Kornimate/medical-research-clean huggingface dataset:
a study of bez235 in adult japanese patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: in this study, bez235 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. the trial will confirmed the safety and tolerability and determine the mtd of bez235 in japanese patients.


Eligibility criteria:
inclusion criteria: 1. patients with histologically-confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists. 2. at least one measurable lesion as defined by recist criteria for solid tumors. 3. age ≥ 20 4. eastern cooperative oncology group performance status (ecog p.s.) of ≤ 2 5. life expectancy of ≥ 12 weeks 6. patients must have the laboratory values patients in the expansion part of this study have to meet the following criteria in addition to the criteria described above. 7. availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening. 8. patients whose molecular status proved to meet the criteria (pik3ca mutation/amplification and/or pten mutation and/or low/null pten expression) during pre-screening. exclusion criteria: 1. patients who have brain metastases or who have signs/symptoms attributable and have not been assessed with radiologic imaging to rule out the presence of brain metastases 2. patients with any peripheral neuropathy ≥ ctcae grade 2 3. patients with unresolved diarrhea ≥ ctcae grade 2 4. patients with a history of photosensitivity reactions to other drugs 5. women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. barrier contraceptives must be used throughout the trial in both sexes. women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least consecutive 1 years (i.e., who has had menses any time in the preceding consecutive 2 years), must have a negative serum pregnancy test ≤ 7 days prior to starting bez235. other protocol-defined inclusion/exclusion criteria may apply

Keywords: pi3k mtor advanced solid tumor
neurosurgical neuronavigation using resting state mri and machine learning

Conditions: Glioblastoma Multiforme

Summary: this study is investigating the use of a computer algorithm to analyze scans of the brain before surgery to predict how a person's tumor will respond to treatment.


Eligibility criteria:
inclusion criteria: * must have a radiological diagnosis of a lesion in the brain with characteristics consistent with glioblastoma multiforme. * must be planning to undergo a pre-operative mri. * must be at least 18 years old. * must be able to understand and willing to sign an irb approved written informed consent document. exclusion criteria: * contraindication to mri. * inability to have clinical follow-up (e.g., patient is out of town and will do follow-up elsewhere).
elderly nsclc/d vs dp (jcog0207)

Conditions: Non-small-cell Lung Cancer

Summary: to evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

the elderly lung cancer vinorelbine italian study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (nsclc). in a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. with the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced nsclc. a japanese phase i/ii study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. there have been no randomized prospective trials dedicated to elderly nsclc patients to evaluate tolerability and efficacy of platinum-based combination. comparison: single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced nsclc.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven non-small-cell lung cancer 2. stage iv, or stage iii disease ineligible for definitive radiotherapy 3. 70 years or older 4. ecog ps 0-1 5. ineligible for standard platinum(bolus infusion)-containing combination chemotherapy 6. no prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms 7. no prior surgery within 4 weeks before enrollment 8. no prior radiotherapy for primary tumor 9. no prior radiotherapy for metastatic lesions within 2 weeks before enrollment 10. adequate organ function 11. signed informed consent exclusion criteria: 1. symptomatic brain metastasis 2. active another neoplasms 3. severe svc syndrome 4. massive pericardial, pleural effusion, or ascites 5. bone metastasis emergent for palliative radiotherapy or surgery 6. uncontrollable systemic hypertension 7. heart failure, unstable angina, myocardial infarction within 6 months 8. uncontrollable diabetes 9. active infection 10. interstitial pneumonia/ pulmonary fibrosis 11. hypersensitivity for polysorbate 80 12. systemic administration of corticosteroids

Keywords: elderly advanced non-small-cell lung cancer cisplatin docetaxel weekly combination chemotherapy randomized trial
assess particle deposition and acute effects of symbicort® forte turbohaler®) in copd patients.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: computational fluid dynamics (cfd) is a new functional imaging method. since cfd is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (symbicort® forte turbohaler®) on the upper airway dimensions in severe copd patients (gold iii). the increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. the regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.


