bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
Condition: Placenta Accreta; Postpartum Hemorrhage; Cesarean Section; Tranexamic Acid
MeSH terms: Postpartum Hemorrhage; Placenta Accreta; Placenta Previa; Hemorrhage
Intervention: Tranexamic Acid; Placebo Drug
Intervention description: 50 cc Normal Saline IV
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is
      effective for reducing blood loss during high risk surgical procedures related to placenta
      previa and placenta accreta. TXA is currently used in other types of surgery for patients who
      are expected to have a large blood loss, such as orthopedic or open heart surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English and Spanish speaking pregnant women

          -  Any order pregnancy (singleton, twin gestation, etc)

          -  Suspected accreta based on ultrasound or MRI imaging studies

          -  All women evaluated for placenta accreta and deemed to be high risk for this disease
             (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal
             to 2 prior c-sections

        Exclusion Criteria:

          -  Women less than 18 years of age

          -  Women with a personal history of venous or arterial thrombosis (deep vein thrombosis,
             pulmonary embolism, myocardial infarction, or stroke

          -  Women with a personal history of a high risk clotting disorder, such as
             anti-phospholipid syndrome

          -  Women who do not have a good understanding of either English or Spanish will be
             excluded.

          -  Women with defective color vision (color-blindness)
Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Cognitive Dysfunction; Psychotic Disorders
Intervention: galantamine
Intervention description: see arm/group description
Intervention MeSH terms: Galantamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: schizophrenia; acetylcholine; cognitive impairments; attention; processing speed; sensory gating; eye-tracking

Summary:

      The purpose of this study is to examine whether adjunctive galantamine is effective in the
      treatment of cognitive impairments in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.

          2. Males and females

          3. Age: 18 and 60

          4. Caucasian or Non-Caucasian

          5. Subjects will be currently treated with one of the following new generation
             antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.

          6. Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable
             Battery for the Assessment of Neuropsychological Status (RBANS) will be used to
             determine the level of cognitive impairment. Patients will meet entry criteria if they
             have a RBANS total score of 90 or less (one standard deviation below the normal
             control mean).

        Exclusion Criteria:

          1. History of an organic brain disease

          2. History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV
             alcohol or substance dependence (within the last six months).

          3. Pregnant women and women taking oral contraceptives (because of the theoretical risk
             of breakthrough ovulation).

          4. Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g.
             donepezil)

          5. History of a second or third degree atrioventricular (AV) block.

          6. Persons with chronic medical conditions, which are unstable.
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
Condition: Narcotic Consumption; Pain; Wound Healing; Patient Satisfaction
Intervention: Iceman® Cold Therapy unit (djOrtho); Ice
Intervention description: postoperative cold therapy; postoperative cold therapy
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Healthy volunteers: No
Keywords: cryotherapy; postoperative pain; Iceman; primary first metatarsal osteotomy (PMO); lateral ankle ligament reconstruction (LAR)

Summary:

      This study will compares differences in pain level, narcotic consumption, wound healing,
      patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho,
      Inc) versus those who use ice. This will be assessed postoperatively following the foot and
      ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament
      reconstruction (LAR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR)
             surgery or primary first metatarsal osteotomy surgery

          -  Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and
             to return to the clinic for a 2 week postoperative follow- up appointment

        Exclusion Criteria:

          -  Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome,
             hypersensitivity to cold

          -  Patients allergic to hydrocodone or oxycodone

          -  Patients who are unwilling to complete the patient diary and/or follow their specific
             cold therapy instructions
Canadian Hemophilia Prophylaxis Study
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS); Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)
Intervention description: escalating dose prophylaxis; escalating dose
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Male
Minimum age: 12 Months
Maximum age: 30 Months
Healthy volunteers: No
Keywords: hemophilia, prophylaxis, cost effectiveness

Summary:

      Primary prophylaxis given less frequently initially, with the infusion frequency increased if
      needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with
      fewer complications than standard prophylaxis while reducing disability to a greater degree
      than intermittent therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A (factor level less than 2%).

          -  Age greater than 1 year and less than or equal to 2.5 years.

          -  Normal joints using the World Federation of Hemophilia orthopedic scale.

