bioihbjkbjnl/mcl2 huggingface dataset:
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Condition: Macular Edema, Cystoid; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Standard Care; intravitreal triamcinolone injection; intravitreal triamcinolone injection
Intervention description: CRVO: observation; BRVO: standard care; 1 mg dose; 4 mg
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 682.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: macular edema; central retinal vein occlusion (CRVO); branch retinal vein occlusion (BRVO)

Summary:

      The SCORE Study will compare the effectiveness and safety of standard care to intravitreal
      injection(s) of triamcinolone for treating macular edema (swelling of the central part of the
      retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein
      occlusion (BRVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with macular edema (swelling of the central part of the retina)
             associated with central retinal vein occlusion (CRVO) and branch retinal vein
             occlusion (BRVO).

          -  Individuals, 18 years of age or older, willing to provide consent may be eligible for
             the SCORE Study.

        Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for
        listing.
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Condition: End Stage Renal Disease (ESRD); Diabetes; CAPD
MeSH terms: Kidney Failure, Chronic
Intervention: Dianeal; Dianeal, Extraneal, Nutrineal
Intervention description: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose; Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin
Intervention MeSH terms: Icodextrin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ESRD; Diabetes; CAPD

Summary:

      Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal,
      Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous
      Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as
      measured by the magnitude of change from the baseline value in the HbA1c levels.

      Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis
      solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to
      lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic
      events requiring medical intervention, improved metabolic control, nutritional status, and
      Quality of Life.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female patients 18 years of age or older

          2. Diagnosis of ESRD [Glomerular Filtration Rate (GFR) ≤ 15 mL/min]

          3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no
             prescribed dry time

          4. Diabetes Mellitus (Type 1 and 2)

          5. HbA1c > 6.0% but ≤ 12.0%

          6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

          7. Total Kt/V ≥ 1.7

        Exclusion Criteria:

          1. Blood Urea Nitrogen (BUN) > 95 mg/dL

          2. Exposure to Extraneal within 60 days of Screening

          3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77mm Hg) at
             Screening

          4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30
             days

          5. Cardiovascular event within the last 30 days

          6. Ongoing clinically significant congestive heart failure [New York Heart Association
             (NYHA) class III or IV]

          7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose
             intolerance

          8. Receiving rosiglitazone maleate
Add-on to Thiazolidinedione (TZD) Failures
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Dapagliflozin; Placebo matching Dapagliflozin; Thiazolidinedione (Pioglitazone)
Intervention description: Tablets, Oral, 5.0 mg, once daily, up to 48 weeks; Tablets, Oral, 10.0 mg, once daily, up to 48 weeks; Tablets, Oral, 0 mg, once daily, up to 48 weeks; Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Intervention MeSH terms: Pioglitazone; Dapagliflozin; 2,4-thiazolidinedione
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 972.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can
      help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well
      controlled on TZD alone. The safety of this treatment will also be studied
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic
             control

          -  All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%

          -  C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)

          -  Body Mass Index ≤ 45.0 kg/m²

        Exclusion Criteria:

          -  AST and /or ALT > 2.5 times the upper limit of normal

          -  Serum total bilirubin > 2 mg/dL (34.2 µmol/L)

          -  Creatinine kinase > 3.0 times the upper limit of normal

          -  Symptoms of severely uncontrolled diabetes

          -  Serum creatinine ≥ 2.0 mg/dL

          -  Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric, or rheumatic diseases
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Bilateral Deep Brain Stimulation; best medical therapy
Intervention description: The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.; Participants will initially be randomized to DBS or to 6 months of "best medical therapy." BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: Parkinson's disease; levo-dopa; tremor; dyskinesia; subthalamic nucleus; globus pallidus

Summary:

      The goals of this study are to determine if simultaneous bilateral subthalamic nucleus
      stimulation or simultaneous bilateral globus pallidus stimulation is more effective in
      reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical
      therapy is more effective in improving Parkinson's disease symptoms
    

Eligibility criteria:

        Inclusion Criteria:

          -  idiopathic Parkinson's disease,

          -  Hoehn and Yahr stage 2 or worse "off" medications,

          -  L-dopa responsive but with persistent disabling symptoms (i.e., refractory to "best
             medical treatment" with motor fluctuations, dyskinesias),

          -  on stable medical therapy for at least one month prior to enrollment,

          -  age > 21,

          -  available and willing to be followed-up according to study protocol, and

          -  no intracranial abnormalities that would contraindicate surgery (based on
             pre-operative magnetic resonance imaging of the brain).

