bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide; Placebo
Intervention description: Oral capsule; Matching placebo oral capsule
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 614.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and
      abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has no clinically significant findings on a physical examination and clinical
             laboratory tests

          -  Female patients of childbearing potential must agree to use one of the following
             methods of birth control:

               1. Hormonal contraception

               2. Double-barrier birth control

               3. Maintenance of a monogamous relationship with a male partner who has been
                  surgically sterilized by vasectomy

          -  Patient meets protocol criteria for diagnosis of IBS-C

          -  Patient demonstrates continued IBS-C symptoms through Pretreatment Period

          -  Patient maintains a minimum level of compliance with daily diary

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
Condition: HIV-1 Infection
Intervention: B/F/TAF
Intervention description: 50/200/25 mg FDC tablet administered orally once daily without regard to food.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to characterize the virologic efficacy of switching
      virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir
      alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil
      fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide
      (B/F/TAF) FDC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine
             [FTC]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826
             [NCT02616783]) for ≥ 3 months

          -  Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with
             E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study
             GS-US-292-1826 [NCT02616783]) for the last 2 visits preceding the screening visit (or
             undetectable HIV-1 RNA level according to the local assay being used if the limit of
             detection is ≥ 50 copies/mL)

          -  Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
             according to the Cockcroft-Gault formula for creatinine clearance

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the investigator to potentially interfere
             with participant study compliance

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Pharmacologic Treatment of PTSD in Sexually Abused Children
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Trauma-Focused Cognitive Behavioral Therapy; Sertraline Pill; Placebo Oral Tablet
Intervention description: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent; 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT; 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: PTSD; Depression; Anxiety

Summary:

      This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused
      Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic
      Stress Disorder (PTSD).
    

Eligibility criteria:

        Inclusion:

          1. Ages 10-17 years, inclusive

          2. Confirmed sexual abuse

          3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom
             clusters (reexperiencing, avoidance, arousal)

          4. Parent/primary caregiver available to participate in treatment

          5. Assent with parental consent to participate

        Exclusion:

          1. Non-English speaking

          2. schizophrenia or other severe psychotic disorder

          3. MR (IQ<60) or PDD preventing CBT treatment

          4. taking current psychotropic medication

          5. documented substance dependence (substance abuse allowed)
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: CF

Summary:

      This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the
      pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of
      lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic
      fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in
      Part B, if they meet the eligibility criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who weigh ≥8 kilogram (kg) without shoes and wearing light clothing at the
             Screening Visit

          -  Subjects with confirmed diagnosis of CF at the Screening Visit

          -  Subjects who are homozygous for the F508del-cystic fibrosis transmembrane conductance
             regulator (CFTR) mutation

        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 subject

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1

          -  A standard 12-lead ECG demonstrating QTc >450 millisecond (msec) at the Screening
             Visit.

          -  History of solid organ or hematological transplantation.

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating LUM and/or IVA) within 30 days of the Screening Visit.

          -  History of cataract/lens opacity or evidence of cataract/lens opacity determined to be
             clinically significant by a licensed ophthalmologist during the ophthalmologic
             examination at the Screening Visit
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; ocrelizumab; Placebo
Intervention description: Methotrexate tablet was administered orally at a dose 7.5-25 mg; Ocrelizumab was administered via IV infusion at a dose specified in arm description; Matching placebo to ocrelizumab was administered via IV infusion
Intervention MeSH terms: Methotrexate; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1015.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anti-CD20; stage; CD20; RA

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
      combination with methotrexate in patients with active rheumatoid arthritis who have had an
      inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of
      intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of
      i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg -
      25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment
      is 1-2 years. Target sample size is 1000.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult patients, ≥18 years of age

          -  Rheumatoid arthritis for ≥ 3 months

          -  Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks

        Exclusion criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease, other than RA

          -  Prior receipt of any biologic therapy for RA

          -  Concurrent treatment with any DMARD (other than methotrexate)
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Intervention description: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese
      migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously
      self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
      The first dose will be self-administered at the trial site under the supervision of the
      investigator and the second dose will be self-administered at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12
             months prior to giving informed consent.

          -  Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4
             days in baseline information collected during the 28-day screening period

        Exclusion Criteria:

          -  History of hypersensitivity reactions to injected proteins, including monoclonal
             antibodies

          -  Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following
             conditions:

               -  Less than 5 months has passed since the final administration of AMG334, ALD304,
                  or LY2951742.

               -  Less than 1 year has passed since the final administration of TEV-48125
Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eplerenone; Spironolactone
Intervention description: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months.; 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.
Intervention MeSH terms: Eplerenone; 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: 52.0
Sex: Male
Minimum age: 7 Years
Healthy volunteers: No

Summary:

      The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving
      cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with
      Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be
      enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will
      use a drug diary to record daily compliance of taking the study medication as well as any
      concerns they may have during the study period. Subjects will undergo cardiac magnetic
      resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12
      months post enrollment. Subjects will also complete a quality of life questionnaire at
      baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at
      baseline and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to
             undergo cardiac magnetic resonance (CMR) without sedation

          -  LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac
             MRI done within 2 weeks of enrollment

        Exclusion Criteria:

          -  Non-MR compatible implants

          -  Severe claustrophobia

          -  Gadolinium contrast allergy

          -  Kidney disease

          -  Prior use of or allergy to aldosterone antagonist

          -  Use of other investigational therapy.
Nutrition and Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Fermented Soy; Placebo
Intervention description: Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.; A placebo compliment to the active intervention with identical packaging and labeling will be used.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fermented Soy

Summary:

      The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults
      with localized prostate cancer prior to radical prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically verified Prostate Cancer (at any stage)

          -  Scheduled to be treated by radical prostatectomy within the next 4-10 weeks

          -  Understanding and willingness to provide consent

        Exclusion Criteria:

          -  Previous (within 6 months of enrollment) or concurrent hormonal therapy or
             chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride
             and dutasteride)

          -  History of hormone dependent malignancies

          -  Concomitant thyroid disease or currently taking thyroid hormone replacement medication

          -  Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or
             vegetarian nutrition, or any other extreme dietary habits

          -  Current or past history of any liver or pancreas disease

          -  History of allergy or hypersensitivity to soy-containing products

          -  Malabsorption conditions that might interfere with absorption of the investigational
             product
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: AR-13324 Ophthalmic Solution 0.02%; Timolol Maleate Ophthalmic Solution 0.5% BID; Placebo
Intervention description: 1 drop once daily (QD), PM, OU; 1 drop BID, AM/PM, OU; 1 drop QD, AM, OU
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic
      Solution compared to Timolol Maleate Ophthalmic Solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes

          3. Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2
             qualification visits

          4. Corrected visual acuity equivalent to 20/200

          5. Able to give informed consent and follow study instructions

        Exclusion Criteria:

          1. Clinically significant ocular disease

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
             or narrow angles

          3. Unmedicated intraocular pressure ≥30mmHg

          4. Use of more than 2 ocular hypotensive medications within 30 days of screening

          5. Known hypersensitivity to any component of the formulation

          6. Previous glaucoma surgery or refractive surgery

          7. Ocular trauma within 6 months prior to screening

          8. Any ocular surgery or non-refractive laser treatment within 3 months prior to
             screening

          9. Recent or current ocular infection or inflammation in either eye

         10. Used ocular medication in either eye of any kind within 30 days of screening

         11. Mean central corneal thickness >620µm at screening

         12. Any abnormality preventing reliable applanation tonometry of either eye

         13. Clinically significant abnormalities in lab tests at screening

         14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists

         15. Clinically significant systemic disease

         16. Participation in any investigational study within 60 days prior to screening

         17. Used any systemic medication that could have a substantial effect in intraocular
             pressure within 30 days prior to screening

         18. Women who are pregnant, nursing, planning a pregnancy or not using a medically
             acceptable form of birth control
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
Condition: Subjects With Hyperlipidemia, Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Inflammation
Intervention: Evolocumab; Placebo
Intervention description: Administered subcutaneously once a month using an autoinjector/pen.; Administered subcutaneously once a month using an autoinjector/pen.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hyperlipidemia; Dyslipidemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9) Inhibition; Arterial Wall Inflamation; Elevated lipoprotein a

Summary:

      A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9)
      inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting lipoprotein(a) (Lp(a)) 50 mg/dL or more at screening 1

          -  Fasting Low-density lipoprotein-cholesterol (LDL-C) 100 mg/dL or more at screening 1

          -  Lipid lowering therapy including statin dose unchanged for at least 8 weeks prior to
             screening

          -  Target-to-background ratio (TBR) maximum higher than 1.6 (either right, left carotid
             or thoracic aorta) on fluorodeoxyglucose-positron emission tomography/computed
             tomography (FDG-PET/CT).

        Exclusion Criteria:

          -  Currently receiving, or less than 4 weeks since receiving, treatment in another
             investigational device or drug study(ies), or participating in other investigational
             procedures

          -  Known diagnosis of diabetes mellitus or screening fasting serum glucose ≥ 126 mg/dL or
             hemoglobin A1C (HbA1C) ≥ 6.5%

          -  Subject with a history of homozygous familial hypercholesterolemia

          -  History of a Cardiovascular event

          -  Subject currently undergoing lipid apheresis

          -  Known contraindications or limitations to FDG-PET/ CT (scanner weight limit, devices
             that can cause image artifacts, or carotid/aortic stents/grafts

          -  Subject has had exposure to investigational drugs targeting Lp(a) within the last 12
             months, prior to Screening

          -  Other Exclusion Criteria May Apply.