bioihbjkbjnl/mcl2 huggingface dataset:
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Condition: Smoking
Intervention: Transdermal Nicotine Patch
Intervention description: Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Behavioral Activation

Summary:

      The primary purpose of this study is to develop a specialized behavioral activation treatment
      for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we
      utilize focus groups and pilot testing with 15 youths to develop the behavioral activation
      smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new
      treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the
      time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A
      subset of participants will also undergo an fMRI session to examine reward sensitivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 18 and 21 years of age

          -  a regular smoker for at least 6 months

          -  currently smoking an average of at least 5 cigarettes per day

          -  want to quit smoking

          -  report current elevated depressive symptoms

        Exclusion Criteria:

          -  current Axis I disorder

          -  psychoactive substance dependence (excluding nicotine dependence) within the past 6
             months

          -  current use of psychotropic medication or participation in any form of psychotherapy

          -  a history of significant medical condition (e.g., cardiovascular , neurological,
             gastrointestinal), pregnancy and/or breast feeding, or other systemic illness

          -  limited mental competency [Mini Mental State Examination score < 23] and/or the
             inability to give informed, voluntary, written consent to participate

          -  current use of any pharmacotherapy for smoking cessation not provided by the
             researchers during the quit attempt

        Additional Exclusion criteria only for the fMRI portion:

          -  cerebrovascular disease

          -  high blood pressure

          -  diabetes

          -  use of psychotropic medications in 3 weeks prior to participation in fMRI protocol

          -  exposure to extreme trauma

          -  lifetime history of mania, psychosis, or pervasive developmental disorder,

          -  being ambidextrous or left handed

          -  any metal implants, heart pacemaker, permanent retainer

          -  tattoos containing metal dyes

          -  claustrophobia.
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DMB-3115; Stelara
Intervention description: 45mg or 90mg dose subcutaneous administration; 45mg or 90mg dose subcutaneous administration
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity
      of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate
      to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

        Exclusion Criteria:

          -  Patients with hypersensitivity to ustekinumab or any of the product excipients.
REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: REGN3918
Intervention description: Subcutaneous (SC) every week (QW) over the treatment period
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The primary objective of the study is to evaluate the long-term safety, tolerability, and
      effect on intravascular hemolysis of REGN3918 in patients with paroxysmal nocturnal
      hemoglobinuria (PNH).

      The secondary objectives of the study are:

        -  To evaluate the long-term effect of REGN3918 on intravascular hemolysis

        -  To assess the concentrations of total REGN3918 in serum

        -  To evaluate the occurrence of the immunogenicity of REGN3918
    

Eligibility criteria:

        Key Inclusion Criteria:

        • Patients with PNH who have completed, without discontinuation, study treatment in one of
        the parent studies in which they participated (either R3918-PNH-1852 [NCT03946748] or
        R3918-PNH-1853)

        Key Exclusion Criteria:

          -  Significant protocol deviation(s) in the parent study based on the investigator's
             judgment and to the extent that these would (if continued) impact the study objectives
             and/or safety of the patient (for example, repetitive non-compliance with dosing by
             the patient)

          -  Any new condition or worsening of an existing condition which, in the opinion of the
             investigator, would make the patient unsuitable for enrollment or could interfere with
             the patient participating in or completing the study

        NOTE: Other protocol defined exclusion criteria apply
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Condition: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Intervention: Revefenacin; Spiriva Handihaler®; Placebo for Revefenacin; Placebo for Spiriva Handihaler®
Intervention description: Revefenacin administered via nebulization.; Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.; Placebo administered as double blind, double dummy via nebulization.; Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)

Summary:

      This study is a randomized, double-blind, double-dummy, parallel group study to compare once
      daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung
      function in subjects with COPD and a Low Peak Inspiratory Flow Rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older with a diagnosis of COPD.

          -  Subject has a current or past cigarette smoking history (or equivalent for cigar or
             pipe smoking history) of at least 10 pack-years.

          -  Subject is willing and able to provide signed and dated written informed consent to
             participate prior to initiation of any study related procedures.

        Exclusion Criteria:

          -  Subject has a concurrent disease or condition that, in the opinion of the
             investigator, would interfere with continued study participation or confound the
             evaluation of safety and tolerability of the study drug.

          -  Subject has a history of reactions or hypersensitivity to inhaled or nebulized
             anticholinergics.

          -  Subject suffers from any medical condition that would preclude the use of inhaled
             anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic
             hyperplasia, bladder neck obstruction, or urinary retention.
Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Abicipar Pegol; Ranibizumab; Sham Procedure
Intervention description: Abicipar pegol intravitreal injection.; Ranibizumab intravitreal injection.; Sham injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 949.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of abicipar pegol in participants with neovascular
      age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of age-related macular degeneration in at least 1 eye

          -  Best corrected visual acuity of 20/40 to 20/320 in the study eye

          -  Best corrected visual acuity of 20/200 or better in the non-study eye

        Exclusion Criteria:

          -  History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

          -  Cataract or refractive surgery in the study eye within the last 3 months
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: Oral Vancomycin
Intervention MeSH terms: Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inflammation of the bile ducts; biliary scarring; obstruction

Summary:

      Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US

          -  Colonoscopy within 1 year or starting of study

          -  2 groups:

               1. IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD

               2. No IBD and PSC, but positive p-ANCA or ASCA serologies indicating possible IBD.

        Exclusion Criteria:

          -  Allergy to Vancomycin

          -  PSC not associated with IBD or NO positive IBD antibodies (p-ANCA [anti- neutrophil
             cytoplasmic antibody] or ASCA [anti-Saccharomyces cerevisiae antibody])

          -  Cholangiocarcinoma

          -  On oral or topical (enemas or suppositories) corticosteroids,topical mesalamine, or
             biologics (infliximab, adalimumab, certolizumab).
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide; Lacosamide
Intervention description: Pharmaceutical form: oral solution
Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)
Route of administration: oral use; Pharmaceutical form: tablet
Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)
Route of administration: oral use
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 540.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; UCB; Epilepsy; Partial-Onset Seizures; Pediatric

Summary:

      The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of
      lacosamide (LCM) in pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
             written Informed Consent form (ICF) is signed and dated by the subject or legal
             representative. The ICF or a specific Assent form, where required, will be signed and
             dated by minors

          -  Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969
             [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric
             epilepsy

          -  Subject is expected to benefit from participation, in the opinion of the investigator

          -  Subject/legal representative is considered reliable and capable of adhering to the
             protocol (eg, able to understand and complete diaries), visit schedule, and medication
             intake according to the judgment of the investigator

          -  Subject is male or female aged 1 month to ≤17 years

          -  Subject has a diagnosis of epilepsy with partial-onset seizures

        Exclusion Criteria:

          -  Subject is receiving any investigational drugs or using any experimental devices in
             addition to lacosamide (LCM)

          -  Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for
             SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)

          -  For subjects ≥6 years of age, subject has a lifetime history of suicide attempt
             (including an actual attempt, interrupted attempt, or aborted attempt), or has
             suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to
             either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
             at Visit 1

          -  Female subject who is pregnant or nursing, and/or a female subject of childbearing
             potential who is not surgically sterile or does not practice 1 highly effective method
             of contraception
In-vivo Efficacy Study of Patient Preoperative Preps
Condition: Skin Flora Bacterial Reduction Post-product Application
Intervention: 3M CHG/IPA Prep Colorless; 3M CHG/IPA Prep Tint; ChloraPrep; Saline
Intervention description: Apply topically.; Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: surgical skin prep; CHG; IPA

Summary:

      The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on
      skin flora of the abdominal and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good general health

          -  Minimum skin flora baseline requirements on abdomen and groin

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test areas

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
Condition: Caries
Intervention: Silver Diamine Fluoride; Conventional Caries Management
Intervention description: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.; These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Caries; Cavity

Summary:

      The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF)
      for treatment of cavities in baby teeth. The investigators will compare the effectiveness of
      stopping the cavity, cost of the treatments and the opinions of the families and the dental
      providers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of at least one active (soft) cavitated carious lesions in the primary
             dentition, extending into dentin (ICDAS 5 or 6)

          -  The selected tooth must have a one or two surface lesion (more than 1/3 of the crown
             of the tooth must be remaining) and must allow for direct application of SDF

          -  Study teeth will not have any spontaneous or elicited pain due to caries, tooth
             mobility, or signs of pulpal infection

          -  Selected primary teeth must have an anticipated exfoliation date greater than 12
             months away

        Exclusion Criteria:

          -  Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis
             Imperfecta

          -  Severe medical conditions that do not allow the child to be managed in the clinic

          -  Known allergy /sensitivity to dental materials being used, including SDF

          -  Inability of the child to cooperate for treatment, recall examinations, or periapical
             radiographs

          -  Wards of the State, for consenting reasons
Long Term Safety Assessment of SER120 in Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Intervention: SER120
Intervention description: once a day treatment of nocturia
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: decrease in the number of nocturic episodes for patients with nocturia

Summary:

      The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies

          -  Willing to provide consent for the study

        Exclusion Criteria:

          -  Incontinence

          -  Diabetes Insipidus, Diabetes Mellitus

          -  CHF

          -  Renal Insufficiency

          -  Significant medical history which make participation unacceptable
Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Condition: Migraine
MeSH terms: Migraine Disorders; Emergencies; Recurrence
Intervention: Dexamethasone; Placebo
Intervention description: Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose; Matched oral solution
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Migraine recurrence is common amongst pediatric patients being discharged from the emergency
      department after treatment for migraine. Despite the commonality of migraine recurrence
      within the week following discharge, no known effective therapies are available in the
      pediatric population, though dexamethasone has been established as efficacious in the adult
      migraine population. The proposed study will randomly assign children and adolescents
      visiting the emergency department (ED) for migraine to receive either one dose of oral
      dexamethasone or oral placebo. Twenty patients will be recruited to this randomized,
      double-blind, pilot trial over a 6 month period, and the aim of the study will be to
      determine the feasibility and acceptability of the protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Between the ages of 8 and 18 years (ie. > 8.0 years and < 18.0 years)

          2. Diagnosed with migraine according to a modified version of International
             Classification of Headache Disorders 3rd edition (ICHD-3, beta version) where
             criterion A (ie. minimum of 5 prior episodes meeting criteria B-D) has been removed to
             increase sensitivity of diagnosis in the emergency department setting

        Exclusion Criteria:

          1. Received a dose of a steroid medication in the past 7 days

          2. Known allergy to dexamethasone

          3. Immunosuppressed

          4. Cushing's syndrome

          5. Known diabetes mellitus

          6. Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative
             colitis)

          7. Known myasthenia gravis

          8. Glaucoma

          9. Febrile at triage

         10. History of head trauma in the past 7 days

         11. Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed
             with active infection in the ED, etc)

         12. Current secondary headache (as per the treating physician's clinical impression)