bioihbjkbjnl/mcl2 huggingface dataset:
Atazanavir and Lamivudine for Treatment Simplification
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Lamiduvine (Epivir); Atazanavir (Reyataz); Ritonavir (Norvir)
Intervention description: Epivir 300 mg; Reyataz 300 mg; Norvir 100 mg
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV/AIDS; HAART; Simplification; Atazanavir; Lamivudine; treatment experienced

Summary:

      Objectives of the study:

        1. To verify the safety of the study treatment, defined as the persistent control of the
           virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with
           ritonavir.

        2. To collect relevant information about the safety and the metabolic impact of this
           strategy in order to eventually design a non-inferiority randomized controlled trial for
           the evaluation of the safety and the efficacy of this strategy in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months

          -  Aged 18 years or older

          -  Who gave informed consent to the participation to the study

          -  With at least two viral load < 50 copies/mL in two consecutive determinations at least
             3 months apart

          -  With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or
             AIDS-related disease by one year at least

        Exclusion Criteria:

          -  Pregnancy or breast feeding, desire of pregnancy in the short term

          -  Previous virological failure to antiretroviral therapy and/or previous exposure to
             mono- or dual therapies with reverse transcriptase nucleosidic analogues

          -  Patients with insufficient atazanavir plasma through concentration (lower than 0.23
             μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline

          -  Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose
             or lipid serum levels and direct or indirect bilirubin)

          -  Concomitant treatment with antacids or proton-pump blockers or any other drug with
             known interactions or contraindications with the study medications
Arresting Vertical Transmission of Hepatitis B Virus
Condition: Hepatitis B; Vertical Transmission of Infectious Disease
MeSH terms: Hepatitis A; Hepatitis B; Communicable Diseases; Infections; Hepatitis
Intervention: Tenofovir Disoproxil Fumarate; Monovalent HBV vaccine
Intervention description: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.; Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.
Intervention MeSH terms: Tenofovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and
      treatment of pregnant women to the existing HIV PMTCT platform in order to prevent
      mother-to-child transmission of hepatitis B virus.
    

Eligibility criteria:

        Inclusion criteria:

          -  Pregnant women receiving care at Binza and Kingasani maternity centers presenting
             prior to 24 weeks gestation

          -  Infants born to HBV-positive women

        Exclusion criteria:

          -  Participants who are severely sick and who require prolonged hospitalization.

          -  Any women who do not intend to stay in Kinshasa for prenatal care through delivery
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Condition: Anterior Ischemic Optic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Ischemia
Intervention: Diagnostic procedures
Intervention description: The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Non-arteritic Anterior Ischemic Optic Neuropathy; NAION; PDE5 inhibitors; vardenafil; Levitra; sildenafil; Viagra; Tadalafil; Cialis; acute vision loss; vision loss; blurred vision; optic neuropathy; erectile dysfunction.

Summary:

      The primary objective of this study is to determine whether the use of PDE5 inhibitors
      (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NAION onset within 45 days before entry to the study

          -  NAION onset definable by the subject within a 2 calendar day window

          -  Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year
             prior to enrollment in the study

          -  Age 40 years or older

        Exclusion Criteria:

          -  History of multiple sclerosis or optic neuritis

          -  Evidence of temporal arteritis

          -  History of vasculitis or collagen vascular disease

          -  Previous history of NAION
APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Percutaneous coronary intervention (PCI)
Intervention description: PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Healthy volunteers: No
Keywords: Open infarct-related artery within 72 hours of thrombolysis

Summary:

      Reocclusion of the infarct artery is observed in about 30% of patients within three months
      after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated
      with an increased risk of death, reinfarction and the need for revascularization. Even in the
      absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV)
      recovery, leaving patients at increased risk of developing heart failure in the long-term.
      Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct
      related stenosis was the only independent predictor of reocclusion. With a lack of clinical
      predictors of reocclusion, many cardiologists therefore empirically favor routine
      revascularization after successful thrombolysis.

      The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty
      techniques to study the question of whether a routine invasive strategy after successful
      thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical
      outcome and LV-function. After successful thrombolysis, patients will be randomized to either
      a routine invasive strategy or an ischemia-guided strategy. The investigators expect to
      demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint)
      and fewer associated events (death, reinfarction, revascularization, admissions for heart
      failure) in the routine invasive arm. In search of non-invasive parameters predictive of
      reocclusion, laboratory analysis of several coagulation and inflammatory markers will be
      performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification
      of clinical predictors of reocclusion that can easily be obtained by history and physical
      examination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis
             for ST-elevation myocardial infarction

        Exclusion Criteria:

          -  Use of oral anticoagulants.

          -  Known intolerance to aspirin or clopidogrel.

          -  Bypass graft as infarct-related artery.

          -  Previously dilated infarct related artery.

          -  Significant left main stenosis.

          -  Unidentifiable culprit stenosis.
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Condition: Extracorporeal Membrane Oxygenation Complication; Pediatric ALL; Anticoagulants
Intervention: Bivalirudin; Unfractionated heparin
Intervention description: Continuous infusion; Continuous infusion
Intervention MeSH terms: Heparin; Calcium heparin; Bivalirudin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 1 Day
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a
      single pediatric Level 1 trauma center. The patients will be randomized into two arms; one
      arm will receive unfractionated heparin and the other arm will receive bivalirudin. There
      will be 15 patients in each arm for a total of 30 patients.

      Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1 day to less than 18 years

          -  Cared for in the pediatric intensive care unit or pediatric cardiac intensive care
             unit

          -  receiving venovenous or venoarterial ECMO

        Exclusion Criteria:

          -  Patients with known or suspected heparin induced thrombocytopenia prior to consent

          -  Patients with hepatic failure defined as coagulopathy with elevated transaminases more
             than three times normal values

          -  Patients with plan to decannulate from ECMO within 48 hours

          -  Known or suspected pregnant women

          -  Previous enrollment in this study

          -  Primary language spoken that is not English or Spanish
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Condition: Shoulder Arthroscopy
Intervention: Bupivacaine with Epinephrine; Bupivacaine alone
Intervention description: Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.; Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Shoulder; Rotator Cuff; Epinephrine; Subacromial bursa

Summary:

      The purpose of this study is to evaluate surgeon-rated visual clarity and the need for
      increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean
      arterial pressure, operative time, and any adverse events that occur during arthroscopic
      shoulder surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position
             requiring visualization within the subacromial space

        Exclusion Criteria:

          -  Are unable to provide informed consent

          -  Non-English speaker

          -  Have a history of adverse medication reaction to epinephrine
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Mavenclad®
Intervention description: Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Intervention MeSH terms: Cladribine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Mavenclad ®; Cladribine

Summary:

      The main purpose of the study was to determine the onset of Mavenclad® action by frequent
      magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in
      participants with highly active relapsing multiple sclerosis (MS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Highly active RMS as defined by:

          -  One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or
             more T2 lesions, while on therapy with other disease modifying drugs (DMDs)

          -  Two or more relapses in the previous year, whether on DMD treatment or not.

          -  Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.

          -  Other protocol defined inclusion criteria could apply.

        Exclusion Criteria:

          -  Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone
             and ocrelizumab.

          -  Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core
             antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).

          -  Current or previous history of immune deficiency disorders including a positive human
             immunodeficiency virus (HIV) result.

          -  Currently receiving immunosuppressive or myelosuppressive therapy with, for example,
             monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine,
             or chronic use of corticosteroids.

          -  History of tuberculosis , presence of active tuberculosis, or latent tuberculosis

          -  Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic
             Resonance Imaging (MRI).

          -  Active malignancy or history of malignancy.

          -  Other protocol defined exclusion criteria could apply.
Spinal Anesthesia Induced Hypotension During Cesarean Section
Condition: Hypotension
MeSH terms: Hypotension
Intervention: Colloid administration; Crystalloid administration; phenylephrine infusion
Intervention description: The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.; The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.; A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: spinal anesthesia; cesarean section

Summary:

      The purpose of this study is to compare two methods for preventing low blood pressure
      associated with spinal anesthesia during Cesarean sections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I and II

          -  Elective cesarean section

          -  Weight 50-120 kg, Height 150-180 cm

          -  Normal singleton pregnancy

          -  Beyond 36 weeks gestation

          -  No known fetal abnormalities

          -  Ages 18-35

        Exclusion Criteria:

          -  Contraindications to spinal anesthesia

          -  Multiple gestation, placenta previa, accreta

          -  Pregnancy induced hypertension or preeclampsia

          -  Diabetes mellitus, cardiovascular diseases

          -  Coagulopathy

          -  Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction

          -  Baseline HR <65

          -  Failed spinal anesthesia/inadequate sensory block for surgery

          -  History of abnormal bleeding

          -  History of adverse reactions to hydroxyethylstarch
Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Intervention: Guanfacine; Hydrochlorothiazide
Intervention description: Guanfacine 1mg for 2 weeks followed by guanfacine 2mg for 4 weeks.; Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks
Intervention MeSH terms: Hydrochlorothiazide; Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.
      They often develop high blood pressure. We are not sure what drug is best to treat the high
      blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ)
      for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24
      hour monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients ranging from 20 - 80 years

          2. Body mass index (BMI) of 20-38 to include the typical obese OSA patients and avoid the
             practical difficulties in blood drawing from the massively obese

          3. Hypertension with blood pressures > 140/90 but less than 180/105 mmHg.

          4. Apnea-hypopnea index above 10

        Exclusion Criteria:

          1. Receiving medications other than anti-hypertensives known to influence the sympathetic
             nervous system, sleep medicines (including heavy alcohol use) or drugs with adverse
             interactions with study medication.

          2. Women who have premenstrual syndrome, or those who are pregnant or capable of
             pregnancy and unwilling to use effective non-hormonal contraception

          3. Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in
             order to minimize confounding effects of other sleep disorders

          4. Have apneas which are primarily central

          5. Have sleep fragmentation caused by syndromes such as chronic pain or movement
             disorders

          6. Have diseases such as asthma or chronic obstructive pulmonary disease that compromises
             respiration.

          7. Have known coronary or cerebral vascular disease, history of arrhythmias,
             cardiomyopathy, history of psychosis, current alcohol or drug abuse.

          8. Have any contraindications to any study materials, such as heart block.

          9. Have secondary hypertension

         10. Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria
             or electrolyte disorders.
Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy
Intervention: Lucentis
Intervention description: Local anesthesia with T-caine with Saline irrigation. Routine eye drap was done by potadine-cotton ball. Lucentis injected to vitreous cavity, finally dressing.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Nonproliferative diabetic retinopathy, Microaneurysms

Summary:

      Title of study:

      Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR)
      with DME assessed by microaneurysm changes: A pilot study Objectives Diabetic retinopathy
      (DR) is a major cause of visual impairment. Anti-vascular endothelial growth factors have
      demonstrated therapeutic benefits in diabetic macular edema (DME). We aimed to prospectively
      analyze the effects of early intensive treatment using intravitreal ranibizumab (IVR)
      injections in nonproliferative diabetic retinopathy patients with macular edema.

      Primary objective:

      To investigate other efficacy endpoints including other visual acuity, anatomical change in
      mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through
      6 months after treatment.

      Secondary objectives:

      To compare microvascular changes assessed by microaneurysm counts and perifoveal
      non-perfusion area changes and safty in eyes of mild-to-moderate NPDR with DME after
      intravitreal Ranibizumab injection from baseline through 6 months after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (Male & female) ≥40 years of age

          -  Type 2 DM

          -  Best corrected visual acuity ≥ 20/200 (Snellen equivalent using Early Treatment
             Diabetic Retinopathy Study chart)

          -  central retinal thickness of ≥300 µm on optical coherence tomography

          -  nonproliferative diabetic retinopathy (NPDR) with diabetic macular edema

        Exclusion Criteria:

          -  proliferative diabetic retinopathy

          -  Vitreous hemorrhage

          -  previous history of vitreoretinal surgery, post-cataract operation status (≤4 months
             before participation in this study)

          -  prior treatment with anti-VEGF drugs, intraocular corticosteroids, and/or retinal
             laser application

          -  Uncontrolled hypertension.

          -  Uncontrolled glaucoma.

          -  If both eyes met the study inclusion criteria, the more severely affected eye was
             selected