Eligibility criteria:
inclusion criteria: 1. patients with documented copd based on the following criteria: smoking history of at least 10 pack-years and decreased tiffeneau index (fev1/(f)vc \< 0.70). 2. patients should present severe copd with an fev1 between 50 and 30% of predicted (gold 3). 3. male or female patients aged ≥ 40 years. 4. patients should be treated according to gold guidelines before study start. 5. patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the turbohalerr. 6. maintained on stable respiratory medications for 6 weeks prior to visit 1. 7. written informed consent obtained. exclusion criteria: 1. pregnancy, breast-feeding or planned pregnancy during the study. fertile women not using acceptable contraceptive measures, as judged by the investigator. 2. inability to carry out pulmonary function testing. 3. a respiratory infection or exacerbation of copd in the four weeks prior to screening. 4. any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study 5. a history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease. 6. cancer or any other chronic disease with poor prognosis and/or affecting patient status. 7. a history of thoracotomy with pulmonary resection. 8. allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients. 9. history of alcohol or drug abuse. 10. patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. 11. patients who received any investigational new drug within the last 4 weeks prior to the screening visit. 12. patients treated with any non-permitted concomitant medication (see 7.2).

Keywords: copd symbicort turbohaler computational fluid dynamics functional imaging budesonide formoterol
educational programme impact on serum phosphate control

Conditions: Renal Insufficiency, Chronic

Summary: background: in chronic kidney disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. objectives: the aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. subjects and methods: a prospective interventional study is being conducted in a dialysis centre with 180 stage 5d chronic kidney disease patients who exhibit phosphate serum levels \> 5.5 mg/dl. the educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. anthropometric, clinical, demographic and laboratory parameters (serum phosphorus concentration will be evaluated and the transtheoretical model of eating behavior (tmfb) will be applied pre- and post-intervention.

background: in chronic kidney disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. objectives: the aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. subjects and methods: a prospective interventional study is being conducted in a dialysis centre with 180 stage 5d chronic kidney disease patients who exhibit phosphate serum levels \> 5.5 mg/dl. the educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. anthropometric (weight, height, body mass index), clinical, demographic (sex, age, time on dialysis programme, literacy/schooling) and laboratory parameters (phosphate serum levels) will be evaluated and the transtheoretical model of eating behavior (tmfb) will be applied pre- and post-intervention. reduction of phosphate serum levels and positive/negative behavioral changes will be the evaluated outcomes. statistical analyses will be carried out in order to compare the effect of educational programme on phosphate serum levels and on the behaviour changes.

Eligibility criteria:
inclusion criteria: * patients who freely consent to participate in this study * aged from 18 years or older * both genders * phosphate serum levels higher than 5.5 mg/dl (last 3 consecutive monthly measures) exclusion criteria: * patients who do not consent to participate in this study * pregnant * cognitive deficit * mental diseases * patients whose phosphate serum levels lower than 5.5 mg/dl or equal to 5.5 mg/dl

Keywords: renal dialysis, hyperphosphatemia, educational programme
efficacy of a smartphone app. designed to manage craving & individual predictors of substance use/addictive behavior

Conditions: Addiction

Summary: test the efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders

this translational project is the clinical application of research results from the university of bordeaux, sanpsy lab, cnrs usr3413 - on individual predictors of substance use. this project will test the efficacy of a smartphone application to help subjects concerned about reducing or stopping their substance use / behavioral addiction. this new therapeutic tool, designed by university of bordeaux, sanpsy lab, cnrs usr3413 - to manage craving and individual predictors of use, will offer the possibility of an easy to-use and personalized intervention accessible to the greatest number of subjects. based on our previous results that supports that, for all types of addiction, craving and individual cues are a significant drive for use in people with addiction, the application tested in this study was designed to be used among people presenting various types of addiction (substance and behavioral addictions). the application will also evaluate all concurrent substance uses and addictive behaviors to identify and prevent risk of addiction transfers.

