bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CNTO 1275 45 mg; CNTO 1275 90 mg; Etanercept 50 mg
Intervention description: Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous; Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous; Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous
Intervention MeSH terms: Etanercept; Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 903.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; CNTO 1275; Etanercept; Immune diorder; Skin disorder

Summary:

      The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in
      patients with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the study

          -  Have plaque-type psoriasis covering at least 10 percentage of total body surface area

          -  Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater and a
             Physician's Global Assessment (PGA) score of 3 or greater at the time of the first
             administration of study drug

          -  Must be suitable for phototherapy or systemic treatment for psoriasis

          -  Have failed to respond to or have condition which prevents use of cyclosporine,
             methotrexate (MTX) or psoralen plus ultraviolet light A (PUVA)

        Exclusion Criteria:

          -  Currently have nonplaque forms of psoriasis

          -  Have current drug-induced psoriasis

          -  Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or IL-23
             (Interleukins are the substance produced by body in immunological disease like
             psoriasis)

          -  Have received phototherapy or any systemic medications/treatments that could affect
             psoriasis or PASI evaluation (including, but not limited to, oral or injectable
             corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens,
             sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first
             administration of study agent

          -  Have used a biologic within the previous 3 months
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Placebo; Erlotinib; Standard of care
Intervention description: Participants will receive placebo tablets (matched to erlotinib) once daily.; Erlotinib will be given as 150 mg PO once daily.; Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo
      in participants with resected head and neck squamous cell cancer who are receiving concurrent
      chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either
      erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease
      progression or unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (≥) 18 years of age

          -  Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3
             pathology, with or without other findings of poor prognosis such as extranodal
             extension, positive resection margins, and perineural or vascular involvement

          -  Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

        Exclusion Criteria:

          -  Macroscopic residual disease after surgery

          -  Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted
             therapies
SSRI and Buprenorphine
Condition: Opiate Dependence; Depression
MeSH terms: Opioid-Related Disorders; Depression
Intervention: escitalopram; placebo
Intervention description: 10mg escitalopram/day for 3 months; placebo capsule/day for 3 months
Intervention MeSH terms: Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: opiate use; depression; buprenorphine; escitalopram

Summary:

      This study is designed to test whether treatment of depressive symptoms using escitalopram
      improves adherence to Buprenorphine and reduces symptoms of depression for individuals
      receiving Buprenorphine through their medical provider.
    

Eligibility criteria:

        Inclusion Criteria:

          -  opiate dependence

          -  Ham-D > 14

        Exclusion Criteria:

          -  no psychiatric contraindications to using escitalopram

          -  no medical contraindications to using escitalopram

          -  methadone dose < 30

          -  no current SSRI use
A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; Peginterferon alfa-2a (PegIFNα-2a ); Ribavirin (RBV)
Intervention description: 100-mg capsule taken by mouth once daily for 12 or 24 weeks.; PegIFNα-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.; RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Hepatitis C; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination
      with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus
      (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy
      in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10
             IU/mL

          -  Participant failed to respond to previous IFN-based therapy

          -  Participant must be willing to use contraceptive measures from the time of informed
             consent to 6 months after last dose of study medication.

        Exclusion Criteria:

          -  Co-infection with any other HCV genotype or co-infection with the human
             immunodeficiency virus (HIV)

          -  Diagnosed with hepatic cirrhosis or hepatic failure

          -  A medical condition which is a contraindication to PegIFNα-2a or ribavirin therapy

          -  History of, or any current medical condition which could impact the safety of the
             patient in the study
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Updated DEX PS DDS Applicator; Approved DEX PS DDS Applicator; Dexamethasone
Intervention description: Intravitreal Administration; Intravitreal administration; Dexamethasone 0.7 mg in a solid polymer drug delivery system
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Edema; Dexamethasone; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion; Diabetic Macular Edema; Noninfectious Uveitis; Ozurdex; Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)

Summary:

      The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to
      deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator.
      This purpose of this study is to show that the updated DEX PS DDS Applicator works in adult
      participants with macular edema due to retinal diseases.

      The DEX PS DDS is approved for the treatment of macular edema. Participants will be placed
      into 1 of 2 groups, called treatment arms. Each group receives the same treatment drug
      delivered using different applicators. Around 54 adult participants with macular edema will
      be enrolled in the study in approximately 7-10 sites in the United States.

      Participants will receive a single intravitreal (into the eye) administration of DEX PS DDS
      implant using either the currently-approved DEX PS DDS Applicator or the the updated
      Applicator. The participants will be observed for a duration of 7 days, with the DEX PS DDS
      implant received on day 1 and follow-up through day 7.

