bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)
Condition: Diabetes Mellitus
Intervention: sitagliptin phosphate
Intervention description: Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 30 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      After 24 weeks of treatment evaluate the efficacy and security.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients Being Treated With Metformin

          -  Patients With Hba1c Between 6.5 % And 12.0%.

          -  Type 2 DM
Effect of Age on Latanoprost 0.005% in Patients With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Latanoprost 0.005%
Intervention description: Latanoprost 0.005% ophthalmic solution QHS 8 weeks
Intervention MeSH terms: Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Latanoprost; Glaucoma; Intraocular pressure

Summary:

      Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it
      is plausible that the age of a patient using the medication may affect its efficacy and time
      of onset.

      We are going to study the effectiveness of Latanoprost in people of different ages, to see if
      it changes based on the age of the patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of open angle glaucoma,

          -  pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both
             eyes;

          -  IOP above their target pressure as determined by a glaucoma specialist;

          -  willingness to participate in the study.

        Exclusion Criteria:

          -  hypersensitivity to any of the components of the treatment medication;

          -  previous use of topical prostaglandins;

          -  documented ocular infection or intraocular inflammation within the past year;

          -  previous filtering surgery or complicated cataract surgery;

          -  active corneal disease;

          -  presence of cystoid macular edema;

          -  laser trabeculoplasty or any other ocular laser procedure within the past three
             months.
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Condition: Immunosuppression
Intervention: Tacrolimus Extended Release Capsule; Mycophenolate mofetil; Prednisone; Mycophenolate Sodium
Intervention description: goal trough 5 - 12ng/mL; ≥500mg twice a day; goal dose 5mg daily; ≥360mg twice a day
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare the difference in dose-normalized trough and total daily dose necessary to reach the
      steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African
      American kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age

          2. Signed informed consent

          3. African American race

          4. History of a solitary renal transplant

          5. Stable tacrolimus dose for at least 2 weeks prior to randomization

        Exclusion Criteria:

          1. A condition or disorder that, in the opinion of the investigator, may adversely affect
             the outcome of the study or the safety of the subject

          2. Currently enrolled in an investigational drug trial

          3. History of a non-renal organ transplant

          4. History of acute cellular rejection within 1 month prior to randomization

          5. An increase in serum creatinine by > 20% in the 2 weeks prior to randomization

          6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice
             daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and
             prednisone ≥ 5mg daily
Study Using Pregnenolone to Treat Bipolar Depression
Condition: Bipolar Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Intervention: Pregnenolone; Placebo
Intervention description: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.; Inactive ingredient matching the active medication in appearance.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Primary purpose of this study is to determine if pregnenolone supplementation is associated
      with greater improvement in depressive symptoms of patients with bipolar disorder. Also the
      study will explore possibilities of improving anxiety and manic symptoms as well as the
      patient's cognition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women of all races age 18-75 years

          -  Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently
             meeting criteria for a major depressive episode

          -  English speaking

        Exclusion Criteria:

          -  Active suicidal ideation with plan and intent

          -  Treatment resistant depression

          -  Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)

          -  Severe or life threatening medical condition

          -  History of allergic reaction or side effects with prior pregnenolone use

          -  Current substance use disorder defined as meeting criteria for abuse or dependence
             based on the Structured Clinical Interview for the Diagnostic and Statistical Manual
             (DSM)(SCID) interview and self-reported use within the past 3 months or a positive
             baseline urine drug screen

          -  Removal or addition of concomitant psychiatric medications within 10 days prior to
             randomization

          -  Current Warfarin therapy

          -  Current use of oral contraceptives

          -  Current hormone replacement therapy

          -  History of heart disease or arrhythmias

          -  Current (past 7 days) systemic
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Evicel fibrin sealant
Intervention description: Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 20 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: osteoarthritis; total knee replacement

Summary:

      Application of "Evicel" hemostatic matrix during operation for unilateral total knee
      replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a
      reduction in transfusion requirements, and less reduction of hemoglobin.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of degenerative joint disease of the knee in patients medically suitable to
        undergo unilateral total knee arthroplasty

        Exclusion Criteria:

          -  Known allergies to human blood products.

