bioihbjkbjnl/mcl2 huggingface dataset:
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine
Condition: Hemorrhage; Healthy
MeSH terms: Hemorrhage
Intervention: Ketamine Hydrochloride; Placebo
Intervention description: A total of 20 mg of Ketamine Hydrochloride will be administered intravenously; Subjects will receive placebo
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this project is to test how ketamine, an analgesics currently employed in the
      pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in
      humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-45 years of age

          -  Healthy

          -  Non-obese (body mass index less than 30 kg/m2)

          -  Body mass greater than or equal to 65 kg

        Exclusion Criteria:

          -  Subjects not in the defined age range

          -  Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses

          -  Any known history of renal or hepatic insufficiency/disease

          -  Pregnancy or breast feeding

          -  Body mass less than 65 kg

          -  Current smokers, as well as individuals who regularly smoked within the past 3 years

          -  Positive urine drug screen

          -  Currently taking pain modifying medication(s)
Colchicine in Percutaneous Coronary Intervention
Condition: Coronary Artery Disease; Acute Coronary Syndrome
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome
Intervention: Colchicine vs Placebo
Intervention description: Colchicine vs Placebo 1.8 mg PO over 1 hour
Intervention MeSH terms: Colchicine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 714.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: inflammation; percutaneous coronary intervention; coronary artery disease; colchicine

Summary:

      Inflammation in the arteries of the heart may increase the risk of cardiac death. The
      proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory
      medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of
      the heart. With its quick onset of action and excellent safety profile, colchicine may have
      the potential to reduce risk of major adverse events related to the heart. This research also
      seeks to better understand the role of neutrophils, the most common type of inflammatory
      white blood cell in the body, when there is damage to the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Referred for possible PCI

        Exclusion Criteria:

          -  Colchicine use within 1 month

          -  History of colchicine intolerance

          -  Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust
             colchicine dose in this setting)

          -  Active malignancy or infection (major confounder with increased inflammatory markers)

          -  History of myelodysplasia (due to suggested cautionary use of colchicine in this
             setting)

          -  High-dose statin load <24 hours prior to procedure (major confounder that is known to
             reduce inflammatory levels in 12 to 24 hours)

          -  Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual
             drug

          -  Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or
             P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine,
             diltiazem and verapamil, again due to drug interactions)

          -  Unable to consent

          -  Participating in a competing study

          -  Any significant condition or situation that may put the subject at higher risk,
             confound the study results or interfere with adherence to study procedures
Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Condition: Coronary Artery Disease; Carotid Artery Diseases; Atherosclerosis
MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Atherosclerosis
Intervention: Atorvastatin; Niacin; Colesevelam; Placebo Niacin; Placebo Colesevelam
Intervention description: 10 to 80 mg of atorvastatin each day; 2000 mg of niacin each day; 3.8 g of colesevelam each day; Placebo niacin each day; Placebo colesevelam each day
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Atorvastatin; Colesevelam Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Magnetic Resonance Imaging; Atherosclerotic Plaque; Lipid Lowering Therapy

Summary:

      Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls
      of arteries. This study will examine the effectiveness of a combination of
      cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in
      people who have coronary artery disease or carotid artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically established coronary artery disease or carotid artery disease with greater
             than 15% stenosis by ultrasound

          -  Family history of cardiovascular disease

          -  Apolipoprotein B level greater than or equal to 120 mg/dL (LDL level should be between
             100 and 190 mg/dL without medication)

          -  Has been undergoing lipid therapy for no more than 12 months before study entry

          -  Medically stable

          -  Medically able to undergo MRI procedure

        Exclusion Criteria:

          -  Uses pacemaker or has metallic implants

          -  Has immediate plans for carotid endarterectomy

          -  History of alcohol or drug abuse

          -  Active liver disease or liver dysfunction, defined by elevations in alanine
             aminotransferase (ALT)/aspartate aminotransferase (AST) levels greater than 1.5 times
             the upper limit of normal

          -  Serum creatine kinase (CK) level greater than 3 times the upper limit of normal before
             study entry

          -  Serum creatinine level greater than 2.5 times the upper limit of normal

          -  Diabetes, with a fasting glucose level greater than 150 mg/dL or hemoglobin A1c
             (HbA1c) level greater than 8% before study entry

