bioihbjkbjnl/mcl2 huggingface dataset:
School-based Asthma Care for Teens (SB-ACT)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the widespread implementation of a developmentally
      appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care
      for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed
      therapy (DOT) to allow the teen to experience the potential benefits from adhering to
      guideline-based asthma treatment, and 2) a developmentally appropriate Motivational
      Interviewing (MI) Counseling Intervention to help the teen transition to independent
      long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT
      program will 1) experience less asthma-related morbidity than an asthma education (AE)
      attention-control comparison group, and 2) have improved adherence, less urgent healthcare
      use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The
      investigators also hypothesize that participants receiving DOT-only will have improved
      asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but
      will not have sustained, clinically significant improvement in outcomes once the DOT phase is
      complete. This represents a unique opportunity to build upon existing community relationships
      with an innovative and developmentally focused program to improve asthma outcomes for urban
      teens.
    


Intervention name(s): School-Based Asthma Care for Teens (SB-ACT); Directly Observed Therapy; Asthma Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation.
      However, preoperative radiation cause kinds of adverse events, some were irreversible. And
      the survival benefit was not obvious. Whether chemotherapy alone is effective enough in
      treating rectal cancer is not yet known. Here, the investigators chose all the three active
      cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen
      (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant
      regimen in treating patients with locally advanced rectal cancer.
    

Detailed description: 
      Preoperative chemoradiotherapy could improve the local control of locally advanced rectal
      cancer, but the role was limited, only 5%. The adverse event cause by radiotherapy was
      severe. This single phase II trial was aimed to evaluate the efficacy of triplet regimen
      (FOLFOXIRI) in treating patients with locally advanced rectal cancer. All patients will
      receive the study regimen every 2 weeks for 4-6 cycles. MRI of the pelvic will be performed
      after 4 cycles of chemotherapy to assess clinical response. If the tumor response over 20%
      after 4 cycles of treatment, the patient will go to surgery (TME) directly or 2 more cycles
      of treatment before surgery under the decision of MDT. On the contrary, if the tumor show
      poor response (<20%), radiotherapy will be performed before operation. After surgery, 6-8
      cycles of mFOLFOX6 will be given as adjuvant chemotherapy.
    

Intervention name(s): FOLFOXIRI
Intervention type(s): Drug
Intervention description(s): irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
Other intervention name(s): 5-FU; Oxaliplatin; Irinotecan
Intervention MeSH terms: Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal Cancer; Locally advanced rectal cancer; Neoadjuvant; chemotherapy; FOLFOXIRI
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
Condition: Influenza (Pandemic)
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian
      flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down
      into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test
      article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment
      following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts
      of the study.
    


Intervention name(s): Monovalent Avian Influenza VLP (H5N1); Monovalent Avian Influenza VLP (H5N1); Monovalent Avian Influenza VLP (H5N1); Adjuvant; Monovalent Avian Influenza VLP (H5N1); Adjuvant; Monovalent Avian Influenza VLP (H5N1); Adjuvant; Saline placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21; Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21; Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21; Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21; Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21; Placebo; Intramuscular, deltoid, Day 0 & Day 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Stress Relief Effect of Korean Red Ginseng
Condition: Stress Relief
Study type: Interventional

Summary: 
      The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red
      Ginseng and examine changes in brain structure, function and metabolites. A total of 60
      healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group
      or placebo group. Individuals will be examined through clinical assessment,
      neuropsychological function tests and neuroimaging.
    


Intervention name(s): Korean Red Ginseng; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Korean Red Ginseng Capsule (1g/day) for 8 Weeks; Placebo Capsule (1g/day) for 8 Weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mechanisms of Refractory Hypertension (Reserpine)
Condition: Refractory Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is deigned to determine if refractory hypertension is attributable to heightened
      sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic
      agent, in patients failing other classes of antihypertensive agents.
    

Detailed description: 
      Patients with refractory hypertension, defined as uncontrolled office blood pressure despite
      use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone.
      After withdrawal from other centrally-acting agents if needed, enrolled patients will be
      randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory
      blood pressure monitoring will be done at baseline, after the initial 4-week treatment
      period. All other antihypertensive medications will remain unchanged during the 4-week
      treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood
      pressure.
    

Intervention name(s): Reserpine
Intervention type(s): Drug
Intervention description(s): Open label reserpine 0.1 mg pill orally
Intervention MeSH terms: Reserpine
Intervention model: Single Group Assignment
Intervention model description: Open-label, dose titration study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; sympathetic tone; resperpine
Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Condition: Beta Thalassemia Major
MeSH terms: Hepatitis C; Liver Cirrhosis; Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.
      The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.
      Excess liver iron is clearly recognized as a co factor for the development of advanced
      fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is
      a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients
      regardless of the degree of iron overload. There is evidence that suggests Spirulina may help
      to protect against liver damage, cirrhosis and liver failure in those with chronic liver
      disease.
    


Intervention name(s): Spirulina
Intervention type(s): Dietary Supplement
Intervention description(s): Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy of Humira in Behcet Patients With Arthritis
Condition: Arthritis; Behcet
MeSH terms: Arthritis; Behcet Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease,
      classified among the vasculitides. The clinical manifestations include mucocutaneous lesions,
      articular, ocular, vascular, gastrointestinal and/or central nervous system involvement.

      The aetiology of Behcet's disease is unknown, however. Experimental evidence suggests that
      TNF-α may play an important role in the pathogenesis of the disease.

      To date, case reports and small open-short term studies report the efficacy of anti-TNFα
      therapy (Infliximab and Etanercept), especially regarding ocular and mucocutaneous
      involvement in Behcet.

      There are no double blind long term studies on larger number of patients regarding the
      efficacy of anti-TNFα, especially Humira in healing arthritis +/- other manifestations of the
      disease.
    

Detailed description: 
      Study Design (including visit schedule, dosing and procedures/methods):

      Screen visit, 1st visit -treatment initiation, follow-up visits - after 1 month and
      afterwards every 8 weeks for 24 weeks.

      Screen visit: informed consent, medical history,inclusion and exclusion criteria, pregnancy
      test, vital signs, physical examination, joint evaluation (no. of tender joints, no. of
      swollen joints), patient/investigator global disease activity, pain VAS, HAQ, Behcet Disease
      Current Activity Forms (BDACF), ECG, PPD and chest X-ray screening for tuberculosis, routine
      labs (performed at local HMO as a routine follow-up of the patient treatment with DMARD's):
      CBC, blood chemistry, ESR, CRP, urinalysis, HbsAg and AntiHCV, immunology labs (rheumatoid
      factor, anti-CCP, anti nuclear antibody - ANA).

      An induration of greater than 5 mm will be considered a positive PPD reaction.

      Follow up visits .: Vital signs, joint evaluation, patient/investigator global disease
      activity, pain VAS, HAQ, BDACF, routine labs (performed at local HMO as a routine follow-up
      of the patient treatment with DMARD's): CBC, blood chemistry, ESR, CRP, urinalysis, research
      blood samples for storage.
    

Intervention name(s): Adalimumab (Humira)
Intervention type(s): Drug
Intervention description(s): Open label pilot trial.
The study includes 3 phases :
Open label treatment period of 24 weeks.
Extension follow -up (3 years): Patients who responded well to study drug and their disease relapsed within the first 12 weeks following study drug interruption will be eligible to receive the study drug for 3 years in order to comply with the Israeli Ministry of Health requirements.
Safety follow-up: For patients who withdraw from either the open label treatment period or extension period, for another 24 weeks.
Other intervention name(s): Anti TNF monoclonal antibodies
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Recurrent Laryngeal Nerve's Motor Function: Sometimes Motor Fibers May Also Be Located in The Posterior Branch
Condition: Recurrent Laryngeal Nerve Injuries
MeSH terms: Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries; Recurrence
Study type: Interventional

Summary: 
      The investigators hypothesized that, sometimes the posterior branch of the recurrent
      laryngeal nerve may also have motor function. The investigators aimed to evaluate motor
      function of the branches in the branching recurrent laryngeal nerves in this study.
    

Detailed description: 
      This study group consisted of consecutive patients, undergoing thyroid and parathyroid
      surgery with IONM. Both anterior and posterior branches of the recurrent laryngeal nerves
      were assessed separately by both electromyography endotracheal tube for adduction and finger
      palpation for detection of laryngeal twitch due to posterior cricoarytenoid abduction. The
      recurrent laryngeal nerves having motor function only in the anterior branches were defined
      as group 1, whereas the nerves having motor function both in the anterior and posterior
      branches were as group 2.
    

Intervention name(s): intraoperative neuromonitoring
Intervention type(s): Device
Intervention description(s): NIM-Response 3.0 Intraoperative Neuromonitoring System (Medtronic Xomed, Jacksonville, FL, USA) was used to record the EMG amplitude signal for the anterior and/or posterior branches of recurrent laryngeal nerves (RLNs).
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Motor function of the extralaryngeal branches; intraoperative neuromonitoring; recurrent laryngeal nerve
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Condition: Insomnia; Fatigue; Breast Cancer
MeSH terms: Sleep Initiation and Maintenance Disorders; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of
      cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female
      breast cancer patients who report sleep disturbances following completion of chemotherapy.
    