          -  History of bleeding disorders.

          -  Patients with previous arthrotomy, however, with exception of medial or lateral
             menisectomy.

          -  Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)

          -  Additionally, any patient with an intra-operative complication (i.e bone fracture,
             vascular injury) or post-operative complication that would affect bleeding tendency
             will be excluded although data will be recorded for later analysis. Also, any patient
             who has a complication with the suction drain (eg inadvertently being pulled out,
             suction failing) will have the remaining data points recorded and drain measurements
             will be excluded from analysis.
Iota-Carrageenan Nasal Spray in Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Placebo; Iota-Carrageenan
Intervention description: Nasal spray saline; Nasal spray containing 1.20 g/l Iota-Carrageenan in saline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on
      cold symptoms. The effect of treatment on the duration of the cold and the patients viral
      load plus cytokine level indicating the inflammatory response will be analyzed.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients consider that they are in an early stage of common cold with symptoms of no
             more than 48 hours duration

          -  Symptom score of equal or more than 1 for for at least one of the symptoms sore
             throat, runny nose and blocked nose on a 0-3 verbal rating scale

          -  Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness,
             sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal
             rating scale

          -  Patients agree to refrain from taking any products intended to prevent, intervene in,
             or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g.
             those containing zinc, Echinacea); use of a daily multivitamin is allowed.

        Exclusion criteria:

          -  Known hypersensitivity or are allergic to any component of the test device

          -  Clinically significant cardiovascular, endocrinological, neurological, respiratory,
             gastrointestinal disease or history or any current disease that is considered by the
             investigator as a reason for exclusion e.g. current allergic rhinitis, chronic
             obstructive pulmonary disease

          -  Severe nasal septum deviation or other condition that could cause nasal obstruction
             such as the presence of nasal polyps.

          -  History of nasal or sinus surgery that in the opinion of the investigator may
             influence symptom scores

          -  Taking any prescribed medication other than for contraception, that is considered by
             the investigator as a reason for exclusion e.g. systemic steroids, intranasal
             medicines, antibiotics

          -  Common cold or flu like symptoms for more than 48 hours.

          -  Recent (within the previous 2 days) intake of a common cold medicine that in the
             opinion of the investigator may influence symptom scores (analgesics, nasal
             decongestants, cough medicines)

          -  Current smoker (more than 10 cigarettes a day)
The Effect of Brimonidine
Condition: Intraocular Pressure
Intervention: Brimonidine; Tropicamide; Phenylephrine Ophthalmic Product
Intervention description: 2 drops administered once in the left eye in both study arms; 1 drop administered at two different times points in both eyes in both study arms; 1 drop administered at two different time points in both eyes in both study arms
Intervention MeSH terms: Brimonidine Tartrate; Phenylephrine; Oxymetazoline; Tropicamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Brimonidine; Pupil Effects

Summary:

      This study will evaluate whether pre-treating patients with Brimonidine 0.2% before and/or
      after dilating the pupils will help to control the changes in intraocular pressure often seen
      when using dilating drops. The study will also evaluate the effects of different sequences of
      administering dilating drops along with Brimonidine on pupil size and reactivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy individuals

          -  Females of childbearing potential must agree to use a reliable method of birth control
             while participating in the study.

        Exclusion Criteria:

          -  Diabetic

          -  Have a history of glaucoma

          -  Have a history of iris trauma

          -  Have a history of eye surgery except for LASIK or PRK

          -  Pregnant

          -  Anisocoria (unequal pupils)
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
Condition: Carcinoma, Non-Small-Cell Lung; ErbB Receptors
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Afatinib
Intervention description: afatinib starting at 30 mg daily dose
Intervention MeSH terms: Afatinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end
      of trial. The end of trial is one year after the last patient has entered the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes
             cytologically proven pleural effusion or pericardial effusion) or recurrent disease.
             Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th
             edition (R12-4710)

          -  Evidence of common EGFR mutation (Del 19 and/or L858R)

          -  Age >= 70 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)

          -  Further inclusion criteria apply.

        Exclusion criteria:

          -  Prior participation in an afatinib clinical study, even if not assigned to afatinib
             treatment

          -  Prior systemic therapy for metastatic or recurrent NSCLC.

