bioihbjkbjnl/mcl2 huggingface dataset:
Physiologic Effects of RBC Transfusion
Condition: Red Blood Cell Transfusion
Intervention: Fresh red blood cell (RBC) transfusion; Storage-aged red blood cell (RBC) transfusion; Electronic infusion pump
Intervention description: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.; 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.; A programmable, electronic infusion pump (Baxter, Inc) will be used for intravenous transfusion of units of packed red blood cells (RBC). The pump will be programmed to deliver 1 unit of packed RBC per hour.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic anemia; Cardiopulmonary testing; Transfusion-dependent anemia

Summary:

      The purpose of this study is to determine how red blood cell transfusions, particularly the
      length of storage time of units of packed red blood cells, affects the cardiovascular
      function in patients receiving transfusions. This study will also determine the most ideal
      way of storing and processing blood, and assess how transfusion affects a person's ability to
      exercise and how their blood vessels relax and contract.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subjects with any condition resulting in transfusion-dependent anemia

        Exclusion Criteria:

          -  Age <21 or >80 years

          -  Pregnancy

          -  Acute infection in previous 4 weeks

          -  Active substance abuse within the past year

          -  Inability to give informed consent

          -  Inability to return for follow-up

          -  The presence of alloantibodies that would limit the blood bank's ability to obtain
             correctly aged red blood cell (RBC) units
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Condition: Tardive Dyskinesia (TD)
MeSH terms: Dyskinesias; Tardive Dyskinesia; Substance Withdrawal Syndrome
Intervention: Valbenazine; Placebo oral capsule
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the
      potential for clinical dependence and withdrawal symptoms associated with valbenazine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment, and follow-up periods of the study.

          2. Have one of the following clinical diagnoses for at least 3 months before screening:
             Schizophrenia, Schizoaffective Disorder, or Mood Disorder

          3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before
             screening.

          4. Be on stable doses if using maintenance medication(s) for schizophrenia or
             schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on
             stable doses of a mood stabilizer.

          5. Be in general good health.

          6. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month
             before screening.

          2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.

          3. Have a significant risk of suicidal or violent behavior.

          4. Have a known history of neuroleptic malignant syndrome.

          5. Have a known history of long QT syndrome or cardiac arrhythmia.

          6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          7. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine
             clinical study.

          8. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          9. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

         10. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg,
             tetrabenazine, deutetrabenazine).

         11. Are currently pregnant or breastfeeding.

         12. Have HIV or hepatitis B.
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide; Placebo
Intervention description: Oral, once daily; Oral, one daily
Intervention MeSH terms: Linaclotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to determine the effect of linaclotide on abdominal girth in
      IBS-C participants with the baseline symptoms of abdominal bloating and an increased
      abdominal girth.
    

Eligibility criteria:

        Inclusion Criteria:

        • Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal
        bloating and abdominal girth

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has both clinically significant findings and unexplained clinically
             significant alarm symptoms

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
Condition: Smoking Cessation
Intervention: Nicoderm Patch
Intervention description: Nicotine replacement therapy patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass Surgery (CABG); Nicotine Replacement Therapy (NRT)

Summary:

      This study will determine whether or not patients who use a Nicotine Replacement Therapy
      (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after
      their surgery and have fewer post-operative complications
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is currently smoking >5 cigarettes/day for the past 30 days; there is no
             evidence that NRT is useful in those who smoke <5cpd.

          2. Patient is able to participate and willing to provide informed consent; participants
             will need to follow directions and adhere to the medication usage instructions as
             outlined in the informed consent document.

          3. Patients is willing to be contacted by phone for follow up at 1 month and 6 months
             post-discharge; these time points will assess our final outcome of cessation at 6
             months post-discharge.

        Exclusion Criteria:

          1. Patient is scheduled for surgery in < 7 days; most patients need to be using NRT
             consistently for 2 weeks for it to be fully effective.

          2. Patient is currently using a smoking cessation product (i.e. nicotine containing
             patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette,
             varenicline, buproprion) or has used a smoking cessation aid consistently for more
             than 72 consecutive hours with the intent to reduce cigarette consumption or quit
             smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will
             ensure the effects of the study patches will be assessed without any contamination
             from other cessation products.

          3. Patient is willing to refrain from using any other cessation products (nicotine
             containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic
             cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the
             usage and side effects with the study patches.

          4. Patient is allergic to the adhesive on the nicotine replacement therapy patch.

          5. Patient is unable to read and understand English or French; study materials will only
             be supplied in these two languages.
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Regadenoson
Intervention description: Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure the changes in cardiac function during a Lexiscan
      pharmacologic stress test using cardiac magnetic resonance imaging test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myocardial rest/regadenoson stress perfusion PET study within 60 days

          -  Normal rest LVEF (greater than or equal to 50%)

          -  No change in symptoms or treatment between the PET and the MRI study

          -  Willing to consent to the study

          -  Male or female who is either post-menopausal, surgically sterile, or if has a
             childbearing potential, a negative pregnancy test within 2 days prior to the MRI
             study.

        Exclusion Criteria:

          -  Renal dysfunction (estimated glomerular filtration rate < 60 mL/min/1.73m2) within 6
             months

          -  Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)

          -  Patient size exceeds MRI bore/table limits: (Max body diameter > 60 cm, weight > 136
             kg)

          -  History of gadolinium contrast allergy or intolerance

          -  Second or third degree AV block

          -  Sinus node dysfunction

          -  Acute myocardial infarction (past 3 months)

          -  Actively wheezing or with acute asthma 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 regadenoson
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: onabotulinumtoxinA; Topiramate
Intervention description: 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.; Topiramate up to a maximum oral dose of 100 mg/day.
Intervention MeSH terms: Topiramate; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative)
      treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chronic migraine

          -  More than 15 headache days in a 28 day period (headaches that last more than 4 hours
             and/or require treatment with prescription medication).

        Exclusion Criteria:

          -  Taking opioid-containing products for acute headache treatment more than 8 days during
             a 28-day period

          -  Previous treatment with botulinum toxin of any serotype for any reason

          -  Previous treatment with topiramate

          -  On a ketogenic diet (high in fat, low in carbohydrates)

          -  History of acute myopia or increased intraocular pressure

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
             or any other significant disease that might interfere with neuromuscular function

          -  Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental
             splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to
             screening.
Use of Sitagliptin to Decrease Microalbuminuria
Condition: Type 2 Diabetes; Microalbuminuria
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo
Intervention description: Sitagliptin 100 mg/day for 3 months; Placebo 1 pill/day for 3 months
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: microalbuminuria; type 2 diabetes

Summary:

      The people being asked to participate in this study have type 2 diabetes and abnormal levels
      of protein in their urine. This indicates that they are starting to develop diabetic kidney
      disease. The standard treatment for this is the use of one of two blood pressure medicines,
      either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker
      (ARB). However, these medicines are not always completely effective in stopping/reversing the
      kidney disease. Some studies have previously suggested that another type of medicine, called
      sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from
      getting worse.

      This study is being performed to test the effectiveness of sitagliptin as compared to a
      placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it
      will reduce protein levels in their urine. Protein levels in the urine are a marker of the
      severity of kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Albumin/creatinine ratio between 30-299 mg/dl.

          -  type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%.

          -  Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three
             months prior and during the trial.

          -  Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more.

          -  Age between 18-75 years old.

          -  For women: at least two years postmenopausal, surgically sterile, or using an
             acceptable contraceptive regiment to include oral contraceptive pill (OCP),
             intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin
             implant and negative urine pregnancy test at trial start.

        Exclusion Criteria:

          -  Pregnancy.

          -  GFR less than 60 mL/min/73m2.

          -  Have a history of malignancy other than basal cell or squamous cell skin cancer and
             have not yet been treated, are currently being treated, or were diagnosed less than 5
             years prior to Visit 1.

          -  Advanced liver disease.

          -  Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least
             4 months before the study start.

          -  Psychiatric condition that would prevent subject from following directions. Per PI
             discretion.
NSAID Use in Postpartum Hypertensive Women
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Acetaminophen; NSAID
Intervention description: Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements; Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: Female
Minimum age: 14 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and
      deliver an infant via vaginal delivery will be placed into two groups in the postpartum
      period. One group will receive Ibuprofen for pain control and the other group will be given
      Tylenol. Blood pressures during the postpartum period will then be collected and compared in
      order to see if NSAIDs use increases blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  vaginal delivery

          -  diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia

          -  preeclampsia without severe features

          -  preeclampsia with severe features gestational hypertension without severe range blood
             pressures

          -  gestational hypertension with severe range blood pressures

          -  singleton pregnancies

        Exclusion Criteria:

          -  Cesarean Delivery

          -  no diagnosis of hypertensive disorder

          -  chronic or acute renal disease

          -  allergy to ibuprofen or acetaminophen

          -  lupus

          -  multiple order pregnancies (twins, triplets)

          -  Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/
             current use of illegal drugs
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Condition: Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Intervention: platelet-rich plasma injection; Kenalog 10 MG/ML Injectable Suspension
Intervention description: platelet-rich plasma injection; 4 mL corticosteroid injection
Intervention MeSH terms: Triamcinolone Acetonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the clinical response of intra-articular platelet
      rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular
      impingement (FAI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic FAI

          -  Clinical and radiographic evidence of FAI

          -  Patients able to provide consent to study participation

          -  Completion of 6 weeks of physical therapy program

        Exclusion Criteria:

          -  Established Osteoarthritis (Kellgren-Lawrence > 3)

          -  Minimum joint space > 2 mm as measured on AP radiograph

          -  Hip dysplasia (center edge angle < 20° on AP radiograph)

          -  Patients with clinically significant cardiovascular, renal, hepatic, endocrine
             disease, cancer or diabetes

          -  Patients with ongoing infection including HIV and Hepatitis

          -  Patient with history of osteomyelitis/septic arthritis

          -  Anticoagulation therapy

          -  Patients who are pregnant or breast feeding

          -  Patients with systemic, rheumatic or inflammatory disease of the knee or
             chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee
             associated with juxta-articular Paget's disease of the femur or tibia, hemophilic
             arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and
             synovial chondromatosis

          -  Patients taking immunosuppressant medication

          -  Patients with abnormal hematology or serum chemistry lab results

          -  Patients receiving injection to treatment knee within 2 months of study enrollment

          -  BMI greater than 35 or less than 20