Detailed description: 
      Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized,
      controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one
      month post treatment. The seven-week intervention is designed to determine the efficacy and
      acceptability of these treatment strategies in reducing insomnia in cancer survivors.
      Assessments will be made by questionnaires before, during, and two weeks following the study
      intervention. All ancillary treatments, as appropriate for control of symptoms caused by the
      cancer or its treatment may be administered as clinically indicated.

      Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data
      collection phase of the study, must have withdrawn from all sleep medications, including:
      prescription, over-the-counter, CAM and herbal remedies for at least one week prior to
      beginning the study.

      CBT-I (Arms 3 & 4): CBT-I will be provided on an individual basis to all patients in study
      Arms 3 & 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in
      these two study arms will receive 7 weeks of CBT-I, using a structured research grade
      protocol developed at the UR-SNRL. This manualized intervention, which exists as a published
      text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy,
      Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.

      Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent
      and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be
      made to each participant not currently receiving CBT-I on each of these Fridays to promote
      compliance, prompt completion, assess potential side effects of study medication, and answer
      patient questions.
    

Intervention name(s): armodafinil; Placebo Comparator; CBT-I
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg); Placebo for 47 days; Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Insomnia; Fatigue; QOL; CBT; Breast cancer; Survivors; Chemotherapy
Duloxetine in the Treatment of Stress Urinary Incontinence.
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to monitor the long term safety of duloxetine in the treatment
      of stress urinary incontinence.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors
Condition: Reperfusion Injury; Hypothermic Oxygenated Machine Perfusion
MeSH terms: Brain Death; Reperfusion Injury; Hypothermia
Study type: Interventional

Summary: 
      Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney
      disease. In an effort to address the widening gap between demand and supply of donor organs,
      there has been an increase in the numbers of "marginal" or functionally impaired renal
      allografts that had to be accepted for KT over the decades. The use of extended criteria
      donor (ECD) allografts is associated with a higher incidence of primary graft non-function
      (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE)
      has been successfully tested in pre-clinical experiments and in a few clinical series of
      donation after cardiac death (DCD) in liver transplantation. The present trial is an
      investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after
      brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before
      implantation and are going to be compared to a case matched group transplanted after
      conventional cold storage (CCS).
    

Detailed description: 
      The present trial is an investigator-initiated pilot study on the effects of HOPE on
      ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria
      will be submitted to 2 hours of HOPE via the renal artery before implantation and are going
      to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS.
      Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted
      biomarker analysis is planned using tissue, serum, and urine samples as the translational and
      basic research aspect of the present study.
    

Intervention name(s): HOPE; Conventional cold storage
Intervention type(s): Procedure; Other
Intervention description(s): HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP); No intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot study, case matched (1:2)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extended criteria donor; Donation after brain death; HOPE; Kidney transplantation
Study of Brain Circuitry in Anxiety Disorders
Condition: Posttraumatic Stress Disorder; Panic Disorder; Specific Phobias
MeSH terms: Anxiety Disorders; Stress Disorders, Post-Traumatic; Panic Disorder
Study type: Observational

Summary: 
      A diverse body of research has implicated the amygdalo-cortical circuitry in the
      pathophysiology of anxiety disorders. For example, one model of PTSD posits exaggerated
      amygdala responsivity to threat-related stimuli as well as deficient top-down modulation of
      amygdala responses by specific cortical regions, including the pregenual anterior cingulate
      cortex, subcallosal cortex, and hippocampus.

      The investigators propose to investigate the pathophysiology of several specific anxiety
      disorders, Posttraumatic Stress Disorder (PTSD), Panic Disorder (PD), and Specific
      Phobia(SP), by using cognitive activation paradigms and magnetic resonance imaging (MRI) to
      probe the function and structure of implicated amygdalo-cortical circuitry.
    

Detailed description: 
      All candidates for this project will undergo a comprehensive clinical assessment by an
      investigator trained to administer these instruments. At the MGH fMRI Center in Charlestown
      or at the Neuroimaging Center at McLean Hospital in Belmont, MA; each subject will undergo a
      single MRI session lasting approximately 2 hours. After the scanning session, subjects may be
      asked to make judgments about the facial expressions or the words that were presented.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Boston metropolitan area