bioihbjkbjnl/mcl2 huggingface dataset:
Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Condition: Pain
MeSH terms: Neuralgia
Intervention: clonidine; clonidine
Intervention description: Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid); Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
Intervention MeSH terms: Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pain, chronic pain; acetylcholine; clonidine; a2-adrenergic agonists; alpha2-adrenergic agonists

Summary:

      The purpose of this study is to compare the amount of acetylcholine release after a single
      injection of clonidine in normal volunteers and individuals with neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers

          -  Patients with neuropathic pain

        Exclusion Criteria:

          -  Pregnancy

          -  Allergy to clonidine

          -  Currently taking clonidine or other direct a2-adrenergic agonists

          -  Taking cholinesterase inhibitors
Effect of CPP-ACP Paste on Dental Caries in Primary Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: 10 % w/v CPP-ACP paste; the paste without CPP-ACP
Intervention description: Apply once a day at school by school teacher, following fluoride toothbrushing after lunch; Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
Intervention MeSH terms: 6-chloro-2-(1-piperazinyl)pyrazine; Caseins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 30 Months
Maximum age: 42 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Caries detection/diagnosis/prevention; Preventive Dentistry; Casien Phosphopeptide; Remineralization; Clinical trial

Summary:

      The purpose of this study is to determine if adding daily application of CPP-ACP containing
      paste for one year is superior to regular fluoride tooth brushing in preventing dental caries
      in high caries risk Thai preschool children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Thai boys and girl aged between 2 1/2 - 3 1/2

          -  Normal development of dentition

          -  Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)

        Exclusion Criteria:

          -  Chronic use of medications or antibiotics.

          -  Lack of cooperation in oral examination

          -  Milk protein allergy and/or benzoate preservatives

          -  Presence at baseline oral soft tissue lesion and enamel hypoplasia.

          -  Receive fluoride supplement and professional topical fluoride application at least
             three months before the beginning of study or during study period
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
Condition: Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: ADU-S100
Intervention description: intratumoral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and
      safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab
      in the first-line setting. The population will consist of adults with PD-L1 positive
      recurrent or metastatic HNSCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmation of recurrent or metastatic HNSCC

          -  Measurable disease as defined by RECIST v1.1

          -  PD-L1 positive

        Exclusion Criteria:

          -  Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell
             carcinoma of unknown primary histology; or salivary gland or non-squamous histologies
             (e.g. mucosal melanoma)

          -  Disease amenable to local therapy with curative intent (surgery or radiation therapy
             with or without chemotherapy)

          -  Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small
             molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or
             metastatic HNSCC
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Condition: Healthy
Intervention: RSV Vaccine; Placebo
Intervention description: Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.; Participants will receive a single IM injection of placebo on Day 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to explore the dose-response relationship of immune responses
      induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess
      the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine
      (Cohorts 2 and 3).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the investigator's clinical judgment, participants must be either in good or stable
             health. Participants may have underlying illnesses such as hypertension, type 2
             diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and
             symptoms are stable and medically controlled in the judgment of the investigator.
             Participants will be included on the basis of medical history and of physical
             examination and vital signs performed at screening (all cohorts), and of physical
             examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)

          -  A woman must be postmenopausal (defined as no menses for 12 months without an
             alternative medical cause) and not intending to conceive by any methods

          -  Agree to not donate blood from the time of vaccination until 3 months after
             vaccination

          -  Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)

          -  Be willing to provide verifiable identification and have means to be contacted and to
             contact the investigator during the study

        Exclusion Criteria:

          -  Has a contraindication to intramuscular injection (IM) injections and blood draws
             (example, bleeding disorders)

          -  Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
             or vaccine components (including any of the constituents of the study vaccine)

          -  History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis

          -  Has hepatitis B or C infection, including history of treated hepatitis C infection

          -  Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored
             vaccine at any time prior to randomization
Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)
Condition: Cancer
Intervention: Cediranib; Cediranib 30 - 90 mg
Intervention description: 45 mg oral dose; oral tablet dose escalation
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced solid tumours; Advanced cancer; tumor; tumour; RECENTIN

Summary:

      The purpose of this study is to determine whether food has any effect on a single dose of
      Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of
      fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of advanced solid tumour.

          -  Ability to eat a high fat breakfast

        Exclusion Criteria:

          -  Poorly controlled high blood pressure.

          -  History of significant gastrointestinal problems
L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Levels
Condition: Asthma; Inflammation
MeSH terms: Asthma; Inflammation
Intervention: L-Arginine; Placebo
Intervention description: L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.; Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Asthma; Severe Asthma

Summary:

      The major impact of this study will be to identify the adult severe asthma cohort that will
      benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of
      adult severe asthma patients will respond to supplemental L-arginine and derive clinical
      benefit from the addition of this therapy to standard-of-care asthma medications. The
      investigators hypothesize that the patients that benefit most will have low exhaled nitric
      oxide concentrations (< 20 ppb) at baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >18 yrs of age

          -  Diagnosis of severe asthma based on American Thoracic Society Workshop definition (Am
             J Respir Crit Care Med 2000; 162:2341)

          -  Active asthma medications of high dose inhaled corticosteroids plus long-acting beta
             agonist

          -  History of recent asthma exacerbations or Asthma control test score < 20/25

        Exclusion Criteria:

          -  <19 yrs of age

          -  Forced expiratory volume 1sec <30% predicted

          -  Pregnant or nursing women

          -  Current smokers or smoking history > 15 pack years

          -  Actively taking or known intolerance to L-arginine
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: lurbinectedin (PM01183)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and
      safety of PM01183 in previously treated patients with advanced solid tumors
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Voluntary signed informed consent (IC)

          -  Pathologically proven diagnosis of any of the following malignancies:

               -  Small cell lung cancer (SCLC).

