bioihbjkbjnl/mcl2 huggingface dataset:
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Botulinum Toxin Type A
Intervention description: Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
      treatment of pediatric upper limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 Kilograms (kg) / 22 Pounds (lb)

          -  Upper limb spasticity due to cerebral palsy or stroke

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 3 months

          -  History of surgical intervention of the upper limb within 1 year, or planned surgery
             of any limb during the study
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Condition: Esophagitis, Reflux; Esophagitis, Peptic
MeSH terms: Esophagitis; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Placebo
Intervention description: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.; Dexlansoprazole MR 60 mg, orally, once daily for up to six months.; Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erosive Esophagitis

Summary:

      The purpose of this study is to assess the ability of once-daily (QD) treatment with
      dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of
      erosive esophagitis (EE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693)
             or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy.
             Complete healing was assessed for change in LA Esophagitis Classification grades A, B,
             C, or D to healed (defined as anything less than the criterion for Grade A). The
             subject was counted as healed if endoscopy findings did not meet the Grade A
             criterion.

        Exclusion Criteria:

          -  Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2)
             receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.

          -  Use of antacids (except for study supplied) throughout the study.

          -  Use of drugs with significant anticholinergic effects such as tricyclics who cannot
             stay on a stable dose throughout the study.

          -  Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or
             cyclo-oxygenase-2 (COX-2) inhibitors.

          -  Need for continuous anticoagulant therapy.

          -  Evidence of uncontrolled systemic disease.

          -  Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164]
             or T-EE04-087 [NCT00255151]).

          -  Subjects who, in the opinion of the investigator, is unable to comply with the
             requirements of the study or is unsuitable for any reason.
A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Dimebon 20 mg po TID; Placebo po TID
Intervention description: Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks; Placebo (matched to Dimebon) po for 26 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer disease moderate-to-severe memantine safety and efficacy

Summary:

      No Dimebon clinical data exist yet in patients with disease that has advanced to the
      moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon
      in patients with moderate-to-severe AD who are receiving existing background therapy with
      memantine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.

          -  Have a Mini-Mental State Exam between 5 and 14 inclusive.

          -  Have been taking the medication memantine (ie., Namenda) for at least six months prior
             to this study.

          -  Must have a caregiver who assists the patient at least five days per week for at least
             three hours per day, who can accompany patient to study visits, and who has an
             intimate knowledge of the patient's health states and personal care.

        Exclusion Criteria:

          -  Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil,
             rivastigmine, galantamine, tacrine) within 2 months prior to this study.

          -  Dementia other than Alzheimers disease.

          -  Any medical condition or reason that interferes with the ability of the patient to
             participate in or complete the trial or places the patient at undue risk, as judged by
             the study doctor.
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Placebo; Golimumab
Intervention description: Participants will receive matching placebo.; Participants will receive 2mg/kg of intravenous infusions of golimumab .
Intervention MeSH terms: Golimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; Golimumab; SIMPONI

Summary:

      The purpose of this study is to evaluate the efficacy of intravenously (administration of a
      fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants
      with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that
      involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral
      joints).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with diagnosis of definite ankylosing spondylitis for at least 3 months
             based on modified New York radiographic and clinical criteria

          -  Participants with symptoms of active disease at screening and at baseline

          -  Participant has either an inadequate response to at least 2 non-steroidal
             anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended
             doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy
             because of intolerance, toxicity, or contraindications to NSAIDs

          -  Participants with C- reactive protein (CRP) level of greater than or equal to (>=) 0.3
             milligram per deciliter (mg/dL) at screening

          -  Additional protocol-defined inclusion criteria apply

        Exclusion Criteria:

          -  Participant with other inflammatory diseases that might confound the evaluations of
             benefit from the golimumab therapy

          -  Pregnant or lactating females

          -  Participants with chest radiograph within 3 months prior to the first administration
             of study agent that shows an abnormality suggestive of a malignancy or current active
             infection, including tuberculosis

          -  Participants who had a serious infection (including but not limited to, hepatitis,
             pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or
             have been treated with intravenous (IV) antibiotics for an infection within 2 months
             prior to first administration of study agent

          -  Additional protocol-defined exclusion criteria apply
Implementing Evidence-Based Mental Health Practices in Primary Care
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Intervention: brief alcohol intervention; standard care
Intervention description: this intervention consists of brief assessment and feedback; education about harmful effects of alcohol use and NIAAA recommended drinking limits
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcohol Consumption

Summary:

      This research study will examine the effectiveness of a brief, computerized motivational
      intervention plus treatment-as-usual to treatment-as-usual alone for treating alcohol misuse
      in Veterans presenting to primary care. The investigators aim to recruit 162 Veterans
      screening positive on the AUDIT-C to participate in this study. Participants will be randomly
      assigned to one of the two intervention conditions and be asked to complete a baseline
      assessment and two follow-up assessments conducted at three and six months post treatment.
      Baseline assessments will be conducted in person by a trained research assistant, while all
      follow-up interviews will be conducted over the phone. The primary outcome for this clinical
      trial is the reduction in the number of heavy drinking days. Several secondary outcomes will
      be collected including health status, depressive symptoms, consequences of drinking, pain
      symptoms, and distress tolerance. The findings from this study may have large scale
      implications for how alcohol misuse is treated in primary care. In addition, this study will
      provide evidence for the feasibility of using the computer as a method for delivering
      evidence-based mental health interventions in primary care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years of age,

          -  speak and read English,

          -  U.S. Veteran status,

          -  screen positive on the AUDIT-C

        Exclusion Criteria:

          -  the presence of any cognitive difficulties that interfere with one's ability to
             consent to study participation
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; LUMIGAN
Intervention description: Consists of 1 Bimatoprost SR administration in the study eye.; Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a
      single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular
      Hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment

          -  Participant is currently a nonsmoker and has not smoked any nicotine-containing
             products within the previous 6 months

        Exclusion Criteria:

          -  Current or anticipated enrollment in another investigational drug or device study

          -  Females who are pregnant, nursing, or planning a pregnancy during the study
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Placebo; CP690,550; CP-690,550
Intervention description: Placebo 10 mg orally (PO) twice a day (BID); CP-690,550 5 mg orally (PO) twice a day (BID); CP-690,550 10 mg orally (PO) twice a day (BID)
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 593.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Janus kinase inhibitor; JAK 3 inhibitor; inflammatory bowel disease; ulcerative colitis; OCTAVE; CP-690; 550; tofacitinib; Xeljanz

Summary:

      The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and
      tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to
      assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves
      mucosal healing and improves quality of life in subjects with UC.The study proposes to assess
      CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18
      years with UC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who met study entry criteria and completed 8-week induction treatment from
             Study A3921094 or A3921095

          -  Subjects who achieved clinical response in Study A3921094 or A3921095

          -  Women of childbearing potential must test negative for pregnancy prior to study
             enrollment

          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures

          -  Evidence of a personally signed and dated informed consent document(s) indicating that
             the subject (or a legally acceptable representative) has been informed of all
             pertinent aspects of the study.

        Exclusion Criteria:

          -  Subjects who had major protocol violation (as determined by the Sponsor) in Study
             A3921094 or A3921095

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis, or clinical findings suggestive of Crohn's disease

          -  Subjects who have had surgery for UC or in the opinion of the investigator, are likely
             to require surgery for UC during the study period.
Treatment of Apathy in Alzheimer's Disease With Modafinil
Condition: Apathy; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Modafinil; Placebo
Intervention description: 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks; 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 65 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: apathy; Alzheimer's disease; activities of daily living performance; caregiver burden

Summary:

      This study examined the effects of modafinil on apathetic symptomatology, performance of
      activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's
      disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of mild to moderate stage Probable Alzheimer's disease

          -  on a stable dose of a cholinesterase inhibitor medication for at least 30 days

          -  clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

        Exclusion Criteria:

          -  diagnosis of Major Depression

          -  focal brain lesion on neuroimaging

          -  history of significant substance abuse

          -  history of significant head trauma with loss if consciousness >10 minutes
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: budesonide and montelukast; Placebo
Intervention description: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks; sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Intervention MeSH terms: Budesonide; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: OSA; Medical treatment

Summary:

      In children with mild apnea combined therapy with an inhaled nasal steroid and a medication
      that decreased nasal congestion (montelukast) was shown to be effective. We are testing to
      see if this combination works in adults with mild apnea as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 - 100 years

          -  RDI between 5 - 15

          -  all races

          -  both sexes

        Exclusion Criteria:

          -  craniofacial, syndromic, neurological abnormalities

          -  current or previous use of Singular, Rhinocort within last 6 months

          -  acute upper respiratory infections

          -  recent nasal trauma, nasal surgery, nasal septum perforation

          -  known immunodeficiency or under going immunosuppressant therapy

          -  current therapy with drugs that interact with Montelukast or Budesonide
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: NKTR-214; Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 783.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: NKTR-214; Nivolumab; Immunotherapy; bempegaldesleukin (BEMPEG: NKTR-214)

Summary:

      The purpose of the study is to test the effectiveness (how well the drug works), safety, and
      tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
      nivolumab given alone in participants with previously untreated melanoma skin cancer that is
      either unable to be surgically removed or has spread
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or
             older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)

          -  Histologically confirmed stage III (unresectable) or stage IV melanoma

          -  Treatment-naive participants (ie, no prior systemic anticancer therapy for
             unresectable or metastatic melanoma) with the exception of prior adjuvant and/or
             neoadjuvant treatment for melanoma with approved agents

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Uveal melanoma

          -  Participants with an active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria apply
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Subcutaneous Insulin; Inhaled Insulin
Intervention description: Subcutaneous insulin with dose adjusted according to premeal blood glucose; Inhaled insulin with dose adjusted according to premeal blood glucose
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 582.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is being done to find out the good and bad effects of a drug that is not approved
      for sale and the effects if any on measures of pulmonary function in adult males and females
      with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

      This study included a 2-year comparative treatment period followed by a 6-month follow-up
      period during which inhaled insulin-treated subjects were switched back to subcutaneous
      short-acting insulin. After this follow-up period, all eligible subjects entered a
      comparative extension period that was to last for 5 years. When the comparative portion of
      the study was terminated, all subjects were requested to return for a final extension
      follow-up month 3 visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus

        Exclusion Criteria:

          -  severe asthma or COPD

          -  smoking

          -  brittle diabetes