          -  Normal radiographs of joints in which bleeding has occurred using the World Federation
             of Hemophilia radiographic scale.

          -  Platelet count of > 150,000.

          -  Informed consent to participate.

        Exclusion Criteria:

          -  Three or more clinically determined bleeds into any single elbow, knee or ankle.

          -  Presence or past history of a circulating inhibitor (level ≥ 0.5 Bethesda Units).

          -  Family judged to be non-compliant by the local hemophilia clinic director.

          -  Competing risk (symptomatic HIV infection, juvenile rheumatoid arthritis, metabolic
             bone disease, or other diseases known to cause or mimic arthritis.)
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Arformoterol tartrate; Placebo: Normal Saline; Treadmill Exercise; Cycle Exercise
Intervention description: 15 mcg in two ml solution administered via nebulizer; Normal saline was nebulized.
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: exercise;; treadmill;; cycle ergometer;; breathlessness;; leg discomfort

Summary:

      Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus
      than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with
      COPD. The hypothesis of the study is that patients with COPD will exhibit greater
      improvements in exercise endurance and breathlessness with arformoterol compared with normal
      saline during treadmill walking than with cycle exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patient 50 years of age or older; diagnosis of COPD; current or
             ex-smoker with at least 10 pack-years of smoking; a patient-reported score for
             breathlessness during activities of daily living of < 9 on the self-administered
             computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a
             post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.

        Exclusion Criteria:

          -  any concomitant disease that interferes with study procedures or evaluation; inability
             to exercise on the treadmill or cycle ergometer; inability to withhold short-acting
             bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or
             formoterol) and for 24 hours (tiotropium) prior to testing
Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
Condition: Anorexia Nervosa; Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Intervention: Fluoxetine; Placebo
Intervention MeSH terms: Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate
      of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of
      people who have been treated for AN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for anorexia nervosa (except the requirement for amenorrhea)

          -  Successfully completed treatment at one of the study sites in an inpatient or
             day-program setting immediately prior to study entry (BMI remained at least 19 kg/m2
             for two weeks)

        Exclusion Criteria:

          -  Currently taking any medications other than occasional lorazepam or zopiclone for
             anxiety or sleep disturbance

          -  Previous serious adverse reactions to fluoxetine (e.g., allergy)

          -  Currently at risk for suicide

          -  Any medical condition requiring treatment with other psychotropic medication (except
             the occasional use of anti-anxiety medication)

          -  Pregnant

          -  Any serious medical illness besides the eating disorder

          -  History of continuous illness (at a low weight with no periods of remission or return
             to normal functioning for more than 15 years)
Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study
Condition: Contraception
Intervention: Etonogestrel contraceptive implant
Intervention description: Place nexplanon
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral contraceptive; contraceptive implant; contraception; adherence; adverse event

Summary:

      Women currently using or starting a combined oral contraceptive will be offered study
      enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate
      if they continue the COC, continue the implant, or both, and to assess adverse events and
      bleeding patterns.
    

Eligibility criteria:

        Inclusion:

          -  Women being seen in a UC Davis medical office or who contact our research office.

          -  Potential participants must be women currently COCs or intending to initiate COCs at
             the time of the office visit.

        Exclusion:

          -  Women who have contraindications to using a COC or a contraceptive implant (Category 3
             or 4 in the CDC Medical Eligibility Criteria) will be excluded.

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners
Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Condition: Erythema Migrans; Post-Lyme Disease Symptoms
MeSH terms: Lyme Disease; Erythema Chronicum Migrans; Glossitis, Benign Migratory; Erythema
Intervention: doxycycline; cefuroxime axetil
Intervention description: 100 mg bid; 15 days; 500 mg bid; 15 days
Intervention MeSH terms: Doxycycline; Cefuroxime; Cefuroxime axetil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 544.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: erythema migrans; doxycycline; cefuroxime axetil; post-Lyme disease symptoms; background symptoms in general population

Summary:

      Background:

        -  While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe
           as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult
           patients with erythema migrans has been assessed only in the USA where the causative
           agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main
           etiologic agents are B. afzelii and B. garinii.

