bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
Condition: Diagnostic Imaging; Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Gadoteridol (ProHance)
Intervention description: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous); Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients referred for a contrast-enhanced MRI of the CNS; CNS Imaging

Summary:

      This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called
      gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look
      at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol
      when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol
      Injection will be compared to the results of MR images taken without contrast and with the
      results of the MR images taken with ProHance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years of age

          -  Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms
             or results of a previous imaging procedure

          -  Has been fully informed about the study, including provisions of the Health Insurance
             Portability and Accountability Act (HIPAA) as applicable, and has consented to
             participate

        Exclusion Criteria:

          -  Has any contraindication to the MRI examinations or the use of Gd-containing contrast
             agents

          -  Has a history of severe allergic or anaphylactoid reaction to any allergen including
             drugs and contrast agents

          -  Has severe cardiovascular disease (eg, known long QT syndrome, acute myocardial
             infarction [< 14 days], unstable angina, congestive heart failure New York Heart
             Association class IV) or acute stroke (< 48 hours)- Patients with acute renal
             insufficiency of any severity due to hepato-renal syndrome or in the perioperative
             liver transplantation period
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: 1mg Finasteride active; 0.02mg dutasteride; 0.1mg dutasteride; 0.5mg dutasteride; Finasteride placebo; Dutasteride placebo
Intervention description: 1mg finasteride active, by mouth once daily; 0.02mg dutasteride active, by mouth once daily; 0.1mg dutasteride active, by mouth once daily; 0.5mg dutasteride active, by mouth once daily; finasteride placebo, by mouth once daily; dutasteride placebo, by mouth once daily
Intervention MeSH terms: Finasteride; Dutasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 917.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this six month study is to show that dutasteride is safe and more effective
      than placebo, and at least as safe and effective as finasteride in treating hair loss in men
      with androgenetic alopecia. Three doses of dutasteride will be investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Norwood-Hamilton Type III vertex, IV, or V

        Exclusion Criteria:

          -  History or evidence of hair loss other than androgenetic alopecia

          -  Scarring of the scalp

          -  Use of dutasteride in previous 18 months

          -  Use of finasteride within previous 12 months

          -  Hair transplantation or hair weaving within 6 months

          -  Use of Minoxidil within previous 6 months

          -  Use of drugs with anti-androgenetic/androgenetic properties within previous 6 months

          -  Use of Drugs that cause hypertrichosis or hypotrichosis within previous 6 months

          -  Light or laser treatment of scalp within previous 3 months

          -  Cosmetic products aimed at improving or correcting signs of hair loss within previous
             2 weeks
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696; Valsartan
Intervention description: LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.; Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4822.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Heart failure; preserved ejection fraction; diastolic heart failure

Summary:

      The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the
      reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF
      with preserved ejection fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or
             within 6 months prior to study entry.

          -  Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at
             least 30 days prior to study entry.

          -  Current symptom(s) of HF (NYHA class II-IV)

          -  Structural heart disease (left atrial enlargement or left ventricular hypertrophy)
             documented by echocardiogram.

          -  Elevated NT-proBNP

        Exclusion Criteria:

          -  Any prior measurement of LVEF < 40%.

          -  Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within
             3 months , or urgent percutaneous coronary intervention within 3 months or and
             elective PCI within 30 days prior to entry.

          -  Any clinical event within the 6 months prior to entry could have reduced the LVEF
             (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF
             ≥45%.

          -  Current acute decompensated HF requiring therapy.

          -  Patients who require treatment with 2 or more of the following: an angiotensin
             converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin
             inhibitor.

          -  Alternative reason for shortness of breath such as: significant pulmonary disease or
             severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.

          -  Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at
             entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110
             mmHg at entry.

        Other protocol-defined inclusion/exclusion criteria may apply.
Safety Study of Entocort for Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Entocort
Intervention description: Entocort capsules, oral
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  All male and female subjects must be aged 5 to 17, inclusive, and must not have
             reached their 18th birthday by the estimated final office visit.

          -  Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending
             colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal
             erosions and/or histology.

          -  Subjects with mild to moderate Crohn's disease.

          -  All subjects must have a stool analysis negative for Clostridium difficile toxin,
             Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days
             prior to visit 1.

          -  All subjects must have had laboratory assessments within 7 days prior to visit 1.

          -  All subjects must weigh >= 15 kg at time of enrollment

        Exclusion Criteria:

          -  Subjects who have had any previous intestinal resection proximal to and including the
             ascending colon

          -  Subjects with evidence of severe active Crohn's disease and/or, stricturing and
             prestenotic dilatation, clinical evidence of obstruction, perirectal abscess,
             perirectal disease with active draining fistulas, perforation, or any septic
             complications

          -  Subjects who do not have a negative stool analysis, within the 30 days prior to visit
             1

          -  Subjects who have been screened/or enrolled in this study previously within the last
             30 days

          -  Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal
             range for age and gender
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Condition: Renal Failure; Hemodialysis
MeSH terms: Renal Insufficiency
Intervention: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface; Percutaneous Transluminal Angioplasty
Intervention description: Deployment of investigational stent graft at the venous anastomosis; Percutaneous Transluminal Angioplasty at the venous anastomosis
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis; Stent Graft; Venous Anastomosis; Arteriovenous Grafts

Summary:

      The objective of the study is to establish efficacy and safety of the GORE VIABAHN®
      Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV)
      prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of
      vascular access for hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm
             prosthetic vascular access graft.

          -  The target lesion starts less than or equal to 30 mm from the venous anastomosis.

          -  The target lesion has > 50% stenosis as measured per protocol.

          -  The patient has a maximum of one secondary stenosis.

        Exclusion Criteria:

          -  The age of the hemodialysis access graft is less than or equal to 30 days old from the
             date of the study procedure.

          -  The patient has undergone an intervention (surgical or percutaneous) of the vascular
             access circuit less than or equal to 30 days from the date of the study procedure.

          -  The secondary lesion is an occlusion.
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Condition: Atherosclerosis; Percutaneous Coronary Intervention; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Atherosclerosis
Intervention: cangrelor P2Y12 (platelet) inhibitor; Clopidogrel - 300 or 600 mg (study arm); Clopidogrel 600 mg post cangrelor
Intervention description: Over encapsulated tablets.; over-encapsulated clopidogrel (600 mg)
Intervention MeSH terms: Clopidogrel; Cangrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to compare the efficacy and safety profile of cangrelor to standard of
      care in patients require percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients may be included in the study if they meet all of the following criteria:

          -  Male or non-pregnant female at least 18 years of age

          -  Patients undergoing percutaneous coronary intervention (PCI):

               1. Stable angina (SA) patients with diagnostic coronary angiography within 90 days
                  prior to randomization demonstrating atherosclerosis

               2. Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with
                  diagnostic coronary angiography within 72 hours prior to randomization
                  demonstrating atherosclerosis

               3. ST-segment elevation myocardial infarction (STEMI) patients (diagnostic
                  angiography not required)

          -  Provide written informed consent

        Exclusion Criteria:

        Patients will be excluded from the study if any of the following exclusion criteria apply
        prior to randomization:

          -  Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization

          -  Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent
             dose must have been administered ≥12 hours prior to randomization)

          -  Abciximab usage within 7 days preceding randomization

          -  Receipt of fibrinolytic therapy in the 12 hours preceding randomization

          -  Increased bleeding risk: ischemic stroke within the last year or any previous
             hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial
             aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery);
             currently receiving warfarin; active bleeding
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
Condition: Pancreatic Solid Lesions; Pancreatic Mass
Intervention: Standard technique EUS-FNA; Capillary suction technique for EUS FNA
Intervention description: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.; Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Pancreatic solid lesions; Pancreatic mass; Pancreatic cancer; Endoscopic Ultrasound; EUS; Fine needle aspiration; FNA; EUS-FNA

Summary:

      The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a
      standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for
      solid pancreatic lesions. Investigators hope to discover the best technique for obtaining
      diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and
      fine needle aspirate procedure.

      There are currently several techniques for obtaining tissue during endoscopic ultrasound and
      fine needle aspirate. The procedure will be performed by either the capillary suction
      technique or no suction technique.
    

Eligibility criteria:

        Inclusion Criteria:

        - In-patients and out-patients between the age of 18years and 90 years with pancreatic
        masses presenting for EUS-FNA

        Exclusion Criteria:

          -  Uncorrectable coagulopathy (INR > 1.5)

          -  Uncorrectable thrombocytopenia (platelet < 50,000)

          -  Uncooperative patients

          -  Pregnant women (women of childbearing age will undergo urine pregnancy testing, which
             is routine for all endoscopic procedures)

          -  Refusal to consent form

          -  Cystic lesions

          -  Inaccessible lesions to EUS
A Study of Aripiprazole in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Aripiprazole+ ADT; Placebo+ ADT
Intervention description: Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks; Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Single or recurrent; non-psychotic episode of Major Depressive Disorder

Summary:

      The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess
      the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned
      open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder
      who demonstrate an incomplete response to a prospective eight week trial of the same assigned
      open-label marketed antidepressant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic
             episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks
             in duration.

          -  Treatment history of an inadequate response to at least one and no more than three
             adequate antidepressant trials.
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Condition: Factor XIII Deficiency
MeSH terms: Factor XIII Deficiency
Intervention: FXIII Concentrate (Human) (FXIII)
Intervention description: Doses will be guided by the individual subject's most recent FXIII activity levels, with the objective of dosing every 28 days to maintain a trough FXIII activity level of approximately 5 to 20%.
Subjects enrolled in this study who have not received at least 3 doses of FXIII Concentrate in a previous study of this product (i.e., NCT00640289, NCT00885742, or NCT00883090) will initially receive a dose of 40 U/kg by intravenous (IV) infusion.
Intervention MeSH terms: Fibrinolysin
Phase: Phase 3
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Healthy volunteers: No
Keywords: Hereditary Factor XIII deficiency; Factor XIII

Summary:

      Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with
      potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose
      blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual
      clotting process, thereby preventing bleeding.

      In this study, patients will be treated with FXIII Concentrate (Human) and followed closely
      to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize
      the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate
      (Human) to patients until the product becomes commercially available in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent for study participation obtained before undergoing any
             study specific procedures

          -  Diagnosed with congenital FXIII deficiency requiring prophylactic treatment

          -  Males and females of any age

        Exclusion Criteria:

          -  Diagnosis of acquired FXIII deficiency

          -  Administration of a FXIII-containing product, including blood transfusions or other
             blood products, within 3 weeks prior to the Baseline/Day 0 Visit

          -  Any known congenital or acquired coagulation disorder other than congenital FXIII
             deficiency

          -  Use of any other IMP within 4 weeks prior to Baseline/Day 0 Visit

          -  Female subjects of childbearing potential not using, or not willing to use, a
             medically reliable method of contraception for the entire duration of the study

          -  Suspected inability (e.g., language problems) or unwillingness to comply with study
             procedures or history of noncompliance

          -  Any laboratory finding or medical condition which, in the opinion of the Investigator,
             would put the subject or subject's disease management at risk
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13 valent Pneumococcal Conjugate Vaccine; 23vPS
Intervention description: 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1; 0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 938.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC
      and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5
      years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of
      13vPnC 1 year after the initial dose of study vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female aged 70 years or older.

          -  Documented vaccination with 1 dose of 23vPS at least 5 years previous.

          -  Healthy.

        Exclusion Criteria:

          -  Receipt of more than one dose of 23vPS prior to enrollment.

          -  History of severe adverse reaction to a vaccine.

          -  Immunodeficiency.