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
Use of Metformin in Treatment of Childhood Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Intervention: Metformin; Placebo
Intervention description: Metformin in the form of 500mg tablets were administer to the Metformin group; A Placebo tablet physically and chemically similar to Metformin tablets except for the absence of the active ingredient was used
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 339.0
Sex: All
Minimum age: 8 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study expects to evaluate the use of metformin in the management of obese children.
      Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had
      been shown in the investigators previous work.

      This study will look at the effect of metformin on changes in insulin resistance, fatty liver
      state, body fat content, BMI and other metabolic derangement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese children (based on >+2SD of BMI to age on WHO 2007 standards)

        Exclusion Criteria:

          -  Children not of Sri Lankan origin

          -  Children who are not planning to live in Sri Lanka during the next one year

          -  Children with a secondary underlying cause for the overweight/obesity
RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
Condition: Acute Pain; Wound Care; Posttraumatic Stress Disorder
MeSH terms: Acute Pain; Stress Disorders, Post-Traumatic
Intervention: ketamine; Fentanyl
Intervention description: Information included in arm descriptions; Information included in arm descriptions
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, repeated exposure (twice daily, 7 days), safety and efficacy trial of Usual Care (fentanyl PLUS saline / placebo) versus Usual Care plus Study Drug Augmentation (fentanyl PLUS ketamine) in reducing acute pain severity assessed before, during and after wound care for acute burn injury in the Burn Center of an Academic Medical Center.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Pharmacy receives order from provider and then prepares the study drug in an unmarked, nondescript delivery system ("bag") and the study drug information is entered from the bag into the pump so that delivery that is timed and volume controlled per study protocol. This is hung next to patient, connected and started. Masked personnel include provider (order study drug protocol), nurse (wound care), data assessor (Research Assistant), and consenting participant (patient with acute burn).
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: opioid; ketamine

Summary:

      The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group
      trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine
      Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of
      Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual
      Care-Opiate (UC-O), dose/timing as per Burn Center protocol).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40%
             TBSA

          -  English speaking

          -  pain in emergency room during initial wound evaluation (on admission) greater than 5
             /10

          -  estimated length of stay greater than or equal to 5 days

        Exclusion Criteria:

          -  requiring endotracheal intubation and sedation,

          -  severe hearing impairment,

          -  cognitive impairment status - Mini-Mental State Examination (MMSE) </=20,

          -  diminished capacity unable to provide informed consent;

          -  Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)

          -  Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren; Placebo to Aliskiren
Intervention description: Aliskiren supplied in 150 mg and 300 mg tablets.; Placebo to Aliskiren matching 150 and 300 mg tablets
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential Hypertension

Summary:

      This study will compare the safety and efficacy of once daily dosing of aliskiren to twice
      daily dosing of aliskiren in patients with moderate hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have diagnosis of uncomplicated essential hypertension; newly diagnosed or who have
             not received antihypertension medication within 4 weeks of visit 1 must have an office
             cuff mean sitting Diastolic Blood pressure (msDBP) > 100 mmHg and < 110 mmHg at visit
             1. If patient is receiving antihypertensive treatment, must have a cuff msDBP > 95
             mmHg and < 110 mmHg at visit 1

          -  Prior to randomization, all patients must have an office cuff msDBP >or= 100 mmHg and
             <or = 110 mmHg.

        Exclusion Criteria:

          -  Participation in another aliskiren trial or previous treatment with aliskiren during
             last 6 months and who qualified to be randomized or enrolled into the active drug
             treatment period

          -  Pregnant or nursing women

          -  Women of child bearing potential unwilling to use protocol specific contraceptive
             methods

          -  Office cuff blood pressure of msDBP ≥ 112 mmHg and/or mean sitting Systolic Blood
             Pressure (msSBP) ≥ 200 mmHg).