          -  Concurrent investigational therapy or investigational therapy within 4 weeks of start
             of afatinib therapy

          -  Radiotherapy within 4 weeks prior to start of study treatment, except as follows:

               -  Palliative radiation to target organs other than chest may be allowed up to 2
                  weeks prior to study treatment, or

               -  Single dose palliative treatment for symptomatic metastasis outside above
                  allowance to be discussed with sponsor prior to enrolling.

               -  Major surgery within 4 weeks before starting study treatment or scheduled for
                  surgery during the projected course of the study

               -  Systemic chemotherapy, biological therapy, immunotherapy or investigational
                  agents within 5 half-life of the drug or within four weeks prior to the start of
                  afatinib treatment (if the half-life of the drug is unknown).

          -  Men, capable of fathering a child, who are unwilling to use adequate contraception
             prior to study entry, for the duration of study participation, and for at least 28
             days after treatment has ended.

          -  Further exclusion criteria apply.
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
Condition: Drug Effect; Rib Fractures; Rib Trauma; Surgical Procedure, Unspecified; Pain; Catheter (Other); Nerve Pain; Local Infiltration; Anesthesia, Local; Intercostal Rib; Opioid Dependence; Chest Injury Trauma; Pneumonia
MeSH terms: Neuralgia; Opioid-Related Disorders; Fractures, Bone; Wounds and Injuries; Rib Fractures; Thoracic Injuries
Intervention: Liposomal bupivacaine injection; Bupivacaine indwelling catheter
Intervention description: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS; Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-inferiority, randomized, clinical trial
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Rib fractures represent a common injury pattern this is highly associated with patient
      morbidity and mortality, as pain control remains a challenge. Even after surgical
      stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes
      such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic
      epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but
      are subject to a wide array of limitations. A more directed therapy with liposomal
      bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have
      undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current
      clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via
      video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable
      analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and
      postoperative narcotic use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing SSRF at Denver Health Medical Center

        Exclusion Criteria:

          -  Allergy or hypersensitivity to bupivacaine

          -  Pregnancy

          -  Incarceration

          -  Age < 18 years

          -  Indwelling continuous thoracic epidural analgesia
Predictors of Response to Iron and Erythropoietin Stimulating Agents
Condition: Renal Failure Chronic; Anemia
MeSH terms: Kidney Failure, Chronic
Intervention: Iron Sucrose Solution for Injection; Epoetin Beta
Intervention description: 200mg iron sucrose given on 5 successive haemodialysis sessions; Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis

Summary:

      The purpose of the study is to identify predictors of treatment response. This involves
      collected baseline clinical parameters and bloods for biochemical parameters prior to
      administering the study treatment. A positive outcome following treatment was defined as an
      uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the
      participants response to treatment against the clinical and biochemical information collected
      prior to treatment being received.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All prevalent haemodialysis patients, established for greater than 3 months

        Exclusion Criteria:

        Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active
        infection Active malignancy Frail with either frequent hospital admissions or unable to
        follow trial protocol due to differing target haemoglobin
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Condition: Gastrointestinal Symptoms; Heart Transplantation
Intervention: Mycophenolate Sodium
Intervention description: 1440mg/day (720mg by mouth, twice a day)
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Transplant; gastrointestinal; Cellcept; Myfortic; GI; GI symptoms with Mycophenolate Mofetil post heart transplant

Summary:

      Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of
      mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of
      transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of
      Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of
      acute kidney rejection only. There is no clinical data of its use in heart transplant
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either sex aged 18 and above who have undergone successful orthotopic
             heart transplant surgery.

          2. Patients who are currently taking Cellcept® and experiencing gastrointestinal
             side-effects from this standard therapy.

          3. Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to
             participate.

          4. Patients who are able to give written informed consent.

        Exclusion Criteria:

          1. Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia
             (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia
             (hemoglobin < 6g/dl) at the time of potential enrollment.

          2. Women of childbearing potential not using the contraception method(s), as well as
             women who are breastfeeding.

          3. Known sensitivity to the study drug or class of the study drug.

          4. Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study.

          5. Use of any other investigational agent in the last 30 days.