bioihbjkbjnl/mcl2 huggingface dataset:
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Condition: Hepatitis A Virus
MeSH terms: Hepatitis A; Hepatitis
Intervention: Comparator: VAQTA™; Comparator: Infanrix™; Comparator: PedvaxHIB™
Intervention description: VAQTA™ (Hepatitis A Vaccine, Inactivated).
Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.; Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis
Vaccine Adsorbed, GlaxoSmithKline).
One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.; PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).
One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1274.0
Sex: All
Minimum age: 12 Months
Maximum age: 17 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis A virus

Summary:

      This two-stage study evaluates the immunogenicity, safety, and tolerability of the
      administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™
      (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria
      and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the
      administration of VAQTA™ in healthy children 15 months of age at study entry.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 1) Healthy males and females 15 months of age with no active liver disease and a
             negative history of hepatitis A who have been vaccinated against Haemophilus
             influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases

          -  Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease
             and a negative history of hepatitis A

        Exclusion Criteria:

          -  Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune
             deficiency, a history of allergy to any of the vaccine components, a history of
             seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine,
             or a bleeding disorder

          -  Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune
             deficiency, a history of allergy to any of the vaccine components, or a history of
             bleeding disorder
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: Pre-LASIK 0.3% hypromellose; Post-LASIK 0.3% hypromellose
Intervention description: Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.; Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 21 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Post LASIK dry eye; Pre LASIK dry eye; Hypromellose

Summary:

      This study is designed to assess the tolerability and comfort of peri-operative 0.3%
      hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3%
      hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to
      control (no pre-operative lubricant).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21 - 35

          -  Both sexes

          -  Seeking LASIK surgery at the Refractive Surgery Centre

          -  Meeting all established criteria for appropriateness for LASIK established by the
             treating center

        Exclusion Criteria:

          -  Any corneal pathology including scars, prior herpes keratitis, prior corneal
             transplant

          -  Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or
             diabetes mellitus

          -  Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3
             months from time of enrollment

          -  Anticipated refusal or inability to undergo planned post-operative visits or
             assessment

          -  Failure to meet all established criteria for appropriateness for LASIK
Antidepressant Medication Plus Donepezil for Treating Late-life Depression
Condition: Depression; Dementia
MeSH terms: Dementia; Depression; Depressive Disorder
Intervention: Escitalopram; Donepezil; Venlafaxine; Placebo; Duloxetine
Intervention description: Escitalopram, 10mg to 20mg daily.; Donepezil, 5mg to 10mg daily.; Venlafaxine, 150mg to 300mg daily.
Intervention MeSH terms: Duloxetine Hydrochloride; Donepezil; Venlafaxine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Depression; Dementia; Alzheimer's Disease; Cognitive; Donepezil; Memory; Function; Elderly; Late-Life

Summary:

      This study will determine the effectiveness of combining escitalopram, venlafaxine, or
      duloxetine with donepezil, a medication used in Alzheimer's disease, in improving memory,
      concentration, attention, and problem solving abilities, and reducing the risk of depressive
      relapse in older individuals with depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current episode of major depression

          -  HRS-D 17-item score of 15 or higher

          -  Must be able to speak English

          -  Willing to discontinue other psychotropics

          -  Availability of family member/caregiver

          -  Hearing capacity adequate to respond to raised conversational voice

          -  Must have no formal diagnosis of dementia

        Exclusion Criteria:

          -  Meets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder,
             or a psychotic disorders

          -  Alcohol/drug abuse within 12 months of study entry

          -  History of treatment non-adherence in other clinic protocols

          -  History of non-response to citalopram in other clinic protocols

          -  History of non-tolerance to SSRI therapy
TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery
Condition: Colorectal Surgery; TAP Blocks
Intervention: Exparel; Ropivacaine
Intervention description: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.; Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This is a prospective randomized study designed to compare the pain control from a single
      shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters
      with ropivicaine bolus in patients undergoing elective colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

        Exclusion Criteria:

