bioihbjkbjnl/mcl2 huggingface dataset:
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Condition: Coronary Artery Disease; Sternal Pain
MeSH terms: Coronary Artery Disease
Intervention: Bupivacaine Group; Placebo
Intervention description: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).; 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiopulmonary Bypass; Cardiac Surgery; Sternotomy

Summary:

      The purpose of this study is to determine whether administration of a pecto-intercostal
      fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative
      analgesia after cardiac surgery as compared to patients who receive a sham block of normal
      saline.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients 18 years of age or older

          -  Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and
             isolated valve surgeries.

        Exclusion Criteria

          -  Current participation in another interventional study

          -  Preoperative LVEF < 30%

          -  Use of mechanical circulatory support

          -  Emergent procedures

          -  Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts

          -  Minimally invasive cardiac procedures or those with thoracotomy approach

          -  Patients receiving other modalities of regional anesthesia like intrathecal morphine

          -  Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an
             opioid at or more than 30 mg morphine equivalent for more than one month within the
             past year)

          -  Current use of TCA, gabapentin, or pregabalin

          -  Hypersensitivity to bupivacaine

          -  Women who are pregnant or breastfeeding

          -  Non English speaking
Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Condition: Jawline Definition
Intervention: VOLUX XC; No-treatment control
Intervention description: Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.; No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel
      for restoring jawline definition
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using
             the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the
             same on both sides, but must be Grade 2 or 3

          -  Treating Investigator (TI) considers the subject's jaw amenable to an improvement of
             at least 1 grade on the scale for the jawline definition

          -  Written Informed Consent (IC) has been obtained

        Exclusion Criteria:

          -  Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone,
             polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted
             with any of these products during the study

          -  Has ever undergone fat injections in the malar, chin or jawline area or is planning to
             undergo this procedure during the study

          -  Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite,
             poly-L-lactic acid) below the subnasale within 36 months before enrollment or is
             planning to undergo such treatment during the study

          -  Has received deoxycholic acid treatment in the submental region in the last 6 months

          -  Has active autoimmune disease

          -  Females who are pregnant, nursing, or planning a pregnancy during the course of the
             study
COVID-19 3rd Dose Vaccine in Transplant Patients
Condition: Covid19
MeSH terms: COVID-19
Intervention: BNT162b2 vaccine; JNJ-78436735 Vaccine
Intervention description: Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle; Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transplant patients

Summary:

      The purpose of this study is to investigate the efficient vaccine type as a booster dose for
      Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age and older

          -  Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas)
             transplant patient from living or deceased donors.

          -  Patients with active graft with at least one immunosuppressive medication

          -  Completed two doses of BNT162b2 vaccination at least 28 days ago

        Exclusion Criteria:

          -  Patient with non-active graft

          -  Any significant side effect with previous COVID-19 vaccination

          -  Within 28 days of BNT162b2 vaccine completion

          -  Already received more than and equal to three doses of COVID-19 vaccination

          -  Previously received COVID-19 vaccine other than BNT162b2 vaccine

          -  Previously received monoclonal Antibody treatment that are specifically directed
             against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2
             (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab
             and/or any combination.

          -  Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)

          -  History of Capillary Leak Syndrome

          -  Adults unable to consent

          -  Individuals who are not yet adults (younger than 18 year old)

          -  Vulnerable patients (prisoners)

          -  Pregnant women
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Intervention: Vehicle; WC3011 Estradiol Vaginal Cream
Intervention description: Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks; WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 576.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: vaginal dryness; vaginal atrophy; estrogen

Summary:

      The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal
      gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as
      measured by self-assessment, vaginal pH and vaginal smear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Moderate to severe vaginal dryness

          -  Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6
             months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) > 40
             milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy
             confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks
             postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL

          -  Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years

          -  Vaginal pH >5.0

          -  Less than or equal 5% superficial cells on vaginal wall cytologic smear

          -  Normal breast exam; if > 40 years, documentation of negative mammogram

        Exclusion Criteria:

          -  Randomization in PR-04409, participation in clinical trial or use of investigational
             drug within 30 days prior to screening

          -  Smokes ≥ 15 cigarettes/day

          -  Known or suspected premalignant or malignant disease

          -  Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure,
             stroke or ischemic attack, thrombophlebitis or thromboembolic disorder

          -  Increased frequency/severity headaches with estrogen therapy

          -  Drug addiction/alcohol abuse within last 2 years

          -  Currently taking St. John's Wort or anticoagulant

          -  Uncontrolled hypertension or thyroid disorder, clinically significant depression or
             untreated urinary tract infection
The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: bococizumab (PF-04950615); Placebo
Intervention description: 150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.; Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16784.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myocardial infarction; stroke; hyperlipidemia

Summary:

      This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to
      placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular
      death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization,
      in high risk subjects who are receiving background lipid lowering therapy and have
      cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL
      (2.6 mmol/L).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be on background lipid lowering treatment.

          -  Must be at high risk of a CV event.

          -  Must have an LDL C >/=70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 mmol/L).

        Exclusion Criteria:

          -  Planned coronary (PCI or CABG) or other arterial revascularization.

          -  New York Heart Association Class IV congestive heart failure or left ventricular
             ejection fraction < 25% by cardiac imaging.

          -  Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD
             formula or with end state renal disease on dialysis.

          -  History of hemorrhagic stroke.

          -  Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
Condition: Abortion in First Trimester
Intervention: Dextromethorphan Hydrobromide; Avicel PH101 (Microcrystalline Cellulose NF) for Compounding; Oxycodone
Intervention description: Dextromethorphan capsule; Placebo capsule; Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
Intervention MeSH terms: Oxycodone; Dextromethorphan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: medication abortion; dextromethorphan; pain control

Summary:

      This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control
      during medication abortion. This is double-blinded, four-arm randomized controlled trial
      enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan,
      narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no
      narcotics and placebo (microcrystalline cellulose).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18 and over

          -  Willing to give voluntary consent

          -  English-speaking

          -  Eligible for medication abortion per Planned Parenthood of Western Pennsylvania
             protocol

          -  Self-reported reliable cellular phone access for the duration of study participation

          -  Able to receive and reply to a "test" text at time of consent

          -  Willing to comply with the study protocol

        Exclusion Criteria:

          -  Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to
             risk of Serotonin Syndrome

          -  Allergy to any component of the medication abortion regimen or study drug

          -  Has any other condition that, in the opinion of the investigator, would preclude
             informed consent, make study participation unsafe, complicate the interpretation of
             the study outcome data, or otherwise interfere with achieving the study objectives

          -  Anticipated use of dextromethorphan during study period
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Placebo-matching Ubrogepant
Intervention description: 50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1672.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50
      and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd edition, beta
             version

          -  Migraine onset before age 50

          -  History of migraines typically lasting between 4 and 72 hours if untreated or treated
             unsuccessfully and migraine episodes are separated by at least 48 hours of headache
             pain freedom

          -  History of 2 to 8 migraine attacks per month with moderate to severe headache pain in
             each of the previous 3 months.

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headache from other headaches

          -  Has taken medication for acute treatment of headache (including acetaminophen,
             nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or
             combination analgesics) on 10 or more days per month in the previous 3 months

          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,
             hemiplegic migraine, or retinal migraine

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy

          -  Required hospital treatment of a migraine attack 3 or more times in the previous 6
             months

          -  Has a chronic non-headache pain condition requiring daily pain medication

          -  Has a history of malignancy in the prior 5 years, except for adequately treated basal
             cell or squamous cell skin cancer, or in situ cervical cancer

          -  Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes,
             inflammatory bowel disease) that may affect the absorption or metabolism of
             investigational product; participants with prior gastric bariatric interventions which
             have been reversed are not excluded

          -  Has a history of hepatitis within previous 6 months.
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Condition: Candidiasis, Invasive; Candidemia; Mycoses
MeSH terms: Infections; Mycoses; Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Isavuconazole; Caspofungin; Voriconazole
Intervention description: Administered by intravenous infusion.; Administered by intravenous infusion.; Administered by intravenous infusion.
Intervention MeSH terms: Voriconazole; Caspofungin; Isavuconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 450.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Invasive Candida infections; BAL8557; ASP9766; Isavuconazole; Candidemia; Candidemia and other invasive candida infections; Phase III study

Summary:

      The purpose of the study is to compare the safety and efficacy of isavuconazole versus
      caspofungin followed by voriconazole in the treatment of candidemia and other invasive
      Candida infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with candidemia or with an invasive Candida infection

          -  Presence of fever, hypothermia or other appropriate local sign of infection

          -  Female patients must be non-lactating and at no risk of pregnancy

        Exclusion Criteria:

          -  Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal,
             esophageal or genital candidiasis; or candidal lower urinary tract infection or
             Candida isolated solely from respiratory tract specimens

          -  Patients with candidemia who failed a previous antifungal therapy for the same
             infection

          -  Patients previously enrolled in a phase III study with isavuconazole

          -  Patients with a body weight <40kg
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Condition: Non-squamous Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Paclitaxel; Carboplatin; Cisplatin; Veliparib; Pemetrexed
Intervention description: Administered by Intravenous infusion on Day 1 of each 21-day cycle; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Oral capsule, administered twice daily for 7 days in each 21-day cycle; Administered by Intravenous infusion on Day 1 of each 21-day cycle
Intervention MeSH terms: Paclitaxel; Carboplatin; Pemetrexed; Veliparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 595.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: veliparib; carboplatin; paclitaxel; cisplatin; pemetrexed; Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP); Metastatic; Non-squamous; Non-small cell lung cancer

Summary:

      The purpose of this study is to evaluate the safety and efficacy of veliparib plus
      carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in
      adults with metastatic or advanced non-squamous non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be ≥ 18 years of age with life expectancy > 12 weeks.

          -  Subject must have cytologically or histologically confirmed advanced or metastatic
             non-squamous NSCLC and are current or former smokers.

          -  Subject must have NSCLC that is not amenable to surgical resection or radiation with
             curative intent at time of screening.

          -  Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed
             tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) version 1.1.

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
             polyethoxylated castor oil (Cremophor).

          -  Subject has a known hypersensitivity to platinum compounds.

          -  Subject has peripheral neuropathy ≥ grade 2.

          -  Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor
             (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known
             anaplastic lymphoma kinase (ALK) gene rearrangement.

          -  Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.