bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of
      repeated administration of adalimumab in participants with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the
        Week 12 ileocolonoscopy.

        Exclusion Criteria:

          -  If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or
             malignancy.

          -  Subject is not in compliance with prior and concomitant medication requirements
             throughout M14-115 (NCT02185014).

          -  Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or
             subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated
             per M14-115 (NCT02185014) procedures.
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure clusters; acute repetitive seizures; rescue treatment

Summary:

      The purpose of this study is to examine the long-term safety and tolerability of USL261 in
      the treatment of seizure clusters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a competent, adult caregiver who can recognize and observe the subject's seizure
             cluster episodes

          -  Has successfully completed study P261-401, and the subject and caregiver have
             demonstrated adequate compliance with P261-401 study procedures as determined by the
             investigator

        Exclusion Criteria:

          -  Has experienced status epilepticus during or since the P261-401 study

          -  In the opinion of the investigator, is experiencing an ongoing, uncontrolled,
             clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a
             clinically significant adverse event in study P261-401 that might prevent the subject
             from safely participating in the study

          -  Has a neurological disorder that is likely to progress in the next year

          -  Has a history of acute narrow-angle glaucoma

          -  Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or
             gastrointestinal disease that could interfere with the study, subject safety/safety
             monitoring, or is not stable despite current therapy

          -  Subject has severe chronic cardio-respiratory disease or the need for ambulatory
             oxygen

          -  Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study

          -  Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical
             history

          -  Subject has had vagus nerve stimulator (VNS) implanted since the completion of study
             P261-401
Protocolized vs Discretionary Use of Opioids in Acute Pain
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone; IV opioid
Intervention description: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later; Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hydromorphone; acute pain; Protocolized; Efficacy; Safety

Summary:

      We are testing whether patients who received protocolized pain management (1 mg of IV
      hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later
      if the patients wants more) will have better pain relief and no more adverse events than
      patients receiving discretionary care, in which the patients receives whatever IV opioid the
      treating physician wants to give, in whatever dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21 to 64 years.

          2. Pain with onset within 7 days.

          3. Emergency Department attending physician's judgment that patient's pain warrants use
             of intravenous opioids.

          4. Normal mental status.

        Exclusion Criteria:

          1. Prior use of methadone.

          2. Use of other opioids, tramadol, or heroin in the past seven days.

          3. Prior adverse reaction to morphine, hydromorphone, or other opioids.

          4. Chronic pain syndrome.

          5. Alcohol intoxication.

          6. Systolic Blood Pressure < 90 mm Hg.

          7. Use of monoamine oxidase (MAO) inhibitors in past 30 days.

          8. Weight less than 100 pounds.

          9. Baseline room air oxygen saturation less than 95%.

         10. C02 measurement greater than 46: In accordance with a number of similar studies that
             we have performed, four subsets of patients will have their CO2 measured using a
             handheld capnometer prior to enrollment in the study. If the CO2 measurement is
             greater than 46, then the patient will be excluded from the study. The 4 subsets are
             as follows:

               1. All patients who have a history of chronic obstructive pulmonary disease (COPD)

               2. All patients who have a history of sleep apnea

               3. All patients who report a history of asthma together with greater than a 20
                  pack-year smoking history

               4. All patients reporting less than a 20 pack-year smoking history who are having an
                  asthma exacerbation
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Cetuximab; Cisplatin; Radiotherapy
Intervention description: Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Nivolumab; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study has two, independent, cohorts, both in locally advanced squamous cell head and
      neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination
      with radiotherapy is more effective than cetuximab in combination with radiotherapy, in
      subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine
      whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and
      radiotherapy in subjects who are eligible to receive cisplatin
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of
             the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx

          -  Locally advanced disease which is unresectable, or resectable but suitable for an
             organ sparing approach

          -  No previous radiotherapy or systemic treatment for SCCHN

        Exclusion Criteria:

          -  Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma
             that originated from the skin and salivary gland or non-squamous histology (e.g.,
             mucosal melanoma), squamous cell carcinoma of unknown primary

          -  Clinical or radiological evidence of metastatic disease

          -  Prior radiotherapy that overlaps with radiation fields

        Other protocol defined inclusion/exclusion criteria could apply
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030; bevacizumab or aflibercept; E10030 sham injection
Intervention description: Patients are randomized to receive either bevacizumab or aflibercept; Pressure on the eye with a syringe with no needle
Intervention MeSH terms: Bevacizumab; Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 645.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; choroidal neovascularization; Fovista®; E10030; Avastin®; Eylea®

Summary:

      The objectives of this study are to evaluate the safety and efficacy of intravitreal
      administration of Fovista® administered in combination with either Avastin® or Eylea®
      compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal
      neovascularization secondary to age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Active subfoveal choroidal neovascularization (CNV) secondary to AMD

          -  Presence of sub-retinal hyper-reflective material (SD-OCT)

        Exclusion Criteria:

          -  Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
             supplements of vitamins and minerals

          -  Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
             of indication (including intravitreal corticosteroids)

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy are excluded

          -  Diabetes mellitus
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; Test Product (tiotropium bromide inhalation powder); Reference Product (Spiriva®)
Intervention description: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.; Double-Blind: Single dose of test product 18 mcg of test product Open-Label: once daily administration of test product (tiotropium bromide inhalation powder) 18 mcg administered by test dry powder inhaler.; Reference product (Spiriva®) 18 mcg.
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, double-dummy, placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 377.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to show bioequivalence of test product to reference product
      based on baseline-adjusted forced expiratory volume in one second (FEV1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female subjects (40 years of age and older).

