bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol
Intervention description: Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).
Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CDP870; certolizumab pegol; Crohn's Disease

Summary:

      This is an open-label extension study designed to measure the safety, efficacy, and
      corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to
      severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

        Exclusion Criteria:

          -  Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under
             specific conditions

          -  Subject who received treatment other than study medication and other than medications
             permitted in C87059 (COSPAR I, NCT00349752)

          -  Subjects from countries where certolizumab pegol is authorized in Crohn's disease
             treatment
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: ABBV-951
Intervention description: Solution for continuous subcutaneous infusion (CSCI)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease (PD); ABBV-951; Levodopa/Carbidopa

Summary:

      The purpose of this study was to assess the safety and tolerability of ABBV-951
      (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

      This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or
      High Dose) based on the modal total daily dose (most frequent dose) over the treatment
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is
             levodopa-responsive

          -  Participants must be judged by the investigator to be inadequately controlled by
             current therapy, have recognizable/identifiable "Off" and "On" states (motor
             fluctuations), and have a minimum of 2.5 hours of "Off" time per day

        Exclusion Criteria:

          -  Participant is cognitively impaired and is not able to safely and effectively manage
             the drug delivery system and the diaries and is not able to adhere to the study

          -  Participant is considered by the investigator to be an unsuitable candidate to receive
             ABBV-951 for any reason
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
Condition: Infertility
MeSH terms: Infertility
Intervention: Low dose hCG plus FSH co-trigger; Standard dose of hCG
Intervention description: Low dose hCG (1,500 IU) plus FSH (450 IU) co-trigger; Standard dose of hCG (10,000 or 5,000 IU) trigger
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 105.0
Sex: Female
Minimum age: 18 Years
Maximum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infertility; In vitro fertilization; IVF

Summary:

      This is a randomized, double-blind, single center clinical trial study to compare oocyte
      competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard
      dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus
      concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro
      fertilization (IVF).
    

Eligibility criteria:

        Inclusion Criteria: The target population includes couples undergoing IVF. All eligible
        couples will be asked to join the study. Study participants will be recruited from the
        Reproductive Endocrinology Clinic at University of California at San Francisco Center for
        Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be
        offered participation in the study.

        Exclusion Criteria:

          -  Age >41 years old

          -  Antral Follicle Count (AFC; 2-10 mm) < 8

          -  Body Mass Index > 30 kg/m2

          -  History of ≥ 2 prior canceled IVF cycles secondary to poor response

          -  Diagnosis of cancer

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow-up, or interpretation of study results

          -  Undergoing embryo co-culture

          -  Use of any of the following medications: Growth Hormone, Sildenafil, or Aspirin
             (except if being used for hypercoagulable state)

          -  Severe male factor infertility diagnosis. Male factor infertility diagnosis should be
             cleared for eligibility by the PI based on previous patient history of fertilization
             outcomes and/or expected fertilization outcomes of the cause of male factor
             infertility based on known scientific data.

          -  Ovulation trigger less than or greater than 36 hours to oocyte retrieval

          -  Serum estradiol level >5,000 pg/ml on the day of expected trigger due to high risk of
             OHSS
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: risedronate; risedronate; risedronate
Intervention description: 5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily; 35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly; 35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 923.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing
      regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female: 50 years of age or older

          -  >5 years since last menses natural or surgical

          -  have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or
             have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean
             value and also have at least one prevalent vertebral body fracture

        Exclusion Criteria:

          -  history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

          -  BMI >32 kg/m

          -  use of medications within 3 months of starting study drug that impact bone metabolism
             such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and
             parathyroid hormone

          -  hypocalcemia or hypercalcemia of any cause

          -  markedly abnormal clinical laboratory measurements that are assessed as clinically
             significant by the investigator
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Rosiglitazone; Sulfonylurea; Metformin
Intervention description: Rosiglitazone maximum 8 mg per day; Sulfonylurea (SU) maximum permitted daily dose; Metformin maximum permitted daily dose .
Intervention MeSH terms: Metformin; Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4447.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; CV outcomes; rosiglitazone; Type II diabetes; sulfonylurea; RECORD; metformin

Summary:

      This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week
      run-in period will be followed by a median of 6 years of treatment with study medication in
      addition to continuation of background glucose lowering therapy. Patients inadequately
      controlled on background metformin will be randomised to receive, in addition to metformin,
      either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio
      of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in
      addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of
      patients receiving background metformin and SU at entry will be entered into the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type II diabetes mellitus as defined by 1999 World Health Organisation
             criteria.

          -  Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.

          -  Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and
             unchanged for 2 months prior to screening.

          -  Body mass index >25.0 kg/m2.

        Exclusion Criteria:

          -  Patients receiving any other glucose lowering therapy which is not metformin or a
             sulfonylurea.

          -  Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.

          -  Patients who have required the use of insulin for glycaemic control at any time in the
             past.

          -  Hospitalisation for any major cardiovascular event in the last 3 months.
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Modified Process Hepatitis B Vaccine (Experimental); Hepatitis B Vaccine (Recombinant); Hepatitis B Vaccine (Recombinant)
Intervention description: Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).; RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.; ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1718.0
Sex: All
Minimum age: 2 Months
Maximum age: 2 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was conducted in healthy infants and will provide new immunogenicity and safety
      data for the modified process hepatitis B vaccine. This study was conducted to address the
      following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the
      modified process hepatitis B vaccine compared with a 10 microgram dose of the modified
      process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and
      to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a healthy infant approximately 2 months of age

        Exclusion Criteria:

          -  Birth mother is a known carrier of hepatitis B virus or another known carrier has
             lived in close contact with the participant

          -  Participant's birth mother did not receive any prenatal care

          -  Participant has previous history of hepatitis B infection

          -  Participant has been vaccinated against hepatitis B or birth mother was vaccinated
             within 6 months before birth of participant

          -  Participant has had a fever within 72 hours of study start

          -  Participant has received any blood-derived product or birth mother received
             blood-derived product within 6 months of birth of participant
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM; IVA
Intervention description: Fixed Dose Combination (FDC) granules (LUM/IVA).; FDC granules (LUM/IVA).
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: No

Summary:

      This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and
      ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF),
      homozygous for F508del (F/F).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants will be 1 to less than 2 years of age on day 1 of the relevant part of
             the study

          -  Homozygous for F508del (F/F)

        Key Exclusion Criteria:

          -  Any clinically significant laboratory abnormalities at the screening visit that would
             interfere with the study assessments or pose an undue risk for the participants

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Odanacatib; Placebo for Odanacatib; Vitamin D3; Calcium carbonate
Intervention description: One 50 mg tablet once weekly; One 50 mg tablet once weekly; 5600 IU of open-label Vitamin D3 once weekly; Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 294.0
Sex: Male
Minimum age: 40 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the hypothesis that treatment with odanacatib will
      result in increased bone mineral density (BMD) compared to treatment with placebo. This study
      will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a male between 40 and 95 years of age

          -  Has osteoporosis

          -  Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar
             spine and and hip

          -  Is ambulatory

        Exclusion Criteria:

          -  Is currently on oral bisphosphonates or other treatment for osteoporosis

          -  Had previous hip fragility fracture and is a candidate for standard of care therapy

          -  Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced
             bone strength) within 12 months

          -  Has had more then one previous vertebral fracture

          -  Has been diagnosed with metabolic bone disorder other than osteoporosis

          -  Is Vitamin D deficient

          -  Has a history of renal stones

          -  Has active parathyroid disease

          -  Has history of thyroid disease not well controlled by medication

          -  Is diagnosed with secondary osteoporosis

          -  Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed
             supplements or increase dietary intake, such that his daily calcium intake is at least
             1200 mg

          -  Has a history of malignancy ≤5 years prior to signing informed consent

          -  Has been diagnosed with hypogonadism due to causes that affect multiple organ and body
             systems
MT10109L in the Treatment of Glabellar Lines
Condition: Glabellar Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109L will be injected into the GL.; Placebo will be injected into the GL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in
      participants with moderate to severe GL.
    

Eligibility criteria:

        Inclusion Criteria

        • Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Tofacitinib; Tofacitinib; Methotrexate; Placebo Methotrexate
Intervention description: Tofacitinib 5 mg tablet twice daily; Tofactinib 10 mg tablet twice daily; Methotrexate 7.5-20 mg weekly; Placebo to match active methotrexate orally once a week
Intervention MeSH terms: Methotrexate; Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: The sub-study will be participant, care provider, investigator and outcomes assessor masked.
Enrollment: 686.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tofacitinib; Psoriatic Arthritis; Xeljanz; CP-690550; Jak-inhibitor; oral treatment; psoriasis; OPAL BALANCE; methotrexate; pruritus; itch; DLQI

Summary:

      This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability
      and efficacy of tofacitinib in subjects with active PsA who have previously participated in
      randomized studies of tofacitinib for this indication.

      This study will include a sub-study to evaluate the efficacy, safety and tolerability of
      tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to
      tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be
      available to subjects who have completed at least 24 months of participation in the
      open-label extension study and meet eligibility criteria for the sub-study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in qualifying PsA study involving tofacitinib

        Exclusion Criteria:

          -  Time from End of Study visit of qualifying study is >3 months.

          -  Pregnant female, breastfeeding female or female of childbearing potential unwilling or
             unable to use highly effective birth control for duration of study and one ovulatory
             cycle thereafter.

        Sub-study Inclusion Criteria:

          -  Subjects who have completed at least 24 months of treatment with tofacitinib in the
             extension study

          -  Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

        Sub-study Exclusion Criteria:

        -Subjects who are receiving methotrexate by a route other than oral