Eligibility criteria:
inclusion criteria: * participants requesting help for substance or behavioral addiction in one of the participating specialized addiction treatment centers, and with more than 1-month-delay before treatment admission * age \>= 18 years of age * with at least one substance or behavioral addiction (dsm-5 criteria) * affiliated person or beneficiary of a social security scheme. * free, informed and written consent signed by the participant and the investigator exclusion criteria: * medical, psychiatric or addiction condition that warrants immediate treatment intervention * patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy....) * difficulty in understanding and / or writing french * not familiar with the use of smartphone * individuals participating in another study that includes an ongoing exclusion period * be deprived of liberty due to an ongoing legal procedure * individuals under legal protection * be under guardianship or under curatorship

Keywords: craving
study to evaluate the pharmacodynamics and safety of hgs1025 in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics of hgs1025 in patients with moderate to severe ulcerative colitis.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * active, moderate to severe ulcerative colitis (uc) confirmed by endoscopy * currently on 1 or more of the following uc treatment medications: 5-aminosalicylates (5-asa), corticosteroids, azathioprine, 6-mercaptopurine (6mp), and/or other immunosuppressive or immunomodulatory agents including cyclosporine, tacrolimus, methotrexate, and mycophenolic acid * not pregnant or nursing * females of non-childbearing potential or females of childbearing potential must be willing to practice abstinence from intercourse from 2 weeks prior to first dose of study agent and for 8 weeks after the last dose of study agent or use effective contraception for 1 month prior to the 1st dose of study agent and through 8 weeks after the last dose of study agent * males must agree to use effective contraception throughout the study and for 8 weeks after the last dose of study agent * have the ability to provide informed consent and comply with study procedures exclusion criteria: * received any of the following within 60 days of the first dose of study agent: anti-tnfα therapy; integrin receptor antagonist; intravenous immunoglobulin; high dose prednisone or prednisone equivalent (greater than 60 mg/day); any investigational agent including immunosuppressive/immunomodulatory or non-biologic agents * have had a change in corticosteroid, 5-asa, or other immunosuppressive/immunomodulatory agents within 30 days of day 0 * history of liver disease * history of a major organ transplant * history of prior large bowel resection * current unstable or uncontrolled acute or chronic diseases not due to uc * history of malignant neoplasm within the last 5 years, except for some types of adequately treated cancers of the skin or carcinoma in situ of the uterine cervix * current or recent drug or alcohol abuse or dependence * history of a positive test for hiv or test positive for hepatitis b (hbsag) or hepatitis c * have a history of severe drug allergies
long-term immunogenicity study of inactivated ev71 vaccine in children

Conditions: Enterovirus 71 Human

Summary: this study is designed to evaluate the long-term antibody titers of ev71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to \< 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to \< 2 years

this is an extension study of protocol ct-ev-21, to evaluate the long-term immunogenicity of ev71vaccine. the first study visit will be approximately 3 or 4 years after the administration of first vaccination of ev71 vaccine or placebo in ct-ev-21 study; 4 years after the first vaccination for subjects 2 to \< 6 years of age (2b), and 3 years after first dose for subjects 2 months to \< 2 years of age (2c and 2d). subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will have 3 clinic visits. immunogenicity response against ev71 virus antigen at each visit will be assessed.

Eligibility criteria:
inclusion criteria: * subjects who have completed participation in study ct-ev-21 part 2b, 2c, and 2d, and have received protocol specified doses of ev71 vaccine or placebo (total of 2 doses in part 2b, and 3 doses for part 2c and 2d). * the subjects' guardians are able to understand and sign the informed consent form. exclusion criteria: * subjects and/or guardians who refuse to comply with the study procedures

Keywords: ev71 vaccine
shamrock - ultrasound/mr image fusion guided lumbar plexus block

Conditions: Hip Fractures; Anesthesia, Local; Pain, Postoperative

Summary: the main objective is to complete a double-blinded randomized controlled crossover trial of lumbar plexus block with the shamrock technique guided by ultrasound (us)/magnetic resonance imaging (mri) image fusion vs. the shamrock technique guided by ultrasound in healthy volunteers. the investigators will assess block procedure-related parameters, anatomical spread of local anesthetic, and motor and sensory effects.


Eligibility criteria:
inclusion criteria * age ≥ 18 years * body mass index (bmi): 18.5 ≤ bmi ≤30 * written and oral consent to participate * normal healthy person (american society of anesthesiology classification i) exclusion criteria: * volunteers not abel to speak or understand danish * volunteers not able to cooperate * allergy against the medicines used in the study * daily use of analgesics * drug abuse - according to the investigator's judgment * alcohol consumption greater than the recommendations of the danish national board of health * contraindication for mri scan (including pregnancy) * volunteers in whom nerve blocks are impossible due to technical reasons or infection * volunteers who are incompetent, eg. surrogate consent is unaccepted

Keywords: hip surgery anesthesia perioperative analgesia
comparing google with a focused diabetes search engine

Conditions: Diabetes

Summary: abstract diabetes behavior can be influenced by patients exploring diabetes topics that may lack scientific credibility. the question this study examines is whether a google or health on the net (hon) internet search, presents websites that would incline a more or less likely recommendation to patients ? a preliminary trial suggests that referrers recommend websites based on rules that may prioritize website source over content. this study will qualitatively assess the rules that participants use in deciding which websites are more suitable than others. method the investigators will inject a diabetes related search term into a hon and a google search engine. the top 5 mutually exclusive websites from each search engine will be presented to 5 people from three groups stratified across endocrinologists, informaticians and pcps. participants will rank the websites and then identify the rules that they applied to reach their decision.


Eligibility criteria:
inclusion criteria: * physician, informatician, diabetologist exclusion criteria: -
technical feasibility of the cfdna test for non-invasive cytogenetic analysis of early miscarriages versus the gold standard microarray

Conditions: Spontaneous Miscarriage

Summary: among the 15% of couples who experience a spontaneous early miscarriage (sem) during their pregnancy, approximately 2 to 5% will suffer from recurrent sem. it is only after the third sm that they will be offered a workup to look for a predisposition to sem. this workup does not currently include a search for foetal chromosomal abnormalities that could be considered causal for this event. these anomalies are responsible for approximately 50% of sem and their detection could lead to an explanation for half of the couples currently without a diagnosis after a standard workup. the diagnosis of chromosomal abnormalities can be made by karyotype analysis or by cytogenetic microarray analysis (cma) on the product of conception. unfortunately, karyotyping has a high failure rate due to poor cell culture of samples that are often degraded or of low quantity. the cma is not always feasible due to the absence of analyzable feto-placental material linked to the use of a drug strategy for its elimination. the study of cell-free dna of syncytiotrophoblastic origin (cfdna) circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21. cfdna is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus, can be easily obtained by maternal venous sampling. if maternal blood sampling is performed before complete removal of the product of conception, then detection of foetal chromosomal abnormalities would be possible. thus, if failure rates of cma and cfdna techniques are comparable, cfdna could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained. this study therefore proposes to compare the failure rates of the two technologies (cma and cfdna) for the detection of chromosomal abnormalities in recurrent sem.


Eligibility criteria:
inclusion criteria: * patient who has suffered a miscarriage and requires a curettage to collect the product of conception * patient consenting to constitutional cytogenetic analysis on cfdna and product of conception * patient of legal age * patient affiliated to a social security system. exclusion criteria: * venous sampling impossible * miscarriage before 8 weeks of pregnancy (unusable cfdna) * patient does not understand french * patient under legal protection

Keywords: cell-free dna spontaneous miscarriage chromosomal abnormalities cytogenetic analysis
gcf il-17 levels and oxidative status of smoking and non-smoking individuals with periodontitis

Conditions: Chronic Periodontitis; Smoking, Cigarette

Summary: this study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(gcf) levels of interleukin (il)-17a, il-17e, total oxidative stress(tos) and total antioxidant capasity(taoc) in smoking and non-smoking patients with severe chronic periodontitis. systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the study. periodontal status were determined by recording periodontal clinical measurements. gcf samples were collected at the baseline, at the end of initial periodontal treatment and 4 weeks after periodontal flap surgery. the data were tested statistically by the student t and paired sample t tests.


Eligibility criteria:
inclusion criteria: * individuals aged ˃35 years and having ≥16 teeth diagnosed as chronic periodontitis * not received any periodontal therapy within the previous 6 months; * not received antibiotic/anti-inflammatory drug treatment within the previous 6 months. exclusion criteria: * receiving medical treatment for cancer, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, or any other systemic disease; * being pregnant or being in the period of menopause or lactation; * receiving any drug therapy that might affect the clinical characteristics of periodontitis; * usage of systemic antimicrobials during the 6 weeks prior to data collection

Keywords: chronic periodontitis smoking, periodontal treatment, il-17, oxidative stress