bioihbjkbjnl/mcl2 huggingface dataset:
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Condition: HIV
MeSH terms: Fibrosis
Intervention: Lisinopril; Placebo
Intervention description: Lisinopril 20mg QD x 24 weeks; Placebo QD x24wks
Intervention MeSH terms: Lisinopril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Lymphoid fibrosis

Summary:

      The investigators propose a proof-of-concept, pathogenesis-oriented, randomized,
      placebo-controlled pilot study to assess whether the addition of an angiotensin converting
      enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses
      lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune
      responses and an accelerated clearance of the latent reservoir.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Stable HAART with maintenance of plasma HIV RNA levels below level of detection (<
             40-75 copies/mL) for ≥ 12 months

          -  > 90% adherence to HAART within preceding 30 days

        Exclusion Criteria include:

          -  Screening systolic blood pressure < 110mm Hg or diastolic blood pressure < 60mm Hg

          -  Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone
             antagonist

          -  Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease

          -  Pregnant/breastfeeding women.
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: decitabine; azacitidine
Intervention description: decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days; azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
Intervention MeSH terms: Azacitidine; Decitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDS; Myelodysplastic Syndromes

Summary:

      The purpose of this study is to compare the response of patients with Intermediate or High
      Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
    

Eligibility criteria:

        Inclusion Criteria

        Subjects who meet all of the following criteria may be included in the study:

          1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1
             transfusion dependent, Intermediate-2, or High-risk [defined by International
             Prognostic Scoring System (IPSS) score of ≥0.5] and recognized French-American-British
             (FAB) classifications

          2. Male or female, 18 years of age or older with signed informed consent

          3. Adequate renal function

          4. Demonstrated normal liver function

          5. Female subjects of childbearing age must have negative pregnancy test within 1 week of
             study entry and agree to use adequate contraception for the duration of the trial and
             for a minimum of six months after last dose of decitabine or azacitidine received.

          6. Male subjects must agree to use adequate contraception for the duration of the trial
             and for a minimum of six months after last dose of decitabine or azacitidine received.

        Exclusion Criteria

        Subjects who meet any of the following criteria will be excluded from participation in the
        study:

          1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering
             study (permitted if > 2 weeks from study entry and if recovered from toxic effects of
             therapy)

          2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing
             signs or symptoms of infection and without improvement despite appropriate treatment)

          3. Pregnancy or current lactation

          4. Significant concurrent disease, illness, or psychiatric disorder

          5. Treatment with an investigational agent 30 days prior to the first dose of decitabine
             or azacitidine
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
Condition: Skin Diseases, Bacterial
MeSH terms: Infections; Skin Diseases, Bacterial; Skin Diseases
Intervention: Tigecycline; ampicillin-sulbactam
Intervention description: Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours); Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.
A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.
Intervention MeSH terms: Ampicillin; Tigecycline; Sulbactam; Sultamicillin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 550.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: skin infection; antibiotics

Summary:

      The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline
      with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of
      a complicated skin and/or skin structure infection (cSSSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of complicated skin or skin structure infection

          -  Male or female, 18 years or older

          -  Need for intravenous treatment for 4 to 14 days

        Exclusion Criteria:

          -  Skin infection that can be treated by surgery & wound care alone

          -  Diabetic foot ulcers or bedsores where the infection is present longer than 1 week

          -  Poor circulation such that amputation of the infected site is likely within a month
             Other exclusions apply
Pain Perception During Vulvar Biopsy
Condition: Any Condition Requiring Vulvar Biopsy
Intervention: EMLA; Lidocaine
Intervention description: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.; Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: vulvar biopsy

Summary:

      The purpose of this study is to compare pain control during vulvar biopsy following either
      (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and
      prilocaine 2.5%) cream or (2) injection of 1% lidocaine. We hypothesize that lidocaine will
      provide better biopsy analgesia, but the benefit will be offset by the pain of lidocaine
      injection compared to EMLA application, thus there will not be a significant difference in
      highest pain scores between the two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females above age 18 presenting to Duke Gynecology Oncology clinic for vulvar biopsy

          -  Able to provide informed consent in English and agree to the risks of the study

        Exclusion Criteria:

          -  Not able to provide informed consent

          -  Vulvar biopsy on a hair bearing surface
Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia
Condition: Myringotomy
MeSH terms: Psychomotor Agitation; Emergence Delirium
Intervention: Dexmedetomidine
Intervention description: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).
All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Emergence Agitation; Myringotomy; Children; General Anesthesia

Summary:

      The investigators are inviting your child to participate in this research study because your
      child is having myringotomy (putting a tiny incision in the eardrum with or without tube
      insertion) under general anesthesia.

      The purpose of this study is to determine whether a single injection of Dexmedetomidine
      (study medication) decreases the frequency of awaking from anesthesia frightened or agitated
      in children having myringotomy surgery as compared to those children who receive placebo
      (sterile saltwater).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I or II (American Society of Anesthesiology classification ASA I means patients
             without systemic disease, ASA II means patients with one controlled systemic medical
             disease eg: Diabetes, Hypertension.)

          -  Between the ages of 1 and 10 years

          -  Undergoing BMT under general anesthesia.

        Exclusion Criteria:

          -  ASA III or higher (Patients with 2 or more medical systemic disease that is not under
             control, eg: uncontrolled Diabetes)

          -  Congenital diseases

          -  Coagulation disorders

          -  Known allergic reaction to dexmedetomidine

          -  Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal,
             neurological or endocrine functions

          -  Severe upper airway infection

          -  Predicted difficult airway

          -  Preexisting psychiatric disorders
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Condition: Bleeding; Surgical Blood Loss
MeSH terms: Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
Intervention: Tranexamic Acid
Intervention description: Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The pharmacy will prepare 1 syringe of 50 ml of topical TA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Cardiac surgery

Summary:

      The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of
      application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in
      patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will
      assess the feasibility to perform a large randomized international trial exploring this
      objective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female >= 18 years old

          -  Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and
             median sternotomy

          -  Provide written informed consent

        Exclusion Criteria:

          -  Poor (English) language comprehension

          -  Minimally invasive valve surgery

          -  Off-pump procedures

          -  Emergency operations

          -  Known history of increased bleeding disorder

          -  Thromboembolic disease

          -  Allergy to tranexamic acid

          -  Severe renal impairment (eGFR <30 mL/min/1.73m2 )
Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Body Weight
Intervention: Metformin XR
Intervention description: Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 371.0
Sex: All
Minimum age: 17 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effect of the baseline body mass index (BMI)
      on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with
      newly diagnosed type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Written Informed Consent

          -  Age≥ 17 and <80 years,

          -  Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)

          -  Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic
             medication therapy before, or having received anti-diabetic medication ≤ 14 days but
             not received any antidiabetic medication within the last 1 month prior to enrollment)

          -  HbA1c ≥ 7.0% and ≤10.0%

        Exclusion Criteria:

          -  Women of child bearing potential

          -  body mass index (BMI)≥35 Kg/m2 or BMI <18.5 Kg/m2

          -  Hemoglobin A1c (HbA1c)>10.0% or <7.0%

          -  Active liver disease and/or significant abnormal liver function

          -  Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without
             coma

          -  Congestive heart failure defined as New York Heart Association (NYHA) class III or IV
             and /or left ventricular ejection fraction ≤40%

          -  Significant cardiovascular history with the past 6 months

          -  Severe retinopathy, persistent uncontrolled hypertension (SBP≥180mmHg, or DBP≥105mmHg)

          -  Severe chronic gastrointestinal disease

          -  History of alcohol abuse or illegal drug abuse within the past 12 months

          -  Diagnosed anemia

          -  Creatine kinase ≥3 X ULN

          -  Serum creatinine ≥1.5 mg/dL(133μmol/L) [males], ≥1.4 mg/dL(124 μmol/L)[females]

