bioihbjkbjnl/mcl2 huggingface dataset:
Alternative Sedation During Bronchoscopy
Condition: Sedation
Intervention: Dexmedetomidine load; Ketamine load; Midazolam load; Fentanyl load; Dexmedetomidine maintenance; Ketamine maintenance; Midazolam demand; Fentanyl demand; Benadryl demand
Intervention description: Dexmedetomidine 1 µg/kg prior to bronchoscopy; Ketamine 30 mg bolus prior to bronchoscopy; 2 mg bolus prior to bronchoscopy; 50 µg bolus prior to bronchoscopy; 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average); 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average); 0.5 mg demand bolus at discretion of pulmonologist; 12.5 µg demand bolus at discretion of pulmonologist; 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Intervention MeSH terms: Diphenhydramine; Midazolam; Fentanyl; Dexmedetomidine; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: bronchoscopy

Summary:

      This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the
      use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in
      less respiratory depression while providing better compliance with the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults over the age of 18 scheduled for elective flexible bronchoscopy in the
             endoscopy suite or OR of HUP

        Exclusion Criteria:

          -  History of inability to complete bronchoscopy attributable to inadequate sedation

          -  Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%

          -  History of allergy to study medications

          -  Pregnancy

          -  A history of psychosis

          -  Any condition deemed likely by the pulmonologist or anesthesiologist to pose a
             significant risk due to elevation of blood pressure, including cerebral/aortic
             aneurysm, and or ischemic cardiovascular disease

          -  Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist

          -  A diagnosis of significant renal or hepatic impairment
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Condition: Breast Cancer; Obesity
MeSH terms: Breast Neoplasms; Obesity
Intervention: Doxorubicin; Cyclophosphamide
Intervention description: Dosed by the patient's treating physician according to local standard of care.; dosage form: IV, Dosage, frequency, and duration: According to local standard of care
Intervention MeSH terms: Cyclophosphamide; Doxorubicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Pharmacokinetics; Obesity; Doxorubicin; Cyclophosphamide; Weight

Summary:

      To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in
      participants who are normal weight (body mass index [BMI] < 25 kg/m2, overweight or class I
      obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that
      participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than
      participants who weigh less. Restated, the area under the drug-concentration time profile,
      also known as the AUC, in participants will decrease as participant weight increases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females, age 18 years of age or older, of all racial and ethnic origins that are
             scheduled to receive the first cycle of a single intravenous dose of doxorubicin (30
             minute infusion) and cylcophosphamide (30 minute infusion) as part of standard medical
             care for breast cancer. English and/or Spanish speaking participants are eligible to
             participate.

        Exclusion Criteria:

          -  Pregnant or nursing or unwilling to use a reliable contraception method during the
             study. The effects of doxorubicin and cyclophosphamide on pregnancy are unknown. In
             addition, the metabolic changes that accompany pregnancy may alter the
             concentration-time profile of doxorubicin or cyclophosphamide, so that the pregnancy
             and post-partum state would be a confounding variable.

          -  Participants unwilling to comply with study procedures.

          -  CrCl < 10 ml/min

          -  Participants requiring peritoneal or hemodialysis

          -  Serum bilirubin > 1.19 mg/dL

          -  Receipt of the following drugs that: a) Alter doxorubicin concentrations:
             carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib,
             valspodar, verapamil; b) Alter cyclophosphamide concentrations: cyclosporine,
             nevirapine, ondansetron; c) All other drugs will be reviewed during screening of the
             patient
Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy
Condition: Posterior Capsule Opacification; Ocular Hypertension
MeSH terms: Ocular Hypertension; Capsule Opacification; Hypertension
Intervention: Brinzolamide/Brimonidine FC; Brimonidine 0.2%; Artificial tears
Intervention description: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy; 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy; 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intervention MeSH terms: Brimonidine Tartrate; Lubricant Eye Drops; Dipivefrin; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, double masked comparative study
Masking: Double (Participant, Investigator)
Masking description: Patients are masked to their assignment by covering the labels on the bottles of the drugs administered The investigator responsible for the measurement of the intraocular pressure is also masked to the intervention administered to each patient.
Enrollment: 79.0
Sex: All
Healthy volunteers: No
Keywords: Nd-YAG capsulotomy; ocular hypertension; brimonidine; brinzolamide

Summary:

      To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine
      0.2% in preventing intraocular pressure (IOP) elevations after neodymium:
      yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients scheduled to undergo laser posterior capsulotomy due to posterior capsule
             opacification (PCO) after uneventful phacoemulsification cataract extraction with
             implantation of posterior chamber intraocular lenses (IOL/PC).

        Exclusion Criteria:

          -  baseline IOP greater than 21mmHg

          -  glaucomatous eyes, already under treatment with anti glaucomatic medications

          -  intraocular surgery except for uncomplicated cataract surgery

          -  previous photorefractive surgery

          -  active ocular inflammation or infection

          -  patients under systemic administration of medications known to affect IOP

          -  patients with severe respiratory or cardiovascular disease

          -  pregnant or breast feeding women, and individuals with known hypersensitivity or
             contraindication for administration of the medications tested

          -  a measurement of IOP > 30 mmHg at any time point of the study, or an increase from
             baseline >20 mmHg
The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
Condition: Post-tonsillectomy Pain; Post-tonsillectomy Activity; Post-tonsillectomy Hydration
Intervention: Lansoprazole; Placebo
Intervention description: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.; Placebo will also be administered based on weight.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tonsillectomy; Pain

Summary:

      This study was designed to determine whether post-operative pain following a tonsillectomy
      can be reduced by adding an antacid-like medication to the medications taken after surgery.
      It is hypothesized that even a small amount of stomach acid backing up and entering the mouth
      can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should
      help to decrease pain and reduce the amount of narcotic medication required for pain control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All healthy children ages 5-18 years scheduled for tonsillectomy and /or
             adenotonsillectomy for sleep disturbance secondary to airway obstruction at Children's
             Hospital Boston

        Exclusion Criteria:

          -  Patients on any medications other than the study drug (Lansoprazole or placebo),
             Amoxicillin®, and acetaminophen with or without codeine

          -  An underlying medical condition which would necessitate an alteration in the
             anesthetic regimen

          -  Patients allergic to any of the medications in the protocol

          -  History of chronic tonsillitis

          -  History of chronic pain conditions

          -  History of active gastro-esophageal reflux disease

          -  Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy)

          -  Cognitive/developmental disorders

          -  Inability to use a self-report pain scale
The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: celecoxib (Celebrex); Placebo
Intervention description: Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet; Placebo pill taken twice per day on each day of the diet
Intervention MeSH terms: Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 22 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Salt sensitivity of Blood Pressure

Summary:

      The purpose of this study is to determine if the drug Celebrex changes the way the kidney
      gets rid of salt and maintains blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men and women

        Exclusion Criteria:

          -  history of heart disease

          -  have had heart surgery

          -  high blood pressure

          -  diabetes

          -  cancer

          -  any other disease such as kidney or neurological diseases

          -  taking medications such as aspirin or medicines for your heart or blood pressure

          -  have asthma or are allergic to sulfa drugs

          -  body mass index greater than 30

          -  use tobacco

          -  pregnant

          -  women using oral contraceptives or hormone replacement therapy
Metabolic Abnormalities in HIV-infected Persons
Condition: Lipodystrophy; HIV Infection
MeSH terms: HIV Infections; Lipodystrophy
Intervention: Metformin; Pioglitazone
Intervention description: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.; Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Intervention MeSH terms: Metformin; Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Lipodystrophy; Insulin resistance; HIV infection

Summary:

      The purpose of this study is to examine the relationship between insulin resistance and
      changes in body fat distribution in HIV-infected persons. This study measures insulin
      sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the
      effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body
      fat in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-70 years

          -  Fasting insulin >12 μU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr
             oral glucose tolerance test

          -  Central fat deposition or Peripheral fat atrophy

          -  Fasting glucose ≤126 mg/dL

          -  BMI ≥18 and ≤35 kg/m2

          -  CD4 cell count ≥100 cells/mm3

          -  Stable antiretroviral regimen ≥12 weeks and HIV RNA <1000 copies

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Cardiac pacemaker or metal implant

          -  Liver enzymes >2.5x upper normal limit

          -  Alkaline phosphatase or prothrombin time >2x upper normal limit

          -  Serum creatinine >1.4 mg/dL

          -  History of congestive heart failure

          -  Hemoglobin <8 g/dL

          -  Alcohol abuse

          -  Pregnancy

          -  History of lactic acidosis

          -  Use of steroids

          -  Acute infection within last one month

          -  History of bladder cancer
Russian Kogenate Pediatric Study
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week; rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg); rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
Intervention description: rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week); rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week); rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for patients in this group
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Kogenate,; Children,; Factor VIII,; Hemophilia A,; Prophylactic

Summary:

      A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on
      bleeding events frequency and development of arthropathy in Previously Treated and Minimally
      treated Hemophilia A pediatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  Severe hemophilia A or moderate hemophilia A

          -  1-12 years of age

          -  Requiring treatment with FVIII

        Exclusion Criteria:

          -  Current or prior inhibitor or familial antecedents of inhibitor

          -  Surgery required during the study (9 months)

          -  Positive for HIV
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Condition: Stage 2 Systolic Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Intervention: valsartan, amlodipine, HCTZ; Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
Intervention description: combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study; losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study
Intervention MeSH terms: Losartan; Amlodipine; Valsartan; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 488.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; combination therapy; valsartan; cardiovascular diseases

Summary:

      This study will compare the antihypertensive efficacy and safety of a
      valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2
      systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and
      less than 200 mmHg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatient of 18 years of age or greater

          -  Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure
             (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization

          -  Patients who were able to participate in the study, and who gave written informed
             consent before any study assessment was performed.

        Exclusion Criteria:

          -  Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure
             (MSDBP) greater than or equal to 110 mmHg at Visit 1.

          -  Use of four (4) or more antihypertensive medications within 30 days of Visit 1.

          -  Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3)
             drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with
             a fixed-dose combination of two active medications represents two drugs).

          -  Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior
             to randomization.

        Other protocol-defined inclusion/exclusion criteria may apply
Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?
Condition: Kidney Failure, Acute; Kidney Failure, Chronic; Blood Platelet Disorders; Hemorrhage
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury; Blood Platelet Disorders; Hemorrhage
Intervention: measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy
Intervention description: measuring Platelet Function Analyser (PFA) -100 platelet function before kidney biopsy
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Platelet Function Analyser-100 (PFA-100); renal failure; kidney biopsy; bleeding; hematoma

Summary:

      The kidneys are highly vascular organs and any trauma or surgery poses risk of severe
      bleeding. Platelet function is an integral part of the blood clotting during the initial,
      so-called vascular phase. So far no universally accepted, easy test has been available to
      measure platelet functions. Renal failure is a condition generally associated with bleeding
      due to platelet dysfunctions. This study is exploring the utility of a novel platelet
      function test, called Platelet Function Analyser-100 to predict bleed after percutaneous
      kidney biopsy. Platelet Function Analyser-100 will be measure before kidney biopsy along with
      routine blood tests. Subjects will undergo renal ultrasound before and after renal biopsy to
      verify post-biopsy bleeding events.
    

Eligibility criteria:

        Inclusion Criteria:

        Will offer enrollment to essentially all patients undergoing standard percutaneous renal
        biopsy here at the University Medical Center. These are:

        age 18-80, Body Mass Index (BMI) <35, Modification of Diet in Renal Diseases (MDRD)
        calculated Glomerular Filtration Rate (GFR) >10 cc/minute/1.73 m2, Hematocrit >25, platelet
        count >100,000/mm3, normal activated Prothrombin Time (aPT)/activated Partial
        Thromboplastin Time (aPTT).

        Exclusion Criteria:

        (essentially the contraindications to a standard percutaneous renal biopsy) known bleeding
        disorder, history of prior bleeding with procedure or known ongoing bleeding at the time of
        the procedure, Hematocrit <25, Platelet count <100, abnormal aPT/aPTT pre biopsy, small
        kidney(s) < 8.0 cm multiple bilateral renal cyst or masses, hydronephrosis, active urinary
        tract infection, recent nonsteroidal anti-inflammatory drug use.

        -
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Intravenous Treprostinil
Intervention description: Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Intervention MeSH terms: Treprostinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Remodulin; 6-Minute Walk Test

Summary:

      This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated
      Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study
      RIV-PH-402 were eligible to enroll.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

        Exclusion Criteria:

          -  Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were
             found to be allocated to the Remodulin treatment group were not eligible to
             participate in this study.