bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Dsuvia
Intervention description: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
Intervention MeSH terms: Dsuvia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      In this case series study, the investigators are testing the hypothesis that sublingual
      sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care
      Unit (PACU) in ambulatory surgery patients taking Suboxone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age range 18-100 years

          -  Currently taking Suboxone

          -  ASA (American Society of Anesthesiology) physical score 1-3

          -  Able to provide a signed informed consent

          -  General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC
             (monitored anesthesia care) without the use of regional anesthesia

        Exclusion Criteria:

          -  Known allergic reactions to Dsuvia and its excipients

          -  Severe respiratory illness including exacerbation of asthma attack

          -  Significant intraoperative hemodynamic instability

          -  Use of Regional anesthesia techniques
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Alendronate
Intervention MeSH terms: Alendronate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 65 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This is a pilot study evaluating the recruitment strategies for sites and patients, data
      collection instruments, follow-up procedures, administrative processes, and the proposed
      management strategy for the future large scale national trial.
    

Eligibility criteria:

        Inclusion Criteria:

        1.Females 65+

        2.3+ years of alendronate (Fosamax/Binosto) use

        3. Valid social security number

        Exclusion Criteria:

          1. History of any other metabolic bone condition, such as Paget Disease of Bone

          2. Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.

          3. Has significant underlying illness that would be expected to prevent completion of the
             study (e.g., life-threatening disease likely to limit survival to less than 3 years)?

          4. HIV positive

          5. Involved in a conflicting (investigational drug) clinical trial
24-hr Intraocular Pressure Control With SIMBRINZA ®
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Vehicle
Intervention description: Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Brimonidine Tartrate; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate differences between treatments in mean change from
      baseline in 24-hr intraocular pressure (IOP) at Week 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either open-angle glaucoma or ocular hypertension;

          -  Able to attend all study related visits and be housed overnight at clinical site for
             the study assessments;

          -  Willing and able to sign an informed consent form;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential who are pregnant, intend to become pregnant during the
             study, breast-feeding, or not using adequate birth control;

          -  Diagnosed with any form of glaucoma other than open angle glaucoma or ocular
             hypertension;

          -  Ocular surgeries or procedures excluded by the protocol;

          -  Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;

          -  Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to
             approximately 20/80 Snellen) in either eye;

          -  Other protocol-specific exclusion criteria may apply.
Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
Condition: Hip Arthroplasty
Intervention: Extended Release Epidural Morphine (EREM); Placebo
Intervention description: A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline; A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hip resurfacing; hip arthroplasty

Summary:

      At Wake Forest University, the investigators have been using Extended Release Epidural
      Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having
      gynecologic surgeries and hip arthroplasties.

      Hypothesis:

      In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in
      conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in
      increasing proportion of patients who meet discharge criteria within 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A primary unilateral Birmingham hip arthroplasty

          -  Men and women 18-65 years

        Exclusion Criteria:

          -  Refusal of regional anesthesia

          -  Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter
             of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time
             greater than 30 seconds, or international normalized ratio of greater than 1.5)

          -  Allergy to morphine

          -  Obstructive sleep apnea

          -  Body mass index (BMI) greater than 40 kg/m2

          -  Pregnant or lactating

          -  Severe renal or hepatic disease
ASCEND: A Study of Cardiovascular Events iN Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Aspirin; Omega-3 Ethyl Esters; Placebo Aspirin; Placebo Omega-3 Ethyl Esters
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15480.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Cardiovascular Disease; Aspirin; Omega-3 fatty acids; Primary prevention; Randomized Controlled Trial; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; n-3 fatty acid

Summary:

      The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or
      supplementation with 1 gram daily omega-3 fatty acids or placebo prevents "serious vascular
      events" (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or
      death from vascular causes) in patients with diabetes who are not known to have occlusive
      arterial disease and to assess the effects on serious bleeding or other adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females with type 1 or type 2 diabetes mellitus.

