bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Adalimumab; Placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 952.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis

Summary:

      To evaluate safety and efficacy of two adalimumab dosing regimens for induction and
      maintenance (standard and higher dosing) in achieving clinical remission in subjects with
      moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy
             during Screening period.

          -  Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite
             concurrent or prior treatment with a full and adequate course, in the opinion of the
             Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is
             confirmed by central reader.

        Exclusion Criteria:

          -  Subject with Crohn's disease (CD) or indeterminate colitis (IC).

          -  Current diagnosis of fulminant colitis and/or toxic megacolon.

          -  Subjects with disease limited to the rectum (ulcerative proctitis) during the
             screening endoscopy.

          -  Chronic recurring infections or active tuberculosis (TB).
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Comparator: raltegravir; Comparator: placebo; Comparator: lopinavir (+) ritonavir; Comparator: placebo
Intervention description: raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment; lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment; lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment; raltegravir 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
Intervention MeSH terms: Ritonavir; Lopinavir; Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment experienced

Summary:

      The purpose of this study is to investigate the efficacy, safety, and tolerability of an
      investigational treatment for patients with Human Immunodeficiency Virus (HIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is at least 18 years of age

          -  Patient is human immunodeficiency virus (HIV) positive

          -  Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50
             copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen

          -  Patient has been on a KALETRA based regimen for at least 3 months without a change in
             background antiretroviral therapy

          -  Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on
             the KALETRA based regimen

        Exclusion Criteria:

          -  Patient is or plans to become pregnant, or is nursing a child

          -  Patient plans to donate eggs or impregnate/donate sperm

          -  Patient is receiving Stavudine (d4T) as a component of the background antiretroviral
             therapy

          -  Patient is currently receiving a second protease inhibitor in addition to KALETRA

          -  Patient is currently receiving, or has received in the past twelve weeks, treatment
             for the management of elevated lipids

          -  Patient has used another experimental HIV-integrase inhibitor

          -  Patient has a current (active) diagnosis of acute hepatitis due to any cause
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: pregabalin (Lyrica); Placebo
Intervention description: Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.; Placebo is supplied as capsules and given 3 times daily.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 633.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic peripheral neuropathy; Lyrica; pregabalin; pain

Summary:

      Patients will be switched from their current medication for painful diabetic peripheral
      neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All
      patients will receive pregabalin, and half of patients will receive placebo at some point
      during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have painful diabetic peripheral neuropathy and be receiving treatment
             for this condition.

        Exclusion Criteria:

          -  Patients with other pain conditions cannot participate.
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: levetiracetam (LEV)
Intervention description: Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Partial Onset Seizures; levetiracetam; Epilepsy; Keppra

Summary:

      To allow pediatric patients with partial onset seizures an opportunity to receive (as
      follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment)
      open-label levetiracetam treatment, continue studying cognition and behavior in children, and
      continue collection of safety/efficacy data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs
             (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or
             N01103) or direct enrollment, for whom levetiracetam treatment will be of possible
             benefit

        Exclusion Criteria:

          -  Patients on a ketogenic diet

          -  Seizures too close together to accurately count

          -  Pseudoseizures

          -  Status epilepticus 1 month prior Visit 1

          -  Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing
             cerebral disease will be excluded from the study.
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
Condition: Hypercholesterolemia; Atherosclerosis; Statin Adverse Reaction
MeSH terms: Atherosclerosis; Hypercholesterolemia
Intervention: Bempedoic acid; Ezetimibe; Placebo
Intervention description: bempedoic acid 180 mg tablet; ezetimibe 10 mg tablet; matching placebo tablet
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlididemia; LDL; cholesterol; statin intolerance

Summary:

      The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe
      therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-cholesterol greater than or equal to 100 mg/dL at screening

          -  Men and nonpregnant, nonlactating women

          -  Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that
             includes ezetimibe 10mg daily

        Exclusion Criteria:

          -  Fasting blood triglycerides greater than or equal to 500 mg/dL

          -  Body Mass Index (BMI) greater than or equal to 50 kg/m2

          -  Recent history of clinically significant cardiovascular disease

          -  Use of statin therapy where doses are greater than those defined as "low-dose" within
             4 weeks prior to screening; where "low-dose" is defined as an average daily dose of
             rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg,
             pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
Condition: Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
MeSH terms: Hypertension
Intervention: spironolactone; placebo
Intervention description: 25 to 50 mg once daily; addition of placebo 1 to 2 tablets daily
Intervention MeSH terms: Spironolactone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hypertension; spironolactone; antihypertensive treatment; Type-2 diabetes

Summary:

      The purpose of this study is to estimate the effect of spironolactone on blood pressure
      resistant to therapy in type-2 diabetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 75 years

          -  Type-2 diabetes

          -  Therapy resistant hypertension (by ABPM)

          -  Treatment with at least 3 antihypertensives

        Exclusion Criteria:

          -  HbA1c > 10.0

          -  BP > 180/110 mmHg

          -  Secondary hypertension

          -  Intolerance to spironolactone

          -  Permanent treatment with nonsteroidal antiinflammatory drugs or systemic
             glucocorticoids

          -  Total cholesterol 10 mmol/l

          -  New York Heart Association class III and IV

          -  Pregnancy or planned pregnancy

          -  Psychiatric disease

          -  Malignant disease

          -  Insufficient adherence
A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Tocilizumab; Placebo
Intervention description: Tocilizumab was supplied as a sterile solution in vials.; Placebo to tocilizumab was supplied as a sterile solution in vials.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active
      polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or
      were intolerant of methotrexate. In Part I of the study, all patients received intravenous
      (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients
      < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate
      response in Part I were randomized to receive either tocilizumab at the same dose as in Part
      I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received
      tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard
      of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID),
      corticosteroids, or methotrexate was continued throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children/juveniles, 2-17 years of age.

