bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Intervention: acyclovir/hydrocortisone cream
Intervention description: cream applied topically to lesion five times daily for five days
Intervention MeSH terms: Acyclovir; Hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Xerese; acyclovir hydrocortisone cream; herpes labialis; pediatric

Summary:

      To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of
      recurrent cold sores in children ages 6-11yrs after 5 days of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 6-11 years at time of enrollment

          -  General good health, as judged by the Investigator

          -  History of recurrent herpes labialis with at least two (2) recurrences during the last
             twelve (12) months, as based on interview with the subject or subject's caregiver

          -  Agreement to refrain from using other topical medical, over-the counter (OTC), or
             cosmetic products in or around the oral area during the herpes recurrence

          -  Agreement to refrain from mechanical disruption of the area affected by herpes
             labialis during the study recurrence

          -  Subjects and their legally acceptable representative(s) must voluntarily sign and date
             the informed assent (subject) and consent (legally authorized representative).

          -  Willingness to comply with all requirements of the study.

        Exclusion Criteria:

          -  Any evidence of an immunosuppressed state of the subject due to underlying disease
             (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)

          -  Significant skin conditions that occur in the area typically affected by herpes
             recurrences, and that would interfere with assessment of lesions such as atopic
             dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders

          -  Administration of an investigational drug or within 30 days prior to inclusion, or
             concurrent participation in another research study

          -  Administration of an immunomodulatory agent within the past 30 days

          -  History of immediate hypersensitivity or serum sickness reaction to any nucleoside
             analog antiviral agent, or to any topical steroid, or to the vehicle

          -  Clinically relevant abnormal physical findings at screening which, in the opinion of
             the investigator, would interfere with the objectives of the study or that may
             preclude compliance with the study procedures Nursing or pregnant (Pubescent females
             require pregnancy testing)
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy Polyethylene Glycol-Epoetin Beta
Intervention description: 120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety
      and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA)
      in predialysis participants with chronic renal anemia. Participants currently receiving
      subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy
      polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or
      360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week
      -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range
      of 10 to 12 grams per deciliter (g/dL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic renal anemia;

          -  Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;

          -  Hb concentration between 10 and 12 g/dL;

          -  Adequate iron status.

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months;

          -  Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;

          -  Poorly controlled hypertension requiring hospitalization or interruption of
             darbopoetin alfa treatment in the previous 6 months;

          -  Active malignant disease.
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Rituximab
Intervention description: Rituximab will be administered at 375 mg/m^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of long-term maintenance
      therapy with rituximab in participants with advanced follicular lymphoma who have had a
      positive response to first-line treatment with a rituximab-containing regimen. The
      anticipated time on study treatment is 2 years, and the target sample size is 124
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants greater than (>) 18 years of age

          -  Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy
             within 4 months of induction treatment

          -  No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated
             participants only are eligible)

          -  Verified complete or partial remission after first-line induction therapy including
             rituximab

        Exclusion Criteria:

          -  Grade 3b follicular lymphoma

          -  Transformation to high-grade lymphoma (except to Grade 3a) of previously existing
             follicular lymphoma

          -  Presence of central nervous system lymphoma

          -  Acquired immunodeficiency syndrome-related lymphoma

          -  Other primary malignancy (other than squamous cell cancer of the skin or in situ
             cancer of the cervix) for which the participant has not been disease-free for greater
             than or equal to (>=) 5 years
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABP 501; Adalimumab
Intervention description: Solution for subcutaneous injection in pre-filled syringe; Solution for subcutaneous injection in pre-filled syringe
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 526.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Arthritis; Rheumatoid

Summary:

      The purpose of this study is to compare the effectiveness and safety of ABP 501 against
      adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an
      inadequate response to methotrexate (MTX).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women ≥ 18 and ≤ 80 years old

          2. Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before
             baseline

          3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and
             baseline

          4. Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to
             25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on
             stable dose throughout the study

          5. Subject has no known history of active tuberculosis

        Exclusion Criteria:

          1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

          2. Major chronic inflammatory disease or connective tissue disease other than RA, with
             the exception of secondary Sjögren's syndrome

          3. Prior use of 2 or more biologic therapies for RA

          4. Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab

          5. Ongoing use of prohibited treatments

        Other Inclusion/Exclusion criteria may apply
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TNX-102 SL
Intervention description: TNX-102 SL 2.8 mg taken daily at bedtime.
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: TNX-102 SL; bedtime; sublingual; 12-month; long term safety; long term efficacy; Fibromyalgia

Summary:

      This was an open-label, extension trial designed to evaluate the long-term safety over 12
      months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia.
      Patients recruited into this trial were those who had successfully completed the double-blind
      study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they
      received during the double-blind study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient met all prior inclusion and exclusion requirements for Study F202
             (NCT01903265) originally, and has had no intervening medical conditions, increased
             suicidal ideation, or requirements for concomitant medications that preclude exposure
             to TNX-102 SL or enrollment in the extension study.

          2. The patient completed expected dosing in F202 (NCT01903265) defined as taking study
             medication up to Week 12, with at least 70% compliance with medication usage (based on
             responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no
             major protocol violations.

