bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
Condition: Migraine Disorders; Headache, Migraine; Pediatrics
MeSH terms: Migraine Disorders; Headache
Intervention: OnabotulinumtoxinA; Placebo (Saline)
Intervention description: The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.; The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the research is to examine the outcomes of pediatric patients receiving
      Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature
      on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric
      patients, specifically in the treatment of migraines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 8 - 17 years of age with a history of migraine meeting the criteria
             established in ICHD-II (2004), Section 1. Patients will provide at least 28-day
             baseline data in the form in the daily diary and must have at least 15 days of
             reported headache during this period, with at least 4 distinct episodes lasting at
             least 4 hours each.

        Exclusion Criteria:

          -  Previous use of botulinum toxin of any serotype for any reason

          -  Pregnancy.

          -  Diagnosis of Myasthenia gravis, Eaton Lambert Syndrome, Amyotrophic Lateral Sclerosis

          -  Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS),
             cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks
             prior to the week of screening visit
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Intervention: Brensocatib 10 mg; Brensocatib 25 mg; Placebo
Intervention description: Administered once per day for 24 weeks; Administered once per day for 24 weeks; Administered once per day for 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: P aeruginosa; bronchiectasis; active neutrophil elastase

Summary:

      The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a
      24-week treatment period in participants with non-cystic fibrosis bronchiectasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or
             recurrent respiratory infections)

          2. Are current sputum producers with a history of chronic expectoration and able to
             provide a sputum sample during Screening

          3. Have at least 2 documented pulmonary exacerbations in the past 12 months before
             Screening

        Exclusion Criteria:

          1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma

          2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common
             variable immunodeficiency, or alpha1-antitrypsin deficiency

          3. Are current smokers

          4. Are currently being treated for a nontuberculous mycobacterial lung infection,
             allergic bronchopulmonary aspergillosis, or tuberculosis

          5. Have any acute infections, (including respiratory infections)
Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Doxil; Carboplatin; Bevacizumab
Intervention description: Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.; Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.; Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Intervention MeSH terms: Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: negative for a protein called HER2/neu; negative for estrogen receptors (ER) and progesterone receptors (PR).; breast cancer

Summary:

      The purpose of this research study is to look at the effectiveness of a combination of doxil,
      carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being
      studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and
      progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on
      both cancer and normal cells. This family of receptors is important for cell growth and is
      found in many tumor types.This study is being conducted for the following research purposes:·
      To find out what effects, if any, the study drug has on metastatic breast cancer. For
      instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the
      safety of the study drugs and to see what affects it has. For instance, are there any side
      effects? If so, what kind of side effects does the study drug cause? How severe are the side
      effects, and how often do they occur?· To see if the study drugs have any effect on keeping
      the disease from getting worse.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.

          2. Age >= 18

          3. ECOG performance status <= 2

          4. Normal organ and marrow function

          5. Normal cardiac function as evidenced by LVEF within institutional normal limits

        Exclusion Criteria:

          1. History of hypersensitivity reactions to doxil or bevacizumab

          2. Myocardial infarct or unstable angina within 6 months before enrollment

          3. Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720
             mg/m2 for epirubicin.

          4. Proteinuria
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: MIV-711
Intervention description: MIV-711 administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 40 Years
Maximum age: 81 Years
Healthy volunteers: No

Summary:

      This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety
      and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

        - Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by

          -  Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary
             endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by

          -  Receiving placebo and had a clinically significant worsening on the primary endpoint
             as defined by a NRS increase of ≥2

        Exclusion Criteria:

          -  The presence of any inflammatory arthritis

          -  Any generalized pain condition that may interfere with the evaluation of the target
             knee pain (e.g., fibromyalgia) as judged by the investigator.

          -  Any clinically severe or significant uncontrolled concurrent illness, which, in the
             opinion of the Investigator, would impair ability to give informed consent or take
             part in or complete this clinical study.

          -  Known or suspected intolerance or hypersensitivity to the investigational product,
             closely related compounds, or any of the stated ingredients.
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
Condition: Dental Plaque; Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Intervention: Bromelain; Powdered sugar
Intervention description: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.; The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Enrolled subjects undergoing orthodontic treatment with fixed appliances will be randomized to receive either the Bromelain rinse or Placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment period (1 day) separated by a washout period of 1 week.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Investigators were blinded during the clinical phase of the study and were unaware of the agents the subjects received. The investigators were also blinded during the visual plaque score analysis of the project and were unaware of what photograph corresponded to what phase or intervention.
Enrollment: 46.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: proteolytic enzyme; plaque removal; oral hygiene; orthodontic treatment

Summary:

      This study aims to investigate the impact of a bromelain pre-rinse adjunct on oral plaque
      removal in orthodontic subjects. The study's null hypothesis states that there is no
      statistically significant difference in visual plaque scores among orthodontic subjects with
      or without proteolytic enzyme rinse aid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female

          -  10 to 25 years of age

          -  willing to consent to participation

          -  able to follow study instructions

          -  in active orthodontic treatment with fixed orthodontic appliances

        Exclusion Criteria:

          -  unwilling/unable to follow study instructions

          -  documented/suspected pineapple allergy

          -  proteolytic enzyme allergy

          -  food dye allergy

          -  smoker
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
Condition: Breast Cancer; Head and Neck Squamous Cell Carcinoma; Colorectal Cancer; Prostate Cancer; Ovarian Cancer; Urothelial Carcinoma; Non-small Cell Lung Cancer
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Intervention: ONM-100
Intervention description: A polymer micelle covalently conjugated to indocyanine green.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of
      ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients
      with solid tumors undergoing routine surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled
             to undergo surgical resection

          -  Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or
             breast cancer

          -  Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer,
             prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.

          -  Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers

        Exclusion Criteria:

          -  Histologically diagnosed by an excisional biopsy procedure

          -  Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging
             would not be feasible

          -  Life expectancy <12 weeks

          -  Hepatic impairment (Child-Pugh score >5) or significant liver disease including active
             hepatitis or cirrhosis
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: OPDC-34712; Placebo; Stimulant Therapy
Intervention description: OPDC-34712 tablets, daily, Orally.; Matching-placebo tablets, daily, Orally.; Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 740.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Inattention; Hyperactivity; Impulsivity; Distractibility; Procrastination; Disorganized; ADHD

Summary:

      This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in
      adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved
      stimulant medication to explore a possible impact on sleep, quality of life and cognitive
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed
             consent.

          -  Participants with a primary diagnostic and statistical manual of mental disorders,
             fourth edition, text revision (DSM-IV-TR) diagnosis of ADHD (including inattentive,
             hyperactive, and combined subtypes) as confirmed by the Conners' Adult ADHD diagnostic
             interview (CAADID). Participants may have received prior treatment for adult ADHD, may
             be currently receiving treatment for adult ADHD at screening, or may be
             treatment-naive.

          -  Participants willing to discontinue all prohibited psychotropic medication starting
             from the time of signing the informed consent and during the study period.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug.

          -  Participants with an adequate response, as determined by the investigator, to any
             stimulant taken for the treatment of adult ADHD after 18 years of age.

          -  Participants with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
             borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality
             disorder.

          -  Participants who participated in a clinical trial within the last 180 days or who
             participated in more than two clinical trials within the past year.
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: GB004; Placebo
Intervention description: oral tablet; oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammatory Bowel Disease

Summary:

      A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week
      open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of
      GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without
      systemic steroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects aged ≥ 18 years at the time of signing the informed
             consent form (ICF) prior to initiation of any study specific activities/procedures.

          -  UC diagnosed at least 3 months prior to first dose of investigational product (IP) on
             Day 1.

          -  Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to
             flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine)
             alone or with one of the following oral treatments:

               1. prednisone ≤ 20 mg/day or equivalent or

               2. beclomethasone ≤ 5 mg/day or

               3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

        Exclusion Criteria:

          -  Prior approved biologic therapy used for the treatment of UC.

          -  Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of
             bacterial or parasitic infection.

          -  Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of
             Day 1.

          -  Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

        NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Condition: Central Adrenal Insufficiency; Mifepristone
MeSH terms: Adrenal Insufficiency
Intervention: Mifepristone
Intervention description: Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin Tolerance Test

Summary:

      The researchers propose the use of mifepristone as an alternative way to test for Central
      Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the
      efficacy of the purposed method.
    

Eligibility criteria:

        Inclusion Criteria (1 of the following):

          -  Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to
             present.

          -  Are scheduled to complete ITT.

          -  Are clinically suspected to have adrenal insufficiency but have not undergone ITT.

        Exclusion Criteria:

          -  Female patients who are of child-bearing potential (defined as a sexually mature woman
             who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or
             bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has
             not been naturally postmenopausal for at least 24 consecutive months prior to study
             enrollment) and not using non-hormonal contraception.

          -  Female patients not willing to use non-hormonal contraception for one month following
             treatment.

          -  Women who are pregnant or breast feeding.

          -  Patients with an existing diagnosis of adrenal insufficiency who are on any
             glucocorticoid replacement other than oral hydrocortisone or prednisone.

          -  Patients on medications that are strong CYP3A

          -  Patients taking other medications metabolized by CYP3A

          -  Patients who have a history of QT prolongation and patients with any recent abnormal
             electrocardiogram (ECG).