bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant 30 mg; Atogepant 60 mg; Placebo
Intervention description: Tablets containing 30 mg atogepant; Tablets containing 60 mg atogepant; 30 mg/60 mg tablets containing atogepant-matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 778.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study evaluated the efficacy, safety and tolerability of atogepant in participants with
      chronic migraine. This study included a 12-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of chronic migraine (CM) consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd Edition
             (ICHD-3), 2018

          -  Age of the participant at the time of migraine onset < 50 years

          -  Confirmation of headache/migraine headache day frequency as follows:

               -  History of, on average, ≥ 15 headache days per month in the 3 months prior to
                  Visit 1 in the opinion of the investigator AND

               -  >=15 headache days during the 4-week screening/baseline period per the electronic
                  diary (eDiary) AND

               -  >=8 days during the 4-week screening/baseline period that qualify as being a
                  migraine day per the eDiary

          -  Participants must be using a medically acceptable and effective method of birth
             control during the course of the entire study

        Exclusion Criteria:

          -  Has a history of migraine, accompanied by diplopia or decreased level of
             consciousness, or retinal migraine

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy

          -  History of an inadequate response to > 4 medications (2 of which have different
             mechanisms of action) prescribed for the prevention of migraine

          -  Woman is pregnant, planning to become pregnant during the course of the study, or
             currently lactating. Women of childbearing potential must have a negative urine
             pregnancy test at Visit 1 and Visit 2.
DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: DS-5565; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 854.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetic Peripheral Neuropathic Pain

Summary:

      Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral
      Neuropathic Pain (DPNP) in comparison to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or type 2 diabetes mellitus at screening

          -  Painful distal symmetric polyneuropathy

          -  At screening, a pain scale of ≥ 40 mm

        Exclusion Criteria:

          -  HbA1c (National Glycohemoglobin Standardization Program) > 10.0%
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: somapacitan; Norditropin
Intervention description: Once weekly subcutaneous injections (s.c., under the skin); Daily subcutaneous injections (s.c., under the skin)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once
      weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in
      previously human growth hormone treated Japanese adults with growth hormone deficiency.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years
        of age at the time of signing informed consent - GHD diagnosed for at least 6 months
        (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive
        months (defined as 180 days) at screening - If applicable, hormone replacement therapies
        for any other hormone deficiencies, adequate and stable for at least 90 days prior to
        randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease
        or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ
        carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete
        local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant
        tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years
        is documented in the subject's medical records - For subjects with surgical removal or
        debulking of pituitary adenoma or other benign intracranial tumour within the last 5
        years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within
        the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of
        growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT
        scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined
        as below or equal to 270 days) prior to randomisation
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Intervention: FOLFOX6m; SIR-Spheres microspheres
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colon; rectum; metastatic colorectal cancer; liver metastases

Summary:

      This study is a randomized, multi-center study that will compare the efficacy and safety of
      selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard
      chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with
      non-resectable liver metastases from primary colorectal carcinoma.

      Treatment with the biologic agent bevacizumab, if part of the standard of care at
      participating institutions, is allowed within this study at the discretion of the
      Investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Willing and able to provide written informed consent

          -  Unequivocal and measurable CT evidence of liver metastases which are not treatable by
             surgical resection or local ablation

          -  Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5
             lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single
             anatomic area (pelvis, abdomen or chest): any number, < 2 cm)

          -  All imaging evidence used as part of the screening process must be within 28 days

          -  Suitable for either treatment regimen

          -  WHO performance status 0-1

          -  Adequate hematological, renal and hepatic function

          -  Life expectancy of at least 3 months without any active treatment

        Exclusion Criteria:

          -  Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement
             or thrombosis as determined by clinical or radiologic assessment

          -  Previous radiotherapy delivered to the liver

          -  Non-malignant disease that would render the patient unsuitable for treatment according
             to the protocol

          -  Peripheral neuropathy > grade 2 (NCI-CTC)

          -  Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin
             chemotherapy

          -  Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for
             colorectal cancer is permitted provided that it was completed more than 6 months
             before entry into the study

          -  Pregnant or breast feeding

          -  Concurrent or prior history of cancer other than adequately treated non-melanoma skin
             cancer or carcinoma in situ of the cervix

          -  Allergy to contrast media that would preclude angiography of the hepatic arteries
The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study)
Condition: Dysfunctional Voiding; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Phenazopyridine; no Phenazopyridine
Intervention description: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 92.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a
      retropubic midurethral sling operation.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Any female subjects scheduled to undergo Mid-Urethral Sling (MUS) through the UMass
        urogynecology service for incontinence.

        Exclusion Criteria:

          1. Planned concurrent prolapse or other procedure besides cystoscopy

          2. Using intermittent self catheterization preoperatively

          3. Undergoing spinal anesthesia for the procedure

          4. Known allergy to phenazopyridine (AKA Pyridium)

          5. Renal insufficiency

          6. Any condition or situation that in the attending physician's opinion would
             contra-indicate the use of phenazopyridine

          7. Subjects not competent to give consent

          8. Prisoners

          9. Non-English speaking patients

         10. Age <18

         11. Pregnant patients

         12. Contraindications to the use of IV methylene blue including

               1. Patients with known hypersensitivity reactions

               2. Severe renal insufficiency

               3. Patients with G6PD deficiency
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Finerenone (BAY94-8862); Placebo
Intervention description: 10 mg or 20 mg Finerenone tablet to be given orally, once daily.; Matching placebo to be taken orally, once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7352.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Kidney diseases

Summary:

      The purpose of this study was to evaluate whether oral finerenone (study drug), in addition
      to standard daily therapy, is effective and safe in treating patients with type 2 diabetes
      mellitus and diabetic kidney disease, when compared to a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women ≥18 years of age

          -  Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes
             Association

          -  Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent
             very high albuminuria at the Run-In and Screening Visit

          -  Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin
             receptor blocker (ARB) at maximal tolerated labeled dose without adjustments

          -  Serum potassium <=4.8 mmol/L

        Exclusion Criteria:

          -  Confirmed significant non-diabetic renal disease, including clinically relevant renal
             artery stenosis

          -  Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP)
             ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or
             mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)

          -  Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and
             persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit
             [class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)]

          -  Dialysis for acute renal failure within 12 weeks of Run-in visit

          -  Renal allograft in place or scheduled kidney transplant within next 12 months

          -  Glycated hemoglobin (HbA1c) >12%
Asthma Action at Erie Trial
Condition: Asthma; Children
MeSH terms: Asthma
Intervention: Community Health Worker; Certified asthma educator
Intervention description: A community health worker is para-professional who performs education, case management, and social support.; A certified asthma educator has is certified and performs asthma education.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 223.0
Sex: All
Minimum age: 5 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The Asthma Action at Erie Trial compares the current best practice in asthma self-management
      education (certified asthma educator services) to an integrated community health worker (CHW)
      home intervention in which the real-life challenges of patients and the health care system
      are taken fully into account. This trial will provide clarity as to the expected effect size,
      cost savings, and resources needed to integrate asthma CHWs into clinical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child is a patient at Erie Family Health Center

          -  Child is age 5-16 at the start of the study

          -  Child lives with the index caregiver at least 5 days out of the week

          -  Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the
             Asthma Control Questionnaire, or report of oral corticosteroid use in the past year

          -  Family has a working telephone

        Exclusion Criteria:

          -  Exclusion criteria include family not fluent in English or Spanish, family lives in
             temporary housing such as a shelter, caregiver does not have permanent custody of
             child, or child has significant developmental delays or co-morbidities that would
             limit their ability to participate in the program.
Study of BHV-3241 in Participants With Multiple System Atrophy
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: Verdiperstat; Placebo
Intervention description: 300mg 2 oral tablets, twice daily; Matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind to Sponsor, Investigator and Subject
Enrollment: 421.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Multiple System Atrophy (MSA)

Summary:

      The purpose of this study is to compare the efficacy of verdiperstat (BHV-3241) versus
      placebo in participants with Multiple System Atrophy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman
             et al 2008), including participants with MSA of either subtype (MSA-P or MSA-C).

          2. Able to ambulate without the assistance of another person, defined as the ability to
             take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.

          3. Anticipated survival of at least 3 years at the time of Screening, as judged by the
             Investigator.

        Exclusion Criteria:

          1. Any condition that would interfere with the participant's ability to comply with study
             instructions, place the participant at unacceptable risk, and/or confound the
             interpretation of safety or efficacy data from the study, as judged by the
             Investigator.

          2. Diagnosis of neurological disorders, other than MSA.
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Condition: Geographic Atrophy; Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Avacincaptad Pegol; Sham
Intervention description: Avacincaptad Pegol Intravitreal Injection; Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are masked
Enrollment: 448.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Geographic Atrophy (GA); Age-related Macular Degeneration; AMD; Zimura; Complement C5 inhibitor; avacincaptad pegol; IZERVAY

Summary:

      The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad
      pegol) intravitreal administration in patients with geographic atrophy secondary to
      age-related macular degeneration (AMD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Diagnosis of Non-foveal GA secondary to dry AMD

        Exclusion Criteria:

          -  Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any
             indication in either eye, except oral supplements of vitamins and minerals

          -  Any intraocular surgery or thermal laser within 3 months of trial entry.

          -  Any prior thermal laser in the macular region, regardless of indication

          -  Any ocular or periocular infection (including blepharitis), or ocular surface
             inflammation in the past 12 weeks.

          -  Previous therapeutic radiation in the region of the study eye

          -  Any sign of diabetic retinopathy in either eye
Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: mometasone furoate nasal spray; placebo nasal spray
Intervention description: intranasal administration; intranasal administration
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study investigated the onset of symptom relief following initiation of treatment with
      mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo
      for 14 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a 2-year history of seasonal allergic rhinitis

          -  Has a positive skin test response to a local seasonal allergen (current, or performed
             in investigator's office within the past year)

          -  Is in good health and free of any unstable, clinically-significant disease, other than
             allergic rhinitis, that would interfere with the study schedule or evaluation of
             seasonal allergic rhinitis

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Women of childbearing potential who are not using an acceptable form of birth control

          -  Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn,
             or nedocromil

          -  Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic,
             cerebrovascular, respiratory, gastrointestinal, or other significant medical illness
             or disorder which, in the judgment of the investigator, could interfere with the
             study, or required treatment which might interfere with the study

          -  Is on immunotherapy with the exception of maintenance therapy

          -  Has a clinically significant upper respiratory or sinus infection

          -  Has used an investigational drug within the previous 30 days

          -  Has nasal structural abnormalities, including large nasal polyps and marked septal
             deviation, that significantly interfere with nasal air flow

          -  Has a history of multiple drug allergies or an allergy to antihistamines or corticoids

          -  Has dependence upon nasal, oral or ocular decongestants, or nasal topical
             antihistamines, in the opinion of the investigator

          -  Has rhinitis medicamentosa

          -  Is using of any chronic medication which could affect the course of seasonal allergic
             rhinitis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor
      (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who
      are homozygous for F508del.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed study drug treatment in parent study (VX18-445-109); or had study drug
             interruption(s) in parent study but completed study visits up to the last scheduled
             visit of the Treatment Period in the parent study

        Key Exclusion Criteria:

          -  History of study drug intolerance in parent study

        Other protocol defined Inclusion/Exclusion criteria may apply.