bioihbjkbjnl/mcl2 huggingface dataset:
The Association of SERPINA1 Gene Disturbance in Patients With Lung and Gum Disorders
Condition: Pulmonary Disease, Chronic Obstructive; Generalized Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases.
      The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with
      COPD serve as a risk factor for developing periodontitis.
    

Detailed description: 
      periodontitis is a polymicrobial inflammatory disease caused by various modifiable and
      non-modifiable risk factors. the non-modifiable risk factors include genetic polymorphisms
      like the gene coding for alpha-1-antitrypsinase

      COPD is a chronic inflammatory disease characterized by deterioration of lung function due to
      loss of elasticity of the lungs.

      SERPINA1 gene product has a protective role on the connective tissue components of both lungs
      and gums.

      Hence, this study tries to determine if the gene polymorphism in COPD serves as a risk factor
      for developing periodontitis.
    

Intervention name(s): SERPINA1 gene
Intervention type(s): Genetic
Intervention description(s): 2ml blood sample collected from patients to extract DNA for assessment of SERPINA1 gene polymorphism
Other intervention name(s): serine peptidase inhibitor; proteinase inhibitor
Intervention MeSH terms: Protease Inhibitors
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients,both male and female aged between 30-70yrs with COPD nd chronic periodontitis
      
Biospecimen description: 
      2ml of blood sample from each subject will be collected in EDTA containing vials and kept at
      -20 degrees until DNA extraction. the genomic DNA will be isolated and Z/S polumorphism in
      SERPINA1 gene will be identified by PCR followed by restriction digestion pattern by Alu 1
      restriction enzyme.
    
Keywords: Pulmonary disease,chronic obstructive,; generalized chronic periodontitis; SERPINA1 gene polymorphism
Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor
      cells less resistant to the drugs.

      PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone
      with or without OGX-011 works in treating patients with recurrent or metastatic prostate
      cancer that did not respond to previous hormone therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel and
           prednisone with or without OGX-011 in patients with hormone-refractory locally recurrent
           or metastatic prostate cancer.

      Secondary

        -  Determine the objective response rate and duration in patients treated with these
           regimens.

        -  Determine the safety and toxic effects of these regimens in these patients.

        -  Determine the overall and progression-free survival of patients treated with these
           regimens.

      OUTLINE: This is a multicenter, randomized, open-label study. Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive a loading dose of OGX-011 IV over 2 hours on days -7, -5, and
           -3. Patients then receive OGX-011 IV over 2 hours on days 1, 8, and 15, docetaxel IV
           over 1 hour on day 1, and oral prednisone twice daily on days 1-21. Treatment repeats
           every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable
           toxicity.

        -  Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice
           daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence
           of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
    

Intervention name(s): custirsen sodium; docetaxel; prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle)
Subsequent cycles:
weekly on days 1, 8, 15 (3 week cycles); 75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles); 5mg PO BID
Intervention MeSH terms: Prednisone; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer
Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer
Condition: Recurrent Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK)
      immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.
    

Detailed description: 
      By enrolling patients with lung cancer adapted to enrolled criteria, this study will document
      for the first time the safety and the short and long term efficacy of the combined therapy
      using Cetuximab and NK cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cetuximab; NK immunotherapy
Intervention type(s): Drug; Biological
Intervention description(s): 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations; For each procedure, 10 billion cells will be infused in 4 times
Other intervention name(s): Erbitux, C225
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent lung cancer; EGFR mutation; Cetuximab; NK immunotherapy
Splanchnic Nerve Anesthesia in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Patients admitted for acute heart failure and undergoing right heart catheterization will be
      enrolled in this study. Subjects will undergo catheterization of the heart to obtain central
      cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will
      undergo a regional nerve block of the splanchnic nerves. Patients will remain in the
      catheterization lab for the duration of anesthetic block and will be continuously
      hemodynamically monitored.

      This study will be a prospective, uncontrolled clinical trial. The study will not be
      controlled as invasive monitoring of hemodynamics will be performed, allowing clear
      demonstration of a cause-effect relationship. The goal of the study is to provide proof of
      concept.
    


Intervention name(s): splanchnic nerve anesthesia with a local anesthetic; regional nerve block with a local anesthetic (Lidocaine)
Intervention type(s): Procedure; Drug
Intervention description(s): regional nerve block of the splanchnic nerve
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers
Condition: Cancer Prevention; Diet Modification; Vegetable Intake
Study type: Interventional

Summary: 
      Whole grains, non-starchy vegetables, fruit, and beans are a consistent feature of diets
      associated with a lower risk of cancer and other diet-related diseases. For cancer risk
      reduction, the American Cancer Society recommendation is to consume at least 2.5 cups of a
      variety of fruits and vegetables daily. Other than dietary choices, weight control and
      physical activity levels are important modifiable determinants of cancer risk. This study
      finalized a novel, theory-driven farm-to-WIC intervention developed in preliminary work to
      promote vegetable intake among low-income adults served by the Special Supplemental Nutrition
      Program for Women, Infants, and Children (WIC). In New Jersey (the location of the study),
      WIC provides participants up to $30 in seasonal Farmers' Market Nutrition Program (FMNP)
      vouchers and monthly cash value vouchers or CVV (valued at $11 for adults and $8 for children
      at the time of the study) redeemable at farmers' markets. The program combined behaviorally
      focused nutrition education with the establishment of a WIC-based farmers' market
      (implemented in the summer of 2019 during the FMNP voucher issuance period). Content to
      address other modifiable determinants of cancer risk was added. To create additional
      opportunities for experiential and hands-on learning, monthly trips to an area farmers'
      market were held (between September 1, 2019 [after the WIC-based market was discontinued] and
      November 30, 2019 [the end of the local growing season]). The research employed an
      experimental design to initially test the intervention in 3 WIC agency sites (1 intervention
      and 2 control sites) with 297 urban, primarily Hispanic adults. Program effects on primary
      outcomes of vegetable intake (measured objectively using dermal carotenoids as a biomarker of
      intake and via self-report) and FMNP voucher redemption (objectively assessed using data
      provided by WIC) were examined at mid- and post-intervention (3 and 6 months post-baseline,
      respectively). Intervention effects on potential hypothesized mediators and the redemption of
      CVV at farmers' markets, participant satisfaction with the program, and the
      cost-effectiveness of the intervention also were examined.
    


Intervention name(s): Multilevel Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers at farmers' markets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence
Condition: Smoking
Study type: Interventional

Summary: 
      The broad objective of this proposal is to identify functional neuroanatomical correlates of
      impairments in response inhibition during smoking abstinence. We will measure changes in
      performance and regional blood oxygenation levels using functional magnetic resonance imaging
      (fMRI)while smokers complete tasks designed to assess decision making and response
      inhibition.

      Our primary hypothesis is that smoking abstinence will result in impaired response inhibition
      accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in brain
      regions associated with these cognitive processes including frontal cortex and the ventral
      striatum. Abstinence may also result in performance-related increases in activation in brain
      regions associated with effortful processing including the anterior cingulate cortex in
      effort to compensate for deficits in other regions.
    

Detailed description: 
      Participants will learn and practice a Go/No-Go reaction time task (Garavan, Hester, Murphy,
      Fassbender, & Kelly, 2006) that measures inhibitory and excitatory aspects of behavioral
      control. During the task subjects are presented with an alternating series of Xs and Ys in
      the center of the screen and must press a button every time they see a Go trial (the letter
      'Y' or the letter 'X') while inhibiting a response when they are presented with a No-Go trial
      (any interruption of the X Y alternating stream, e.g., X Y Y).
    

Intervention name(s): Smoking Abstinence
Intervention type(s): Behavioral
Intervention description(s): Smokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Smoking; fMRI
Immunology and Safety of Menactra® in Children in Saudi Arabia
Condition: Meningitis; Meningococcemia
MeSH terms: Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted among children in Saudi Arabia who previously received two doses
      of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal
      vaccine-naïve children (Control Group). This study will evaluate the administration of
      Menactra® in terms of the serum bactericidal antibody it induces in the two study groups.
      Safety of Menactra® vaccine will be described.
    


Intervention name(s): Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra® Vaccine; Menactra® Vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: N. meningitidis; Meningitis; Meningococcemia
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
Condition: Preterm Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in
      pregnant women with short cervical length after an episode of threatened preterm labour.
    


Intervention name(s): Device: Silicon ring (Arabin Pessary)
Intervention type(s): Device
Intervention description(s): Placement of a silicon pessary in the vagina, around the cervix.
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*02 Disease Controlled Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which
      was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung
      cancer. In this clinical study, the investigators examine using the peptides the safety,
      immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease
      for HLA-A*0201-positive advanced non-small cell lung cancer patients whose disease are
      controlled after any standard therapies.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*0201 restricted epitope peptides URLC10 emulsified with
      Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.

      The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which
      was derived from a cancer-testis antigen, URLC10 as a target for cancer vaccination against
      lung cancer. In this phase I/II trial, the investigators examine using the peptides the
      safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*0201-positive
      advanced non-small cell lung cancer patients whose disease are controlled after any standard
      therapies, but who do not have any options for additional standard ones to prevent .future
      relapse of the disease.
    

Intervention name(s): HLA-A*0201restricted URLC10 peptides with adjuvant
Intervention type(s): Biological
Intervention description(s): Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*0201restricted URLC10 peptides with adjuvant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine whether, in patients with mild to moderate knee
      osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.
    

Detailed description: 
      This is a randomized, double-blind, parallel group, placebo controlled 18 weeks study,
      consisting of two parts:

        1. Part A: an ascending single dose part in which the safety and tolerability of up to 4
           different canakinumab doses are studied (starting dose 150 mg, maximum dose 600 mg).

        2. Part B: a double-dummy, active-controlled, parallel design part in which the pain
           reduction of the canakinumab dose selected from part A is studied in comparison to
           Placebo and Naproxen.
    

Intervention name(s): Canakinumab; Placebo to canakinumab; Naproxen; Placebo to Naproxen
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Intra-articular injection; Intra-articular injection; Tablets for oral administration; Tablets for oral administration
Other intervention name(s): ACZ885
Intervention MeSH terms: Naproxen; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteo arthritis; pain control; intra- articular injections; Knee OA
Preconception Nutrition Education Intervention for Prospective Brides
Condition: Health Education
Study type: Interventional

Summary: 
      This research focuses on the importance of preconception health care. In this research, an
      intervention was carried out providing health education regarding preconception nutritional
      preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control
      Group method. Example used in this research were 100 prospective brides and grooms in
      Indonesia. The intervention group will be provided with education through a preconception
      nutrition education module and the brides health card, and the control group was given
      education using the brides health leaflet.
    


Intervention name(s): Health promotion of education pre-conception nutritional preparation
Intervention type(s): Other
Intervention description(s): Providing education on pregnancy nutritional preparation during the preconception period 3 months before the wedding
Intervention model: Single Group Assignment
Intervention model description: In this study there were 2 groups, namely the group that was given intervention and the group that was not given intervention / control group. The intervention group will be provided with education through a preconception nutrition education module and the leaflet, and the control group was given education using the leaflet.
Masking: None (Open Label)
Primary purpose: Prevention
A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study of the pharmacokinetics (PK) of MK-7655. In Part I, the PK of a single
      125 mg dose of MK-7655 given in combination with 250 mg of PRIMAXIN® (imipenem + cilastatin)
      will be determined in participants with impaired renal function and matched control
      participants. In Part II, the potential for renal insufficiency to affect non-renal clearance
      mechanisms will be investigated.
    


Intervention name(s): MK-7655; Imipenem + Cilastatin; Caffeine; Midazolam; Omeprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 125 mg intravenous (IV) over 30 minutes as a single dose; 250 mg IV over 30 minutes as a single dose; Caffeine caplet, single 200 mg dose, orally; Midazolam hcl syrup single 2.0 mg dose by mouth.; Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally
Other intervention name(s): RELEBACTAM®; PRIMAXIN®; No Doz®; VERSED®; PRILOSEC®
Intervention MeSH terms: Imipenem; Relebactam; Cilastatin, Imipenem Drug Combination; Midazolam; Caffeine; Omeprazole; Cilastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NicVAX/Placebo as an Aid for Smoking Cessation
Condition: Smoking Cessation; Smoking; Tobacco Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term
      abstinence.
    


Intervention name(s): NicVAX vaccine; Placebo vaccine
Intervention type(s): Biological; Biological
Intervention description(s): NicVAX vaccine given 6 times over 6 months; Placebo vaccine given 6 times over 6 months
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; NicVAX; smoking vaccine; smoking abstinence; smoking; tobacco cessation