          -  Alanine amino transferase (ALT) and/or aspartate amino transferase (AST)> 1.5 X ULN
             and/or total bilirubin > 2 X ULN

          -  Hemoglobin <12g/dL [males], <11g/dL [females]

          -  Allergies and Adverse Drug Reactions

          -  Prohibited Treatments and/or Therapies

          -  Prisoners or subjects who are involuntarily incarcerated

          -  Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical (eg, infectious disease) illness

          -  Subjects decline to participate
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Favor one of two thiazides for new prescriptions & attempt target dose
Intervention description: Providers will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prescribing patterns; thiazide; chlorthalidone; hydrochlorothiazide; target dose; cluster randomized trial

Summary:

      This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead
      of putting single patients into one of two drug groups, the investigators will assign the
      doctors who prescribe these drugs for high blood pressure into two groups. One group of
      doctors has agreed to prescribe mostly ("favor") one drug, chlorthalidone, if that drug would
      be a good choice for a patient. The other group has agreed to prescribe mostly
      hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be
      protective in other trials. If the doctors mostly prescribe the drug they agreed to favor,
      the investigators will be able to compare outcomes, like heart attacks, in the two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  VA prescribers of thiazides for hypertension

        Exclusion Criteria:

          -  at non-participating VA sites
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Condition: Parenteral Nutrition Associated Liver Disease
MeSH terms: Liver Diseases
Intervention: Omegaven
Intervention description: 1 gram/kg/day daily until on feeds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Parenteral nutrition associate liver disease; TPN cholestasis; TPN Associated Liver Disease

Summary:

      Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a
      long period of time frequently develop liver damage. The fat used is called intralipid and is
      made from soybean oil. There is a suggestion in the literature that using fish oil based fats
      called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer
      babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver
      damage reverses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants in the newborn intensive care unit

          -  TPN cholestasis of at least 2.5 mg/dl

          -  Anticipated TPN treatment for at least one month

          -  signed informed consent

        Exclusion Criteria:

          -  Enrollment in another trial

          -  Lack of consent
Telemedicine Outreach for Post Traumatic Stress in CBOCs
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Telemedicine Outreach for PTSD
Intervention description: The intervention involves an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and uses telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager educates/activates patients, identifies preferences, overcomes treatment barriers, monitors symptoms, side-effects and adherence, identifies psychiatric comorbidities, and encourages patient self-management. Tele-pharmacists provide medication management by phone. Tele-psychologists provide Cognitive Processing Therapy via interactive video. Tele-psychiatrists supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: telemedicine; rural; veterans; care management; psychotherapy

Summary:

      The purpose of this study is improved outcomes for veterans with Post Traumatic Stress
      Disorder (PTSD) treated in small VA Community Based Outpatient Clinics (CBOCs). Although
      psychotherapy and pharmacotherapy treatments for PTSD have been proven to be efficacious in
      controlled trials, geographic barriers often prevent veterans from accessing these
      evidence-based treatments. Telemedicine technologies will be used to overcome geographic
      barriers to care. Specifically, we will evaluate the Telemedicine Outreach for PTSD (TOP)
      intervention which is based on the principals of the Chronic Care Model and Disease
      Management, and builds on the evidence base of quality improvement for depression in primary
      care settings. The TOP intervention will employ an off-site PTSD care team
      (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will
      use telemedicine technologies (telephone, interactive video and electronically shared medical
      records) to treat CBOC patients with a newly emerging or chronic PTSD. We hypothesize that
      study participants randomized to the TOP intervention will receive higher quality of care and
      experience better outcomes compared to study participants randomized to treatment as usual.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnostic Criteria for PTSD (CAPS),

          -  veterans,

          -  treated in CBOC

        Exclusion Criteria:

          -  schizophrenia,

          -  bipolar disorder,

          -  current substance dependence,

          -  current specialty PTSD treatment at VA Medical Center,

          -  no access to telephone,

          -  hearing or speech impediment,

          -  terminal illness,

          -  non-capacity to consent