bioihbjkbjnl/mcl2 huggingface dataset:
CeraVe Diabetes Mellitus
Condition: Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications
Intervention: CeraVe Hydrating Cleanser; CeraVe Moisturizing Cream
Intervention description: topical cleanser applied twice a day for 28 days; topical cream applied twice a day for 28 days
Intervention MeSH terms: Dimenhydrinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: cutaneous complication of DM

Summary:

      The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin
      Line for the improvement of skin condition in patients with diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women between the ages of 18 and 75 years of age.

          2. Willing to provide written informed consent.

          3. A diagnosis of diabetes mellitus (DM).

          4. DM-related skin changes classified into one or more of the following four categories:
             i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of
             DM complications; iv) skin reaction to DM treatment.

        Exclusion Criteria:

          1. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in
             CeraVe Hydrating Cleanser or Moisturizing Cream

          2. History of allergic contact dermatitis secondary to cleansers or moisturizers.

          3. Has a heightened immune response to common allergens, especially inhaled, topical or
             food allergens (atopy).

          4. Has any clinical manifestation in the treatment are(s) or other disorders that, in the
             investigator's opinion, may affect assessments or the study products.

          5. Inability to attend all study visits and follow treatment regimen.
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept; Placebo
Intervention description: Etanercept 50 mg QW initiated during taper of ciclosporin; Randomized to placebo during taper of ciclosporin
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      The purpose of this study is to evaluate the use of etanercept as a replacement therapy for
      ciclosporin in patients with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between age 18 and 70 years

          -  Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.

        Exclusion Criteria:

          -  Evidence of skin conditions other than psoriasis

          -  Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept,
             anakinra, or any other systemic anti-psoriasis therapy or disease-modifying
             antirheumatic drugs (DMARD) with 28 days of screening

          -  ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog
             preparations, or anthralin

          -  Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab

          -  Corticosteroid dose of prednisone >10 mg/day

          -  Serious infection

          -  Receipt of any live vaccine

          -  Abnormal hematology or chemistry

          -  Body mass index (BMI) > 38

          -  Pregnancy or Breastfeeding

          -  Significant concurrent medical conditions
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Individualized management of AD including caregiver training; Memantine
Intervention description: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.; Patients receive 10 milligrams of memantine twice daily.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; caregiver training; caregiver counseling; individualized management; memantine; dementia

Summary:

      The purpose of this study is to determine whether a comprehensive, individualized management
      approach with caregiver training and medication with memantine will alleviate symptoms in
      community dwelling patients with moderate to severe Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, 50 years of age or greater, residing in the community

          -  Presence of a family and/or professional caregiver willing and able to participate in
             all aspects of this study

          -  A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of
             Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al.,
             Neurology,1984;34: 939-944) criteria

          -  A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA
             diagnostic criteria for Alzheimer's disease

          -  Mini-Mental State Examination scores of 3-14

          -  Global Deterioration Scale stages of 5 or 6

          -  A stage of 6a or greater on the Functional Assessment Staging instrument signifying
             the presence of dementia deficits in the ability to perform one or more basic
             activities of daily living

        Exclusion Criteria:

          -  Non-English speaking patients and/or caregivers

          -  Subjects with a diagnosis of dementia due to conditions other than Alzheimer's
             disease.

          -  Subjects with a diagnosis of vascular dementia or a score greater than 4 on the
             modified Hachinski Ischemic Rating scale

          -  Patients with a major depressive disorder

          -  Patients with clinically significant laboratory abnormalities

          -  Patients receiving investigational pharmacologic agents
A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation
Condition: Anesthesia
Intervention: Dexmedetomidine and Midazolam; Propofol, Midazolam, and Fentanyl
Intervention description: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.; Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral Surgery; Third Molars; Intravenous Sedation; Dexmedetomidine

Summary:

      Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar
      surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and
      3) no significant hemodynamic or respiratory changes when compared to a sedation combination
      of midazolam, fentanyl and propofol for sedation during third molar surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have 3-4 partial or full bony impacted third molars requiring surgical
             extraction

          -  ASA Class I or II

          -  English-speaking and Spanish-speaking subjects

        Exclusion Criteria:

          -  ASA Class III or higher

          -  Patients taking alpha-2 agonists or benzodiazepines

          -  Allergy or drug reaction to any of the drugs used in this study (benzodiazepines,
             opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)

          -  BMI greater than 30

          -  History of or current substance abuse or alcoholism

          -  History of mood-altering medications, tranquilizers, or antidepressants.

          -  Pregnant females
Patiromer With or Without Food for the Treatment of Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: patiromer
Intervention description: 8.4 g/day starting dose, administered orally
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of Hyperkalemia; Hyperkalemia; Potassium; Chronic Kidney Disease

Summary:

      The purpose of this study is to evaluate the efficacy and safety of patiromer administered
      once daily (QD) when given with food compared to without food (experimental treatment group)
      for the treatment of hyperkalemia (high potassium in the blood).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Potassium concentration > 5.0 mEq/L from two blood draws at Screening

          -  Stable RAASi medication, if taking

          -  Medications taken on a chronic basis are given once daily or twice daily

          -  Informed consent given

        Key Exclusion Criteria:

          -  Expected need for dialysis

          -  Major organ transplant

          -  History of conditions associated with pseudohyperkalemia

          -  History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or
             severe gastrointestinal disorders or major gastrointestinal surgery

          -  Cancer or unstable medical condition
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
Condition: Acute Pain; Pain
MeSH terms: Emergencies; Acute Pain
Intervention: Ketamine; Normal Saline; opiate analgesic
Intervention description: 0.1mg/kg ketamine IV; 1ml/kg normal saline placebo; 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request
Intervention MeSH terms: Ketamine; Analgesics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study investigates the use of low doses of ketamine, along with opiate pain medication,
      is more effective at controlling the acute pain of patients in the emergency department than
      opiate pain medication alone. In addition, this study examines whether patients treated with
      low doses of ketamine, along with opiate pain medication, will require less opiate pain
      medication to control their pain, and whether these patients are equally happy with their
      pain control as patients who receive only opiate pain medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 18 years but less than 70 years old.

          -  Exhibiting pain defined on a numerical rating scale (NRS-11 [Farrar et al. 2001])
             score of equal to or greater than 6 out of 10

          -  Deemed by the treating EM physician to require opioid analgesia.

        Exclusion Criteria:

          -  Respiratory, hemodynamic or neurologic compromise, as determined by observation of
             signs of respiratory distress, systolic blood pressure less than 90 mmHg or
             systolic/diastolic blood pressure greater than 160/90, or a Glasgow -Coma Score less
             than 15.

          -  A history of chronic ventilation, dialysis or with previously diagnosed cirrhosis or
             hepatitis by istory.

          -  Active psychosis.

          -  Clinical intoxication.

          -  Known sensitivity to any study drug.

          -  An inability to understand the NRS-11 pain measurement scale.

          -  Presentation with headache or chest pain.

          -  Pregnancy.

          -  A lack of decision-making capacity.

          -  A pain score less than 6 on the NRS-11 scale.

          -  A concern by the treating physician or study personnel of current or prior history of
             narcotic abuse, or other secondary gain.

          -  Previously participated in the study.
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
Condition: Blood Loss; Tranexamic Acid; Cardiac Surgery
MeSH terms: Hemorrhage
Intervention: 2 gr tranexamic acid; Saline
Intervention description: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).; This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 750.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: blood loss; tranexamix acid; cardiac surgery

Summary:

      It remains still unclear whether topical tranexamic acid has an added value besides the
      administration of intravenously tranexamic acid. We hypothesize that the addition of topical
      tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25%
      reduction of post-operative blood loss after cardiac surgery.

      The aim of this study is to determine whether the application of topical tranexamic acid
      reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery
      on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.

      Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic
      acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial
      lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group)
      receives no pericardial lavage. The main study parameter is 12 hours post-operative blood
      loss and is assessed by 12 hours post-operative chest tube production.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gender; male/ female

          -  Age: ≥ 18 year

          -  Elective cardiac surgical patients

               -  Coronary artery bypass graft (CABG) (conventional, E.CCO)

               -  Aortic valve replacement (AVR) (conventional)

               -  Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional)

               -  Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL)

               -  Bentall

               -  Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)

        Exclusion Criteria:

          -  MVR/MPL (minimal invasive, Port Access Surgery)

          -  Maze (minimal invasive, via Thoracoscopy)

          -  AVR (minimal invasive, via mini Sternotomy)

          -  off-pump procedures

          -  Emergency operations

          -  Patient with increased or decreased blooding tendency (FV leiden, prot C, S
             deficiency, anti-thrombin deficiency, prothrombin mutation)
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: methotrexate (MTX); adalimumab (ADA)
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis

Summary:

      An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country
      study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up
      to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between
      participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX
      alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week
      32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment
      regimens using adalimumab and/or MTX, with participant allocation based on the initial
      randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
    

Eligibility criteria:

        Inclusion Criteria:

          1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit
             and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria

          2. Not in MDA at the time of screening

          3. Has 3 or more tender and 3 or more swollen joints

          4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

        Exclusion Criteria:

          1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or
             its excipients

          2. History of methotrexate intolerance/toxicity

          3. Medical conditions(s) precluding methotrexate dose increase above 15 mg

          4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of
             action biologic DMARD (bDMARD) or any systemic biologic agent in general
Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Intervention: Insulin LISPRO; Insulin, Long-Acting and Insulin
Intervention description: Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history.; Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Isophane insulin, insulin lispro drug combination 50:50; Insulin, Long-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: gestational diabetes mellitus; insulin analogues in pregnancy

Summary:

      Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections
      daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in
      terms of glucose control for women with Gestational Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant and at least 13 weeks gestation

          -  Diagnosed with gestational diabetes mellitus

          -  Failed diet therapy

        Exclusion Criteria:

          -  <18 years old or over 45 years old

          -  urine dipstick >2+ protein

          -  blood pressure >140/80 mmHg

          -  hematocrit <30%

          -  refusal to take insulin

          -  inability to understand instructions or to consent to participate.
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
Condition: Liver Transplantation
Intervention: Mycophenolate mofetil, adjusted dose; Tacrolimus; Corticosteroids, IV; Mycophenolate mofetil, Standard dose; Corticosteroids, PO
Intervention description: 3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.; Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; 10-15 mg/kg IV pre-operation on Day 0; 2 g/d PO BID during meals from Day 0 to Month 12; 20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
Intervention MeSH terms: Mycophenolic Acid; Methylprednisolone Hemisuccinate; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment
      regimens in de novo liver transplant patients. Patients will be randomized into one of two
      groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to
      exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed
      dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day
      0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  recipient of a first orthotopic liver transplant.

        Exclusion Criteria:

          -  history of organ transplants;

          -  patient receiving a multi-organ transplant;

          -  calculated creatinine clearance <=30mL/min before transplant;

          -  leukocyte count < 2000/mm3 at randomization;

          -  history of cancer within past 5 years, except for successfully treated basal cell or
             squamous cell cancer, or in situ cervical cancer;

          -  pregnant or breast-feeding females, or females of childbearing age not using effective
             contraception.