               -  Head and neck carcinoma (H&N). Salivary glands tumors are excluded.

               -  Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health
                  Organization classification.

               -  Biliary tract carcinoma.

               -  Endometrial carcinoma.

               -  BRCA 1/2- associated metastatic breast carcinoma

               -  Carcinoma of unknown primary site.

               -  Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant
                  transformation.

               -  Ewing's family of tumors (EFTs)

          -  Prior treatment. Patients must have received:

               -  SCLC, endometrial carcinoma: one prior chemotherapy-containing line.

               -  H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines

               -  GCTs: no limit of prior therapy

               -  EFTs: no more than two prior chemotherapy-containing lines in the
                  metastatic/recurrent setting.

               -  BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than
                  three prior chemotherapy-containing lines.

          -  Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]

          -  Adequate major organ function

          -  At least three weeks since the last chemotherapy

          -  Women of childbearing potential must have pregnancy excluded by appropriate testing
             before study entry

        Exclusion Criteria:

          -  Prior treatment with PM01183 or trabectedin

          -  Prior or concurrent malignant disease unless in complete remission for more than five
             years

          -  Known central nervous system (CNS) involvement

          -  Relevant diseases or clinical situations which may increase the patient's risk

          -  Pregnant or breastfeeding women and fertile patients (men and women) who are not using
             an effective method of contraception
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; PF-06649751
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Early Parkinson Disease; Phase 2

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751
      in Parkinson's disease patients at early stage of the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential and/or male subjects

          -  Clinical diagnosis of Parkinson's disease.

          -  Parkinson's Disease Hoehn & Yahr Stage I-III inclusive

          -  Treatment naïve or history of prior incidental treatment with dopaminergic agents for
             no more than 28 days

          -  Able to refrain from any Parkinson's disease medication not permitted by the protocol.

        Exclusion Criteria:

          -  History or presence of atypical Parkinsonian syndrome.

          -  Severe acute or chronic medical or psychiatric condition or cognitive impairment or
             laboratory abnormality.

          -  Any condition possibly affecting drug absorption.

          -  Participation in other studies involving investigational drug(s), or treatment with
             any investigational drug within 30 days.
Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Bortezomib; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Dexamethasone
Intervention description: Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.; Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).; Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion; Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.; 1 mg administered by IV on day 3 of each cycle.; 40 mg orally on days 1-4 of each cycle.
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Untreated Mantle Cell Lymphoma

Summary:

      Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine,
      Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4)
      , then one dose of rituximab every 12 weeks until 5 years or disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable
             disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of
             CHOP-like chemotherapy.

        Exclusion Criteria:

          -  Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral
             neuropathy, history of myocardial infarction in last 6 months, or patients who are
             Hepatitis B Surface Antigen positive.
Study of Gardasil in Mid-Adult Males (MAM)
Condition: Human Papillomavirus
Intervention: Gardasil
Intervention description: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3).
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Male
Minimum age: 27 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV

Summary:

      The purpose of this study is to test the effectiveness of the research study vaccine,
      Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human
      Papillomavirus [HPV] infection in men (HIM) Study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men that have completed 4 years of follow-up in the on-going international prospective
             natural history study of HPV in men (The HIM Study)

          -  Willing to comply with 4 scheduled visits within a 7-month period

        Exclusion Criteria:

          -  Have received an HPV vaccine

          -  Have a prior diagnosis of penile or anal cancers

          -  Have a prior diagnosis of high grade anal intraepithelial neoplasia

          -  Have been diagnosed with human immunodeficiency virus (HIV)/acquired immune deficiency
             syndrome (AIDS)

          -  Have a history of anaphylaxis to vaccines

          -  Have known impairment of the immune system

          -  Have received any blood products within 6 months of enrollment
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Anrukinzumab; Anrukinzumab; Anrukinzumab; placebo
Intervention description: 200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12; 200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12; 200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.; 200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Active Ulcerative Colitis; Phase 2A; Double-blind; Randomized; PK/PD Biomarker Study

Summary:

      This study represents the first investigation of anrukinzumab in patients with active
      ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism
      based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and
      hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics
      (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, Age >=18 and <=65 years

          -  Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score

          -  women of childbearing potential with highly effective method of contraception

        Exclusion Criteria:

          -  Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV,
             positive or history of tuberculosis infection, active enteric infections, transplant
             organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CINRYZE
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: CINRYZE; C1 INH; HAE; C1 inhibitor; Pediatric; PK/PD

Summary:

      The objectives of this study were to evaluate: (1) the dose response and (2) the
      pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE
      for the treatment of acute angioedema attacks in children above and below 25 kg and less than
      12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and
      tolerability following IV administration of CINRYZE in this study population.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for this protocol, subjects must:

          1. Be at least 10 kg of body weight.

          2. Have a confirmed diagnosis of HAE.

          3. Have an acute HAE attack and be able to initiate treatment within 8 hours after onset
             of symptoms.

        Exclusion Criteria:

        To be eligible for this protocol, subjects must not:

          1. Have any active infectious illness.

          2. Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to
             dosing with study drug.

          3. Have received therapy with antifibrinolytics (e.g., tranexamic acid), androgens (e.g.,
             danazol, oxandrolone, stanozolol, or testosterone), ecallantide (Kalbitor®), or
             icatibant (Firazyr®) within 7 days prior to dosing with study drug.

          4. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of
             the components of CINRYZE), or other blood products.

          5. Have participated in any other investigational drug evaluation within 30 days prior to
             dosing with study drug, or have previously received treatment with CINRYZE in this
             study at any time.