bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Information from blood samples may help us for choosing the best treatment in future
      personalized medicine. Natalizumab (NTZ) a current treatment for MS can be used as a second
      line therapy if a suboptimal response to disease modifying drugs. When to introduce NTZ is
      not consensual. The investigators hypothesized that biological information could rationalize
      choice and thus designed a prospective open label trial to test biological markers before
      treatment.
    

Detailed description: 
      Current state of knowledge of the topic of the project and The general interest of the
      project; Pharmacogenomic aims to determine biomarkers related to treatment response, a step
      toward patient-tailored medicine. Natalizumab, a monoclonal antibody has just received the
      EMEA approval for MS patients who do not respond to interferon treatment or who experience a
      severe disease course. Efficacy of the drug is outstanding with 37% of the patients
      completing the "disease free" definition after 2 years (7% in placebo group). On the other
      hand, natalizumab may be associated with severe adverse events such as progressive multifocal
      leucoencephalopathy and high costs. Overall, this emphasizes the need beyond current approval
      criteria to identify those patients with the best efficacy to safety ratio, a major public
      health issue.

      Scientific aims The primary scientific aim is to define biomarkers that would allow
      predicting long term response to natalizumab.

      Methodology; The investigators plan to conduct a 5 years study to search for the best
      predicting factors at the beginning of treatment and after 2 years. In this grant application
      the investigators will perform a multivariate analysis of clinical, MRI, and biological
      markers (neutralizing antibody, DNA, and mRNA expression) from baseline to 2 years. For
      feasibility reasons, long term follow up (5 years) and proteomics study will be performed in
      a second stage.
    

Intervention name(s): Natalizumab
Intervention type(s): Drug
Intervention description(s): 300mg, IV, every 4 weeks
Other intervention name(s): Tysabry (brand name)
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Multiple sclerosis; natalizumab; pharmacogenomics
Quantification of Clinically Relevant Drug Induced Changes in HbO2 Affinity
Condition: Oxygen Deficiency
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The presented study is an experimental in-vitro study without intervention in-vivo. The
      effects of nitric oxide and prostacyclins, 5-hydroxymethylfurfural and alpha-ketoglutarate,
      volatile anaesthetics on haemoglobin oxygen (HbO2) affinity will be investigated in-vitro.
      Venous blood samples of 20 healthy young volunteers (10 female, 10 male) will be collected
      twice in the period of one week. Informed consent will be given. Every blood collection will
      be accompanied by a venous blood gas analysis. The blood samples will be transferred to the
      laboratory for in-vitro recording of the complete oxygen dissociation curve (ODC). A newly
      developed in-vitro method will be used. On the first study day the blood samples will be
      exposed to three different concentrations of nitric oxide during the measurement, followed by
      two different vapourized prostacyclins. In addition, different concentrations of
      5-hydroxymethylfurfural and alpha-ketoglutarate will be given to the blood samples for ODC
      recording. On the second study day the dose dependent effects of three different volatile
      anaesthetics will be investigated by exposing the blood samples to these drug while the
      measurements. Following these ODC recordings, aliquots of the blood samples will be frozen
      and investigated for storage related changes in HbO2 affinity.
    


Intervention name(s): Venous blood collection
Intervention type(s): Other
Intervention description(s): Two venous blood collections in within one week. No drug-related intervention in-vivo.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Matrix Metalloproteinases (MMPs),Neutrophil Gelatinase-associated Lipocalin (NGAL) Tissue and Plasma Levels and Aneurysms
Condition: MMPs and NGAL in Ruptured and Non-ruptured Aneurysms
MeSH terms: Aneurysm
Study type: Observational

Summary: 
      An association between arterial aneurysms and matrix metalloproteinases (MMPs) has been
      described previously. MMPs regulate extracellular structural proteins and tissue remodeling.
      Neutrophil Gelatinase-associated Lipocalin (NGAL) is involved in the regulation of MMP
      activity. The aim of this work was to study the relationship between the levels of MMPs and
      NGAL and arterial aneurysms.

      In a multicenter, open label, parallel groups, prospective study, patients with aneurysmal
      disease were divided into two groups: Group I (with ruptured aneurysm) and Group II (with
      non-ruptured aneurysm). Healthy volunteer patients were also enrolled and represented the
      control group (Group III).

      The investigators enrolled 307 patients (Group I: 107, Group II: 200) with arterial aneurysm:
      49 popliteal, 31 common femoral, 2 superficial femoral, 29 common iliac artery, 3 common
      carotid and 193 abdominal aorta. Finally, 11 healthy volunteer patients (9 males and 2
      females, age range 40-70 year-old, median 56) were enrolled in Group III.

      Elisa test and Western blot analysis revealed greater levels of immunoreactive MMP-9 and NGAL
      in all patients with ruptured aneurysms, both central and peripheral aneurysms, and in the
      aneurismal vessels.

