bioihbjkbjnl/mcl2 huggingface dataset:
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)
Condition: Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy; Vascular Diseases
Intervention: Ranibizumab; Verteporfin PDT; Sham PDT
Intervention description: Intravitreal injection of 0.5 mg ranibizumab; Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm); Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polypoidal choroidal vasculopathy; Visual acuity; Ranibizumab; Verteporfin PDT

Summary:

      This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab
      administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in
      patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of
      this study provided long-term safety and efficacy data used to generate further guidance on
      the management of patients with PCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of symptomatic macular PCV in the study eye

          -  A qualifying vision score at study entry

          -  A qualifying lesion size in the study eye at study entry

        Exclusion Criteria:

          -  Active inflammation or infection in the study eye

          -  Uncontrolled intraocular pressure in the stuy eye

          -  Ocular condition in the study eye which may impact vision and confound study outcomes

          -  Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser
             and surgical interventions, intraocular corticosteroids
Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
Condition: Pregnancy Related; Antepartum DVT
Intervention: Standard Dose of Unfractionated Heparin; Gestational Age-Based Dose of Unfractionated Heparin
Intervention description: 5,000 units subcutaneous unfractionated heparin every 12 hours; First trimester (< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours
Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours
Third trimester (> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Thromboprophylaxis; Antepartum admission; Heparin

Summary:

      This study is a randomized control trial to compare gestational age-based dosing with
      standard dosing of unfractionated heparin for thromboprophylaxis of hospitalized antepartum
      patients. The investigators aim to determine the effect of dosing on receipt of neuraxial
      anesthesia and pregnancy outcomes and evaluate the pharmacokinetics and pharmacodynamics of
      unfractionated heparin in pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Speak English or Spanish

          -  Antepartum admission for at least 72 hours at Ronald Reagan UCLA Medical Center

          -  Provides informed consent for study participation

        Exclusion Criteria:

          -  Active or threatened antenatal bleeding

          -  Disseminated intravascular coagulation

          -  Risk of imminent delivery (delivery within 12 hours)

          -  Thrombocytopenia (platelet count < 100 x 109)

          -  Elevated baseline aPTT (> 36.2 seconds)

          -  Concern for hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome

          -  Congenital bleeding disorders (hemophilias)

          -  Receiving therapeutic or prophylactic anticoagulation (unfractionated heparin, low
             molecular weight heparin, oral anticoagulants) for alternative indication (e.g.,
             acquired or inherited thrombophilia, history of VTE)

          -  History of heparin-induced thrombocytopenia (HIT)

          -  SARS-CoV-2 positive

          -  Cognitive impairment, psychiatric instability, or language barriers that limit their
             ability to provide informed consent

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data.
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Condition: Acute Bacterial Skin and Skin Structure Infections
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Intervention: Usual Care; Dalbavancin
Intervention description: Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.; Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Intervention MeSH terms: Dalbavancin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Critical Pathways; Health Facilities; Clinical Protocols; Patient Satisfaction; Absenteeism; Anti-Bacterial Agents; Quality of Life; Economics, Medical; Health Resources; Health resource utilization; Acute bacterial skin and skin structure infection (ABSSSI)

Summary:

      This study will evaluate a new critical pathway (use of guideline-based patient
      identification criteria and for those who meet these criteria, use of dalbavancin) for the
      treatment of ABSSSI compared to usual care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents to the Emergency Department (ED) and meets the clinical definition for Acute
             Bacterial Skin and Skin Structure Infections (ABSSSI)

          -  Known or suspected gram-positive infection.

        Exclusion Criteria:

          -  Known or suspected gram-negative infections, anaerobic infections, or fungemia

          -  Known or suspected infections that are severe, life threatening or are not included in
             the ABSSSI Food and Drug Administration (FDA) guidance

          -  Injection drug users with a fever

          -  Severe neurological disorder leading to immobility or confined to a wheelchair

          -  Bilateral Lower extremity involvement of the suspected infection.
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
Condition: Chronic Kidney Diseases; Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: KRX-0502
Intervention description: Oral ferric citrate with meals
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the long-term efficacy and safety of different
      dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects
      with non-dialysis dependent chronic kidney disease (CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min

          -  Hgb ≥8.5 g/dL and ≤11.5 g/dL

          -  Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%

          -  Serum intact parathyroid hormone ≤600 pg/mL

        Exclusion Criteria:

          -  Serum phosphate <3.0 mg/dL

          -  Intravenous (IV) iron administered within 4 weeks prior to Screening

          -  Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening

          -  Blood transfusion within 4 weeks prior to Screening
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
Condition: Cesarean Section Complications; Wound Breakdown; Wound Infection; Satisfaction; Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound
Intervention: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG); Standard Wound Care
Intervention description: Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7; Wound care will be administered as standard protocol in our institution
Intervention MeSH terms: Disinfectants
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label randomized control trial
Masking: None (Open Label)
Masking description: Data analysis will be blinded to assignment including the principal investigator.
Enrollment: 154.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cesarean; Wound care; Wound complication; Surgical site infection

Summary:

      This will be an open label pilot randomized controlled clinical trial. Women undergoing
      cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine
      gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-50 years of age.

          -  Women ≥ 24 weeks' viable gestation.

          -  To undergo cesarean delivery.

          -  Admission BMI ≥ 35.

        Exclusion Criteria:

          -  Patient unwilling or unable to provide consent.

          -  No prenatal care or a non-resident patient who is unlikely to be followed-up after
             delivery.

          -  Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g.
             transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or
             other.

          -  Decision not to have skin closure (e.g. secondary wound closure, mesh closure).

          -  Current skin infection.

          -  Coagulopathy.

          -  High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled
             hysterectomy, bowel or adnexal surgery).

          -  Known allergy to CHG.

          -  Incarcerated individuals.

          -  Chorioamnionitis.

          -  Subjects participating on other treatment trials or studies that would interfere with
             the current study's primary outcome.
Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Passive enhanced safety surveillance
Intervention description: Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged <9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1060.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pilot study; Safety surveillance; Quadrivalent seasonal influenza vaccine; Influenza

Summary:

      The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on
      enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and
      aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination
      with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit
      Tetra in Germany, Fluarix Tetra in Spain).

      This study may help to inform decisions regarding future influenza vaccine safety
      surveillance for influenza vaccines in Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol (e.g., complete the ADR card, return for the next
             scheduled visit or return the ADR card by mail within a timely manner).

          -  A male or female subject vaccinated with GSK's quadrivalent seasonal influenza vaccine
             (one or two dose schedule) according to the routine medical practices between 01
             October 2018 and 31 December 2018.

          -  Subjects aged 6 months or above at the time of the vaccination according to the
             countries' specificities.

          -  Written informed consent/informed assent obtained from the subjects/subjects'
             parent(s)/Legally Acceptable Representative(s) (LARs).

        Exclusion Criteria:

        • Child in care.
A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])
Condition: Nephrolithiasis; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Nephrolithiasis; Kidney Calculi
Intervention: nitrofurantoin monohydrate/macrocrystalline capsules; ampicillin; gentamicin; vancomycin; ceftriaxone
Intervention description: 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily; IV (2 g); IV (5 mg/kg); IV (1 g); IV (2 g)
Intervention MeSH terms: Vancomycin; Gentamicins; Ceftriaxone; Ampicillin; Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      When patients are going to have surgery to remove large kidney stones (percutaneous
      nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of
      prophylactic preoperative oral antibiotics; currently both the use of prophylactic
      preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be
      within standard-of-care.

      This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics
      to determine if the use of preoperative prophylactic antibiotics decreases the postoperative
      risk of localized urinary tract infection (UTI) and/or systemic infection that started in the
      urinary tract (sepsis or urosepsis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal stone of any size for which PCNL is recommended

        Exclusion Criteria:

          -  eGFR < 60 mL/min/1.73 m2

          -  cirrhosis and/or hepatitis

          -  Pregnancy

          -  Positive preoperative urine culture within 2 weeks

          -  History of temperature >=38.3 C associated with nephrolithiasis or sepsis thought to
             be due to urinary source within 12 months prior to randomization

          -  Current internalized ureteral stent, nephrostomy tube, or nephroureteral stent

          -  Antibiotic use within 2 weeks prior to randomization

          -  Severe hydronephrosis (defined by > =2cm in largest dimension) preoperatively as
             judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy.
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Condition: HIV/AIDS; Substance Use Disorders; Adherence, Medication
MeSH terms: Substance-Related Disorders
Intervention: Digital pill; Truvada
Intervention description: Digital pills over encapsulating Truvada; Truvada prescribed with digital pills for PrEP
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Single group pilot demonstration project
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PrEP; Substance Use Disorder; Digital Pills; Medication Adherence

Summary:

      This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with
      substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected
      MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills
      over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of
      using digital pills in this study population as well as understand the acceptability of
      digital pills for adherence measurement using semi-structured individual interviews.
      Additionally, the investigators will measure adherence over time, as well as episodes of
      suboptimal PrEP adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          1. MSM (cisgender male)

          2. Self-reported use of non-alcohol substances of abuse in past 6 months

          3. Currently taking PrEP

          4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and
             syphilis)

          5. Age 18 or older

        Exclusion Criteria:

          1. Does not speak English

          2. HIV positive

          3. Identifies as transgender

          4. Estimated creatinine clearance <60ml/min

          5. Active hepatitis B treatment

          6. Does not own a smartphone

          7. Taking proton pump inhibitors

          8. History of Crohn's disease or ulcerative colitis

          9. History of bowel surgery, gastric bypass, bowel stricture

         10. History of GI malignancy or radiation to abdomen

         11. Unable/unwilling to ingest digital pill
Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Rejuvesol; Blood transfusion
Intervention description: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this proposal is to test the feasibility of red blood cell (RBC)
      rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of
      RBC rejuvenation in this population to determine if a larger clinical trial powered to
      definitively characterize the benefits of rejuvenation is warranted.

      This is a small pilot study is to see if restoring important energy molecules (ATP and
      2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution
      (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects
      will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6
      transfusions (over approximately a 6-month period) in a pre-defined order to maximize
      detection of any signal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable, compliant, chronically transfused sickle cell disease (SCD) patients

          -  Currently maintained crisis-free with repeated RBC therapy for at least 3 consecutive
             sessions

          -  ≥18 years old

          -  Have Hb SS disease

          -  Have the capacity to give informed consent

        Exclusion Criteria:

          -  Baseline need for washed RBCs

          -  Pre-treatment SaO2 < 92%.
Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty
Condition: Rhinoplasty; Non-steroidal Ant Inflammatory Drugs; Opioid Use
Intervention: Norco; NSAID
Intervention description: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco); Ibuprofen 400mg for post-operative pain
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of oral opiate pain
      medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative
      rhinoplasty pain. This study will also evaluate potential contributing factors affecting the
      efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs
      in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used
      for post-operative pain. The study will then compare which is more effective in controlling
      post operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either
             obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical
             techniques utilized will be included. This will include patients that undergo
             additional procedures during the rhinoplasty including osteotomies, turbinate
             reduction, septoplasty, nasal valve repair and ear cartilage graft.

        Exclusion Criteria:

          -  Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure
             as this is known to cause significant pleuritic chest pain.

          -  Patients receiving functional endoscopic sinus surgery concurrently with the
             rhinoplasty will be excluded.

          -  Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who
             have other comorbidities that prevent them from taking NSAIDs.

          -  Patients with a history of radiation, active head and neck malignancy or other pain
             disorders such as various rheumatologic diseases will be excluded to decrease
             confounding factors in the control of pain.