bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling
Condition: Advanced Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      The purpose of this study is to determine the percentage of CTC-positive patients and total
      CTC numbers in patients with advanced Non Small Cell Lung Cancer .
    

Detailed description: 
      The primary aim of the Project is to determine the percentage of CTC-positive patients and
      total CTC numbers in advanced NSCLC at baseline, before starting treatment.

      To valuate CTC count modifications as an early predictor of response to treatment a
      prospective observational study will be conducted, consecutively enrolling 150 patients
      regardless of type or line of therapy, which will be reevaluated for disease status and CTC
      count depending on the type and schedule of treatment.

      Furthermore, purified CTC will be obtained by automated platform and DNA sequencing will be
      performed to assess sensitizing mutations in advanced NSCLC patients. The EGFR mutations or
      EML4-ALK fusion gene detected in CTC will be compared with those reported for the tumor
      specimen using standard sequencing.

      In parallel, the CTC count assay will be integrated with mAb targeting EGFR or EML4-ALK
      fusion gene, to test whether assaying the quote of EGFR-positive and ALK-positive CTC
      provides a more sensitive marker for rating pharmacodynamic effects in patients compared with
      total CTC counts.

      Moreover, it was reported that NSCLC cells with EGFR mutations manifest activation of the
      PI3K (phosphatidylinositol 3-kinase)-AKT and MEK-ERK (extracellular signal-regulated kinase)
      signaling pathways under the control of EGFR, and exposure of such cells to EGFR-TKIs blocks
      signaling by both pathways and induces apoptosis 13. To evaluate whether live vs. apoptotic
      CTC changes under treatment may be used as predictor of tumor response, M30-positive CTC will
      be quantified as previously 8.

      Data obtained with the CTC assay will be correlated with common prognostic factors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      Whole blood.
    
Keywords: Circulating tumour cells in Advanced Non Small Cell Lung Cancer
Dry Needling in Patients Who Had Experience Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Individuals who had experience a stroke usually suffer from spasticity at medium and
      long-terms. The presence of spasticity in the lower extremity implies several impairments for
      standing and walking inducing high disability. A recent study has proposed the use of dry
      needling for improving spasticity in the lower extremity. No study has investigated the
      effects of deep dry needling inserted into spastic musculature in stabilometry and moto
      function in patients who had experience a stroke. A randomized controlled trial investigating
      the effects of the inclusion of deep dry needling into a Bobath interventional program on
      spasticity, motor function and balance (stabilometry) in individuals who had experience a
      stroke
    


Intervention name(s): Dry needling; Bobath
Intervention type(s): Other; Other
Intervention description(s): Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.; Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Dry needling; Spasticity; Motor function; Stabilometry
Nutrition Labeling Program to Promote Healthy Dietary Patterns
Condition: Nutrition; Diet
Study type: Interventional

Summary: 
      This study aims to evaluate a nutrition labelling program in improving university canteen
      customers' dietary pattern and behavioural determinants (e.g. knowledge).
    

Detailed description: 
      The increase in diet related diseases worldwide is considered to be primarily caused by a
      changing environment encouraging high energy intakes and a sedentary lifestyle. Examples of
      important environmental factors are the changing nature of the food supply, the changing
      socio-demographic structure of the population, the lack of nutrition information and the
      increasing reliance on foods consumed away from home. This evolution has driven the
      development of measures to encourage more healthy eating patterns. Nutrition labelling is one
      of those measures. Since adults and students spend approximately half their waking hours at
      the workplace or university, the work or study environment is believed to be an appropriate
      setting to assess and try to change individuals' dietary behaviour. This study aims to
      evaluate a nutrition labelling program in improving university canteen customers' dietary
      pattern and behavioural determinants (e.g. knowledge).
    

Intervention name(s): nutrition label
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Relationship Between HLA Tissue Compatibility and Biliary Complications in Patients With Liver Transplantation
Condition: Liver Transplant; Complications; HLA Antigens
Study type: Observational

Summary: 
      Liver transplantation has become the accepted treatment option for advanced liver failure in
      recent years. In addition to the increase in the number of centers performing transplant and
      the decrease in complication rates depending on the experience gained, the most common
      biliary complications did not improve at the desired level. For this reason, studies in this
      field are frequent today.

      The structural complexities of HLA antigens have been the subject of investigation in recent
      years. With the development of DNA and RNA amplification methods; It is increasingly
      difficult for physicians to keep up with the increasing burden of knowledge regarding the
      genetic aspects of these antigens. Concrete benefits of this gene complex, which has been
      investigated in various fields and preserves its mystery, have not been determined in liver
      transplant patients. However, there are publications showing its connection with the bile
      epithelium in liver transplantation and its relationship with the disappearing bile duct
      syndrome. In this study, our aim is to explain whether the bile duct complications, which
      appear like a continuous wall and can lead to frightening pictures, are related to HLA tissue
      compatibility.
    