          -  Uncontrolled high blood pressure, defined as average resting systolic blood pressure
             greater than 200 mm Hg or average resting diastolic blood pressure greater than 95 mm
             Hg
Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.
Condition: Constipation
MeSH terms: Constipation
Intervention: Polyethylene glycol (MiraLAX, BAY81-8430); Mannitol
Intervention description: Oral solution, 17g polyethylene glycol, one time; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Intervention MeSH terms: Mannitol; Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Study to gather information on the acceptability of a new flavor system with increasing
      levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG)
      3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel
      movements. The taste of the various preparations will be measured by use of a rating scale.
    

Eligibility criteria:

        Male and female subjects, aged 18 years and older, suffering with occasional constipation
CeraVe Diabetes Mellitus
Condition: Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications
Intervention: CeraVe Hydrating Cleanser; CeraVe Moisturizing Cream
Intervention description: topical cleanser applied twice a day for 28 days; topical cream applied twice a day for 28 days
Intervention MeSH terms: Dimenhydrinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: cutaneous complication of DM

Summary:

      The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin
      Line for the improvement of skin condition in patients with diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women between the ages of 18 and 75 years of age.

          2. Willing to provide written informed consent.

          3. A diagnosis of diabetes mellitus (DM).

          4. DM-related skin changes classified into one or more of the following four categories:
             i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of
             DM complications; iv) skin reaction to DM treatment.

        Exclusion Criteria:

          1. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in
             CeraVe Hydrating Cleanser or Moisturizing Cream

          2. History of allergic contact dermatitis secondary to cleansers or moisturizers.

          3. Has a heightened immune response to common allergens, especially inhaled, topical or
             food allergens (atopy).

          4. Has any clinical manifestation in the treatment are(s) or other disorders that, in the
             investigator's opinion, may affect assessments or the study products.

          5. Inability to attend all study visits and follow treatment regimen.
A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)
Condition: Hemophilia A With Inhibitors
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously.
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Healthy volunteers: No

Summary:

      The primary purpose of this study was to describe the time to tolerization (i.e., ITI
      success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability of the participant or his legally authorized representative (e.g., parent or
             legal guardian) to understand the purpose and risks of the study and provide signed
             and dated informed consent and authorization to use protected health information in
             accordance with national and local participant privacy regulations

          -  Male participants of any age diagnosed with severe hemophilia A (as confirmed from the
             medical record)

          -  Currently diagnosed with high titer inhibitors (historical peak greater than or equal
             to (>=) 5 Bethesda units per milliliter (BU/mL), according to medical records)

          -  Previously treated with any plasma-derived or recombinant conventional or Extended
             Half-Life FVIII

        Exclusion Criteria:

          -  Other coagulation disorder(s) in addition to hemophilia A

          -  Previous immune tolerance induction (ITI)

          -  History of hypersensitivity or anaphylaxis associated with any factor VIII (FVIII)
             administration

          -  Planned major surgery scheduled during the study unless deferred until after study
             completion (minor surgery such as tooth extraction or insertion/replacement of central
             venous access device is allowed)

          -  Abnormal renal function (serum creatinine >1.5 milligram per deciliter (mg/dL) or 2 ×
             upper limit of normal (ULN) for participant age based on local laboratory range) as
             assessed by local laboratory

          -  Serum alanine aminotransferase or aspartate aminotransferase > 5 × upper limit of
             normal (ULN) as assessed by local laboratory
TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone
Condition: Myofascial Pain
Intervention: Ketorolac; Lidocaine; Dexamethasone
Intervention description: Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.; Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.; Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Intervention MeSH terms: Dexamethasone; Ketorolac; Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trigger Point Injections; steroid; nsaid

Summary:

      Hypothesis

      The main hypothesis of this study is that anti-inflammatory medications (ketorolac or
      dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in
      trigger point injections where a local twitch response is evoked at the time of the
      injection.

