bioihbjkbjnl/mcl2 huggingface dataset:
Co-Administration Of Methotrexate And CP-690,550
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics
      (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate
      the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and
      tolerability of co-administration of CP-690,550 and MTX.
    


Intervention name(s): CP-690,550 (tofacitinib); Methotrexate (MTX)
Intervention type(s): Drug; Drug
Intervention description(s): CP-690,550 30 mg q12h for 5 days; individual dose of methotrexate (stably dosed)
Intervention MeSH terms: Methotrexate; Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; oral JAK inhibitor; methotrexate (MTX); rheumatoid arthritis (RA)
Evaluating the Safety and Immune Response of an Adenovirus-Based HIV Vaccine in HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response of an
      adenovirus-based HIV vaccine in HIV-uninfected adults.
    

Detailed description: 
      Control of the global HIV pandemic will require the development of a safe and effective
      vaccine. Many HIV preventive vaccines that are in development use a recombinant adenovirus
      serotype 5 (rAd5) vector as a way of delivering the vaccine into cells. However, the majority
      of people, particularly in the developing world, have immunity against the Ad5 vector, which
      means the vaccine will not be effective at preventing HIV infection. This study will use a
      rAd26 vector as part of a HIV vaccine, as research has shown that relatively few people have
      immunity against this vector. The purpose of this study is to evaluate the safety and
      immunogenicity of a rAd26 vector preventive HIV-1 vaccine.

      This study will enroll healthy, HIV-uninfected people. Participants will be randomly assigned
      to receive either the rAd26 vaccine or a placebo vaccine. All vaccines will be injected into
      the upper arm. At the vaccination study visit, participants will undergo a medical and
      medication history review, physical examination, and a rectal sampling procedure. They will
      then receive their assigned vaccine. After receiving the vaccine, participants will remain in
      the clinic for at least 30 minutes for observation and monitoring of side effects.
      Participants will receive counseling on HIV risk reduction and pregnancy prevention. For 7
      days after the vaccination, participants will monitor their temperature and side effects.
      Additional study visits will occur at Days 1, 3, 7, 14, 28, 61, 168, and 365. At these
      visits, participants will undergo a medical history review, physical examination, counseling,
      and blood collection. At the Day 14 and 168 visits, a rectal sampling procedure will be
      performed. Participants will attend a study visit or be contacted by study researchers by
      telephone or e-mail 18 months after receiving the vaccine for follow-up health and safety
      monitoring. Participants may elect to attend optional follow-up visits for blood collection
      at Years 2, 3, 4, and 5.
    

Intervention name(s): Ad26.ENVA.01 (rAd26); Placebo Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 5 x 10^10 virus particles (VP) vaccine delivered intramuscularly (IM); Placebo vaccine delivered IM
Other intervention name(s): FFB, final formula buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine
Cedar Honey in Oral Lichen Planus
Condition: Erosive and Atrophic Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic
      oral lichen planus ( a common oral problem).
    


Intervention name(s): orally administered cedar honey
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: oral lichen planus; cedar honey; atrophic; erosive; pain; treatment; clinical trial
Cutting-through at the Greater Tuberosity
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      The investigators evaluated the correlation between cutting-through at the greater tuberosity
      (GT) just medial to the lateral knotless anchor in arthroscopic suture-bridge rotator cuff
      repair and the bone mineral density (BMD) of the lumbar spine, hip and GT of the proximal
      humerus and to evaluate factors and clinical outcomes related to cutting-through at the GT.
    

Detailed description: 
      Seventy-eight patients who underwent arthroscopic suture-bridge rotator cuff repair and who
      had undergone dual energy X-ray absorptiometry (DEXA) scans before surgery were included.
      Patients were divided into two groups: patients who had cutting-through (46, group I) and
      patients who did not (32, group II). Clinical and radiological data including demographics,
      BMDs, fatty infiltration of rotator cuff muscles, tear size, tear involvement, VAS pain
      score, and ASES score were analyzed.
    

Intervention name(s): Arthroscopic suture-bridge rotator cuff repair
Intervention type(s): Procedure
Intervention description(s): Arthroscopic suture-bridge repair is a widely used and universal surgical method for symptomatic rotator cuff tear patients. It is arthroscopic surgery to reattach ruptured rotator cuff tendons to the original insertion (greater tuberosity) using medial and lateral row anchors.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator
        cuff tears
      
Keywords: rotator cuff tear; cutting-through; Bone mineral density; suture-bridge repair
Addressing Systemic Health Disparities in Early Identification and Treatment of Autism Spectrum Disorder (ASD): ABCD Project
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The intervention under examination is designed to promote parents' school engagement
      following the transition from Early Intervention (EI) to preschool for parents of young
      children who were diagnosed with ASD through our screening and assessment protocol. The brief
      intervention employs principles of motivational interviewing to address not only the
      particular child characteristics and needs associated with ASD but also the unique,
      system-related challenges of navigating the special education system and advocating for
      appropriate services. Motivational interventions with parents are designed to elicit parents'
      specific, action-oriented goals for themselves and their children, enhancing motivation to
      pursue change, and addressing and resolving obstacles or sources of ambivalence.

      By identifying and capitalizing on parents' strengths, empowering parents to develop specific
      goals, and improving parents' readiness to engage actively with their children's school,
      teacher, and educational team, we expect that this brief intervention will lead to higher
      levels of parental school involvement, higher special education engagement, and closer and
      more productive parent teacher relationships.
    


Intervention name(s): Parent Preschool Engagement intervention; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This 1-2 session intervention (2-4 hours total) will involve one-on-one session(s) for parents whose children (all of whom have received a diagnosis of ASD through our study) are turning 3 and therefore transitioning from the Early Intervention system to the public school special education system. The intervention will utilize motivational interviewing (MI) principles to equip parents with the skills, knowledge, and clarity of goals necessary to collaborate effectively with school special education staff and teachers, to advocate for their children's needs, and to be empowered to navigate the special education system.; The attention control condition is parallel in format (one-on-one between parent with interventionist) and intensity (1-2 sessions, or 2-4 hours total). It involves open-ended interviews with parents about their child's development and plans for school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood
      arthritis.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of
      12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis
      (systemic onset vs pauciarticular disease vs polyarticular disease).

      Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower
      seed oil) orally. Parents are asked to maintain the child's usual diet over the course of
      study.

      Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.
    

Intervention name(s): gamma-Linolenic acid
Intervention type(s): Drug
Intervention MeSH terms: Evening primrose oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: arthritis & connective tissue diseases; juvenile rheumatoid arthritis; rare disease
Treatment of Refractory Chronic Cough With PA101
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in
      adult patients with refractory chronic cough.

      The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via
      eFlow high efficiency nebulizer for treating refractory chronic cough.
    

Detailed description: 
      The study consists of 2 treatment cohorts with refractory chronic cough: Idiopathic Pulmonary
      Fibrosis (IPF, Cohort 1) and Chronic Idiopathic Cough (CIC, Cohort 2). In each cohort, the
      study will include two treatment periods of 14 days each separated by a Washout Period of 14
      days between Period 1 and Period 2. The two periods will be identical except that in Period
      2, patients will crossover to the alternate treatment from that received in Period 1,
      according to a 1:1 randomization scheme.

      During each period, patients will self-administer study drug (i.e., 40 mg PA101 or Placebo
      PA101 via eFlow) three times daily for 14 consecutive days of each period. Objective cough
      count will be recorded over 24-hour period using a cough count device (Leicester Cough
      Monitor) at the Baseline, Day 7 and Day 14 of each treatment period.

      In the IPF cohort, patients will be allowed to use antifibrotic therapy (i.e., pirfenidone,
      nintedanib, and N-acetylcysteine) during the course of the study provided that the dose is
      stabilized at least 3 months prior to Screening and throughout the study period.

      Clinical safety assessments will be performed at the start and end of each treatment period.
    

Intervention name(s): PA101; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-Label Influenza Vaccine Evaluation
Condition: Immune Response
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the
      immune response to consecutive influenza vaccination across 2 seasons. Participants will be
      randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will
      receive the same vaccination in the second year and the third arm will be randomized again to
      1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood
      draws for a total of 6 draws over 18 months.
    


Intervention name(s): High Dose Influenza vaccine; Adjuvanted Influenza vaccine; Standard Dose Influenza vaccine; Recombinant Influenza vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Licensed and FDA approved Fluzone HD vaccine to be administered to study participants; Licensed and FDA approved FluAd vaccine to be administered to study participants; Licensed and FDA approved Fluvirin vaccine to be administered to study participants; Licensed and FDA approved FluBlok vaccine to be administered to study participants
Other intervention name(s): Fluzone HD; FluAd; Fluvirin Standard Dose; FluBlok
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vaccine; Influenza; High Dose; Adjuvanted; Recombinant
Open-Label Study of OTO-201 for Treatment of AOMT
Condition: Acute Otitis Media; AOMT
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
      either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible
      subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is
      designed to characterize safety, procedural factors and clinical effect of OTO-201
      administered in subjects with AOMT.
    


Intervention name(s): OTO-201
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute otitis media with tympanostomy tubes
BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by
      gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple
      sclerosis.
    

Detailed description: 
      People with multiple sclerosis are thought to have abnormal immunity. Usually the body's
      immune system attacks only foreign substances, but people with MS have abnormal immunity,
      where the immune system attacks normal proteins, one of which is a protein found in the brain
      called MBP (myelin basic protein). This abnormal immunity causes inflammation in the brain
      resulting in nerve damage. BHT-3009 is a drug that is designed to decrease this abnormal
      immunity to MBP. BHT-3009 is a DNA plasmid that contains the gene for MBP. Plasmids are
      circular pieces of DNA that are being tested in clinical trials for their ability to alter
      patients' immune systems. Two different doses of BHT-3009 will be tested to determine if
      there are any differences in their safety or effects on inflammation.

      Treatment in this study is 3 doses every two weeks for 6 weeks, followed by a dose every 4
      weeks for a total of 13 doses in 44 weeks.
    

Intervention name(s): BHT-3009 0.5 mg; BHT-3009 1.5 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Butylated Hydroxytoluene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Multiple sclerosis; MS; Bayhill; BHT-3009; immunotherapy
Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, randomized, parallel study to evaluate effect of exenatide on
      24h-UAER in patients with diabetic nephropathy.

      Screening will be made to select eligible participants before intervention. The trial will
      include 2-week run-in period of stable doses of glargine plus lispro insulin and 24-week
      treatment period. After the run-in period, patients were randomly assigned to one of two
      groups for antihyperglycaemic therapies for a total of 24-weeks: glargine plus exenatide and
      continued glargine plus lispro insulin. The treatment of exenatide will be initiated by 5ug
      bid, and uptitrated to 10 ug bid after 4 weeks and then maintained at 10ug bid until the
      completion of the study. Lispro insulin will be initially treated according to the insulin
      dosage of previous antihyperglycaemic therapies, and further titrated up at 4-week intervals
      until to reach the target fasting blood glucose (FPG).
    

Detailed description: 
      Objective:

      To evaluate effect of exenatide on 24-UAER in patients with diabetic nephropathy

      Hypothesis:

      Compared with glargine plus lispro group, at 24 weeks, glargine plus exenatide group can: 1)
      take more significant reduction of 24h-UAER; 2) take more reduction of ACR; 3) take more
      weight loss, blood pressure reduction; 4) take lower hypoglycemia incidence and less insulin
      dosage.

      Primary endpoint： The proportion of reduction of 24h-UAER(urinary albumin excretion rates)

      Secondary endpoints： 24h-UAER at 24 weeks; the rate of urinary albumin to creatinine
      ratio(ACR) change at 24 weeks; HbA1c, FPG,PPG, weight , BP

      Treatment duration： 24weeks

      Patient/Sites： 90 patients / 3 sites

      Timeline (best case)： Planed duration of recruitment period: 6 month Planed date for first
      screening: 1 October 2015 Planed completion of the last subject: 1 March 2017 Planned
      completion of clinical trial report: 30 October 2017
    

Intervention name(s): Exenatide; Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Exenatide (Astrazeneca ) 5 μg(initial dose)/10ug(maintenance dose) Subcutaneous injection Bid; Lispro (Eli Lilly), the dosage is initiated according to the previous treatment plan and weight of the patients, distribute the dosage to 1:1:1 before 3 meals, titration following PPG <10.0mmol/L.
Other intervention name(s): Byetta; Humalog
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Cryotherapy Combine Icotinib for Advanced NSCLC Treatment
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is to designed to assess the efficacy and safety of Cryotherapy combine with
      Icotinib for Advanced NSCLC Patients harboring EGFR mutation.
    

Detailed description: 
      In this single arm clinical study, enrolled patients, with advanced stage NSCLC and confirmed
      epidermal growth factor receptor (EGFR) mutation, would receive cryotherapy for tumors and
      begin Icotinib, an EGFR tyrosine kinase inhibitor administration thereafter. Progression free
      survival, overall survival and safety wil be observed.
    

Intervention name(s): Cryotherapy; Icotinib
Intervention type(s): Procedure; Drug
Intervention description(s): After entering the group subject receive Cryotherapy on lung cancer; After Cryotherapy, subjects begin Icotinib administration
Other intervention name(s): Cryoablation; EGFR-TKI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Neoplasms; EGFR mutation; Cryotherapy; Icotinib
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The concept of the investigators risk-adapted multicenter treatment trial for younger adults,
      AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of
      risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after
      first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p),
      abn(17p), complex]; intermediate-risk: complete remission after induction therapy and
      intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations];
      low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)].
      Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment
      consists of a first induction therapy with ICE followed by a second cycle ICE in case of
      response to first induction therapy. Patients with refractory disease after first induction
      therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose
      cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is
      extended from the family to unrelated persons. All patients achieving a CR after induction
      therapy with ICE are assigned to a first consolidation therapy with HAM. For
      intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended
      during the hematological recovery after the first consolidation. Second consolidation therapy
      was stratified according to the risk definition. For high risk patients a allogeneic
      transplantation is assigned from a related or unrelated donor preferentially after a
      dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched
      family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a
      family donor and normal karyotype at diagnosis are randomized between an autologous stem cell
      transplantation and a second course of HAM. The other intermediate-risk patients are assigned
      to autologous transplantation. For low-risk patients a second course of HAM is assigned.
    


Intervention name(s): Idarubicin; Cytosin-Arabinosid; Etoposide; All-trans Retinoid acid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Etoposide; Idarubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment