bioihbjkbjnl/mcl2 huggingface dataset:
Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome
Condition: Phelan-McDermid Syndrome
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Intervention: Oxytocin; Saline
Intervention description: Intranasal oxytocin; Placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin
      as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized,
      placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12
      weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments
      in attention, social memory, socialization, language, and repetitive behaviors.
    

Eligibility criteria:

        Inclusion criteria:

          -  Have a diagnosis of Phelan-McDermid syndrome defined by pathogenic deletion or
             mutation of the SHANK3 gene and confirmed by chromosomal microarray or sequencing.

          -  Must be between the ages of 5 and 17

          -  Must be on stable medication and psychosocial therapy regimens for at least three
             months prior to enrollment

        Exclusion criteria:

          -  Allergy to oxytocin

          -  Active cardiovascular disease, epilepsy, or renal disease that is not controlled by
             medication

          -  Pregnant, lactating or refuse to practice contraception if sexually active

          -  Have caretakers who are unable to speak English, be consistently present at visits to
             report on symptoms, or are otherwise judged unable to comply with the protocol by the
             study team

          -  Comorbid conditions such that the patient is too medically compromised to participate
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Condition: Liver Transplantation
Intervention: tacrolimus modified release (MR); tacrolimus
Intervention description: Oral; Oral
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Child; Pharmacokinetics; Immunosuppression Drugs; Hepatic transplant; Liver Transplantation

Summary:

      A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable
      pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen
      to a modified release tacrolimus based immunosuppression regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is currently receiving Prograf® based immunosuppressive therapy for liver
             transplantation.

          -  Patient has stable whole blood trough level concentrations of Prograf® and is
             clinically stable

        Exclusion Criteria:

          -  Patient has previously received an organ transplant other than a liver

          -  Patient is currently receiving sirolimus immunosuppression therapy.
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Placebo
Intervention description: Subjects will receive bimekizumab injections every four weeks (Q4W); Subjects will receive Placebo injections every four weeks (Q4W)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic plaque psoriasis; Psoriasis; Bimekizumab

Summary:

      This is a multicenter extension study to assess the long-term safety, tolerability and
      efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent

          -  Subject completes all dosing requirements in feeder study and completes PS0010 study
             without meeting any withdrawal criteria

          -  Female subjects of childbearing potential and male subjects with a partner of
             childbearing potential must continue to use an acceptable method of contraception (as
             detailed in PS0010) for up to 20 weeks after the last dose of study treatment in
             PS0011

        Exclusion Criteria:

          -  Subject has previously participated in this study.

          -  Female subjects who plan to become pregnant during the study or within 20 weeks
             following last dose of study medication. Male subjects who are planning a partner
             pregnancy during the study or within 20 weeks following the last dose

          -  Subject has any medical or psychiatric condition that, in the opinion of the
             Investigator, could jeopardize or would compromise the subject's ability to
             participate in this study.

          -  Subject must have a negative interferon gamma release assay (IGRA) as measured at Week
             8 of PS0010
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Comparator: Placebo
Intervention description: V501; Gardasil, 0.5 ml injection in 3 dosing regimen; Placebo 0.5 ml injection in 3 dosing regimen
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1021.0
Sex: Female
Minimum age: 18 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult
      women
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Subject Aged 18 To 26 Years

          -  With 1-4 Lifetime Sexual Partners

        Exclusion Criteria:

          -  Male Subject
Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Zoledronate
Intervention description: 4 mg IV over 15 minutes administered once every 12 weeks times 4
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bone mineral density; postmenopausal women

Summary:

      This is a two arm, double-blind randomized study looking at the effect of zoledronate, a
      bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women, Stage III or axillary node positive

          -  Currently disease free of breast cancer and other invasive malignancies at the time of
             registration

          -  No concurrent use of bisphosphonates

        Exclusion Criteria:

          -  Metastatic disease
Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Usual Care Group; Reduction Group
Intervention description: Nicotine replacement therapy; Subject selects preferred method for reduction.
Intervention MeSH terms: Lobeline; Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine Dependence; Tobacco Dependence