          -  Patients under 18 years of age

          -  Patient over 90 years of age

          -  Pregnancy

          -  Prisoners

          -  Patients unable to provide consent

          -  Patients on systemic anticoagulation therapy

          -  Patients with an allergy to local anesthetics
Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment
Condition: Administration Site Reaction
Intervention: Fentanyl
Intervention description: FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Desflurane, Fentanyl, Airway responses

Summary:

      The investigators plan to test the hypothesis that pretreatment with fentanyl prior to
      induction of anesthesia would result in reduce the incidence of movements and airway
      responses to desflurane in patients breathing spontaneously through a laryngeal mask airway
      (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the
      incidence of movement during induction of anesthesia. Secondary aim of the study is to
      evaluate the effects of titration of fentanyl according to the respiratory rate on the
      incidence of intraoperative respiratory events such as coughing, breath holding and
      laryngospasm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-64 years of age

          -  Subjects scheduled for elective superficial and peripheral surgery of less than 2 h
             duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery,
             superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological
             procedures [i.e., hysteroscopy])

        Exclusion Criteria:

          -  obesity (body mass index >30)

          -  pregnancy

          -  history of gastroesophageal reflux, hiatal hernia, significant cardiovascular,
             pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and
             endocrine disease

          -  history of alcohol and drug abuse

          -  requiring tracheal intubation.
Clinical Trial for the Prevention of Vasovagal Syncope
Condition: Syncope, Vasovagal, Neurally-Mediated
MeSH terms: Syncope; Syncope, Vasovagal
Intervention: fludrocortisone acetate
Intervention description: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Intervention MeSH terms: Fludrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: vasovagal syncope; randomized clinical trial; quality of life

Summary:

      The main question in the study is whether people taking fludrocortisone are less likely to
      faint than people taking an inactive pill called a placebo.

      Fludrocortisone is a drug that stimulates the body to retain salt and water. The
      investigators know from some studies that it might prevent people from fainting at home and
      in the community, while they are carrying on with their lives. There is some evidence that
      salt and water retention help prevent fainting, but no one has a clear idea about whether
      this is true. This study will try to determine if that is true.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Syncope as a cause of loss of consciousness according to European Society of
             Cardiology criteria

          -  > 2 lifetime syncopal spells preceding enrollment

          -  > or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts

          -  Age > 18 years with informed consent, or age > 14 years with consent and informed
             parental consent

        Exclusion Criteria:

          -  Other causes of syncope, such as ventricular tachycardia, complete heart block,
             postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome

          -  An inability to give informed consent

          -  Important valvular, coronary, myocardial or conduction abnormality or significant
             arrhythmia

          -  Hypertrophic cardiomyopathy

          -  A known intolerance to fludrocortisone

          -  Another clinical need for fludrocortisone that cannot be met with other drugs

          -  A permanent pacemaker

          -  A seizure disorder

          -  A major chronic non cardiovascular disease

          -  Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure

          -  Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m2
             according to the Cockroft-Gault formula)

          -  Diabetes mellitus

          -  Hepatic disease

          -  Glaucoma

          -  Any prior use of fludrocortisone acetate

          -  A 5-minute stand test resulting in diagnosis of postural orthostatic tachycardia
             syndrome or orthostatic hypotension
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin NPH
Intervention description: Insulin detemir once daily plus insulin aspart at mealtime; Insulin NPH once daily plus insulin aspart at mealtime
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of this clinical trial is to compare the change in
      trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of
      treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined
      with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one
             of them must be a premix) for at least 3 months prior to inclusion in trial

          -  Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %

          -  Body Mass Index (BMI) between 27.5-40 kg/m^2

        Exclusion Criteria:

          -  Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except
             metformin (subjects currently treated with metformin within the interval of 1000 -
             2550 mg daily may be included in the trial. The dose should have remained unchanged
             for a period of 2 months prior to randomisation and should be expected to remain
             unchanged throughout the trial period)

          -  Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin,
             rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal
             anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical
             anti-psychotics)

          -  Previous or planned surgical treatment of obesity

          -  Total daily insulin dose higher or equal 2 IU/kg

          -  Proliferative retinopathy or maculopathy that has required acute treatment within the
             last six months

          -  Receipt of any investigational drug within 1 month prior to this trial

          -  Cardiac disease defined according to New York Heart Association (NYHA) class III or
             IV, unstable angina pectoris and/or myocardial infarction within the last 6 months
             previous to the selection
Post Hematopoietic Stem Cell Transplantation
Condition: Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Intervention: ICL670
Intervention description: Oral dose of ICL670 at 10 mg/kg daily
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: hematopoietic stem cell transplantation, beta-thalassemia major, deferasirox, iron overload

Summary:

      This was a prospective, single-arm, multicenter, national, phase II clinical study. The
      purpose of this Phase II study was to examine the safety and efficacy of deferasirox to
      decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia
      major.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients who had hematopoietic stem cell transplantation (HSCT) for beta-thalassemia
             major

          -  hematopoietic stem cell transplantation (HSCT) was performed minimum 6 months and
             maximum 2 years ago

          -  The washout period after the immunosuppressive therapy should be at least 3 months.

          -  Signifacant IOL should be present including:

        A. Serum ferritin >1000 μg/L or B. cardiac MRI <20 ms or C. liver iron concentration ≥ 5
        mg/g dry weight measured by R2* MRI

        Exclusion Criteria

          -  Patients who had any contraindication for treatment with deferasirox according to the
             prescribing information

             •Patients who depended on transfusion

          -  Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or
             exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)

          -  Patients who were experiencing severe complication of HSCT e.g. acute Graft-versus
             host disease (GVHD)

          -  Significant proteinuria / Increase in serum creatinine
Angiotensin II Blockade for Chronic Allograft Nephropathy
Condition: Kidney Disease; Proteinuria
MeSH terms: Kidney Diseases; Proteinuria
Intervention: Losartan 100mg; Placebo
Intervention description: To be started within three months of transplant and continued for five years.; No treatment with continued follow-up for five years.
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic allograft nephropathy; post transplant proteinuria

Summary:

      Chronic allograft nephropathy continues to be a major cause of kidney transplant loss and
      return to dialysis. Treatment options are limited and the course of the disease tends to be
      progressive. This trial is designed to prevent a major mediator of this process, namely the
      expansion of the cortical interstitial compartment of the kidney where most of the scarring
      occurs. The drug being studied, Losartan, has proven efficacious in a number of kidney
      diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years.

          -  Recipients of a first or a second renal transplant alone or in combination with a
             pancreas transplantation.

          -  Informed consent

          -  Adequate baseline biopsy; at least 10 cortical projection fields.

        Exclusion Criteria:

          -  Age < 18 years.

          -  Serum creatinine 2.5mg/dL.

          -  Persistent hyperkalemia; potassium > 5.4 mEq/L.

          -  Known hypersensitivity to losartan or iodine allergy.

          -  Documented renal artery stenosis by duplex ultrasonography.

          -  Recipients of grafts from an HLA-identical sibling.

          -  Recipients whose primary renal disease is primary hyperoxaluria,dense-deposit disease,
             focal segmental glomerulosclerosis or hemolytic uremic syndrome.

          -  Women of childbearing age who wish to become pregnant and/or are unwilling to use
             contraceptive measures or who are pregnant.

          -  Recipients requiring ACE inhibitors or AII blockers for a cardiovascular indication
             (e.g. systolic dysfunction).

          -  Recipients who are > 55 years old and had a history of cardiovascular disease
             (coronary artery disease, stroke or peripheral vascular disease).
Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Intervention: Dietary advice; rosuvastatin; atorvastatin
Intervention description: rosuvastatin 5 mg; atorvastatin 10 mg
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cholesterol; statin; Asian; LDL-cholesterol

Summary:

      The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in
      lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian
      patients in the UK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self described Asian, first or second generation

          -  Male or female > or = 18 years with primary hypercholesterolaemia.

        Exclusion Criteria:

          -  Use of cholesterol lowering drugs from visit 1

          -  Homozygous familial hypercholesterolaemia

          -  Active arterial disease within 3 months of study entry

          -  Poorly controlled diabetes

          -  Uncontrolled hypothyroidism

          -  Active liver disease

          -  History of alcoh/drug abuse.