          -  Aged ≥ 40 years.

          -  No previous history of vascular disease.

          -  No clear contra-indication to aspirin.

          -  No other predominant life-threatening medical problem.

        Exclusion Criteria:

          -  Definite history of myocardial infarction, stroke or arterial revascularisation
             procedure.

          -  Currently prescribed aspirin, warfarin or any other blood thinning medication.
Plegridy Satisfaction Study in Participants
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: peginterferon beta-1a
Intervention description: 125 mcg administered subcutaneously (SC) every 2 weeks.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the
      satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with
      injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction
      Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are
      to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants'
      satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants'
      adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN
      beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on
      participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on
      participants' injection-system satisfaction; Evaluate the relationship between participants'
      satisfaction and adherence; Evaluate the relationship between participants' satisfaction and
      social-demographic factors (age, sex, employment working, level of education, etc) and
      clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate
      the treatment safety and tolerability.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria.

          -  Subjects with EDSS score between 0.0 and 5.0 at baseline.

        Key Exclusion Criteria:

          -  Pregnancy or breast-feeding.

          -  Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary
             of Product Characteristics.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)
Intervention description: Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor
Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
Intervention MeSH terms: Grazoprevir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: hemodialysis; peritoneal dialysis; renal failure; kidney transplant

Summary:

      Proof of concept, open-label single center study for the donation of HCV positive kidneys to
      HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission
      upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already
             be listed for isolated kidney transplant

          2. No available living kidney donor

          3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤
             1095 days of accrued transplant waiting time if blood type B or O.

          4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate
             <15mL/min/1.73m2 at the time of screening

          5. Weight ≥ 50kg

          6. Serum alanine transaminase (ALT) within normal limits

        Exclusion Criteria:

          1. AB blood type

          2. Body mass index (BMI > 35

          3. History of liver disease

          4. Pregnant or nursing (lactating) women

          5. Cardiomyopathy (LV ejection fraction < 50%)

          6. Positive crossmatch or positive donor specific antibodies

          7. Human immunodeficiency virus (HIV) positive

          8. Hepatitis C virus (HCV) RNA positive

          9. Hepatitis B virus (HBV) surface antigen positive

         10. Any contraindication to kidney transplant per MGH center protocol
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
Condition: Chronic Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696; Enalapril; Placebo matching enalapril; Placebo matching LCZ696
Intervention description: LCZ696 100 mg bid for 2 weeks followed by LCZ696 200 mg bid for 10 weeks. Treatment was administered as oral tablets.; Enalapril 5 mg bid for 2 weeks followed by enalapril 10 mg bid for 10 weeks. Treatment was administered as oral tablets.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.; Patients randomized to LCZ696 arm also received placebo matching enalapril (enalapril 0 mg tablets) to ensure the blinding during the entire course of the study.; Patients randomized to enalapril arm also received placebo matching LCZ696 (LCZ696 0 mg tablets) to ensure the blinding during the entire course of the study.
Intervention MeSH terms: Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LCZ696; sacubitril/valsartan; VO2peak; heart failure; systolic heart failure; heart failure with reduced ejection fraction; exercise capacity

Summary:

      The purpose of the study was to determine the effect of LCZ696 vs. enalapril on improvement
      of exercise capacity in patients with chronic heart failure with reduced ejection fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of chronic heart failure (NYHA class III) and reduced
             ejection fraction (LVEF ≤ 40%)

          -  Reduced ability to exercise, evidenced by VO2peak ≤ 18 ml/min per kg

          -  Patients had to be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d
             or equivalent for at least 4 weeks prior to the screening visit and until
             randomization visit.

        Exclusion Criteria:

          -  History of hypersensitivity or allergy to any of the study drugs, drugs of similar
             chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected
             contraindications to the study drugs

          -  Previous history of intolerance to recommended target doses of ACEIs or ARBs

          -  Known history of angioedema

          -  Requirement of treatment with both ACEIs and ARBs

          -  Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
             symptoms that may require intravenous therapy)

          -  Symptomatic hypotension

          -  Impaired renal function

          -  Pregnant or nursing (lactating) women
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: sacubitril/valsatran; valsartan; placebo to valsartan; placebo to sacubitril/valsartan
Intervention description: sacubitril/valsatran 100 or 200 mg BID; Valsartan 80 or 160 mg BID; placebo to valsartan 80 or 160 BID; placebo to sacubitril/valsartan 100 or 200 mg BID
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Heart failure with reduced left ventricular ejection fraction; LVEF; Cardiac dysfunction; Heart muscle dysfunction; Left ventricular (LV) dilation; Left ventricular hypertrophy; HF; AHF; CHF; CCF; acute heart failure; chronic heart failure; congestive heart failure; congestive cardiac failure

Summary:

      This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group
      study.

      The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared
      with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart
      failure (HF) and reduced systolic function using 11C-acetate positron emission tomography
      (PET) and echocardiography.
    

Eligibility criteria:

        Inclusion criteria:

          -  40-80 years of age

          -  Chronic HF with reduced EF (left ventricle EF 25-35%) and NYHA class II-III symptoms.

          -  Systolic BP 110-160 mm Hg

          -  Optimal standard HF therapy according to European Society of Cardiology (ESC)
             guidelines at a stable dose for at least 4 weeks before the screening visit.

        Exclusion criteria:

          -  Estimated glomerular filtration rate (eGFR) < 45 ml/min

          -  Serum potassium > 5.2 mmol/l and creatinine >1.5 x ULN
IV Acetaminophen as an Analgesic Adjunct
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: IV acetaminophen + 0.5 mg IV hydromorphone; Normal saline + 0.5 mg IV hydromorphone
Intervention description: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone; 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
Intervention MeSH terms: Acetaminophen; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Older adults; Elderly; Acute pain; IV acetaminophen; IV hydromorphone; Analgesia; Adjunctive analgesia

Summary:

      To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV
      hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED)
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV)
             opioids in the judgement of the treating attending physician

        Exclusion Criteria:

          -  Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly
             bias related to recent opioid use, since this may affect baseline levels of pain and
             need for analgesics.

          -  Prior adverse reaction to hydromorphone, morphine, or acetaminophen.

          -  Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months
             results in modulation of pain perception which is thought to be due to down-regulation
             of pain receptors. Examples of chronic pain syndromes include sickle cell anemia,
             osteoarthritis, fibromyalgia, and peripheral neuropathies.

          -  Alcohol intoxication: the presence of alcohol intoxication as judged by the treating
             physician may alter pain perception.

          -  Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation
             that may result in orthostatic hypotension.

          -  Heart Rate (HR) < 60/min: Opioids can cause bradycardia.

          -  Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or
             above on room air in order to be enrolled.

          -  Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been
             reported to intensify the effects of at least one opioid drug causing anxiety,
             confusion and significant respiratory depression or coma.

          -  Patients using transdermal pain patches
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine patch - transdermal; placebo
Intervention description: 21 mg patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine dependence; cigarette; smoking; nicotine replacement therapy; positron emission tomography

Summary:

      The proposed research will provide significant new gender-specific information of scientific
      and clinical relevance on the function of the mu-opioid system in nicotine dependence and
      therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to
      explain the differences in the prevalence of smoking in men and women, sex-specific
      differences in nicotine craving and withdrawal as well as the poorer therapeutic response to
      NRT. This work may pave the way to the design of improved pharmacotherapies that can more
      effectively target the endogenous opioid system in the treatment of nicotine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 - 60 years old

          -  must meet DSM-IV criteria for nicotine dependence and be actively smoking

        Exclusion Criteria: subjects must meet study guidelines for medical and mental health
        status.