        -  Controversy exists over the significance and even the existence of post-Lyme disease
           symptoms because of the high rate of similar background symptoms in the general
           population.

      Purpose:

      The two main purposes of this European, prospective clinical trial in which doxycycline and
      cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and
      which included a control group to address the significance of post-Lyme disease symptoms are:

        -  To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the
           treatment of erythema migrans using clinical and bacteriological criteria
           (noninferiority testing approach), and

        -  to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM
           with antibiotics and the frequency of similar symptoms in control subjects without Lyme
           disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients 15 or more years old

          -  with typical erythema migrans

          -  evaluated between 6/06 and 9/06

          -  evaluated at the Lyme Disease Outpatient Clinic, University Medical Center Ljubljana,
             Slovenia.

        Exclusion Criteria:

          -  history of Lyme disease in the past

          -  pregnancy

          -  lactation

          -  immunocompromising condition

          -  history of a serious adverse reaction to a beta-lactam or tetracycline drug

          -  receiving an antibiotic with known anti-borrelial activity within 10 days

          -  multiple erythema migrans lesions or an extracutaneous manifestation of Lyme disease.
Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: etanercept
Intervention description: etanercept subcutaneous injection
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase IV; Psoriasis; Inflammation

Summary:

      The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of
      psoriasis in patients for a period of up to 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older at baseline

          -  Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or
             severe on the Physician Global Assessment (score of 3, 4 or 5)

          -  Able to start Enbrel (Etanercept) therapy per the approved product monograph

        Exclusion Criteria

          -  Active infections at the initiation of Enbrel therapy.

          -  Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere
             with evaluations of the effect of study medication on psoriasis.

          -  Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B
             (UVB) therapy within 2 weeks of study drug initiation.

          -  Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis
             therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug
             initiation and during the study period.

          -  Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug
             initiation and during the study period.

          -  Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept)
             within 3 months before the initiation of study medication or during the study period.
Aflibercept in Polypoidal Choroidal Vasculopathy
Condition: Neovascular Macular Degeneration
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Visudyne
Intervention description: Eylea is administered as an intravitreal injection; Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Intervention MeSH terms: Aflibercept; Verteporfin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 333.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: PCV

Summary:

      To collect data reflecting the efficacy and safety of aflibercept with and without
      photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype
      of wet age-related macular degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Men and women ≥50 years of age

          -  Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study
             eye established by Indocyanine Green Angiography(ICGA) at the study center

          -  Greatest linear dimension of the lesion of < 5400 mm (approximately, 9 Macular
             Photocoagulation Study disk areas), assessed by ICGA.

          -  An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the
             study eye.

        Exclusion Criteria:

          -  Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3
             months prior to study entry

          -  Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents
             in the study eye, or systemic use of anti VEGF products within 3 months prior to study
             entry

          -  Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)

          -  History of allergy to fluorescein used in fluorescein angiography, iodine and/or
             indocyanine green.

          -  History of allergy to aflibercept, verteporfin, or their excipients.
Pregabalin and Colonic Function
Condition: Healthy
Intervention: Pregabalin; Placebo; Bowel preparation
Intervention description: FDA approved medication (capsules) at 75 mg and 200 mg doses; Placebo capsules; Polyethylene glycol electrolyte solution bowel preparation
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pregabalin; motor; sensation; colon; pain; gas

Summary:

      This study is being done to evaluate the effects of pregabalin, a drug approved for
      anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy
      individuals.

      The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds,
      decreases sensation ratings, and increases compliance in response to balloon distension in
      the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a
      standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
    

Eligibility criteria:

        Inclusion criteria:

        - Healthy males or females

        Exclusion criteria:

          -  Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean
             section, vaginal or laparoscopic hysterectomy or tubal ligation

          -  A history of chronic gastrointestinal or systemic illnesses that could affect
             gastrointestinal motility

          -  Any history of hypertension

          -  Use of medications that may alter gastrointestinal motility or interact with the study
             medications

          -  Use of any of the study medications within the past 30 days

          -  Pregnancy

          -  Chronic renal insufficiency (serum creatinine >1.5 mg/dL)

          -  Psychiatric or psychologic dysfunction.