          -  Patients with diagnosis of COPD according to the GOLD guidelines.

          -  Post-bronchodilator FEV1 <80% of the predicted value at the screening visit.

          -  Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.

          -  Current or former smokers (e.g., with history of = 10 pack-years).

          -  Written informed consent.

        Exclusion Criteria:

          -  Known respiratory disorder other than COPD including, but not limited to the
             following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active
             bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema,
             or interstitial lung disease.

          -  History of allergy or hypersensitivity to anticholinergic/muscarinic receptor
             antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known
             hypersensitivity to any of the proposed ingredients or components of the delivery
             system.

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.

          -  Treatment for COPD exacerbation within 12 weeks prior to the screening visit.

          -  Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus
             infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or
             illness within 6 weeks prior to the screening visit.

          -  Abnormal and significant ECG finding prior to the screening, during the run-in and
             treatment periods.
A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: RT001; Placebo
Intervention description: RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001.; The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the Efficacy, Long Term Safety and Tolerability of
      RT001 in subjects with Friedreich's Ataxia
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female 12 to 50 years of age

          2. Medical history consistent with the symptoms of FRDA at ≤ 25 years of age

          3. Detection of biallelic pathogenic variants in frataxin gene (FXN)

          4. Ambulatory (with or without assistive device) and capable of performing other
             assessments/evaluations.

          5. Must be able to walk 25 feet during the timed 1-minute walk

        Key Exclusion Criteria:

          1. Received treatment with other experimental therapies within the last 30 days prior to
             the first dose

          2. Previously participated in the RT001 trial

          3. Refusal to discontinue fish oils or other oil-based supplements for the duration of
             the study (Screening till last study procedure completed)

          4. History of malignancies (other than basal cell carcinomas)

          5. Inability to complete CPET protocol

          6. Female who is breastfeeding or has a positive pregnancy test

          7. History of uncontrolled diabetes mellitus (Type 1 or 2)
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Intervention: Risperidone; Olanzapine; Lu AF35700; Lu AF35700
Intervention description: 4-6 mg/day, encapsulated tablets, orally; 15-20 mg/day, encapsulated tablets, orally; 10 mg/day, encapsulated tablets, orally; 20 mg/day, encapsulated tablets, orally
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1098.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in
      patients with treatment-resistant schizophrenia (TRS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and
             Statistical Manual of Mental Disorders) and confirmed by the Mini International
             Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders

          -  The patient is either an inpatient at a psychiatric setting or outpatient consulting a
             psychiatrist.

          -  Patients should be treated with adequate dose(s) and agent(s) of antipsychotic
             treatment for at least 2 weeks prior to Screening

          -  The patient has failed to show an adequate response in the level of psychotic symptoms
             despite at least one documented treatment trial with an adequate dose of an
             antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks)
             during 2 years prior to Screening. The failure to respond to the current antipsychotic
             treatment trial may be considered a retrospective failed treatment, if the patient was
             treated for 6 weeks with adequate dose(s) and agent(s)

          -  The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the
             following PANSS items (at Screening and at the first visit of Period A)

          -  The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

        Exclusion Criteria:

          -  The patient has any current primary psychiatric disorder other than schizophrenia as
             assessed by the Mini International Neuropsychiatric Interview (MINI)

          -  The patient is experiencing an acute exacerbation of his/her psychotic symptoms

          -  The patient has not responded to treatment with clozapine

        Other protocol defined inclusion and exclusion criteria may apply
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Condition: Low Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Intervention: NKTR-181 BID tablets
Intervention description: NKTR-181 tablets 100-600 mg twice daily (BID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 638.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this 52-week open label study is to determine the long-term safety of a new
      opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or
      chronic non-cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-nursing female aged 18 to 75 years old

          -  Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at
             least three months

          -  Not experiencing adequate pain relief or have failed previous treatment with
             non-opioid analgesics

          -  Opioid analgesia is necessary

          -  Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate
             equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry

          -  Females of child bearing potential must be using a highly effective form of birth
             control. All subjects must agree to use double-barrier contraception during
             participation in this study and for at least 2 months after the last dose of the study
             drug.

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  History of hypersensitivity, intolerance, or allergy to opioids

          -  Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during
             the study period

          -  Untreated moderate to severe sleep apnea

          -  Chronic migraines as the primary pain condition

          -  Cancer related pain