medical illness as judged by the investigator

          -  Severe personality disorder

          -  Serious suicidal risk

          -  Known history of intolerance or hypersensitivity to pioglitazone

          -  Treatment with pioglitazone in the 3 months prior to randomization

          -  Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study
             entry

          -  Currently taking an antidiabetic/glucose-lowering agent.

          -  Diagnosed with dementia

          -  Acute Mania as defined by a Young Mania Rating Scale (YMRS) score > 15

          -  Diagnosed with heart failure

          -  Transaminase elevation >2.5 times the upper limit of normal

          -  Presence of renal impairment (eg. creatinine > 1.5)

          -  Fasting blood glucose >150 mg/dL

          -  Hb A1c > 7.5%
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: teriparatide
Intervention description: Subcutaneous, 20 microgram (mcg)/day, 18 months
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of teriparatide on skeleton images in
      postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that
      stimulates the production of new bone in the skeleton. This process of bone formation can be
      studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This
      trial will test whether bone scans will identify areas of the skeleton that are forming new
      bone during teriparatide therapy. It also will study what these areas look like after therapy
      is stopped.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory with osteoporosis

          -  Hip or spine bone mineral density (BMD) measurement more than 2.5 standard deviations
             below the average bone mass of young healthy women or more than 2.0 standard
             deviations in women who have a history of a vertebral or nonvertebral fragility
             fracture.

        Exclusion Criteria:

          -  Diseases of bone other than osteoporosis

          -  Treatment with estrogens in the 3 months prior to enrollment or for more than 2 months
             in the past year

          -  Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more
             than 2 months in the past year; treatment with intravenous bisphosphonates in the 12
             months prior to enrollment

          -  Increased risk for the development of osteosarcoma
First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Topiramate add-on therapy; Topiramate monotherapy
Intervention description: Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.; Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; Topiramate; Neuro-surgical patients; Nervous disorder; Seizures

Summary:

      The purpose of this study is to examine seizure control and tolerability of Topiramate after
      either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be diagnosed with seizure disorder

          -  Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable
             dose prior to trial entry

          -  Must be dissatisfied with the current treatment

        Exclusion Criteria:

          -  Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active
             infection, or neoplasm)

          -  Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with
             progression

          -  Have seizures occurring only in clustered patterns defined as numerous seizures
             occurring in less than 30 min

          -  Have had history (within past six months) of a psychiatric or mood disorder requiring
             electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors

          -  Have had schizophrenic or history of exhibiting psychotic symptomatology

          -  Inability to take medication or maintain a seizure calendar, independently or with
             assistance
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Intervention description: the effects of the drug on the colon preparation for colonoscopy
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Miralax with gatorade and dulcolax; Movi pre; Patient satisfaction and efficacy

Summary:

      This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade
      versus Movi Prep for outpatient colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  outpatient colonoscopy for screening for other Gi related problems

        Exclusion Criteria:

          -  Severe Congestive Heart Failure (CHF),

          -  Chronic Kidney Disease (CKD),

          -  less than age 18 or more than 80 years
Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
Condition: Laparoscopic Sleeve Gastrectomy; Subcostal Transversus Abdominis Plane Block
Intervention: Saline; Bupivacaine
Intervention description: 40 mL sterile normal saline; 40 mL 0.25% bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Group allocation and instructions on preparing the injectate solution for the subcostal TAP block will be included in a sealed envelope. On the day of the surgery, the group allocation will be revealed to an anesthesiologist not involved with the research study. The anesthesiologist not involved in the study or the care of the patient will prepare the solution to be used for the subcostal TAP block.
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Randomized control trial; Subcostal transversus abdominis plane block; Laparoscopic sleeve gastrectomy; Regional anesthesia; Opioid consumption; Bariatrics

Summary:

      The study team will be assessing if the unilateral subcostal transversus abdominis plane
      (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy
      surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18-80 years old

          -  Candidate for general anesthesia

          -  Undergoing laparoscopic sleeve gastrectomy

          -  Patients of participating surgeons

        Exclusion Criteria:

          -  Prior bariatric surgery of any kind

          -  Previous abdominoplasty

          -  Allergy or intolerance to one of the study medications

          -  ASA > 4

          -  Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine
             equivalent of >5mg/day for one month)

          -  History of alcohol/drug abuse

          -  History of hepatic or renal insufficiency

          -  Patient refusal
BPO vs Hibiclens Soap for Surgical Preparation
Condition: Propionibacterium Acnes
Intervention: Benzoyl Peroxide 10% Bar; Chlorhexidine Gluconate
Intervention description: Patients will wash with Benzoyl Peroxide 10% Bar; Patients will wash with Chlorhexidine Gluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical
      preparation. The objective is to determine whether benzoyl peroxide soap, commonly available
      in drug stores for over-the-counter acne treatment, is as or more effective than the standard
      surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of
      Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty
      (joint replacement).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects

          -  Subjects scheduled for elective shoulder arthroplasty at the University of Washington
             Medical Center

          -  Subjects between ages 18-89

        Exclusion Criteria:

          -  Subjects who self-report very sensitive skin

          -  Subjects who are sensitive to benzoyl peroxide

          -  Subjects who are allergic to chlorhexidine

          -  Subjects who had recent prior use of antibiotics (or expect to use them prior to
             surgery)

          -  Subjects who had recent use of acne treatment

          -  Subjects who are not fluent in English.
Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale
Condition: Nerve Block
Intervention: levobupivacaïne 0,5 %; ropivacaïne 0,5 %
Intervention description: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %; 20mL de ropivacaïne 0,5 %
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major
      surgery of the foot. The literature does not highlight a significant difference in terms of
      onset of action between these two molecules to block the sciatic nerve [4]. Our hypothesis is
      that this lack of difference is due to the use of a neurostimulator for locating the
      injection site (indiscriminate nature of the anatomical approach to the sciatic nerve).
      Indeed, the sensitivity of neurostimulation is low compared with ultrasound [58] and
      ultrasound, for accurate visualization of the deposit of the local anesthetic around the
      nerve to improve the quality of the block and reduce the onset of action of local anesthetic
      [46, 47].

      The investigators propose to make a comparative trial between levobupivacaïne 0.5%
      ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block.
      The use of ultrasound will reduce the variability of results because the changes would be
      linked exclusively to the local anesthetic. The investigators test the hypothesis that
      levobupivacaïne gives better results in terms of onset of action than ropivacaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with unilateral major surgery of the foot: hallux valgus (not ambulatory),
             claw toes, fusion-Astragalo calcaneum, complex syntheses of tarsus-aged over 18 years
             .

          -  Male and female

          -  ASA 1 or 2

          -  Insured Social

          -  Informed Consent

        Exclusion Criteria:

          -  Diabetes

          -  Intoxication-alcoholic chronic

          -  Allergy to local anesthetics

          -  Hemostasis disorders

          -  Hepatic failure

          -  Chronic pain syndrome