          -  Secondary form of hypertension

          -  History of heart failure New York Heart Association (NYHA Class II, III and IV)

          -  Previous history of hypertensive encephalopathy or stroke, transient ischemic attack
             (TIA), heart attack, coronary bypass surgery or any percutaneous coronary intervention
             (PCI)

          -  Elevated Serum potassium (> or = 5.3 mEq/L (mmol/L) at Visit 1

          -  Type 1 or Type 2 diabetes mellitus not well controlled

          -  Other protocol-defined inclusion/exclusion criteria may apply
Triple Combination Therapy in High Risk Crohn's Disease (CD)
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Vedolizumab; Adalimumab; Methotrexate
Intervention description: Vedolizumab intravenous infusion.; Adalimumab injection for subcutaneous use.; Methotrexate oral tablets.
Intervention MeSH terms: Adalimumab; Methotrexate; Vedolizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the effect of triple combination therapy with an
      anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist
      (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic
      remission in participants with newly-diagnosed CD stratified at higher risk for
      complications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has an initial diagnosis of CD established within 24 months prior to screening with
             involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

          2. Has moderate to severely active CD during Screening defined by a centrally assessed
             simple endoscopic score for Crohn disease (SES-CD) score >=7 (or >=4 if isolated ileal
             disease).

        Exclusion Criteria:

        Gastrointestinal (GI) Exclusion Criteria

          1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

          2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal
             abscess.

          3. Has a known perianal fistula with abscess. (The participant may have a perianal
             fistula without abscess.)

          4. Has a known fistula (other than perianal fistula).
Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Intervention: Methylprednisolone 80 mg; Methylprednisolone 40 mg; Saline
Intervention description: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine; 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine; 2 mL saline + 1 mL lidocaine
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Between 2008 and 2012 the investigators performed a single-center randomized double-blind
      placebo-controlled trial to assess the efficacy of local injection of two different doses of
      methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18
      to 70 years, not previously treated with steroid injection. The primary outcomes were change
      in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on
      the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3
      groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the
      1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary idiopathic CTS

          -  Symptoms of classic or probable CTS according to the Katz diagnostic criteria
             (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)

          -  Failed treatment with wrist splinting (2 months)

          -  Nerve conduction tests showing median neuropathy at the wrist or, if normal, two
             orthopedic surgeons independently make CTS diagnosis

          -  Symptom severity that warranted referral for consideration for surgery

        Exclusion Criteria:

          -  Previous steroid injection for CTS

          -  Thenar muscle atrophy

          -  Sensory deficit (two-point discrimination >8 mm)

          -  Diabetes, thyroid disorder, or inflammatory disease

          -  Polyneuropathy or vibration-induced neuropathy

          -  Current pregnancy

          -  Previous carpal tunnel surgery on the study hand

          -  Surgery on the contralateral hand in the past 2 months

          -  Inability to respond to questionnaires

          -  Severe medical illness

          -  Known drug/alcohol abuse
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Condition: Plaque Psoriasis
MeSH terms: Psoriasis; Erythema Multiforme
Intervention: Clobex Spray
Intervention MeSH terms: Clobetasol
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
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the utility of a technological based rating scale for
      assessing improvement in plaque psoriasis with Clobex spray treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age or older.

          -  Subjects with a board certified dermatologist clinical diagnosis of active moderate to
             severe psoriasis lesions affecting up to 20% of the body surface area at the baseline
             visit, and in the opinion of the investigator, is otherwise a good candidate for
             treatment with clobetasol propionate 0.05% spray.

          -  Subjects with a target lesion of at least 1 cm x 1 cm

          -  Subjects who agree to be photographed at each visit

        Exclusion Criteria:

          -  Subjects with any condition or presentation that may, in the opinion of the
             investigator, may put the subject at risk, may confound study results, or may
             interfere with participation in the study.

          -  Subjects with any known allergies to any of the ingredients listed on the test article
             label or surgical ink.

          -  Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast
             feed during the course of the trial.

