bioihbjkbjnl/mcl2 huggingface dataset:
Corneal Collagen Cross-Linking for Ectasia (CXL)
Condition: Ectasia
MeSH terms: Dilatation, Pathologic
Intervention: riboflavin ophthalmic solution; UVA Irradiation
Intervention description: riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL); UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Intervention MeSH terms: Riboflavin; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: ectasia; cross-linking; crosslinking; cornea; riboflavin; UVA

Summary:

      Prospective, randomized multicenter study to determine the safety and effectiveness of
      performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with
      ectasia after refractive surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ectasia after refractive surgery

          -  Documented ectasia on Pentacam or topography map

          -  BSCVA worse than 20/20

          -  Must complete all study visits

        Exclusion Criteria:

          -  History of delayed wound healing

          -  History of corneal melt or corneal dystrophy
OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
Condition: Muscle Spasticity; Stroke
MeSH terms: Muscle Spasticity
Intervention: onabotulinumtoxinA; placebo (normal saline)
Intervention description: OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.; Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper
      limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent
             stroke at least 3 months ago

        Exclusion Criteria:

          -  Spasticity in the non-study upper limb that requires treatment

          -  Presence of fixed contractures in of the study muscles in elbow or shoulder

          -  Profound atrophy of muscles to be injected

          -  Previous surgical intervention, nerve block, or muscle block for the treatment of
             spasticity in the study limb in the last 12 months

          -  Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or
             constraint-induced movement therapy (CIMT) for the study limb within 3 months

          -  Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1
             month

          -  Condition other than stroke contributing to upper limb spasticity

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral
             sclerosis
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
Condition: Ankylosing Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Apremilast tablet 20 mg; Apremilast tablet 30 mg BID; Placebo
Intervention description: Apremilast 20 mg was taken orally twice a day (BID); Apremilast 30 mg was taken orally twice a day; Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spondylitis; spondyloarthritis; Spondyloarthropathy; Oral preparation

Summary:

      Apremilast is a new, orally available, small molecule drug that specifically inhibits
      phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical
      study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain
             and stiffness, which improves with exercise, but is not relieved by rest for more than
             3 months prior to screening. At the completion of screening procedures, a documented
             diagnosis of definite active AS, as defined by the modified New York criteria (1984)
             whereby both criteria, at least 1 radiographic criterion and at least 1 clinical
             criterion, must be met

          -  Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4

          -  Total back pain is ≥ 4

          -  On stable dose of AS medication (or lack of medication) prior to randomization and
             through week 24

        Exclusion Criteria:

        - Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for
        AS
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Placebo; Abiraterone acetate; Prednisone/prednisolone
Intervention description: Four tablets once daily until disease progression; Four 250-mg tablets once daily until disease progression; 5 mg twice daily until disease progression
Intervention MeSH terms: Prednisone; Prednisolone; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1195.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Castration-Resistant Prostate Cancer; CRPC; Abiraterone Acetate; CB7630

Summary:

      This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus
      prednisone with placebo plus prednisone in patients with metastatic castration-resistant
      prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the
      previous chemotherapies must have contained docetaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
             cytotoxic chemotherapies

          -  At least one chemotherapy must have contained docetaxel

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2

          -  Medical or surgical castration with testosterone < 50 ng/dL

          -  Adequate bone marrow, hepatic and renal function

          -  Potassium >= 3.5 mmol/L

          -  Able to swallow the study drug whole as a tablet

          -  Informed Consent

        Exclusion Criteria:

          -  More than two prior cytotoxic chemotherapy regimens

          -  Prior Ketoconazole for prostate cancer

          -  Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting
             the androgen receptor for prostate cancer

          -  Uncontrolled hypertension

          -  Active or symptomatic viral hepatitis or chronic liver disease

          -  History of pituitary or adrenal dysfunction

          -  Clinically significant heart disease

          -  Other malignancy

          -  Known brain metastasis

          -  GI disorder affecting absorption

          -  Not willing to use contraception
The Hemophilia Inhibitor Eradication Trial
Condition: Hemophilia A With Inhibitor
MeSH terms: Hemophilia A
Intervention: Eloctate ITI; Emicizumab
Intervention description: This is a factor VIII-Fc infusion protein.; This is a bispecific monoclonal antibody FVIII mimic.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase III open-label, randomized controlled trial comparing immune tolerance induction with one drug, with or without a second drug in the eradication of hemophilia inhibitors.
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Healthy volunteers: No
Keywords: hemophilia; inhibitor formation; Eloctate; Emicizumab

Summary:

      This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial,
      in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate
      inhibitors in severe hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male adults or children > 4 months of age.

          2. Severe hemophilia A (FVIII < 0.01 U/ml).

          3. Current or past high-responding inhibitor, anti-FVIII >= 5.0 B.U., ITI-refractory or
             ITI-naive.

        Exclusion Criteria:

          1. Acquired hemophilia or any bleeding disorder other than hemophilia A.

          2. Current use of Emicizumab, or if used, > 8 weeks since last treatment.

          3. Use of an experimental drug(s).

          4. Surgery anticipated in the next 48 weeks.

          5. Life expectancy less than 5 years.

          6. Patient/parent/caretaker unable or unwilling to keep a personal diary of bleeding
             frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 8,
             12, 24, 36, and 48.

          7. Other illness, condition, or reason in the opinion of the investigator that would make
             the patient unsuitable for the trial.
Does Endometrial Injury Improve Intrauterine Insemination Outcome?
Condition: Infertility
MeSH terms: Infertility
Intervention: endometrial injury.; intrauterine insemination; ovarian stimulation
Intervention description: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.; Placement of washed sperm in the uterus using a catheter, around the time of ovulation.; Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 360.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No

Summary:

      The investigator suggests that local endometrial injury using pipelle catheter performed in
      the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy
      rates among patients undergoing intrauterine insemination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 38 years.

          -  patent fallopian tunes.

          -  mild male factor.

          -  anovulation.

          -  unexplained infertility.

        Exclusion Criteria:

          -  indications for ICSI.

          -  evidence of pelvic inflammatory disease.
Study to Investigate the Potential of Probiotics in Yogurt
Condition: Healthy
Intervention: Bifidobacterium lactis (BB-12); Placebo
Intervention description: The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).; The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 1 Year
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: probiotic; health; bifidobacterium lactis; BB-12

Summary:

      The purpose of this study is to determine if the consumption of a yogurt drink containing a
      high dose of probiotics decreases absences, due to illnesses, in daycare centers for children
      between the ages of 1 and 3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 1-3

          -  attending daycare or preschool centers at least 3 days a week

          -  male or female

          -  parents must speak English or Spanish

          -  subjects or parents/legal guardians who agree to have their child refrain from
             consuming any other yogurts or foods containing probiotics for the duration of the
             study

        Exclusion Criteria:

          -  subjects with developmental delays

          -  subjects with chronic conditions such as diabetes or asthma that require daily
             medication

          -  subjects with birth weight <2500 grams

          -  subjects with strawberry allergies

          -  subjects with active diarrhea

          -  subjects with congenital anomalies

          -  subjects with failure to thrive

          -  subjects with parental belief of lactose intolerance
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
Condition: Intraoperative Complication; Malignant Female Reproductive System Neoplasm; Pain
MeSH terms: Genital Neoplasms, Female; Intraoperative Complications
Intervention: Epidural analgesia; Intraoperative Complication Management and Prevention; Pain Therapy
Intervention description: Receive epidural placement. Standard epidural medications and dosage are as follows:
0.1% ropivicaine + 10 mcg/mL hydromorphone at 6 mL/hr continuous rate
3 mL/hr RN bolus, to be used as needed based on pain ratings
3 mL/30 minutes patient bolus, which is available on patient demand.; Undergo ERP; Undergo ERP
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized clinical trial studies epidural anesthesia within an enhanced recovery
      pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural
      analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and
      stops the feeling of pain. It stays in place for several days after surgery and may be
      helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of
      specific steps used before, during, and after surgery by health care providers to care for
      patients after surgery. ERPs include patient education, not using laxatives before surgery,
      increasing activity after surgery, and scheduled use of medications for pain and nausea.
      Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing
      gynecologic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing gynecologic surgery via midline vertical laparotomy at University
             of Wisconsin Hospital and Clinics (UWHC)