Summary:

      Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks
      associated with its use. While treatment programs that focus on stopping tobacco use may be
      effective, past research has shown that interventions that specifically focus on reducing
      tobacco use may be equally effective and may motivate individuals to eventually quit using
      tobacco. This study will compare the effectiveness of a ST reduction treatment program versus
      a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in
      ST users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No interest in stopping ST use within 90 days of study entry

          -  Daily use of ST in the 6 months prior to study entry

        Exclusion Criteria:

          -  Current use of tobacco or nicotine products, other than ST

          -  Current unstable medical and mental health conditions

          -  Use of any medication that may affect tobacco use or be affected by a reduction in
             tobacco use

          -  Pregnant or breastfeeding
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Intervention: pemetrexed
Intervention description: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to help answer the following research questions:

      If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological
      parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed;
      To evaluate adverse events
    

Eligibility criteria:

        Inclusion Criteria:

          -  no prior therapy for rectal cancer

          -  pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must
             have operable rectal cancer that is amenable to surgery.

          -  adequate organ function

          -  Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1

          -  signed informed consent

          -  at least 18 years of age

          -  surgically sterile, postmenopausal (women) or compliant with a medically approved
             contraceptive regimen during and for 6 months after the treatment.

        Exclusion Criteria:

          -  concurrent administration of any other anti-tumor therapy

          -  treatment within the last 30 days with a drug that has not received regulatory
             approval for any indication at the time of study entry

          -  serious concomitant systemic disorders

          -  previously completed or withdrawn from this study

          -  pregnant or breast-feeding

          -  second primary malignancy

          -  history of significant neurological or mental disorder, including seizures or dementia

          -  inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)

          -  presence of clinically relevant third space fluid collections that cannot be
             controlled by drainage or other procedure prior to the study entry

          -  inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
Condition: Asthma
Intervention: 80/2.25 μg Symbicort pMDI; 80/4.5 μg Symbicort pMDI; Foradil Aerolizer 12 μg; 40 μg budesonide HFA pMDI; placebo HFA pMDI
Intervention description: inhalation; inhalation; inhalation; inhalation; inhalation
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthmatic children; Symbicort; Foradil

Summary:

      This purpose of the study is to investigate the bronchodilating effects of 3 different
      dosages of formoterol given in combination with budesonide as Symbicort pMDI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1

          -  Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting
             β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting
             β2-agonist of =60% and =85% of predicted normal.

          -  Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level
             within 15 to 30 minutes after administration of a standard dose of short acting beta
             agonist

        Exclusion Criteria:

          -  Has been hospitalized for >24 hours at least once or required emergency treatment or
             urgent care visit more than once for an asthma-related condition during the 6 months
             prior to Visit 1

          -  Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal)
             for any reason within the 12 weeks prior to Visit 1.
Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%
Condition: Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Capmatinib; Pembrolizumab
Intervention description: INC280 tablets were administered orally at 400 mg on a continuous twice daily (BID) dosing schedule, from Day 1 until Day 21 of each 21-day cycle.; Pembrolizumab was administered by intravenous infusion at 200 mg once every 3 weeks (Q3W).
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capmatinib; pembrolizumab; NSCLC; PD-L1; EGFR; ALK; MET,; squamous; non-squamous

Summary:

      The purpose was to evaluate the efficacy and safety of the combination of capmatinib with
      pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with
      locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR
      mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when
      combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET
      dysregulation. The combination of capmatinib with checkpoint inhibitors has been established
      to be tolerable and could provide additional clinical benefit to the subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed and documented locally advanced stage III (not candidates for
             surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per
             AJCC/IASLC v.8) for treatment in the first-line setting

          -  Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild
             type status and ALK- negative rearrangement statu

          -  Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1
             expression (TPS ≥ 50%)

          -  ECOG performance status score ≤ 1

          -  Have at least 1 measurable lesion by RECIST 1.1

          -  Have adequate organ function

        Exclusion Criteria:

          -  Prior treatment with a MET inhibitor or HGF-targeting therapy

          -  Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell co-stimulation or immune
             checkpoint pathways)

          -  Have untreated symptomatic central nervous system (CNS) metastases

          -  Clinically significant, uncontrolled heart diseases

          -  Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study
             treatment
Promoting Tolerance to Peanut in High-Risk Children
Condition: Eczema; Egg Allergy; Food Allergy
MeSH terms: Eczema; Hypersensitivity; Food Hypersensitivity; Egg Hypersensitivity
Intervention: Peanut Consumption Group
Intervention description: Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 640.0
Sex: All
Minimum age: 4 Months
Maximum age: 10 Months
Healthy volunteers: No
Keywords: peanut allergy; egg allergy; eczema; peanut; allergy; allergies; allergic reaction; anaphylaxis; infants; children

Summary:

      This study will evaluate whether early exposure to peanuts promotes tolerance and provides
      protection from developing peanut allergy in children who are allergic to eggs or who have
      severe eczema.

      This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to consume solid food

          -  Allergy to eggs and/or severe eczema

          -  Informed consent obtained from parent or guardian.

        Exclusion Criteria:

          -  Clinically significant chronic illness. Participants with eczema or recurrent wheeze
             are not excluded.

          -  Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm
             in the presence of a negative saline control

          -  Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein
             on at least one occasion or 0.5 g over a single week

          -  Investigator-suspected allergy to peanut protein

          -  Investigator-suspected allergy to peanut protein in care provider or current household
             member.

          -  Diagnosis of persistent asthma

          -  ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal
             value

          -  BUN or creatinine greater than 1.25 times the upper limit of age-related normal value

          -  Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or
             investigator-suspected immunocompromise

          -  Unwillingness or inability to comply with study requirements and procedures
An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
Condition: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Pelvic Pain
Intervention: Tanezumab; Placebo
Intervention description: Intravenous, 20 mg, single dose.; Intravenous placebo, single dose
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Prostatis

Summary:

      The purpose of this study is to determine whether tanezumab is effective in the treatment of
      pain associated with chronic prostatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic prostatitis

          -  Male adults at least 18 years of age

          -  Moderate to severe chronic prostatitis, with an average pain score above a pre-defined
             level

          -  To use contraception.

        Exclusion Criteria:

          -  History of symptoms for less than 3 of the last 6 months

          -  History of recurrent urinary tract infections, or genito-urinary cancer

          -  Use of finasteride or dutasteride within 6 months.

          -  History of hepatitis B, C or human immunodeficiency virus (HIV)
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: PF-04191834; PF-04191834 placebo; Naproxen placebo; PF-04191834 placebo; PF-04191834; Naproxen placebo; PF-04191834; Naproxen; PF-04191834 placebo; Naproxen; PF-04191834 placebo; PF-04191834
Intervention description: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks; Matching PF-04191834 placebo tablets to be administered BID for two weeks; Matching naproxen placebo tablets to be administered BID for 4 weeks; Matching PF-04191834 placebo tablets to be administered BID for two weeks; 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks; Matching naproxen placebo tablets to be administered BID for 4 weeks; 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks; Naproxen 500 mg tablet administered BID for a total of four weeks; Matching PF-04191834 placebo tablets to be administered BID for two weeks; Naproxen 500 mg tablet administered BID for a total of four weeks; Matching PF-04191834 placebo tablets to be administered BID for two weeks; 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
Intervention MeSH terms: Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cross-over; safety; efficacy; tolerability; osteoarthritis; knee; pain

Summary:

      PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which
      is involved in the pathway that causes inflammation and pain. The purpose of this study is to
      test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the
      knee by itself or with naproxen, particularly to test if patients have less pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of osteoarthritis based on the American College of
             Rheumatology criteria confirmed by an X-ray

          -  Subjects must be willing and able to stop all current pain therapy for the duration of
             the study

          -  Subjects must be willing and able to complete a daily diary

        Exclusion Criteria:

          -  BMI of >39 kg/m2

          -  Known allergy or hypersensitivity to naproxen

          -  Any condition or medical history that might interfere with the subject's ability to
             complete the study visits and assessments