bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Vildagliptin; Glimepiride; Metformin
Intervention description: Vildagliptin 50 mg twice daily; Glimepiride 1-6 mg once daily; Metformin (1000-1500 mg daily)
Intervention MeSH terms: Metformin; Glimepiride; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, Glycemic variability

Summary:

      Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on
      glucose variability in T2DM patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who have given written informed consent to participate in the study.

          2. Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age
             (both inclusive).

          3. Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks
             (1000-1500 mg daily and HbA1c > 7.5 - 9%).

          4. Patients with HbA1C levels within the range > 7.5% - 9%. (If a past value is available
             within the last 12 weeks, it would be considered acceptable provided it was obtained
             after at least 4 weeks of metformin therapy 1000-1500 mg daily).

        Exclusion Criteria:

          1. Age > 75 years ; BMI <22 or >40 kg/m2

          2. Patients who are on Insulin therapy at the time of study entry.

          3. Type 1 Diabetes Mellitus patients.

          4. Patients with severe renal (creatinine clearance < 50 ml/min) or hepatic impairment
             (including pre-treatment ALT or AST > 3 x ULN).

             Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault
             formula (Cockcroft and Gault, 1976)

          5. Patients with contraindications as mentioned in the Summary of Product Characteristics
             (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and
             glimiperide plus metformin.

        Other protocol defined inclusion/exclusion criteria may apply.
Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
Condition: Acute Bipolar Mania
MeSH terms: Mania
Intervention: Quetiapine fumarate (Seroquel XR)
Intervention description: Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute bipolar mania; Seroquel XR; Quetiapine fumarate; Add-on therapy

Summary:

      The primary objective of this study is to evaluate the broad clinical benefit of dosing
      Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial
      response to existing therapy. Clinical benefit will be assessed with the Clinical Global
      Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the
      principles outlined in the CGI efficacy index. Improvement in clinical benefit will be
      defined as a decrease from baseline in CGI-CB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition (DSM-IV) criteria (1. Bipolar I Disorder, manic or mixed type
             with/without psychotic feature, 2. Diagnosis should be confirmed by the Mini Inte)

          -  Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive
             treatment YMRS total score ≥16 at study entry

        Exclusion Criteria:

          -  Non-response to antipsychotic treatments for manic symptoms in previous episodes

          -  A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (1.
             Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%, 2. Admitted to
             hospital for treatment of DM or DM related illness in past 12 weeks, etc)

          -  An absolute neutrophil count (ANC) of 1.5 x 10^9 per liter
Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Intervention description: olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: hypertension; angiotensin II type 1 receptor blocker; olmesartan

Summary:

      In patients naive to treatment or after a 2-week washout period for patients whose treatment
      was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme:
      monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 1 and 2 hypertension without treatment for at least 2 weeks

          -  Women with no risk of becoming pregnant

        Exclusion Criteria:

          -  Study participation could result in risk to health of subject

          -  Cardiovascular disease

          -  Secondary hypertension or stage 3 hypertension

          -  Myocardial infarction within the last 6 months

          -  Congestive heart failure

          -  Pulmonary edema

          -  Valvular alterations or rheumatic cardiopathy

          -  Clinically relevant conduction disorders significant arrhythmias

          -  Alcohol or illicit drug use

          -  Medication abuse

          -  Pregnant or nursing women
Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
Condition: Venous Thromboembolism; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Thromboembolism; Venous Thromboembolism
Intervention: Aspirin
Intervention description: 81 mg aspirin daily
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study to determine the safety and efficacy of low dose aspirin for the
      prevention of venous thromboembolism among women with advanced ovarian cancer receiving
      neoadjuvant chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Khorana score = 1

          -  Over age 18

          -  English-speaking female patients

          -  Able to consent

          -  Receiving neoadjuvant chemotherapy Cancer of primary ovarian, fallopian tube,
             mullerian, or peritoneal origin

        Exclusion Criteria:

          -  Allergy or intolerance to study medication

          -  Indication for a non-aspirin form of antiplatelet (i.e. cardiac stent)

          -  Already on alternative form of anticoagulation

          -  Active bleeding

          -  High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal
             bleed, known brain metastases)

          -  Thrombocytopenia (platelets <50,000)

          -  Unable to complete medication adherence diary

          -  Unable to take oral medications
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Condition: Granulomatosis With Polyangiitis; Microscopic Polyangiitis
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Intervention: Glucocorticoids; Rituximab
Intervention description: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.
Prednisone will be tapered over 8 weeks as follows:
60mg for 2 weeks
40mg for 2 weeks
30mg for 1 week
20mg for 1 week
10mg for 1 week
5mg for 1 week; Rituximab will be administered in four weekly doses at 375mg/m2
Intervention MeSH terms: Prednisone; Rituximab; Glucocorticoids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,
      combined with rituximab, is effective in treating ANCA-associated vasculitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ages 18-85 years old

          -  Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus
             Conference

          -  New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's
             granulomatosis (BVAS/WG) of > 3

        Exclusion Criteria:

          -  Renal disease in patients with PR3-ANCA as defined by any of the following:

          -  Urinary red blood cell casts

          -  Biopsy-proven glomerulonephritis

          -  Increase in serum creatinine of >30% over baseline

          -  Severe renal disease in patients with MPO-ANCA as defined by both of the following:

          -  Urinary red blood cell casts or biopsy-proven glomerulonephritis

          -  Estimated glomerular filtration rate < 30 ml/min/1.73m2

          -  Diffuse alveolar hemorrhage requiring ventilatory support

          -  GC treatment for longer than 14 days prior to enrollment unless patient has been on a
             stable maintenance dose of prednisone at the time of the flare

          -  Daily oral cyclophosphamide within 1 month prior to enrollment

          -  Completed a remission induction course of cyclophosphamide or rituximab within 4
             months of enrollment

          -  Hepatitis B infection

          -  HIV infection

          -  History of anti-GBM disease

          -  Other uncontrolled disease, including drug and alcohol abuse, that may interfere with
             the study

          -  Pregnancy or breastfeeding

          -  History of severe allergic reactions to human or chimeric monoclonal antibodies
Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy; Tractional Retinal Detachment
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment
Intervention: Conbercept
Intervention description: Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Conbercept; Proliferative diabetic retinopathy; Silicone oil tamponade

Summary:

      To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment
      of severe proliferative diabetic retinopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of either sex aged ≥ 18 years.

          2. Diagnosis of diabetes mellitus (type 1 or type 2);

          3. Active proliferative diabetic retinopathy was clinically evident;

          4. Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage
             with significant fibrous proliferation, tractional retinal detachment in the posterior
             pole or complicated retinal detachment, which can be detected by B-scan
             ultrasonography.

          5. Ability to give informed consent.

        Exclusion Criteria:

          1. Coexistent ocular disease that may interfere with visual outcome;

          2. Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF)
             pharmacotherapy in either eye;

          3. A macula-involving retinal detachment for >6 months in the study eye;

          4. Iris or angle neovascularization and neovascular glaucoma;

          5. known allergy to any components of conbercept formulation

          6. severe external ocular infection;

          7. pregnancy or current oral contraceptive intake;

          8. usage of anticoagulant or antiplatelet therapy;

          9. preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c)
             >11.0%];

         10. uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting
             abnormal coagulation-associated blood diseases;

         11. <6 months of follow-up post initial surgery.
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Hydromorphone
Intervention description: Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 28 Days
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Postoperative pain; Hydromorphone oral solution; opioid; pharmacokinetics; pharmacodynamics

Summary:

      The primary objective of this study is to characterize the pharmacokinetics and
      pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16
      years inclusive. The secondary objectives are to characterize the safety and efficacy of
      hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric subjects aged 28 days to 16 years,

          -  Prospective subjects anticipated to have postoperative pain requiring oral opioid
             analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral
             analgesia (up to 48 hours),

          -  Prospective subjects have received no more than a total of 7 doses of opioids in the
             30 days prior to surgery.

        Exclusion Criteria:

          -  Prospective subjects with clinically significant hepatic or renal dysfunction and
             impaired cardiac and/or respiratory reserve,

          -  Prospective subjects who have received opioid analgesic therapy other than
             hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior
             to administration of first dose of oral hydromorphone,

          -  Prospective subjects who have received regional anesthetic blockade OR analgesic
             treatment with nonopioid medication within 6 hours prior to administration of first
             dose of oral hydromorphone.

        Other protocol-specific inclusion/exclusion criteria may apply.
Study of Trilipix Effects on Lipids and Arteries
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Trilipix; placebo
Intervention description: 135 mg po daily; one tablet po daily
Intervention MeSH terms: Fenofibric acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: high density lipoprotein; arterial compliance; brachial artery flow-mediated dilatation

Summary:

      Fibrates reduce atherosclerosis and cardiovascular disease events. A major mechanism of this
      benefit appears to be their ability to raise plasma high density lipoprotein cholesterol
      (HDL-C), especially in patients with high triglyceride levels. This study will investigate
      the effects of the addition of Trilipix (fenofibric acid) versus placebo to ongoing statin
      treatment on high density lipoprotein (HDL) composition and arterial function in subjects
      with insulin resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Triglyceride 150-500 mg/dL

          -  HDL-C < 45 mg/dL in men, < 55 in women

          -  LDL-C < 130 mg/dL

          -  stable statin dose x 8 weeks

        Exclusion Criteria:

          -  Prior use of a fibrate > 4 weeks ever (minimum 12 months off fibrate)

          -  Intolerance to medications to be used in study (fenofibric acid, albuterol,
             nitroglycerin)

          -  Niacin or thiazolidinedione within the prior 12 months, or anticipated need to add
             either during 6-month study period

          -  Diabetes Mellitus if either (1) diagnosed less than 3 months ago, (2) treated with
             insulin, or (3) with an A1c >8%

          -  Anticipated need to change treatment regimen of statin (or other lipid agent) or
             glycemic treatment during 6-month study period

          -  Uncontrolled hypertension (BP > 140/90 mm Hg), or changes in BP meds within prior 4
             weeks, or anticipated need to change BP meds during 6-month study period

          -  Documented cardiovascular disease event (heart attack, stroke, or hospitalization for
             unstable angina or revascularization procedure) in the past 6 months

          -  Use of warfarin (potential to interact adversely with fibrate therapy)

          -  Uncontrolled thyroid disease (TSH outside of normal range)

          -  Renal insufficiency (calculated Glomerular Filtration Rate <50 ml/min)

          -  Hepatic disease (ALT > 1.5x Upper Limit of Normal, diagnosis of hepatitis, cirrhosis)

          -  Active cholecystitis/cholelithiasis

          -  Active cancer (except basal cell or squamous cell skin cancer)

          -  Pregnancy, plan/desire to become pregnant, breast feeding

          -  Inability or unwillingness to provide informed consent
Riluzole in Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: Riluzole
Intervention description: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
Intervention MeSH terms: Riluzole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effectiveness and tolerability of riluzole in
      adults with Fragile X Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females age 18 years or older.

          -  Confirmed molecular diagnosis of Fragile X Syndrome.

          -  Clinical Global Impression Severity (CGI-S) score of 3 or greater.

          -  Significant interfering repetitive behavior as determined by the principal
             investigator.

          -  Must be in good health as determined by screening procedures including a detailed
             medical history, and complete physical and neurological examination.

          -  Dosing of concomitant medications during the study must remain stable.

        Exclusion Criteria:

          -  Pregnancy.

          -  Concomitant use of another glutamatergic agent (memantine, topiramate, amantadine,
             among others.

          -  Evidence of prior trial of riluzole and/or hypersensitivity/allergic reaction to
             riluzole.

          -  Abnormal baseline liver function tests at screen or by history; or complete blood
             count abnormalities at screen or by history.
Exparel for Postoperative Pain Management in Shoulder Surgery
Condition: Fracture of Shoulder and Upper Arm
MeSH terms: Pain, Postoperative; Shoulder Fractures
Intervention: 1.3% Liposomal Bupivacaine; 0.125% Bupivacaine
Intervention description: local tissue infiltration of Liposomal Bupivacaine during surgery; Continues nerve block with Bupivacaine during surgery and postoperatively
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into
      the shoulder to continues nerve block with Bupivacaine on postoperative pain control and
      functional outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing shoulder arthroplasty under general anesthesia

          -  Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus
             fracture under general anesthesia

          -  Patients with American Society of Anesthesiologist (ASA) physical status
             classification of 1-3

          -  Patients meeting criteria for standard of care continuous peripheral nerve block
             (CPNB) per anesthesia guidelines.

          -  Patients agreeing to be available for brief follow up telephone survey post-
             operatively and being mentally able to respond.

          -  Patients available for follow up routine post-operative clinic visits, per standard of
             care.

        Exclusion Criteria:

          -  Contraindications to regional anesthesia

          -  Significant peripheral neuropathy or neurological disorder affecting the upper
             extremity

          -  Contraindication to a component of multimodal analgesia

          -  Pregnancy

          -  Opioid tolerance

          -  Cognitive or psychiatric condition that might affect patient assessment and/or
             inability to provide informed consent.