bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
Condition: Postoperative Urinary Retention
MeSH terms: Urinary Retention
Intervention: Tamsulosin; Placebo
Intervention description: 0.4 mg daily; one capsule daily
Intervention MeSH terms: Tamsulosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 176.0
Sex: Male
Minimum age: 35 Years
Healthy volunteers: No

Summary:

      The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence
      of postoperative urinary retention in primary total knee and hip arthroplasty patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men age 35 or older

          -  Primary total hip and knee arthroplasty patients (general, spinal, or epidural
             anesthesia

          -  No current use (>1 month) of alpha-blockers

          -  Community ambulator

          -  Adequate organ and marrow function as defined below:

        leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at
        least 100,000/µL, creatinine within normal institutional limits

          -  Ability to understand, and the willingness to sign, a written informed consent

        Exclusion Criteria:

          -  History of radical prostatectomy

          -  Receiving any other investigational agents

          -  Revision hip and knee arthroplasty patients

          -  Severe liver or kidney disease

          -  Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin,
             ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)

          -  Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin,
             phenoxybenzamine, or silodosin)

          -  Being of 5-alpha reductase inhibitors (finasteride, dutasteride)

          -  History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin,
             doxazosin, prazosin, terazosin, or phenoxybenzamine)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Taking Sildenafil,Tadalafil, or Vardenafil
Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)
Condition: Anesthesia, General
Intervention: Sugammadex; Succinylcholine; Rocuronium
Intervention description: Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex; Single bolus IV dose of 1.0 mg/kg succinylcholine; Single bolus IV dose of 1.2 mg/kg rocuronium
Intervention MeSH terms: Rocuronium; Succinylcholine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced
      by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with
      recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;

          -  18 to 65 years of age (inclusive);

          -  Scheduled for elective surgical procedure under general anesthesia requiring a short
             duration of neuromuscular block with the use of rocuronium or succinylcholine and
             requiring endotracheal intubation;

          -  Scheduled for surgery in supine position;

          -  Body mass index (BMI) < 30;

          -  Given written informed consent.

        Exclusion Criteria:

          -  Has ischemic heart disease or history of myocardial infarction within the last year;

          -  May experience difficult intubation due to anatomical malformations;

          -  Known or suspected to have neuromuscular disorders impairing neuromuscular blockade
             and/or significant renal dysfunction;

          -  Known or suspected family history of malignant hyperthermia;

          -  Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or
             other medications used during surgery;

          -  Is receiving medication known to interfere with neuromuscular blocking agents such as
             anticonvulsants, antibiotics and Mg2+;

          -  Individuals in whom the use of neostigmine and/or glycopyrrolate may be
             contraindicated;

          -  Females who are pregnant or breast-feeding;

          -  Females of childbearing potential who are not using an acceptable method of birth
             control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD,
             abstinence];

          -  Has already participated in a sugammadex trial including Protocol 19.4.303.
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Condition: Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol
Intervention description: IV Ferumoxytol
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; chronic kidney disease; CKD; pediatric; dialysis-dependent; nondialysis-dependent

Summary:

      Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375)
      and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic
      treatment of iron deficiency anemia (IDA) with ferumoxytol.
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Participants who had completed participation in the combined AMAG-FER-CKD-251 and
             AMAG-FER-CKD-252 studies within 4 weeks of screening

          2. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control and agree to remain on birth control until
             completion of participation in the study

          3. Participant and/or legal guardian is capable of understanding and complying with the
             protocol requirements and is available for the duration of the study

        Key Exclusion Criteria include:

          1. Experienced a serious adverse event related to IV iron therapy in the combined
             AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies

          2. Hemoglobin level ≤7 g/dL
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: S5G4T-1; S5G4T-2
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 372.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: papulopustular rosacea

Summary:

      To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once
      daily for 12 weeks in participants with papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 18 years of age and older.

          3. Participants must have clinical diagnosis of moderate to severe rosacea.

          4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules
             and/or pustules) including those present on the nose.

          5. Have 2 nodules or less.

        Exclusion Criteria:

          1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of
             their study participation or were found to have positive pregnancy test at Baseline or
             screening visits.

          2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).

          3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or
             keratitis) of sufficient severity to require topical or systemic antibiotics.
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: placebo for risankizumab; risankizumab IV; risankizumab SC
Intervention description: Placebo for risankizumab administered by intravenous infusion; Risankizumab administered by intravenous infusion; Risankizumab administered by subcutaneous (SC) injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 931.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Crohn's Disease (CD); Risankizumab; ABBV-066; BI 655066

Summary:

      The purpose of this study is to evaluate the efficacy and safety of risankizumab versus
      placebo during induction therapy in participants with moderately to severely active Crohn's
      disease (CD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
             local regulations, at the Baseline Visit. Where locally permissible, participants 16
             to < 18 years of age who meet the definition of Tanner stage 5 for development at the
             Baseline Visit.

          -  Diagnosis of CD for at least 3 months prior to Baseline.

          -  Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
             abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

          -  Demonstrated intolerance or inadequate response to conventional or to biologic therapy
             for CD.

          -  If female, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participants with unstable doses of concomitant Crohn's disease therapy.

          -  Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
             certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
             within 12 weeks prior to Baseline), or any investigational biologic or other agent or
             procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.

          -  Prior exposure to p19 inhibitors (e.g., risankizumab).

          -  Complications of Crohn's disease.

          -  Having an ostomy or ileoanal pouch.

          -  Known active Coronavirus Disease 2019 (COVID-19) infection.
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer; Locally Recurrent Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Eribulin; Balixafortide
Intervention description: Eribulin alone; Balixafortide + Eribulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to
      investigate the efficacy, safety and tolerability of intravenous balixafortide given with
      eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or
      Metastatic Breast Cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed Breast cancer

          -  Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally
             recurrent breast cancer

          -  refractory to the most recent chemotherapy, documented by progression on or within six
             (6) months of therapy

          -  At least 14 days from the completion of any previous cancer therapy

          -  Adequate organ function

          -  Life expectancy of 3 months or more

          -  Willing and able to comply with the protocol and able to understand and willing to
             sign an informed consent

        Key Exclusion Criteria:

          -  Previously treated with eribulin

          -  Peripheral neuropathy Grade ≥3

          -  Receipt of prior CXCR4 therapy

          -  Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or
             sargramostim, or radiation therapy within 14 days prior to study Day 1

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to balixafortide or eribulin or other agents used in the study

          -  Breast feeding or pregnant

          -  Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias,
             known congenital long QT syndrome, QT interval corrected with Fridericia's formula
             (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently
             taking drugs at known risk of prolonging the QT interval or causing torsades de
             pointes
Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence
Condition: Tobacco Dependence; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Omega 3; Placebo
Intervention description: Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.; mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule
Intervention MeSH terms: Mineral Oil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco dependence; tobacco treatment; omega 3 series; polyunsaturated fatty acids

Summary:

      Nicotine dependence may prolong the exposure to toxic substances that cause various diseases.
      The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty
      Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the
      modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning
      of the mesolimbic and mesocortical pathway, related to the reward system, involved on the
      context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows
      improvements in several diseases, including mood disorders such as anxiety and depression.
      The investigators hypothesis is that supplementation with these fatty acids can restore the
      levels of omega-3 and could decrease nicotine dependence. The investigators objective is to
      investigate a possible association between increased serum levels of omega-3 and the
      reduction in nicotine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine
             Dependence (FTND) up to 5 points (FTND > 5); high motivation to stop smoking (accessed
             by Richmond Test)

        Exclusion Criteria:

          -  psychiatric disorders; taking psychoactive medications; history of alcohol and/or
             other drugs abuse or dependence;
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Placebo; Alirocumab
Intervention MeSH terms: Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2
      weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL)
      apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH)
      undergoing weekly or bi-weekly LDL apheresis therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥18 years of age at the time of the screening visit

          2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)

          3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or
             Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

        Exclusion Criteria:

          1. Homozygous FH (familial hypercholesterolemia)

          2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been
             stable for at least 8 weeks prior to the screening visit

          3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8
             weeks prior to the screening visit

          4. An LDL apheresis schedule other than QW to Q2W

          5. Initiation of a new exercise program or exercise that has not remained stable within 8
             weeks prior to the screening visit (week -2)

          6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to
             the screening visit (week -2)

          7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a
             dose/amount that has not been stable for at least 8 weeks prior to the screening visit
             (week -2), or between the screening and randomization visit

          8. Presence of any clinically significant uncontrolled endocrine disease known to
             influence serum lipids or lipoproteins

          9. Known history of a positive test for human immunodeficiency virus

         10. Use of any active investigational drugs within 1 month or 5 half-lives of screening,
             whichever is longer

         11. Patients who have been treated with at least 1 dose of alirocumab or any other
             anti-PCSK9 monoclonal antibody in any other clinical studies

         12. Pregnant or breastfeeding women
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Intervention description: 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months; 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 607.0
Sex: All
Minimum age: 12 Months
Maximum age: 84 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial
      V118_05
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject who has completed their Day 181 clinic visit for non-naïve
             subjects or their Day 209 clinic visit for naïve subjects in parent study.

          2. Individuals who give written informed consent, who can comply with study procedures,
             and who are available for follow-up

        Exclusion Criteria:

          1. Individuals recently vaccinated against influenza.

          2. Subjects with contraindications to receive influenza vaccine.

          3. Please contact the site for additional eligibility criteria.