          3. The patient has provided written informed consent to participate in this extension
             protocol.

        Exclusion Criteria:

        None
Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: NBP607-QIV; NBP607-Y; NBP607-V
Intervention description: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria; Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata; Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1503.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine; Quadrivalent; Inactivated cell culture-derived

Summary:

      All participants received a single dose of their assigned vaccine on Day 0. They were
      followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse
      events were collected for 6 months post-vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 19 years and older

          -  Those who are able to comply with the requirements for the study

          -  If women, a negative pregnancy test and willingness to use birth control measures for
             the entire study duration

        Exclusion Criteria:

          -  Disorders in immune function

          -  Any malignancy or lymphoproliferative disorder

          -  History of Guillain-Barré syndrome

          -  Individuals with a known bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time

          -  Experience of fever (>38.0 ℃) within 24 hours following vaccination

          -  Body temperature >38.0 ℃ at the vaccination day

          -  Concomitant medications/therapy such as immunosuppressants or immune modifying drugs,
             systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3
             months

          -  Influenza vaccination within 6 months

          -  Subjects who have participated in other interventional study within 4 weeks

          -  Any vaccination within 1 month

          -  Those who are planning to receive any vaccine within 1 month from the study vaccine

          -  Individuals with any serious chronic or progressive disease

          -  Pregnant or breast-feeding women

          -  Any other reason that in the opinion of the investigator might interfere with the
             study
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan
Intervention description: Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1803.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADPKD

Summary:

      The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in
      participants with autosomal dominant polycystic kidney disease (ADPKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants ≥ 18 years with confirmed diagnosis of ADPKD (during
             participation in prior tolvaptan trials) who have completed and transferred from the
             double-blind Trial 156-13-210 (12-month period including post treatment follow-up,
             regardless of whether this was on-treatment or off-treatment), or completed Trial
             156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a
             prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled
             with the medical monitor approval, and additional close monitoring may be required at
             the beginning of the trial.

          -  eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior
             to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m^2 may be
             enrolled with medical monitor approval.

        Exclusion Criteria:

          -  Need for chronic diuretic use

          -  Hepatic impairment based on liver function abnormalities other than that expected for
             ADPKD with cystic liver disease

          -  Women of childbearing potential who do not agree to practice 2 different methods of
             birth control or remain abstinent during the trial and for 30 days after the last dose
             of investigational medicinal product (IMP)

          -  Women who are breast-feeding and/or who have a positive pregnancy test result prior to
             receiving IMP.

          -  Participants with contraindications to required trial assessments (contraindications
             to optional assessments, for example, magnetic resonance imaging [MRI] are not a
             limitation).

          -  Participants who in the opinion of the investigator or the medical monitor, have a
             medical history or medical finding inconsistent with safety or trial compliance
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Intervention: DCCR; Placebo for DCCR
Intervention description: Once daily oral administration; Once daily oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: PWS; Prader-Willi Syndrome

Summary:

      The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled
      release tablets) in children and adults with Prader-Willi syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
             patient); provide voluntary, written assent (patients, as appropriate)

          -  Genetically-confirmed Prader-Willi syndrome and hyperphagic

          -  In a stable care setting for at least 6 months prior to Visit 1

          -  Caregiver must have been caring for the patient for at least 6 months prior to Visit 1

        Exclusion Criteria:

          -  Have participated in an interventional clinical study (i.e., investigational drug or
             device, approved drugs or device evaluated for unapproved use) within prior 3 months

          -  Positive urine pregnancy test (in females of child-bearing potential) or females who
             are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during
             or within 30 days after study participation

          -  Any other known disease and/or condition, which would prevent, in the opinion of the
             Investigator, the patient from completing all study visits and assessments required by
             the protocol
A Primary Care Behavioral Approach for Addressing Childhood Overweight
Condition: Obesity
MeSH terms: Obesity
Intervention: Group-based behavioral intervention
Intervention description: The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Behavioral/Social; Obesity; Pediatrics; Preventive Medicine

Summary:

      The purpose of this study is to determine whether participation in a group-based health
      education curriculum is superior to receipt of standardized health educational materials for
      children who are overweight or at risk for overweight with regard to achievement of a
      healthier body weight and improvement of key eating and physical activity behaviors.
    

Eligibility criteria:

        Inclusion criteria included that the child must be:

          1. Obese (BMI ≥ 95th percentile for age and gender) or at-risk for obesity (85th ≥ BMI >
             95th percentile for age and gender);

          2. African-American by parent report;

          3. 7-11 years of age;

          4. Without any medical or psychological condition that would make weight loss or physical
             activity dangerous, or psychological disorders that would make adoption of health
             behaviors difficult;

          5. Without any complications of obesity that indicate prompt referral to a pediatric
             obesity treatment center for more aggressive weight loss therapy;

          6. Together with the parent/caregiver indicate that they are ready to make changes in
             their eating and physical activity behaviors;

          7. Have a parent/caregiver willing to participate.

        Exclusion Criteria:

        As noted above, to participate in this study the child must not have a medical or
        psychological condition that would make weight loss or physical activity dangerous,
        psychological disorders that would make adoption of health behaviors difficult, or
        complications of obesity that necessitate prompt referral to a pediatric obesity treatment
        center for more aggressive weight loss therapy. Examples of medical or psychological
        conditions that would render the child ineligible for this study include uncontrolled or
        poorly-controlled asthma or hypertension, bulimia, mental retardation or severe learning
        disability, as well as pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome,
        and slipped capital femoral epiphysis.