Intervention name(s): HLA antigen results
Intervention type(s): Other
Intervention description(s): HLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who had liver transplantation and HLA tissue tests between 2017 and 2019 at Inonu
        University liver transplant institute
      
Keywords: Liver Transplant; Complications; HLA; biliary fistula; biliary stricture
Dose Ranging Study With LT, Monotherapy, PPAR
Condition: Diabetes Mellitus II
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the
      Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to find out how the brain of people with autism is affected by
      Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA
      approved for the treatment of heart conditions such as blood pressure

      This research is being done because there are currently no drug treatment options for
      language impairments and social difficulties often experienced by people with autism.
    

Detailed description: 
      The specific aim of this study is to examine the effects of serial doses of propranolol on
      social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and
      global function in high functioning adults and adolescents with autism in a double-blinded,
      placebo-controlled trial. The investigators will also examine whether response to treatment
      can be predicted based upon markers of autonomic functioning, such as skin conductance, heart
      rate variability (HRV), and the pupillary light reflex (PLR), and whether anxiety can predict
      treatment response. The hypothesis is that social functioning and language abilities will
      benefit from serial doses of propranolol, and that those with the greatest degree of
      autonomic dysregulation, or the lowest functional connectivity, will demonstrate the greatest
      benefit from the drug.
    

Intervention name(s): Propranolol; Placebo; Magnetic Resonance Imaging (MRI)
Intervention type(s): Drug; Drug; Device
Intervention description(s): Propanolol will be given on a titration schedule in which participants will begin with small doses (single capsules) of the drug and increase to a larger dosage (divided over 3 capsules) over the course of three weeks. Participants aged 15-24 years will undergo an MRI.; Placebo will be given in the form preferred by the participant and on the same schedule as the propanolol regime. Participants aged 15-24 years will undergo an MRI.; An MRI will be performed on participants aged 15-24 years.
Other intervention name(s): Inderal; Hemangeol; Innopran
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; ASD
Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare the bioavailability of the Test Product Metformin 500mg
      Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg
      Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under
      fasting conditions.
    

Detailed description: 
      An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of
      Single Doses of Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine)
      and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK)
      in Healthy, Adult Male and Female Subjects under Fasting Conditions.

      During each period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0,
      4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0
      hours after Investigational Medicinal Product (IMP) administration.
    

Intervention name(s): Metformin 500mg prolonged release tablets (JSC Farmak, Ukraine); Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of the Test product was administered orally with 240 mL of water.; One tablet of Reference (R) Product was administered orally with 240 mL of water.
Other intervention name(s): Diaformin® SR (sustained-release) 500mg tablets (JSC Farmak, Ukraine); Diabufor® XR 500mg tablets (JSC Farmak, Ukraine)
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Metformin 500 mg Prolonged Release Tablets; Prolonged Release Tablets; oral dosage form
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sponsor is developing the test medicine, AZD5718, for the potential treatment of
      cardiovascular disease.

      The study is an open-label, single dose study involving 6 healthy male subjects. The
      volunteers will receive a single dose of 200 mg radiolabelled AZD5718 (14C-AZD5718 Oral
      Suspension) containing not more than 9.9 MBq of radiocarbon.

      Volunteers will attend the clinic for 9 days (Day -1 to Day 8) to receive a single dose of
      the test medicine. It is planned that the volunteers will be discharged as a group once all
      volunteers have reached the discharge criteria. This may result in the subjects being
      discharged as a group prior to completion of the planned residency period. If the discharge
      criteria are not met by volunteers by Day 8, the individual volunteers who have not met the
      criteria will remain in the clinical unit for a further 48 h (until Day 10).

      A follow-up call will take place 7 to 10 days after discharge to ensure the ongoing wellbeing
      of volunteers.
    


Intervention name(s): [14C]AZD5718 Oral Suspension
Intervention type(s): Drug
Intervention description(s): 200 mg dose of [14C]AZD5718 Oral Suspension
Other intervention name(s): [14C]AZD5718
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease
Long-term Study With Clevudine
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is
      to investigate safety and efficacy of clevudine in patients chronically infected with
      hepatitis B virus, HBeAg positive or negative.
    


Intervention name(s): Clevudine
Intervention type(s): Drug
Intervention description(s): clevudine 30 mg qd
Intervention MeSH terms: Clevudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents
Condition: PCOS
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To exam in the effect of a combination of low dose Metformin and Spironolactone on functional
      brain MRI, menstrual regulation and metabolism in adolescents with PCOS.
    

Detailed description: 
      Polycystic Ovarian Syndrome (PCOS) is the most common endocrinopathy in adolescent females
      and also one of the most complex. Patients experience an exaggerated ovarian/adrenal androgen
      production in response to physiologic and supra-physiologic elevations in insulin. The
      hormonal dysregulation is not only associated with acne, hirsutism, and menstrual
      irregularity, but also with perpetuated insulin resistance, central adiposity, and clinical
      depression.

      In the proposed study, we aim to treat a hormonally and metabolically well-defined group of
      adolescent girls with PCOS with a combination of two pharmacological agents: metformin
      (insulin sensitizer) and spironolactone (anti-androgen) for 6 months. Although
      hyperandrogenism is a fundamental component of PCOS and responsible for the perpetuation of
      insulin resistance, adiposity and anovulation, there are few pediatric studies that have
      examined the benefits of treating both insulin resistance and hyperandrogenism
      simultaneously. Preliminary studies in adults, however, suggest synergistic effect of both
      spironolactone and metformin (spiro-met) with near normalization of the metabolic and
      ovulatory dysfunction. Therefore, we hypothesize that spiro-met will improve adolescent
      metabolism, body composition, ovarian morphology/function. We anticipate that our study will
      generate key pilot data for further randomized, double blind placebo controlled trials using
      both agents.

      We also plan to examine functional brain MRI before and after the spiro-met intervention.
      This will allow us to inspect the effects of the hyperinsulinemic/androgenic hormonal milieu
      in PCOS on structural and functional brain MRI. We hypothesis, that the hormonal environment
      in PCOS affects centers of appetite and mood.
    

Intervention name(s): Metformin and Spironolactone
Intervention type(s): Drug
Intervention description(s): Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months.
Intervention MeSH terms: Metformin; Spironolactone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CT Window Setting to Select Double-lumen Tube Size
Condition: Bronchial Cuff Volume at Air-tight Seal; Intracuff Cuff Pressure at Air-tighe Seal
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the appropriate window setting of chest computed
      tomography to select a correct size of double-lumen endobronchial tube.
    


Intervention name(s): Width 1000 HU/Level -450 HU; Width 400 HU/Level 25 HU
Intervention type(s): Device; Device
Intervention description(s): Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.; Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults
Condition: Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to determine if oligofructose supplementation promotes weight
      loss in overweight and obese adults.
    

Detailed description: 
      Obesity is a primary health concern for many western countries as it is linked to several
      chronic diseases as well as, large health care costs. Although obesity is a multifactorial
      disease, it is known that levels of satiety hormones including glucagon like peptide-1
      (GLP-1) and peptide YY (PYY) are reduced in obesity. The ability of prebiotic fiber to
      promote weight loss through the production of satiety hormones has been tested previously
      using rodents. Here it was found that prebiotic supplementation resulted in a decreased
      energy intake, higher GLP-1 levels in the plasma and increased proglucagon mRNA levels in the
      gut. This study will address the important question of whether prebiotic fiber
      supplementation is effective in reducing body weight in overweight or obese human subjects.
    

Intervention name(s): Oligofructose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 21 grams per day in distributed over 3 doses per day for 3 months; 7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months
Other intervention name(s): Raftilose P95; Maltrin M100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; weight loss; satiety hormones; body composition; appetite ratings
Immune Damage and Vaccination in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Better understanding of the specificities of the vaccine response in patients with COPD
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death
      worldwide in 2020 (3.5 million patients, 16500 deaths in France). Its socio-economic cost is
      related to the handicap induced by the decline of the respiratory function, as well as to the
      occurrence of exacerbations, main causes of hospitalization and mortality. Since
      exacerbations are mostly infectious, a preventive strategy involves routine influenza
      vaccination. Although it is highly recommended in this population, there is no formal
      evidence of its effectiveness during COPD. While correlates of influenza vaccine efficacy
      exist, cellular and humoral responses to this vaccine have been poorly evaluated in these
      patients. This alteration of the vaccine response could also be integrated into an overall
      deficit of the response to a vaccine in these patients.

      As influenza virus infection is one of the most important causes of death in patients with
      COPD, and vaccination is the best way to prevent it, it is essential to better understand the
      immune response in the context of vaccination in this population. The investigator's
      hypothesis is that there would be a global alteration of the immunological immune response in
      the COPD patient involving abnormalities of lymphocyte B differentiation and the effector
      capacity of T lymphocytes, notably through the activation of the PD1 / PDL1 axis.
    

Intervention name(s): Anti-influenza and DTp pertussis vaccinations
Intervention type(s): Other
Intervention description(s): Anti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be offered to patients for whom there is a prescription for influenza
        vaccination and DTp, COPD or non-COPD
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation Number - SR15-47-Z13-076)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment