bioihbjkbjnl/mcl2 huggingface dataset:
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Parcopa; carbidopa-levodopa (Sinemet)
Intervention description: at subjects current stable dose of comparator; at subjects current stable dose
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 31 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's disease; time to "on"; delayed on

Summary:

      To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth,
      works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's
             disease for at least three years duration

          -  Patients requiring levodopa for their PD

          -  Good subjective response to levodopa

          -  Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose
             failures

          -  A UPDRS -off- motor score of at least 25

          -  Subjects willing to give informed consent

          -  Subjects who are able and willing to comply with study procedures

          -  If female of child-bearing potential, will use one of the approved birth control
             measures:

               1. Hormonal contraceptives

               2. Spermicidal and barrier

               3. Intrauterine device

               4. Partner sterility

        Exclusion Criteria:

          -  Subjects with evidence of significant dementia

          -  Subjects with significant oral lesions

          -  History of unstable cardiac disease including angina or congestive heart failure
             within 3 months prior to study entry

          -  History of clinically significant renal disease including renal insufficiency of
             sufficient degree to require adjunctive treatment or dietary restrictions

          -  History of clinically significant hepatic disease, including previously documented
             cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.

          -  Subjects with poor response to levodopa

          -  Women who are pregnant, breast-feeding, or planning to become pregnant during this
             study are excluded from participation due to unknown effects of the study drug on the
             fetus.
Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Doxycycline 100mg; Aczone 5% gel
Intervention description: Doxycycline 100mg by mouth once daily; Aczone 5% gel twice daily
Intervention MeSH terms: Doxycycline; Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 12 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel
      following combination treatment with with doxycycline and Aczone 5% gel can maintain
      therapeutic response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient, male or female subjects of any race, age 12 or older. Female subjects of
             childbearing potential must have a negative urine pregnancy test result at Baseline
             and practice a reliable method of contraception throughout the study;

          -  Facial acne vulgaris characterized by the following:

        IGA Score >3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial
        non-inflammatory lesions (open/closed comedones)

          -  Able to understand and comply with the requirements of the study and sign Informed
             Consent/HIPAA Authorization forms

        Exclusion Criteria:

          -  Female subjects who are pregnant (positive urine pregnancy test), breast feeding, or
             who are of childbearing potential and not practicing a reliable method of birth
             control.

          -  Allergy/sensitivity to any component of the test treatment (Section 5.2), lincomycin,
             tetracyclines, or sulfites.

          -  Subjects who have not complied with the proper wash-out periods for prohibited
             medications/procedures (Supplement 1)>

          -  History of clinically significant anemia or hemolysis.

          -  History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous
             colitis, or antibiotic-associated colitis).

          -  Skin disease/disorder that might interfere with the diagnosis or evaluation of acne
             vulgaris

          -  Evidence of recent alcohol or drug abuse

          -  Medical condition that, in the opinion of the Investigator, contraindicates the
             subject's participation in the clinical study

          -  History of poor cooperation, non-compliance with medical treatment or unreliability

          -  Participation in an investigational drug study within 30 days of the baseline visit.
Effect of Propranolol on Preventing Posttraumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Propranolol; Placebo
Intervention description: Propranolol short-acting or long-acting capsule; Placebo-matching propranolol short-acting or long-acting capsule
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post-Traumatic Stress Disorder; Prevention; Propranolol; Psychophysiology

Summary:

      This study will assess the effectiveness of taking propranolol soon after a traumatizing
      incident in reducing the incidence and severity of posttraumatic stress disorder in acutely
      traumatized individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Experienced an acute psychological traumatic event

          -  Heart rate of 80 beats per minute (bpm) or greater

          -  Understands English

        Exclusion Criteria:

          -  Traumatic event that occurred more than four hours before arrival to emergency
             department

          -  Physical injury that may affect safe participation (e.g., head injury)

          -  Systolic blood pressure less than 100 mm Hg

          -  Medical or surgical condition that poses a risk of shock

          -  Medical condition that may affect the safe administration of propranolol

          -  Previous adverse reaction to, or non-compliance with, a beta-blocker

          -  Current use of medication that may react badly with propranolol

          -  Elevated saliva alcohol level

          -  Presence of salivary opiates, marijuana, cocaine, or amphetamines

          -  Pregnant or breastfeeding

          -  Traumatic event reflecting ongoing victimization

          -  Psychiatric condition that may affect safe participation

          -  Unwilling or unable to commute to Boston for research visits

          -  Attending physician in emergency department does not advise participation
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Condition: Pain, Postoperative; Analgesics, Opioid; Analgesics, Non-Narcotic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Patient Satisfaction; Return to Work; Activity, Sexual
MeSH terms: Pain, Postoperative
Intervention: Abdominal wall block with liposomal bupivicaine
Intervention description: Abdominal wall block with liposomal bupivicaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TQL block, TAP block, donor nephrectomy, pain, patient satisfaction

Summary:

      A blinded randomized control trial in living kidney donors. The study group will receive a
      liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general
      anesthesia. The following study variables will be collected postoperatively following arrival
      in the post-anesthesia care unit. Current and maximum intensity pain scores will be
      documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24
      hours will be collected from the EHR and pain diary after discharge. Patient satisfaction
      will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire
      (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing
      notes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic donor nephrectomy

        Exclusion Criteria:

          -  Pregnancy

          -  Systemic or local infection at the potential block site.

          -  Allergy or hypersensitivity to the local anesthetic,

          -  Possible variations in surgical approach to donor nephrectomy other than what is
             defined in this protocol.

          -  Scarring or anatomic abnormality over the proposed injection site
Depakote ER in Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Depakote ER
Intervention description: Depakote ER
Intervention MeSH terms: Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar
      depression and to evaluate metabolic and GABA changes with Depakote ER administration using
      PET and MRI/MRS brain imaging techniques.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bipolar I, II or NOS currently suffering from depression

          -  Both: both female and male participants are being studied

          -  Adults 18 years and older of any race

        Exclusion Criteria:

          -  Schizophrenia or schizoaffective disorder and other disorders excluded at the
             discretion of the investigator's discretion

          -  Substance dependence within the past 3 months and abuse within the past 2 weeks prior
             to study.

          -  Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding
             marijuana, as long as dependence and abuse are ruled out according to DSM-IV)

          -  Significant risk harm to self or others based on history and mental status exam

          -  Clinically significant or unstable medical condition

          -  Unstable thyroid pathology and treatment initiated or altered within the past 3 months

          -  Clinically significant abnormal laboratory test results, vital signs, as judged by the
             investigators

          -  Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are
             judged to be unreliable in their use of contraception

          -  Subjects who failed (because of inefficacy or adverse effects) an adequate trial of
             Depakote; eligible patient's may not have received Depakote within 30 days of screen
Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Condition: Myocardial Blood Flow Reserve
Intervention: Regadenoson; Rubidium-82
Intervention description: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PET; Lexiscan; Regadenoson; Rubidium; Blood Flow Reserve; Myocardial Perfusion; Quantitated Myocardial Perfusion

Summary:

      The purpose of this study is to evaluate the consistency of quantitative peak stress
      myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2
      minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson)
      injection. It is anticipated that there will be no or minimal difference between the four
      delay times.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent normal clinically-indicated exercise myocardial perfusion SPECT, treadmill
             maximal exercise test or exercise echocardiographic study

          -  No change in symptoms between the exercise study and PET study

          -  Capable of providing written informed consent

          -  BMI 25-32 kg/m2

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Coronary Artery Calcium Score >25

          -  Second and Third Degree Atrioventricular Node Block

          -  Sinus Node Dysfunction

          -  Recent Syncope of unknown etiology

          -  Left ventricular hypertrophy per ECG or echocardiography

          -  Slowed circulation times

          -  Active wheezing or with acute asthmatic or bronchospastic attacks requiring changes in
             therapy within the past 30 days.

          -  Patients that have experienced a previous hypersensitivity reaction thought to be
             related to Lexiscan
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Spinal analgesia for labour pain; Epidural analgesia for labour pain
Intervention description: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique; Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be
      compared when given either intrathecally or epidurally in primiparous parturients during
      early phase of the labour.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primiparous parturients

          -  In early phase of labour (cervical dilatation at or under 5 cm)

          -  No prior opioids by any route of administration within past 120 min

          -  Pain at or over 80 mm on 0-100 mm visual analog scale during contraction

        Exclusion Criteria:

          -  Allergy for any of the medications used

          -  Contraindications for epidural/spinal analgesia

          -  BMI at the time of delivery under 20 or over 35 kg/m2
PEP uP Protocol in Surgical Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Intervention: PEP uP Protocol; Metoclopramide
Intervention description: Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.; Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked.
Intervention MeSH terms: Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: feeding protocol; enteral nutrition protocol; critically ill; surgical ICU; enteral nutrition; nutrition therapy

Summary:

      The main objective of this project is to asses for safety, feasibility and effectiveness of
      an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral
      Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical
      patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe,
      acceptable, and effectively increase protein and energy delivery to critically ill surgical
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  ICU admission within past 48 hours

          -  Initiation of tube feeds currently planned by the surgical ICU (SICU) team and primary
             surgical team

          -  Admitted by a surgical service to the SICU (not a medical ICU or neurology patient)

          -  Expected to remain mechanically ventilated for > 24 h and expected to require ICU care
             for > 72 h after screening

        Exclusion Criteria:

          -  Pregnancy

          -  Attending surgeon preference (they must agree to feeding their patient according to
             the protocol in either arm using the goal rate determined by the SICU team and the
             nutritionist)

          -  Contraindication to enteral nutrition (bowel obstruction, bowel discontinuity,
             proximal enterocutaneous fistula, and short gut syndrome)

          -  Do not resuscitate (DNR) status or goals of care that specify limitations in medical
             therapies

          -  Death expected within 24 hours
Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib
Condition: Metastatic Renal Cell Carcinoma (mRCC)
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Everolimus (RAD001)
Intervention description: Everolimus was used as commercially available formulated tablets of 10 mg strength
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney cancer; mRCC; metastic renal cell carcinoma; everolimus; sunitinib; pazopanib

Summary:

      Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with
      sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was
      evaluated in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with advanced renal cell carcinoma of a histological or cytological
             confirmation of clear cell renal carcinoma.

          -  Progression during or after a treatment with sunitinib or pazopanib given in a 1st
             line treatment situation for mRCC.

          -  Patients scheduled for treatment with everolimus.

          -  Patients with at least one measurable lesion at baseline as per RECIST v1.1.

        Exclusion Criteria:

          -  Patients who have received >1 prior systemic treatment for their metastatic RCC. Prior
             systemic treatment in an adjuvant setting is allowed.

          -  Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus,
             temsirolimus, everolimus).

          -  Patients who are using other investigational agents or who had received
             investigational drugs ≤ 2 weeks prior to study treatment start.

          -  Patients unwilling or unable to comply with the protocol.
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Condition: ESRD; Diabetes; CAPD; APD
Intervention: Physioneal; Dianeal; Extraneal; Nutrineal
Intervention description: Physioneal 40 or Physioneal 35; Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose); 7.5% Icodextrin; Amino Acids 1.1%
Intervention MeSH terms: Icodextrin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ESRD; Diabetes; CAPD; APD

Summary:

      Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal
      only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and
      Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured
      by the magnitude of change from the baseline value in the HbA1c levels.

      Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal
      only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control
      medication requirements, decreased incidence of severe hypoglycemic events requiring medical
      intervention, improved metabolic control, nutritional status, and Quality of Life. In a
      subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on
      abdominal fat and left ventricular (LV) structure and function will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. M/F patients 18 years of age or older

          2. Diagnosis of ESRD (GFR ≤ 15 mL/min)

          3. CAPD or APD using only Dianealand/or Physioneal, at least 1 exchange of 2.5% or 4.25%
             dextrose/day, no prescribed dry time

          4. DM (Type 1 and 2) on glycemic-control medication, for 90 days

          5. HbA1c > 6.0% but ≤ 12.0%

          6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

        Exclusion Criteria:

          1. Cardiovascular event within the last 90 days

          2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)

          3. Allergy to starch-based polymers

          4. Glycogen storage disease

          5. Maltose, or isomaltose intolerance

          6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30
             days

          7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77) at Screening.

          8. Serum urea > 30 mmol/L

          9. Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit,
             Day 1.

         10. Receiving rosiglitazone maleate