          -  Subjects that are relatives of the investigator, or are themselves or a relative of
             any study staff or any Galderma employee.

          -  Subjects who have participated in an investigational study within 30 days of
             enrollment; participated in biologic investigational studies within 90 days of
             enrollment, or subjects planning to participate in any other interventional clinical
             research study while enrolled in this trial.
Anesthetic Effect Duration Assessment
Condition: Healthy Volunteers
Intervention: Lidocaine 7% + Tetracaine 7% cream
Intervention description: Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.
Intervention MeSH terms: Lidocaine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      The purpose of this study is to evaluate the duration of anesthetic effect produced ,
      Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face
      and thigh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male of female subjects aged 18 or older with a normal not excessive hairy
             skin,

        Exclusion Criteria:

          -  Female subjects who are pregnant or breast-feeding; or plan to become pregnant,

          -  Subjects who have a known allergy to one of the components of the test drug lidocaine,
             tetracaine or other local anesthetics,

          -  Subjects who are at risk in terms of precautions, warnings, and contra-indication with
             the study product.
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Elagolix; Placebo
Intervention description: Oral; Tablet; Oral; Tablet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Elagolix; ABT-620; Uterine Fibroids; Heavy Menstrual Bleeding (HMB)

Summary:

      The main objective of this study is to assess safety and efficacy of elagolix compared to
      placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in
      premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces
      HMB associated with uterine fibroids in premenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant at the time of screening has a diagnosis of uterine fibroids documented by
             a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound
             (TVU)].

          -  Participant has HMB associated with uterine fibroids as evidenced by menstrual blood
             loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin
             method.

          -  Participant has negative urine and/or serum pregnancy test in Washout (if applicable)
             and/or Screening and just prior to first dose.

          -  Participant has an adequate endometrial biopsy performed during Screening, the results
             of which show no clinical significant endometrial pathology.

        Exclusion Criteria:

          -  Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS)
             or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a
             clinically significant gynecological disorder.

          -  Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.

          -  Participant has clinically significant abnormalities in clinical chemistry,
             hematology, or urinalysis.

          -  Participant has a history of major depression or post-traumatic stress disorder (PTSD)
             episode within 2 years of screening, OR a history of other major psychiatric disorder
             at any time (e.g., schizophrenia, bipolar disorder).

          -  Participant is using any systemic corticosteroids for over 14 days within 3 months
             prior to Screening or is likely to require treatment with systemic corticosteroids
             during the course of the study. Over the counter and prescription topical, inhaled,
             intranasal or intra-articular injectable (for occasional use) corticosteroids are
             allowed.
A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
Condition: Kidney Diseases; Coronary Artery Disease
MeSH terms: Kidney Diseases; Renal Insufficiency; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Regadenoson; Placebo
Intervention description: IV; IV
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: regadenoson; chronic kidney disease stage III; chronic kidney disease stage IV; renal impairment; coronary artery disease

Summary:

      This study is intended to assess the safety and tolerance of regadenoson in subjects with
      renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a Stage III or Stage IV renal impairment based on the National Kidney
             Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular
             filtration rate (GFR) classification

          -  Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as
             determined by a current medical diagnosis of at least 2 of the following conditions:
             Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette
             smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) > 30)

          -  Subject must abstain from smoking 3 hours prior and 8 hours post study drug
             administration

          -  Subject must abstain from any intake of foods and beverages containing a methylated
             xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours
             prior to study drug administration through the Follow-Up visit, as these foods may
             reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or
             methylxanthine) within 12 hours prior to study drug administration through the
             Follow-Up visit, as these foods may reduce the effects of regadenoson

        Exclusion Criteria:

          -  Subject has a history of an additional clinically significant illness, medical
             condition, or laboratory abnormality within 2 weeks prior to Screening

          -  Female subject who is pregnant, lactating or of childbearing potential who refuses to
             use a medically acceptable form of contraception until the Follow-Up visit is complete