      These results provide important advances in the understanding of the natural history of
      arterial aneurysms. MMPs and NGAL play a role in development of arterial aneurysms and they
      may represent molecular markers for the prevention of aneurysmal rupture
    

Detailed description: 
      In the present study, the analysis of MMPs levels in plasma and tissues in patients with
      aneurysmal lesions identified several patterns of protease activity. Levels of both MMP-9 and
      NGAL were increased in aneurismal vessels, while the patterns of MMP-9 and NGAL expression
      was very high in all patients with ruptured aneurysm, both central and peripheral. These
      results show: 1) the chronic and degenerative nature of the aneurysmal lesion which is
      associated with increased levels of inflammatory proteinases, like MMP-9; 2) the apparent
      pivotal role of MMP-9 and NGAL in the pathophysiologic processes which lead to the final
      stage of natural history of aneurysms; and 3) the ubiquitous distribution of MMP-9 and NGAL.
      The pattern increased expression of MMP-9 and NGAL appears to be specific for aneurysmal
      arteries and it is not dependent on the anatomic site of the lesion.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with diagnosis of aneurysmal disease (central and peripheral, ruptured and
        non-ruptured).
      
Keywords: MMP; NGAL; Arterial Aneurysms
LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      ATLAS-IT-04 is a two part, single arm study designed to determine the safety and
      effectiveness of LTX-315 to induce T-cell infiltration prior to TIL expansion in patients
      with soft tissue sarcoma. Following intratumoural injection of LTX-315 to a selected lesion,
      the lesion will be extracted for T-cell culture, expansion and infusion.
    

Detailed description: 
      Patients with advanced/metastatic tumours who have received at least one approved standard of
      care treatment will be recruited. All patients must have at least two lesions, one that can
      injected with LTX-315 and another that can used to assess response. In the first part of the
      study, LTX-315 will be administered intratumorally on 4-6 dosing days over a 2-4 week period
      to an index lesion which will be biopsied or removed after treatment for T-cell expansion.
      The second part will involve culturing and expanding T-cells for infusion of tumour
      infiltrating lymphocytes (TILs) following an induction regimen. The safety and efficacy of
      the LTX-315 and TIL treatment will be assessed. Patients will be followed up for 15 months.
    

Intervention name(s): LTX-315 and TILs
Intervention type(s): Combination Product
Intervention description(s): Intratumoural injection of LTX-315 and infusion of TILs
Intervention model: Single Group Assignment
Intervention model description: LTX-315 and TILs
Masking: None (Open Label)
Primary purpose: Treatment
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
Condition: Gastroesophageal Reflux; Esophageal Atresia; Hernia, Diaphragmatic
MeSH terms: Gastroesophageal Reflux; Esophageal Atresia; Hernia; Hernia, Diaphragmatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment
      in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic
      hernia.
    

Detailed description: 
      Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease
      (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due
      to this fact extemporaneous formulations of omeprazole are administered to these infants. The
      oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and
      produce variable degrees of drug exposure. The dose range for GERD management in pediatric
      studies using omeprazole is 0.3 - 3.5 mg/kg/day.

      Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available
      in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an
      omeprazole suppository is an effective dosage form.This study is designed to evaluate and to
      compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal
      omeprazole treatment in infants with gastroesophageal reflux disease.
    

Intervention name(s): Omeprazole rectally 1mg/kg
Intervention type(s): Drug
Intervention description(s): A single dose of 1 mg/kg rectally administered omeprazole.
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Omeprazole, suppository, infants
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of the endoscopic
      ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF)
      with pulmonary vein isolation (PVI).
    


Intervention name(s): CardioFocus EAS-AC
Intervention type(s): Device
Intervention description(s): PVI for PAF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment of PAF using EAS-AC
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients
Condition: Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin
      vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric
      Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.
    

Detailed description: 
      The primary endpoint is Overall survival time (OS).Secondary endpoints are overall response
      rate (ORR), time to treatment failure (TTF),progression free survival (PFS)and the adverse
      reactions(AE) of the two groups .

      Study design:

      This is a prospective randomized control study.

      Sample size:

      Sample size considerations were based on the survival end point. The improvement in median
      survival from 10 months in the S-1+cisplatin arm to 13 months in the S-1+oxaliplatin arm was
      considered clinically relevant in this patient population. A total of 576 patients were
      required for a two-tailed log-rank test at the 5% significance and at least 80% power. The
      planned enrolled time was 48 months and 1 year of follow up, and a drop-out rate of 5%.
    

Intervention name(s): S-1; Oxaliplatin; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): S-1：40~60mg bid，d1~14 q3W; oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W; cisplatin：60mg/m2，iv drip ，d1,q3W
Intervention MeSH terms: Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-intestinal type gastric cancer; Advance Gastric Cancer; Recurrent Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; SOX, S-1+Oxaliplatin; OS,; ORR,; PFS,; TTF,; safety
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
Condition: Obesity; Type 2 Diabetes; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Sugar-sweetened beverage (SSB) consumption is associated with the development of obesity,
      type 2 diabetes, and dental caries. The current study attempts to explore whether an
      educational, science-based intervention is able to produce a measurable negative change in
      preferences for sugar-sweetened beverages, as well as initiate plans to reduce future SSB
      consumption in 12-year old children. In the first condition (SSB Intervention), participants
      will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade,
      and apple juice), followed by the evaporation of these beverages over a heat source,
      revealing their sugar content. In the second condition (Water Intervention), participants
      will watch a video showing an egg maintaining its shell in water, followed by the evaporation
      of water. In the third condition (Control), participants will watch a video of an egg
      maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol.
      Before and after watching their assigned video, participants will complete survey questions
      to assess self-reported: SSB consumption intentions, attitudes toward SSBs, and health
      perceptions of SSBs. Therefore, the aims of this study are to (1) quantify changes in SSB
      consumption intentions, attitudes towards SSBs, and health perceptions of SSBs from pre-video
      to post-video, (2) establish the effectiveness of the SSB Intervention and Water Intervention
      over the control, (3) establish the effectiveness of the SSB Intervention over the Water
      Intervention, (4) determine the efficacy of incorporating scientific evidence in a public
      health intervention, and (5) make recommendations for the future application of the method
      employed in this intervention to future public health campaigns.
    


Intervention name(s): Sugar-Sweetened Beverage (SSB) Video; Water Video; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content.; Participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water.; Participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive
Condition: Post Traumatic Stress Disorder; Depression; Anxiety; Stress, Psychological
MeSH terms: Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of the study is to investigate whether an occupational therapy program could
      enhance mental health outcomes for veterans who SCUBA dive. SCUBA diving requires modified
      breathing techniques and has been found to provide calming effects to individuals who engage
      in this activity. Occupational therapy interventions such as mindfulness, journaling, and
      deep breathing techniques can also provide similar calming effects. Therefore, this study
      will explore whether occupational therapy can provide additional benefits to overall mental
      health of veterans who SCUBA dive.
    


Intervention name(s): SCUBA with Occupational Therapy (OT); Self-Contained Underwater Breathing Apparatus (SCUBA) without OT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Study participants will complete two OT sessions in conjunction to their regular SCUBA diving activity. OT intervention includes breathing techniques, mindfulness strategies and a journal activity.; Study participants will continue their regular SCUBA diving activity through the Wounded American Veterans Experience SCUBA (WAVES) program. They will complete two dives.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups for this study. Both groups will engage in two SCUBA dives. Additionally one group will receive occupational therapy and the other will not. The occupational therapy sessions will occur in conjunction with the SCUBA dive.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy
The V-Wave Shunt: FIM Safety and Feasibility Study
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial
      filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA)
      class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to
      enable a first evaluation of the safety and performance of the V-Wave shunt implant when
      implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with
      intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant
      (baseline) status.
    

Detailed description: 
      V-Wave Ltd, an Israeli based medical device company, has developed the V-Wave atrial-septal
      shunt, a permanent implant indicated for Heart Failure (HF) patients with elevated Left
      Atrial filling Pressures (LAP). The V-Wave shunt, developed by V-Wave Ltd, has been designed
      specifically to meet the needs of an interatrial shunt and thus represents a dedicated
      device, to be implanted percutaneously in the interatrial septum creating an interatrial
      communication.

      This study aims to enable a first evaluation of the safety and performance of the V-Wave
      shunt implant when implanted in Heart Failure patients with elevated LAP. Study endpoints
      were then chosen to portray both safety (device related Major Adverse Cardiac And
      Neurological Events) as well as preliminary performance as assessed by a well characterized
      measure (e.g., LAP which is known to be associated with the general state of the disease and
      most importantly left ventricular ejection fraction and cardiac function in general).
    

Intervention name(s): Implantation of the V-Wave inter-atrial shunt
Intervention type(s): Device
Intervention description(s): Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Heart Failure (HF); Left Atrial Pressure
Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib
      hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on
      cells. It may also help doctors understand how well patients respond to treatment.

      PURPOSE: This research study is studying biomarkers predicting response in patients with
      non-small cell lung cancer previously treated with erlotinib hydrochloride.
    

Detailed description: 
      OBJECTIVES:

        -  To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be
           utilized as biomarkers to predict response in patients with non-small cell lung cancer
           treated with erlotinib hydrochloride.

      OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by
      ELISA and Luminex assays.
    

Intervention name(s): enzyme-linked immunosorbent assay; laboratory biomarker analysis
Intervention type(s): Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E3503
      
Keywords: non-small cell lung cancer
Effect of Monosaccharides on Intestinal Barrier Function
Condition: Dietary Habits; Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The aim of the present study is to determine the effect of monosaccharides on intestinal
      barrier function in healthy subjects.
    

Detailed description: 
      In the intervention study normal weight participants will receive defined amounts of
      monosaccharides for several days. Before and after intervention parameters of intestinal
      barrier function will be assessed.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): Participants receive different monosaccharides for a defined number of days.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants receive all interventional diets.
Masking: None (Open Label)
Primary purpose: Basic Science