bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
Condition: HIV-1
Intervention: TMC125
Intervention description: 200 mg twice daily until commercially available
Intervention MeSH terms: Etravirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; treatment experienced; virologic failure

Summary:

      The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200
      mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator
      selected optimized background in HIV-1 infected patients who have participated in a DUET
      trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week
      24 or later in these trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and
             completed at least 24 weeks of treatment

          -  Patient was virologically failing in a DUET trial.

        Exclusion Criteria:

          -  Use of disallowed concomitant therapy

          -  Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table

          -  Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials
             because of any of the mandatory withdrawal criteria of that trial.
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
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocuronium
Intervention description: Sugammadex solution for injection.; Rocuronium bromide solution for injection.
Intervention MeSH terms: Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the trial is to research the safety and to show faster recovery after
      administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal
      agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants
      diagnosed with or having a history of pulmonary disease. All drug administration will be via
      the intravenous (IV) route.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 to 3;

          -  Has been diagnosed with or having a past history of pulmonary disease;

          -  Is scheduled for elective surgical procedure under general anesthesia requiring
             neuromuscular block with the use of rocuronium;

          -  Is scheduled for surgery in supine position;

          -  Has given written informed consent;

        Exclusion Criteria:

          -  Is expected to have a difficult intubation due to anatomical malformations;

          -  Has known or suspected of having neuromuscular disorders impairing neuromuscular
             blockade and/or significant renal dysfunction;

          -  Has known or suspected of having a (family) history of malignant hyperthermia;

          -  Has known or suspected of having an allergy to narcotics, muscle relaxants or other
             medications used during surgery;

          -  Is receiving medication known to interfere with neuromuscular blocking agents such as
             anticonvulsants, antibiotics and Mg2+;

          -  Is a female who is pregnant or breast-feeding;

          -  Is a female of childbearing potential not using an acceptable method of birth control
             [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD,
             abstinence] or using only hormonal contraception as birth control;

          -  Has already participated in a sugammadex trial including Protocol 19.4.308;

          -  Has participated in another clinical trial, not pre-approved by Organon, within 30
             days of entering into Protocol 19.4.308.
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Intervention: Lacosamide
Intervention description: 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this trial is to determine safety and efficacy of Lacosamide under long
      term therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of Epilepsy

          -  completion of double blind trial

        Exclusion Criteria:

          -  taking other investigational drug than Lacosamide

          -  meeting withdrawal criteria from double blind trial
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Besivance; Vehicle
Intervention description: Ocular administration to affected eye for 7 days; Vehicle of Besivance administered to affected eye for 7 days
Intervention MeSH terms: Besifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 518.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic
      suspension, 0.6%) compared to vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit
             purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one
             eye.

          -  Subjects who are willing to discontinue contact lens wear for the duration of the
             study.

          -  Subjects who are able and willing to comply with all treatment and follow- up/study
             procedures.

        Exclusion Criteria:

          -  Subjects who have any uncontrolled systemic disease or debilitating disease.

          -  Subjects with a known hypersensitivity or contraindications to Besivance,
             fluoroquinolones, or any of the ingredients in the study drugs.

          -  Subjects who are expected to require disallowed concurrent systemic or ocular
             therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast
             cell stabilizers, antihistamines, decongestants or antimicrobial therapy)

          -  Subjects having ocular surgery (including laser surgery) in either eye within six
             weeks prior to entry into this study.

          -  Subjects with suspected viral or allergic conjunctivitis or any other disease
             conditions that could interfere with the efficacy and safety evaluations of the study
             medication.

          -  Subjects with suspected iritis.

          -  Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or
             secondary to previous corneal trauma or dry eye syndrome.

          -  Subjects with any active ulcerative keratitis, specifically any epithelial loss
             greater than punctate keratitis.

          -  Subjects who are immune compromised.
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551 Foam; Vehicle Foam
Intervention description: 122-0551 Foam applied twice daily to treat psoriasis; Vehicle Foam applied twice daily to treat psoriasis
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study has been designed to determine and compare the efficacy and safety of
      122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
             and no more than 12% affected body surface area.

          -  Subject has an Investigator's Global Assessment (IGA) score of at least three
             (moderate) at study start.

          -  If subject is a woman of childbearing potential, she must have a negative urine
             pregnancy test and agree to use an effective form of birth control for the duration of
             the study.

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          -  Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
             by study participation.

          -  Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
             of photo based therapy for the treatment of their psoriasis within 30 days prior to
             study start.

          -  Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
             [including intralesional, intra-articular, and intramuscular corticosteroids],
             cyclosporine or analogous products within 90 days prior to study start.

          -  Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
             therapy) within five half-lives of the biologic prior to study start.
Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Intervention: green tea tablets (Green tea extract 5:1) 200 mg; Triamcinolone Acetonide
Intervention description: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.; topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 30 Years
Maximum age: 68 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral
      lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen
      planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presented with painful oral lichen planus lesions

          -  Free of any visible oral lesions other than oral lichen planus

          -  Free of any systemic diseases

        Exclusion Criteria:

          -  Topical treatment or systemic therapy of OLP for one month before starting the study

          -  Pregnant or breast feeding women

          -  Smokers

          -  Use of corticosteroids or other immunosuppressive drugs
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Condition: Anesthesia, Local
Intervention: AG-920; Proparacaine Ophthalmic
Intervention description: AG-920 Sterile Topical Ophthalmic Solution; 0.5% Proparacaine Hydrochloride
Intervention MeSH terms: Proxymetacaine; Propoxycaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or proparacaine into one (study) eye (2 drops 30 seconds apart).
Masking: Single (Participant)
Masking description: The study is single masked. Treatment assignments will be masked to the subjects and their parent/legal guardian only.
Enrollment: 61.0
Sex: All
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AG-920; Articaine; Septocaine; Intravitreal Injection; Proparacaine

Summary:

      A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to
      evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution
      compared to Proparacaine Hydrochloride Ophthalmic Solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pre-pubescent with no childbearing potential

          2. Capable of undergoing an eye exam

          3. Subject's legally appointed and authorized representative willing to sign and date an
             informed consent form (ICF) and, where appropriate, the subject willing to sign an
             assent form prior to any study-related procedures being performed.

          4. Parent/legal guardian and subject are willing and able to follow instructions and can
             be present for the required study visits and Follow-up Phone Call for the duration of
             the study.

          5. Have a healthy, normal cornea.

        Exclusion Criteria:

          1. Have participated in an investigational study (drug or device) within the past 30
             days.

          2. Have a known contraindication to local anesthetics.

          3. Children with known autism spectrum disorders or known to have heightened sensitivity.

          4. Corneal pathology that would make the corneal sensitivity lower/higher or make the
             test hard to perform or interpret.

          5. Have low visual acuity

          6. Manifest nystagmus

          7. Have had ocular surgery or general surgery within the past 45 days.

          8. Have had an intravitreal injection in either eye within 14 days of randomization.

          9. Have ocular surface disease.
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MEDI4736; PLACEBO
Intervention description: MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).; PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
Intervention MeSH terms: Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 713.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Locally advanced; Unresectable Non-Small Cell Lung Cancer; MEDI4736; PD-L1; Stage III Non-Small Cell Lung Cancer; Chemoradiation; Immune-mediated cancer therapy

Summary:

      A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in
      Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age at least 18 years.

          2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)

          3. Patients must have received at least 2 cycles of platinum-based chemotherapy
             concurrent with radiation therapy.

          4. World Health Organisation (WHO) Performance Status of 0 to 1.

          5. Estimated life expectancy of more than 12 weeks.

        Exclusion Criteria:

          1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.

          2. Active or prior autoimmune disease or history of immunodeficiency.

          3. Evidence of severe or uncontrolled systemic diseases, including active bleeding
             diatheses or active infections including hepatitis B, C and HIV.

          4. Evidence of uncontrolled illness such as symptomatic congestive heart failure,
             uncontrolled hypertension or unstable angina pectoris.

          5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.

          6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
             colitis).
Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
Condition: Atrial Fibrillation; Lung Cancer
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone; Control arm, standard care
Intervention description: Perioperative orally administered; Control
Intervention MeSH terms: Amiodarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; Lung cancer; Pulmonary resection; Post-operative complications

Summary:

      Atrial fibrillation is a very common complication of pulmonary resection. Patients who
      develop atrial fibrillation require additional treatment and are more likely to stay in the
      hospital for longer period of time increasing the costs associated with the operation. We
      propose a randomized controlled trial to see if oral amiodarone given for one week before
      surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the
      incidence of atrial fibrillation in patients who received preoperative amiodarone and compare
      them to the incidence of atrial fibrillation in patients who did not received preoperative
      amiodarone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Resectable lung nodule or mass

        Exclusion Criteria:

          -  Allergy to amiodarone

          -  Currently taking amiodarone

          -  Documented atrial fibrillation within past 12 months

          -  Known pulmonary fibrosis

          -  Known hepatic dysfunction

          -  Thyroid disease

          -  2nd or 3rd degree heart block

          -  Severe SA node disease

          -  Bradycardia-induced syncope

          -  Pregnancy
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Bimatoprost 0.03% Formulation B Ophthalmic Solution; Bimatoprost 0.03% Ophthalmic Solution
Intervention description: One drop administered in each eye, every evening, for 12 weeks; One drop administered in each eye, every evening, for 12 weeks
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 597.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B
      ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12
      weeks in patients with glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has ocular hypertension or glaucoma in both eyes

          -  Requires IOP-lowering therapy in each eye

        Exclusion Criteria:

          -  Active or recurrent eye disease that would interfere with interpretation of study data
             in either eye

          -  History of any eye surgery or laser in either eye within 6 months

          -  Required chronic use of other eye medications during the study

          -  Anticipated wearing of contact lenses during the study.

          -  Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days