      Purpose/Specific Aims

      The primary objective of this study is to compare the efficacy of three substances used in
      TPIs with a LTR identified at the time of the injection: a CS (dexamethasone), a NSAID
      (ketorolac), or only a local anesthetic (lidocaine).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women age 18 or over

          2. At least one active trigger point

        Exclusion Criteria:

          1. Allergy or contraindication to any NSAID, CS, or local anesthetic

          2. Receiving anticoagulant medication

          3. History of bleeding disorder

          4. Pregnant or breast feeding women

          5. Gastrointestinal ulceration

          6. Pre-existing renal disease

          7. Pre-existing congestive heart failure

          8. Diabetes mellitus

          9. Prior myocardial infarction or stroke

         10. Fibromyalgia
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Guanfacine; Methylphenidate (MPH)
Intervention description: Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures; Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.
Intervention MeSH terms: Guanfacine; Methylphenidate; Dexmethylphenidate Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 7 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: ADHD; Guanfacine; Methylphenidate; Focalin XR; Pediatric; Cognitive function; Combination therapy

Summary:

      This study will evaluate the effectiveness of a single drug versus a combination of drugs in
      treating attention deficit hyperactivity disorder in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview

          -  Clinical Global Impression-Severity score of at least 4 for ADHD

          -  Resided with primary caretaker for at least 6 months prior to study entry

        Exclusion Criteria:

          -  History of autism, pervasive developmental disorder, chronic tic disorder, psychosis,
             or bipolar disorder

          -  Current major depression or panic disorder

          -  Systolic or diastolic blood pressure at screening greater than the 95th percentile or
             less than the 5th percentile for age and body mass index (BMI)

          -  Any medical condition that might make stimulant or alpha agonist therapy medically
             inadvisable

          -  Need for chronic use of other medications with central nervous system effects

          -  Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test

          -  History of structural heart defects, syncope, or fainting while exercising

          -  Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at
             study entry

          -  Mental retardation as determined by clinical functional assessment and an IQ estimate
             of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests
Diurnal Variation of Plasminogen Activator Inhibitor-1
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Intervention: Eplerenone (Morning); Eplerenone (Night-time)
Intervention description: Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg.
100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks.; Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg
Intervention MeSH terms: Eplerenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Metabolic syndrome; Aldosterone inhibitor; Diurnal drug regimen; PAI-1 levels

Summary:

      To determine if nighttime administration of an aldosterone antagonist would effectively lower
      peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning
      administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age18-65

          -  Metabolic Syndrome (3 or more of the following):

               1. Blood pressure 130/85 or greater

               2. Central obesity (Waist - Male > 40", Female > 35")

               3. Fasting glucose ≥ 110 mg/dl

               4. Low HDL (Male < 40 mg/dl, Female < 50 mg/dl)

               5. Elevated Triglycerides (> 150 mg/dl)

        Exclusion Criteria:

          -  Cigarette Use

          -  Renal insufficiency

          -  Coronary Artery Disease

          -  Diabetes

          -  Blindness

          -  Cerebrovascular Disease

          -  Secondary hypertension (renal artery stenosis, pheo, etc.)

          -  RAAS disease (Primary Aldosteronism, etc.)

          -  Other chronic illness (cancer, autoimmune or liver disease)

          -  Pregnancy

          -  Anemia (Hgb < 12 mg/dl)

          -  Evening or Night Shift work

          -  Transmeridian travel in previous 6 months

          -  History of sleep disorders

          -  Hypokalemia (serum potassium < 3.5 milliequivalent (mEq/L)

          -  Hyperkalemia (serum potassium > 5.5 mEq/L

          -  Reported hypersensitivity to HCTZ or eplerenone
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Condition: Short Stature
MeSH terms: Dwarfism
Intervention: Letrozole; Anastrozole
Intervention MeSH terms: Letrozole; Anastrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Male
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if there are differences in the final height or
      hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now
      routinely used to increase stature: Anastrozole and Letrozole. It also should determine if
      there are differences in the side effect profiles of the two drugs to be used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current height less than 5th percentile AND/OR

          -  Predicted adult height (based on bone age) more than 10 cm below target height (mid
             parental height)

          -  Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and
             testosterone > 15 ng/dl

        Exclusion Criteria:

          -  Bone age reading more than 14.0 years

          -  Follicle stimulating hormone > 20 IU/L