      The updates being evaluated in this study are related to the DEX PS DDS Applicator only, with
      the safety and efficacy of the DEX PS DDS implant well characterized and the same as the
      currently marketed product. Participants will attend regular visits during the study at a
      hospital or clinic. The applicator function will be checked by medical assessment, checking
      for side effects, procedural complications and/or product complaints, and evaluating the
      administration procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        - Participants with macular edema due to retinal vein occlusion (branch retinal vein
        occlusion or central retinal vein occlusion) or diabetic macular edema.

        Exclusion Criteria:

        - Participants with ocular conditions in the study eye for which Dexamethasone Posterior
        Segment Drug Delivery System Implant is contraindicated.
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate
Intervention description: Oral suspension administered once a day via syringe.
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Cognitive Function; Phase 3; Neurogenic Detrusor Overactivity; Pharmacokinetics; Ocular Accommodation; Urodynamics

Summary:

      The purpose of this study was to investigate a medicine for the treatment of symptoms and
      complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of NDO, confirmed by urodynamics

          -  Practicing clean intermittent catheterization (CIC)

          -  Currently on treatment with an antimuscarinic drug

        Exclusion Criteria:

          -  Known genitourinary condition (other than NDO) that may cause incontinence

          -  Bladder augmentation surgery

          -  Current Faecal impaction

          -  Electro-stimulation therapy within 2 weeks prior to screening and at any time during
             the study

          -  Subjects with the following gastro-intestinal problems: partial or complete
             obstruction, decreased motility like paralytic ileus, subjects at risk of gastric
             retention

          -  Reflux grade 3 or 4

          -  Current urinary tract infection (UTI)

          -  Subject has severe renal impairment (glomerular filtration rate < 30 ml/min)

          -  Subject has severe hepatic impairment (Child-Pugh score > 9).

          -  Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LCZ696; Olmesartan; Placebo
Intervention description: 200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily; Olmesartan 20 mg capsule one daily; Placebo to LCZ696 or Olmesartan
Intervention MeSH terms: Olmesartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1161.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Essential hypertension; LCZ696

Summary:

      This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mild-to-moderate hypertension, untreated or currently taking
             antihypertensive therapy.

          -  Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1)
             must have an msSBP ≥ 150 mmHg and < 180 mmHg at the randomization visit (Visit 201)
             and msSBP ≥140 mmHg < 180 mmHg at the visit immediately proceeding Visit 201 (Visit
             102 or 103).

          -  Untreated patients (newly diagnosed with essential hypertension or having a history of
             hypertension but have not been taking any antihypertensive drugs for at least 4 weeks
             prior to Visit 1) must have an msSBP ≥ 150 mmHg and < 180 mmHg at both Visit 1 and
             Visit 201.

          -  Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and
             the immediately preceding visit;

        Exclusion Criteria:

          -  Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg).

          -  History of angioedema, drug-related or otherwise, as reported by the patient.

          -  History or evidence of a secondary form of hypertension, including but not limited to
             any of the following: renal parenchymal hypertension, renovascular hypertension
             (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary
             hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease,
             and drug-induced hypertension.

          -  Patients who previously entered a LCZ696 study and had been randomized or enrolled
             into the active drug treatment epoch.

        Other protocol-defined inclusion/exclusion criteria may apply.
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 Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Vemurafenib; Dacarbazine
Intervention description: 960 mg (as 240 mg tables) orally twice daily; 1000 mg/m2 intravenously every 3 weeks
Intervention MeSH terms: Dacarbazine; Vemurafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 675.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label study evaluated the efficacy, safety and tolerability of
      vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with
      metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally
      twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was
      continued until disease progression or unacceptable toxicity occurred. The data and safety
      monitoring board recommended that patients in the dacarbazine group be allowed to cross over
      to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both
      overall survival and progression-free survival endpoints had met the prespecified criteria
      for statistical significance in favor of vemurafenib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults, >/=18 years of age

          -  metastatic melanoma, stage IIIC or IV (AJCC)

          -  treatment-naïve (no prior systemic anticancer therapy)

          -  positive for BRAF V600E mutation

          -  measurable disease by RECIST criteria

          -  negative pregnancy test and, for fertile men and women, effective contraception during
             treatment and for 6 months after completion

        Exclusion Criteria:

          -  active central nervous system metastases

          -  history of carcinomatous meningitis

          -  severe cardiovascular disease within 6 months prior to study drug administration

          -  previous malignancy within 5 years prior to study, except for basal or squamous cell
             carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix