bioihbjkbjnl/mcl2 huggingface dataset:
PRP vs Corticosteroid in Baker's Cyst
Condition: Baker's Cyst
MeSH terms: Cysts; Popliteal Cyst
Intervention: Platelets-Rich-Plasma; Corticosteroid
Intervention description: Platelet-Rich Plasma; Corticosteroid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Baker's Cyst

Summary:

      This is a Prospective study with Randomized patients into either Ultrasound-guided
      Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months
      and 6 months follow ups after aspiration at our institution. There will be 25 patients in
      each group, including any patient with symptomatic baker's cyst.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years old.

          -  Patients with baker's cyst who also present with at least one of the following:
             swelling, local pain or discomfort, limited range of motion or any other symptom
             directly caused by the baker's cyst.

        Exclusion Criteria:

          -  Patients younger than 18 years old

          -  Local or Systemic active infection

          -  Active cancer treatment

          -  Immunodeficiency

          -  Diabetes

          -  Hypersensitivity or allergy to Corticosteroid or Lidocaine
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab; ABP 501
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis

Summary:

      The purpose of this research study is to compare the efficacy and safety of ABP 501 and
      adalimumab (HUMIRA®) in adults with plaque psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          1. Men or women ≥ 18 and ≤ 75 years of age at time of screening

          2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline

          3. Moderate to severe psoriasis defined at screening and baseline by:

             Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score
             of 12 or greater, and static physician's global assessment score of 3 or greater

          4. No known history of active tuberculosis

          5. Subject is a candidate for systemic therapy or phototherapy procedures

          6. Previous failure, inadequate response, intolerance, or contraindication to at least 1
             conventional anti-psoriatic systemic therapy

        Exclusion Criteria:

          1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg,
             eczema)

          2. Ongoing use of prohibited treatments

          3. Prior use of 2 or more biologics for treatment of psoriasis

          4. Previous receipt of adalimumab or a biosimilar of adalimumab

        Other Inclusion/Exclusion criteria may apply
Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
Condition: Tonsillectomy
Intervention: Intravenous ibuprofen; Normal Saline
Intervention description: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.; Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tonsillectomy, Pediatric

Summary:

      The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will
      significantly reduce post-operative fentanyl use compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.

        Exclusion Criteria:

          1. Have inadequate intravenous access

          2. Patients with significant cognitive impairment

          3. Active, clinically significant asthma

          4. History of allergy or hypersensitivity to any component of intravenous ibuprofen,
             NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.

          5. Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active
             clinically significant bleeding

          6. Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater
             than or equal to 5.0

          7. Have taken investigational drugs within 30 days before clinical trial material
             administration.

          8. Inability to understand the requirements of the study or be unwilling to provide
             written informed consent (as evidenced by signature on an informed consent document
             approved by an Institutional Review Board [IRB]) and agree to abide by the study
             restrictions. Surrogates will be needed for most patients.

          9. Refusal to provide written authorization for use and disclosure of protected health
             information.

         10. Be otherwise unsuitable for the study, in the opinion of the Investigator.
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Condition: Recurrent Glioblastoma
MeSH terms: Glioblastoma
Intervention: Nivolumab; Bevacizumab; Ipilimumab
Intervention description: specified dose on specified days; specified dose on specified days; specified dose on specified days
Intervention MeSH terms: Bevacizumab; Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 529.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the efficacy and safety of nivolumab administered
      alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain
      cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab
      administered alone or in combination with ipilimumab in patients with different lines of GBM
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with histologically confirmed Grade IV malignant glioma

          -  Previous treatment with radiotherapy and temozolomide (Cohorts 1, 1b and 2 only)

          -  First recurrence of GBM (Cohorts 1, 1b and 2 only)

          -  First diagnosis of GBM with resectable disease (Cohorts 1c Part A only)

          -  First diagnosis of unmethylated MGMT GBM (Cohort 1d and Cohort 1c Part B only)

          -  Karnofsky performance score of 70 or higher

        Exclusion Criteria:

          -  More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)

          -  Any recurrence of GBM (Cohorts 1c and 1d only)

          -  Presence of extracranial metastatic or leptomeningeal disease

          -  Active, known or suspected autoimmune disease

          -  Clinically significant cardiovascular disease

          -  Prior bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or
             anti-angiogenic treatment (Cohort 2 only)
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: pregabalin (Lyrica); pregabalin (Lyrica); matched placebo
Intervention description: 150 mg/day double blind (divided doses); 300 mg/day double blind (divided doses); matched placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 501.0
Sex: Female
Minimum age: 25 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: pain after hysterectomy; amount of opioids used

Summary:

      To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy ,
      measured using subject reported assessments of pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject will have elective total abdominal hysterectomy using a transverse
             incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may,
             however, be cervix-sparing.

          -  The subject is expected to remain at the hospital (or intermediate care facility) for
             a minimum of 2 days following surgery.

          -  The subject's preoperative health is graded as the American Society of
             Anesthesiologist P1 to P2.

        Exclusion Criteria:

          -  Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)

          -  Subjects having additional procedures (such as those involving the bladder) at the
             same time as the total abdominal hysterectomy

          -  The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical
             pain control

          -  Subjects who have been using any opioid medications 2 weeks or more continuously
             within 3 months prior to the screening visit.

          -  The subject has taken any NSAID or any analgesic other than acetaminophen within 3
             days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics,
             except as specified in the protocol, during the study. (Subjects taking <325 mg per
             day of aspirin at a stable dose for at least 30 days before the first dose of study
             medication will be allowed to continue their aspirin regimen for the duration of the
             study).
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors; Neoplasm Metastasis
Intervention: Octreotide LAR (Long-acting release); Placebo
Intervention description: 30 mg intramuscularly every 28 days; Sodium chloride intramuscularly every 28 days
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Double blind; Phase III; Disease; Clinical trial; Octreotide; Neuroendocrine tumor; Cancer; Tumor; Midgut

Summary:

      Placebo-controlled prospective randomized phase III study to investigate the
      antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of
      the midgut
    

Eligibility criteria:

        Inclusion Criteria:

          -  Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable
             or metastasized well-differentiated neuroendocrine tumor of the midgut

          -  curative surgery impossible

          -  two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic
             Resonance Imaging (MRI)

          -  Age ≥ 18

          -  Karnofsky-index > 60

          -  written informed consent

          -  proliferation index for Ki67

        Exclusion Criteria:

          -  hypersensitivity to octreotide

          -  poorly differentiated or small cell neuroendocrine tumors

          -  primary tumor outside of the midgut

          -  prior treatment with somatostatin-analogue > 4 weeks

          -  prior treatment with alpha-interferon, chemotherapy, or chemoembolisation

          -  participation in any other clinical trial

          -  pregnancy or lactation

          -  no secondary malignancy in anamnesis; with the exception of patients without any
             manifestation of the secondary malignancy (without relapse) after curative therapy
             within the last five years

          -  severe decompensated organ malfunction (heart-, liver- insufficiency)

        Other protocol-defined exclusion criteria may apply.
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Condition: Fluoride Varnish and Oral Health Promotion; Usual Care
Intervention: Fluoride varnish; Oral health education; Dental services delivered by the Indian Health Service.
Intervention description: Fluoride varnish will be administered by the COHS quarterly for 2 years.; Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2060.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An intensive intervention of specially trained paraprofessionals, called community oral
      health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish
      and oral health promotion education, compared to usual care, will reduce decayed, missing,
      and filled tooth surface measures at 2 years for children in American Indian Head Start
      Programs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and
             having a primary caregiver (preferably mother, or the child's legal guardian as
             documented by the HSC)

          -  American Indian, as defined by the tribe, or

          -  Children of other racial/ethnic groups who are in the Head Start classes on the
             Reservation

          -  Parent/caregiver able to read, understand, and sign the study consent form, and

          -  Willing and able to follow the study procedures and instructions

        Exclusion Criteria:

          -  Allergy to any of the components of the fluoride varnish

          -  Ulcerative gingivitis

          -  Stomatitis

          -  Other conditions resulting in disrupted or irritated oral mucosa

          -  Any other conditions or findings that, in the opinion of the investigators, would
             interfere with or preclude participation in the study.
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: dabigatran dose 1; dabigatran dose 2
Intervention description: dabigatran high dose twice daily; dabigatran low dose twice daily
Intervention MeSH terms: Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 5897.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study are:

        1. To evaluate the long-term safety of dabigatran etexilate

        2. To assess the effect of a knowledge translation intervention on patient outcomes
    

Eligibility criteria:

        Inclusion criteria:

        Participation in RE-LY, requires long term anticoagulation, provides written informed
        consent

        Exclusion criteria:

        Permanent discontinuation of dabigatran during RE-LY
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
Condition: Hyperlipidemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Hyperlipidemias
Intervention: Evolocumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously
      once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial
      hypercholesterolemia (HeFH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 80 years of age

          -  Diagnosis of heterozygous familial hypercholesterolemia

          -  On a stable dose of an approved statin and lipid regulating medication

          -  Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  Homozygous familial hypercholesterolemia

          -  LDL or plasma apheresis

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes, poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
L-Menthol Injection as a Novel Technique During Colonoscopy
Condition: Colonic Polyps; Colon Cancer
MeSH terms: Colonic Neoplasms; Colonic Polyps
Intervention: Peppermint Oil; Placebo
Intervention description: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640 mg of L-Menthol).; During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, also has 0 mg of L-Menthol).
Intervention MeSH terms: Peppermint oil; Menthol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 82.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Colon Cancer; Colonic Polyps; L-Menthol; C-Mint

Summary:

      The primary objective of this double-blinded, prospective, randomized placebo-controlled
      study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of
      peppermint oil solution vs placebo application during colonoscopy. The investigators
      hypothesize that ADR will be increased with the use of the peppermint oil solution and thus
      further reduce the risk of colon cancer by means of colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 50 years of age in Caucasians or 45 years of age in African-Americans.

          2. Patients undergoing primary screening colonoscopy (either average risk or
             increased-risk) or surveillance colonoscopy after prior screening/surveillance
             colonoscopy.

          3. Capable of understanding instructions, adhering to study schedules and requirements,
             and willing to provide informed consent.

        Exclusion Criteria:

          1. History of colectomy, partial or complete

          2. Symptoms suggesting possible colorectal stenosis or cancer

          3. Inflammatory bowel disease

          4. Familial polyposis syndromes

          5. History of, or current diagnosis of colorectal cancer

          6. American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater

          7. Non-correctable coagulopathy

          8. Currently receiving anti-thrombotic therapy, with an INR > 1.5

          9. Poor prep, total BBPS score < 6, or any part of the colon < 2.

         10. Patients with known allergy to peppermint oil or peppermint containing products.

         11. Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil,
             Diltiazem, Dihydropyridine, Felodipine, etc).
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
Condition: Neuromuscular Blockade
MeSH terms: Renal Insufficiency
Intervention: sugammadex; Rocuronium
Intervention description: At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.; After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium
      complex; it's safety and efficacy in participants with severe renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  American Society of Anesthesiologists (ASA) Class >=4

          -  Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis

          -  Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure
             under general anesthesia requiring neuromuscular relaxation with the use of rocuronium

          -  Scheduled for a (surgical) procedure in supine position

          -  Written informed consent (of the legal representative)

        Exclusion Criteria:

          -  Known or suspected to have neuromuscular disorders impairing neuromuscular blockade
             and/or significant hepatic dysfunction

          -  Known or suspected to have a (family) history of malignant hyperthermia

          -  Known or suspected to have an allergy to narcotics, muscle relaxants or other
             medication used during general anesthesia

          -  Have already participated in a sugammadex trial

          -  Have participated in another clinical trial, not preapproved by NV Organon, within 30
             days of study entry

          -  Females who are pregnant*

          -  Females who are breast-feeding * In females pregnancy will be excluded both from
             medical history and by a human chorionic gonadotropin (hCG) test within 24 hours
             before surgery except in females who are not of childbearing potential, i.e. at least
             2 years menopausal or have undergone tubal ligation or an hysterectomy.