bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; methotrexate
Intervention description: 8 mg/kg iv every 4 weeks for a total of 6 infusions; 10-25 mg orally weekly
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label, single arm study will assess the safety and efficacy of
      RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active
      rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying
      antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously
      every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly.
      Anticipated time on study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration

          -  Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)

          -  Inadequate clinical response to stable dose of non-biologic DMARD (either single or in
             combination)

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following enrollment

          -  Autoimmune disease other than RA

          -  History of or current inflammatory joint disease other than RA

          -  Previous treatment with any biologic drug that is used in the treatment of RA

          -  Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline

          -  Impaired liver, renal or hematologic function

          -  Active current or history of recurrent infection

          -  History of or currently active primary or secondary immunodeficiency
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Condition: Preterm Delivery; Cervical Length
MeSH terms: Premature Birth
Intervention: 17 alpha-hydroxyprogesterone caproate; Placebo Oil
Intervention description: Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.; Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment with 17 alpha-hydroxyprogesterone caproate via weekly injections of 250 mg of 17p until 37 weeks gestation or delivery vs. weekly injections of placebo oil until 37 weeks gestation or delivery.
Masking: Double (Participant, Care Provider)
Masking description: Patients and care providers are masked to treatment assignment.
Enrollment: 657.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nulliparous; pregnancy; short cervix; progesterone

Summary:

      The purpose of this study is to see if giving progesterone medication to pregnant women, who
      have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers
      the risk of early delivery and improves the health of their baby.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nulliparous

          -  Cervical length as measured on transvaginal examination < 30mm between gestational
             ages of 16 weeks 0 days to 22 weeks 3 days

          -  Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization

        Exclusion Criteria:

          -  Multifetal gestation

          -  Progesterone treatment after 14 weeks 6 days during current pregnancy

          -  Vaginal bleeding, heavier than spotting, after 15 weeks 6 days

          -  Amniotic membranes prolapsed beyond external os

          -  Preterm rupture of membranes

          -  Fetal anomaly

          -  Pregnancy without a viable fetus

          -  Current or planned cervical cerclage

          -  Congenital Mullerian abnormality of the uterus

          -  Contraindication to intra-muscular injections

          -  Hypertension requiring medication

          -  Diabetes managed with insulin or oral hypoglycemic agents

          -  DES exposure

          -  Cervical surgery such as cold knife conization

          -  Planned indicated preterm delivery

          -  Participation in another interventional study that influences age at delivery

          -  Participation in this trial in a previous pregnancy

          -  Prenatal care or delivery planned outside a MFMU Network center
Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Web-based coping skills training; Online disease education
Intervention description: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.; The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this multi-site randomized clinical trial is to determine if an online coping
      skills training program will produce superior improvements in pain and health-related quality
      of life outcomes for adolescents with JIA relative to outcomes attained with reviewing online
      educational information about JIA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12-18 years of age (inclusive)

          -  diagnosed with JIA by a pediatric rheumatologist

          -  able to speak and read English and/or Spanish

          -  able to complete online measures

          -  reporting pain in at least one joint over the past 6 months

        Exclusion Criteria:

          -  have another chronic medical condition that adversely impacts pain and/or
             health-related quality of life (e.g., inflammatory bowel disease, fibromyalgia,
             cancer, genetic disorder, pervasive developmental disorder, diabetes)

          -  have a significant cognitive impairment or illiteracy that would prevent understanding
             of the intervention and outcome measures

          -  currently in psychotherapy
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Condition: Post-stroke Spasticity of the Lower Limb
MeSH terms: Muscle Spasticity; Stroke
Intervention: IncobotulinumtoxinA (400 Units); Placebo Comparator
Intervention description: Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.; Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the leg are effective in treating patients with increased muscle
      tension/uncontrollable muscle stiffness (spasticity) after a stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age from 18-80 yrs

          -  Lower limb spasticity

          -  Time since stroke greater than 3 months

          -  Need for 400 U Botulinum toxin type A

        Exclusion Criteria:

          -  Body weight below 50kg

          -  Fixed contractures of the lower limb

          -  Generalized disorders of muscle activity like Myasthenia gravis that preclude use of
             Botulinum toxin type A

          -  Infection at the injection site
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: AMG 510; Docetaxel
Intervention description: 21 day cycles; 21 day cycles
Intervention MeSH terms: Docetaxel; Sotorasib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC)
      subjects with KRAS p. G12c mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women greater than or equal to 18 years old.

          -  ECOG ≤ 1

          -  Pathologically documented, previously treated, locally-advanced and unresectable or
             metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have
             documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

        Exclusion Criteria:

          -  Active brain metastases

          -  Myocardial infarction within 6 months of study day 1

          -  Gastrointestinal (GI) tract disease causing the inability to take oral medication
Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, multi-centre single arm trial to investigate long-term safety and
      tolerability of degarelix in Korean patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has given written informed consent before any trial-related activity is performed. A
             trial-related activity is defined as any procedure that would not have been performed
             during the normal management of the patient

          -  Has completed the 7-month main trial, FE200486 CS42

        Exclusion Criteria:

          -  Has been withdrawn/discontinued from the FE200486 CS42 trial

          -  A patient may also not be entered into the CS42A trial at the discretion of the
             investigator due to safety or lack of efficacy concerns (LH or PSA response) in the
             CS42 trial.
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: Sofosbuvir; RBV; PEG
Intervention description: Sofosbuvir 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Intervention MeSH terms: Sofosbuvir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1 (GT-1); HCV genotype 4 (GT-4); HCV genotype 5 (GT-5); HCV genotype 6 (GT-6); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; Treatment-Naïve; GS-7977; Ribavirin; RBV; Peginterferon Alfa 2a; PEG

Summary:

      This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated
      interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with
      hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral
      response (SVR) 12 weeks after discontinuation of therapy (SVR12).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infection with HCV genotype 1, 4, 5, or 6

          -  Cirrhosis determination

          -  Subject met the following classifications:

               -  Treatment-naive

               -  Screening laboratory values within defined thresholds

               -  Not treated with any investigational drug or device within 30 days of screening

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein
             (NS)5B polymerase

          -  Pregnant or nursing female, or male with pregnant female partner

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically-significant illness or any other major medical disorder that may
             have interfered with subject treatment, assessment, or compliance with the protocol

          -  Excessive alcohol ingestion or significant drug abuse
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
Condition: Lipid Metabolism, Inborn Errors; Hypercholesterolemia, Autosomal Dominant; Hyperlipidemias; Metabolic Diseases; Hyperlipoproteinemia Type II; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolic Disorder; Congenital Abnormalities; Hypercholesterolemia; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders
MeSH terms: Congenital Abnormalities; Hyperlipoproteinemia Type II; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolism, Inborn Errors; Lipid Metabolism, Inborn Errors; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: Mipomersen Sodium
Intervention description: Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.
Intervention MeSH terms: Mipomersen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Familial Hypercholesterolemia; FH; Heterozygous Familial Hypercholesterolemia; HeFH; Homozygous Familial Hypercholesterolemia; HoFH

Summary:

      To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in
      participants with familial hypercholesterolemia or severe hypercholesterolemia on
      lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7
      (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfactory completion of dosing in their initial study (Protocol 301012-CS5
             [NCT00607373], 301012-CS7 [NCT00706849], 301012-CS17 [NCT00477594], or MIPO3500108
             [NCT00794664])

        Exclusion Criteria:

          -  Had any new condition or worsening of existing condition which in the opinion of the
             Investigator would make the participant unsuitable for enrollment, or could interfere
             with the participant participating in or completing the study
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Condition: Rosacea
MeSH terms: Rosacea
Intervention: CLS001 (Omiganan); Vehicle
Intervention description: Topical gel; Vehicle Gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel
      compared to vehicle gel in subjects with severe papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

          2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
             Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

          3. Subjects with the presence of telangiectasia at Baseline.

          4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
             Erythema scale at Baseline.

          5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

        Exclusion Criteria:

          1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

          2. Subjects with nodular rosacea.

          3. Standard exclusion criteria.
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Evolocumab Pre-filled Syringe; Evolocumab AI/pen
Intervention description: Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.; Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: LDL-C, triglycerides, high cholesterol

Summary:

      The primary objective of this study was to assess users' ability to administer a full dose of
      evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C at screening > 85 mg/dL

          -  Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes or poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin 100 mg; Canagliflozin 300 mg; Antihyperglycemic agent(s); Placebo
Intervention description: One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.; One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.; Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.; One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Intervention MeSH terms: Canagliflozin; Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 716.0
Sex: All
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Canagliflozin; Placebo; Hemoglobin A1c; Bone; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2
      diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and may be currently treated with a stable
             regimen of antihyperglycemic agent(s)

          -  Patients in the study must have a HbA1c between >=7 and <=10.0%

          -  Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a
             severe hypoglycemic episode within 6 months before screening