          -  Patients must be English speaking

          -  Patients must have the ability to understand visual and verbal pain scales

          -  Patients must be eligible for epidural placement

        Exclusion Criteria:

          -  Known allergy to local anesthetics

          -  Known history of chronic pain disorders and/or chronic opioid use defined as > 10 mg
             of oral (PO) morphine or equivalent used daily for at least 30 days prior to
             enrollment

          -  Patient is a prisoner or incarcerated

          -  Significant liver disease that would inhibit prescription of opioids

          -  Significant kidney disease that would inhibit administration of gabapentin

          -  Patient has a history of opioid dependence requiring rehabilitation or the use of
             opioid antagonists

          -  Patient is pregnant

          -  Patients with a planned exploration with biopsies (no organs removed) will be excluded
             from the study
Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MR Prednisone; IR Prednisone; Placebo - MR Prednisone; Placebo - IR Prednisone
Intervention description: Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time.; Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.; Participants will receive placebo matching to MR prednisone tablet at bed time.; Participants will receive placebo matching to IR prednisone tablet in the morning.
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: active disease; morning stiffness of joints; nighttime application of prednisone; modified release prednisone

Summary:

      The objective of this study is to investigate if low doses of prednisone MR formulation,
      given at night and, with active drug release at 2 am, are more effective in controlling joint
      stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone
      given in the morning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active disease (inflammatory signs, erythrocyte sedimentation rate [ESR], C-reactive
             protein [CRP])

          -  Stable condition

          -  Stable basic treatments

          -  Morning stiffness on previous treatment with standard prednisone (below or equal to 10
             mg per day) greater than or equal to (>/=) 45 minutes

        Exclusion Criteria:

          -  All contra-indications for glucocorticoids

          -  Pregnancy

          -  Concomitant treatment with biologics

          -  Intra-articular injections or synovectomy within the previous 4 months
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Oseltamivir
Intervention description: Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
Intervention MeSH terms: Oseltamivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This open-label randomized 2 arm study will determine the emergence of viral resistance in
      participants with seasonal influenza A infection treated with oseltamivir. Eligible
      participants less than or equal to (</=) 5 years of age will be randomized to receive
      oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or
      double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.
    

Eligibility criteria:

        Inclusion Criteria:

          -  positive rapid antigen test for influenza A

          -  onset of symptoms of influenza (fever, at least one respiratory symptom) </=48 hours

        Exclusion Criteria:

          -  clinical suspicion of infection with a respiratory virus other than influenza

          -  suspicion of invasive bacterial infection

          -  evidence of poorly controlled underlying disease

          -  known immunosuppression

          -  known allergy to Oseltamivir

          -  women who are pregnant or planning to get pregnant during the study
A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: voglibose
Intervention description: sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks; voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
Intervention MeSH terms: Inositol; Sitagliptin Phosphate; Voglibose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 319.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients
      with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have type 2 diabetes mellitus on diet/exercise therapy

        Exclusion Criteria:

          -  Patients have type 1 diabetes mellitus
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: SB11 (Proposed ranibizumab biosimilar); Lucentis (ranibizumab)
Intervention description: SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks; Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 705.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a randomised, double-masked, parallel group, multicentre study to evaluate the
      efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in
      subjects with neovascular AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 50 years

          2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to
             AMD in the study eye

          3. BCVA of 20/40 to 20/200 in the study eye

          4. Written informed consent form

        Exclusion Criteria:

          1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to
             treat neovascular AMD in either eye

          2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis,
             trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or
             pathologic myopia

          3. Any concurrent macular abnormality other than AMD in the study eye