        Exclusion Criteria:

          -  "Parkinson's plus" syndromes,

          -  medical contraindications to surgery or stimulation,

          -  active alcohol or drug abuse,

          -  score on minimental status exam 24 or lower, or other neuropsychological dysfunction
             (e.g., dementia) that would contraindicate surgery,

          -  concurrent participation in another research protocol.
Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin degludec
Intervention description: Injected subcutaneously (under the skin) once daily. Dose individually adjusted.; Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in
      insulin naïve subjects with type 2 diabetes mellitus when titrated using two different
      self-titration algorithms (dose individually adjusted) in combination with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation
             (Visit 2)

          -  Current treatment: metformin monotherapy or metformin in any combination with 1 or 2
             other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl
             peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones
             (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit
             2)-metformin: alone or in combination (including fixed combination) must be at least
             1000 mg daily

          -  HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis

          -  BMI (Body Mass Index) no higher than 45.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12
             weeks prior to Visit 2

          -  Suffer from a life threatening disease (e.g. cancer)

          -  Females of childbearing potential who are pregnant (as determined by central
             laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to
             become pregnant or are not using adequate contraceptive methods (adequate
             contraceptive methods as required by law or practise [for Germany, adequate
             contraceptive methods are: implants, injectables, combined oral contraceptives,
             hormonal IUD, sexual abstinence or vasectomised partner])
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe 10 mg; atorvastatin; Comparator: rosuvastatin
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1547.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This study will compare the lipid-altering efficacy and safety of switching to
      co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or
      rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not
      achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis
      is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to
      both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in
      low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is at high cardiovascular risk and meets one of the following conditions: has
             never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks;
             or, is currently taking a stable dose of certain lipid-lowering agents

          -  Patient is willing to maintain a cholesterol lowering diet during the study

          -  Female patients receiving non-cyclical hormone therapy have maintained a stable dose
             and regimen for at least 8 weeks and are willing to continue the same regimen during
             the study

        Exclusion Criteria:

          -  Patient is Asian

          -  Patient routinely has more than 2 alcoholic drinks per day

          -  Female patient is pregnant or breastfeeding

          -  Patient has congestive heart failure

          -  Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or
             acute coronary syndrome within 3 months of screening

          -  Patient has uncontrolled cardiac arrhythmias

          -  Patient has had a partial ileal or gastric bypass or other significant intestinal
             malabsorption

          -  Patient has uncontrolled high blood pressure

          -  Patient has kidney disease

          -  Patient has any disease known to influence blood lipid levels

          -  Patient has any disorders of the blood, digestive system, or nervous system including
             stroke and degenerative disease that would limit study participation

          -  Patient has poorly controlled or newly diagnosed diabetes

          -  Patient is known to be HIV positive

          -  Patient has a history of cancer in the last 5 years, except certain skin and cervical
             cancers
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Intervention: Botulinum toxin type A Dose 1; Botulinum toxin type A Dose 2; Placebo (Normal Saline)
Intervention description: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.; Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.; Placebo (Normal Saline) intramuscular injections into specified muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)
      as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history of chronic migraine for at least 6 months

          -  15 or more headache days during a 4 week period

        Exclusion Criteria:

          -  Previous use of any botulinum toxin of any serotype for any reason

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

          -  Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS),
             cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks
             prior to the week -4 screening visit

          -  Use of any headache prophylaxis medication within 4 weeks prior to the week -4
             screening visit
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (Adempas, BAY63-2521)
Intervention description: BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Intervention MeSH terms: Riociguat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic Hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

Summary:

      Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348)
      will be asked to participate in this long term extension study with BAY63-2521. The aim of
      the long term study is to collect additional information to evaluate the safety and
      tolerability of BAY63-2521. Patients will be treated with open label medication on their
      individual optimal dose between 0,5 mg - 2,5 mg tid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

        Exclusion Criteria:

          -  Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as
             related to BAY63-2521 are not allowed to participate in the extension trial
Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Januvia; Placebo
Intervention description: 200 mg t.i.d; Placebo
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: GLP-1; GIP; Incretin hormones; DPP-IV inhibitor; Hyperglycaemic clamp; Meal test

Summary:

      We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function
      of the incretin hormones

      Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by
      DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and
      potency of GLP-1 and leads to a restoration of the lost action of GIP.
    

Eligibility criteria:

        Inclusion criteria

          -  Type 2 diabetes diagnosed according to and in accordance with the WHO criteria

          -  Metformin treatment of ≥ 1 gram

          -  7,5 % ≤ HbA1c ≤ 10%

          -  Age > 18

          -  BMI ≥ 25 kg/m2

          -  Informed consent

          -  Contraception, if appropriate

        Exclusion criteria

          -  Proliferating retinopathy

          -  Uremia, end stage renal disease, diabetic nephropathy or any other cause of impaired
             renal function with s-creatinine > 130 µM and/or albuminuria (>300 mg/day)

          -  Liver disease with ALAT and/or ASAT > 2 x normal value

          -  Complicated coronary artery disease, NYHA group III and IV

          -  Positive screening for islet cell auto antibodies and/or GAD-65 auto antibodies

          -  Occurrence of type 1 diabetes in first degree relatives

          -  Anaemia

          -  Pregnancy and/or breast feeding

          -  Treatment with medication affecting insulin secretion

          -  non-compliance

        Withdrawal criteria

          -  The subject may withdraw at will at any time

          -  Pregnancy discovered during the trial

          -  Severe illness

          -  Unacceptable side effects

          -  If self-measured fasting plasma glucose on three consecutive days exceeds 15 mM, the
             result is repeated in an immediately scheduled visit, and no treatable intercurrent
             cause for the hyperglycaemia can be found.
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; ALKS 5461 Placebo
Intervention description: Samidorphan + buprenorphine, administered sublingually; Placebo tablet, administered sublingually
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; Major Depressive Disorder; Treatment Refractory MDD; ALKS 5461

Summary:

      This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in
      adults who have treatment refractory MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a Major Depressive Disorder (MDD) primary diagnosis

          -  Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2

          -  Be willing and able to follow the study procedures and visits as outlined in the
             protocol (including agreeing not to enroll in any other clinical trials)

          -  Have inadequate responses to antidepressant therapy (ADT) in the current Major
             Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Has any finding that would compromise the safety of the subject or affect their
             ability to adhere to the protocol visit schedule or fulfill visit requirements

          -  Has any other significant medical condition (eg, neurological, psychiatric, or
             metabolic) or clinical symptom that could unduly risk the subject or affect the
             interpretation of study data

          -  Has any current primary diagnosis other than MDD, where primary diagnosis is defined
             as the primary source of current distress and functional impairment

          -  Has experienced hallucinations, delusions, or any psychotic symptoms in the current
             MDE

          -  Has been hospitalized for MDD within 3 months before screening

          -  Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days prior to screening

          -  Has received electroconvulsive therapy treatment within the last 2 years or within the
             current MDE or failed a course of electroconvulsive treatment at any time

          -  Has a significant risk for suicide

          -  Has a positive breath alcohol test at screening

          -  Has a positive test for drugs of abuse at screening or visit 2

          -  Is pregnant, planning to become pregnant, or is breastfeeding during the study

          -  Additional criteria may apply