          -  Polyarticular-course juvenile idiopathic arthritis (pcJIA) ≥ 6 months duration.

          -  Active disease (≥ 5 active joints, ≥ 3 with limitation of motion).

          -  Inadequate response to or inability to tolerate methotrexate.

          -  Methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (NSAID)
             at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.

          -  Biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending
             on biologic.

        Exclusion Criteria:

          -  Auto-immune, rheumatic disease or overlap syndrome other than pcJIA.

          -  Wheelchair bound or bedridden.

          -  Intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4
             weeks prior to baseline.

          -  Disease-modifying anti-rheumatic drugs (DMARD) (other than methotrexate) within 4
             weeks prior to baseline.

          -  Previous treatment with tocilizumab.
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Condition: Candida Vulvovaginitis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vulvovaginitis
Intervention: Ibrexafungerp; Placebo
Intervention description: Ibrexafungerp 300mg BID for one day; Matching Placebo
Intervention MeSH terms: Ibrexafungerp
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind study
Masking: Double (Participant, Investigator)
Enrollment: 455.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vaginitis; Yeast infection

Summary:

      This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in
      female subjects 12 years and older with AVVC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a postmenarchal female subject 12 years and older

          -  Subject has a diagnosis of symptomatic AVVC at baseline including a positive
             microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample
             revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

        Exclusion Criteria:

          -  Subject has any vaginal condition other than AVVC that may interfere with the
             diagnosis or evaluation of response to therapy, such as suspected or confirmed
             concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)

          -  Need for systemic and/or topical (vaginal) anti fungal treatment, including
             prescription or over-the-counter products during the study and treatment for
             vulvovaginal candidiasis (VVC) 28 days prior to randomization.

          -  Subject has uncontrolled diabetes mellitus.

          -  Subject has a vaginal sample with pH >4.5.

          -  Subject has a history of or an active cervical/vaginal cancer.
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: indocyanine green; isotope
Intervention description: One injection, 2.5 milligrams per patient, intradermal use; One injection, 20 MBq techntium99, intradermal use
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sentinel lymph node; indocyanine green; fluorescence method; radioisotope conventional method; breast cancer

Summary:

      The sentinel node has a fundamental role in the management of early breast cancer.

      Currently, the double detection of blue and radioisotope is recommended. A radioactive
      material requires the presence of a nuclear medicine department and the approval of health
      authorities. In many centers, this technique is not available. The use of blue is easier to
      implement technique. However, allergic reactions and prolonged breast tattoo led many teams
      to stop the practice.

      So in common practice, many center use a single method. However, with a single detection, the
      risk of false negatives and the identification failure rate increased to a significant extent
      and the number of sentinel lymph node detected and removed is not enough.

      Under these conditions, find another method of detection seems crucial. According to the
      literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

      The investigators therefore propose a prospective, randomized study to investigate the
      interest of fluorescence associated with the isotopic method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a
             carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis,
             radiologically evaluated size more than 40mm, or immediate mastectomy…)

          -  Unifocal or multifocal but in same quarter

          -  Size < 5cm clinically palpable or not

          -  Clinically or ultrasound axillary N0

          -  Isotopic sentinel node detection

          -  Adult patient

          -  Signed informed consent by patient or legally responsable authority

          -  Patient registered to a social security system

          -  No surgical contra-indication

        Exclusion Criteria:

          -  Mammary carcinoma recurrence

          -  Previous same side mammary reduction

          -  Previous lumpectomy

          -  Contra-indication to surgery

          -  Pregnant or breast feeding patient

          -  Denial of participation
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
Condition: Gout
MeSH terms: Gout
Intervention: Placebo; Rilonacept; Rilonacept
Intervention description: Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.; Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.; Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.
Intervention MeSH terms: Rilonacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Intercritical Gout; Metabolism, Inborn Errors; Allopurinol; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors; Gout

Summary:

      The purpose of this clinical research study was to determine the safety and effectiveness of
      an experimental drug called rilonacept in participants with gout who are beginning
      allopurinol treatment for gout. Participants will participate in this study for approximately
      22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 to 80 years of age;

          -  Previously met the preliminary criteria of the American Rheumatism Association (ARA)
             for the classification of the acute arthritis of primary gout;

          -  At least 2 gout flares in the year prior to the screening visit;

          -  Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit.

        Exclusion Criteria:

          -  Acute gout flare within 2 weeks of the screening visit or during screening;

          -  Persistent chronic or active infections;

          -  History of an allergic reaction to allopurinol;

          -  History or presence of cancer within 5 years of the screening visit;

          -  Previous exposure to Rilonacept;

          -  Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3
             months prior to the screening visit.
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Intervention: Ospemifene (Dose 1); Ospemifene (Dose 2); Placebo
Intervention MeSH terms: Tamoxifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Menopausal symptoms; Urogenital atrophy; Vulvar and vaginal atrophy in menopausal women; Vaginal atrophy

Summary:

      The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily
      doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal
      women with an intact uterus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal
             atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and
             self-reported symptoms at Baseline for Protocol 15-50310

          -  Had an intact uterus

          -  Met the inclusion and exclusion criteria for Protocol 15-50310

          -  Had completed Protocol 15-50310

        Exclusion Criteria:

          -  Had clinically significant abnormal findings at the Week 12 End of Study visit for
             Protocol 15-50310

          -  Had any physical or mental condition which, in the opinion of the investigator, may
             have interfered with the subject's ability to comply with the study procedures