Kornimate/medical-research-clean huggingface dataset:
additional effect of a life style program on antihypertensive treatment with telmisartan

Conditions: Hypertension

Summary: this post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of micardis® and micardisplus® in patients at cardiovascular risk under general practice conditions. the aim of the study is to investigate the effect of a six-month treatment with micardis® / micardisplus® on blood pressure and the effect of the lifestyle education tool for weight reduction on blood pressure control. in addition, the post-marketing surveillance study will provide information on the effects on target measurement of the lifestyle education tool and various laboratory parameters produced by treatment with micardis® and micardisplus® in an unselected patient population under general practice conditions.


Eligibility criteria:
inclusion criteria: 1. patients with essential hypertension (blood pressure (bp) higher or equal to 140/90 mmhg or higher or equal to 130/80 mmhg in case of diabetic patients) 2. patients with hypertension under treatment with one or more antihypertensive drug exclusion criteria: patients are excluded according to the summary of product characteristics (smpc).
test of cd47-sirpα inhibitors on the immune microenvironment colon cancer

Conditions: Cancer of the Colon

Summary: our goal is to create novel cd47-sirpα inhibitors using small molecules to reverse tam-mediated immune suppression and restore anti-tumor immunity in crcs. our program uses structure-based drug design to create selective and potent small molecule inhibitors of sirpα-cd47 to target the tumor microenvironment with greater efficacy and lower toxicity than cd47-targeting antibodies. . in order to study the activity of cd47-sirpα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient who has signed a consent to participate; * patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed; * patient affiliated to a social security scheme, or beneficiary of such a scheme exclusion criteria: * patient who had emergency colon cancer surgery * person in an emergency situation or unable to express their consent. * adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), * patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons
single-dose study to describe the safety of sarilumab and tocilizumab in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: primary objective: to describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (sc) as monotherapy in japanese patients with rheumatoid arthritis (ra). secondary objectives: to describe the laboratory abnormalities (absolute neutrophil count \[anc\], platelet counts, total cholesterol, high-density lipoprotein \[hdl\] cholesterol, low-density lipoprotein \[ldl\] cholesterol, and liver function tests \[lfts\]) following a single dose of sarilumab or tocilizumab administered sc as monotherapy in japanese patients with ra. to describe the pharmacokinetics (pk) of sarilumab and tocilizumab.

total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis (ra) as defined by the american college of rheumatology (acr)/european league against rheumatism (eular) 2010 * rheumatoid arthritis classification criteria. * acr class i-iii functional status, based on the 1991 revised criteria. exclusion criteria: * patients less than 20 years of age. * prior treatment with any biologic anti-interleukin-6 (anti-il-6) or interleukin-6 receptor (il-6r) antagonist. * any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization. * treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization. * treatment with disease-modifying antirheumatic drugs (dmards), immunosuppressive agents, tumor necrosis factor (tnf) antagonists or any other ra-directed biologic agents within a certain amount of time prior to randomization. * participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer. * active or suspected tuberculosis (tb) or at high risk of contracting tb. * fever, or chronic, persistent, or recurring infection(s) requiring active treatment. * the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study evaluating the safety of etanercept in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis

Conditions: Ankylosing Spondylitis; Arthritis, Psoriatic; Arthritis, Rheumatoid; Spondylitis, Ankylosing

Summary: this is a phase 4 open label, non-interventional, multi-center study to evaluate the safety of enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. the improvement of health-related quality of life will also be evaluated.

patients already prescribed to receive etanercept for the first time for treatment of rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis according to the summary of product characteristics (smpc). patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.

Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of consent * satisfies the 1987 acr revised criteria for rheumatoid arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor * provides informed consent * demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. sexually active women participating in the study must use a medically acceptable form of contraception. * patients already prescribed etanercept according to approved labelling exclusion criteria: * has hypersensitivity to etanercept * has sepsis or risk of sepsis. treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis c, hepatitis b, active tbc) * is pregnant or breast-feeding * has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (hiv) infection, immunodeficiency syndromes, or central nervous system (cns) demyelinating events suggestive of multiple sclerosis * has a history of confirmed blood dyscrasias * received any live (attenuated) vaccines within 4 weeks of screening visit

Keywords: rheumatoid arthritis ankylosing spondylitis psoriatic arthritis
repetitive transcranial magnetic stimulation on dysphagia in the stroke patient

Conditions: Stroke; Dysphagia; Repetitive Transcranial Magnetic Stimulation

Summary: participants suffered from acute stroke with dysphagia in single hospital who were determined by ct/mri and clinical evaluation. current project will recruit participants and randomize into two groups.one group will receive nmes, traditional swallowing therapy and rtms therapy five times per week for 2 weeks ; another group will receive nmes and traditional swallowing therapy with shame rtms five times per week for 2 weeks. fees and ssa were used for evaluated swallowing function before the therapy and after 2 weeks therapy.

participants suffered from acute stroke with dysphagia in single hospital who were determined by ct/mri and clinical evaluation. the aim of this study is to compare the effects of rtms, nmes and conventional swallowing therapy to those of sham rtms, nmes and conventional swallowing therapy. one group will receive nmes, to sham one group will receive nmes,traditional swallowing therapy and rtms therapy five times per week for 2 weeks ; another group will receive nmes and traditional swallowing therapy with shame rtms five times per week for 2 weeks. mep character, fees, degrees of dysphagia, fois, and ssa were used for evaluated swallowing function before the therapy and after 2 weeks therapy.

Eligibility criteria:
inclusion criteria: 1. stroke 2. onset time at least for one week，area not be limited. 3. patient was first time stroke patient without obvious infection condition. 4. patients with dysphagia in the stroke who were diagnosed by neurologist and ct/mri in our institute. patient was clear with adequate motivation and could cooperate the whole therapy and fees evaluation. exclusion criteria: 1. lower motor neuron disease, such as autonomic dysreflexia, facial palsy, hyhoid muscle denervation. 2. mental status unstable, mental retardation, schizophrenia, bipolar disease were be excluded. 3. metal implantation of head, ventroperotoneal shunt or any seizure history, pacemaker, as well as head and neck cancer. 4. allergy to specific subjects 5. cognition impairment 6. alcohol or drugs abuse 7. afraid of the noise of rtms.
efficacy of 0.05% cyclosporin eye drop in stevens johnson syndrome patient with chronic dry eye

Conditions: Stevens-Johnson Syndrome

Summary: the purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (restasis) in patients with stevens-johnson syndrome that have dry eyes by subjective symptoms and signs.

stevens-johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (fluorescein, rose bengal), schirmer i,fct and impression cytology

Eligibility criteria:
inclusion criteria: * males or females, of legal age of consent * patient with stevens-johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms * dry eye symptoms are defined as 1. has dry eye symptom everyday for more than 3 months 2. has foreign body sensation frequently 3. use tear substitutes more than 3 times per day * tear test shaw abnormalities at least 1 of 2 of following: 1. schirmer test without anesthesia is not more than 5 millimeters in 5 minutes 2. fluorescein clearance test at first 10 minutes is not more than 3 millimeters and has at least 1 of 3 of the following: 2.1.rose bengal score is not less than 4 2.2.fluorescein stain at cornea 2.3.impression cytology is consistent to dry eye * patent punctum exclusion criteria: * age \< 18 years old * patients with steven johnson syndrome without dry eye * patients used oral cyclosporine or anticholinergic drug within past 2 months * patients with hiv or immunocompromise status * patients with active ocular infections and patients with a history of herpes keratitis * patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342) * female patients are pregnant or nursing

Keywords: cyclosporin stevens-johnson syndrome dry eye
feasibility of an adapted mindfulness program to parkinson's disease

Conditions: Parkinson Disease

Summary: the objective of this study is to determine the feasibility (primary objective) and the effects (secondary objectives) of an mindfulness based stress reduction (mbsr) program adapted specifically for patients with parkinson's disease.

in parkinson's disease (pd) the psychological distress (anxiety and depression), is particularly impacting and often resistant to conventional drug treatment explaining the growing interest of patients in non-drug methods, such as mindfulness meditation. the mindfulness based stress reduction (mbsr) program has been evaluated in parkinson's disease, showing main effects on anxiety and depression symptoms. these data remain, however, still fragile, particularly in terms of methodological robustness and number of patients involved and variable size of effects. a clinical trial was recently conducted at the bordeaux university hospital with 28 patients with parkinson's disease . preliminary results suggest that a program tailored specifically to the expectations and needs of patients with parkinson's disease could, optimize accessibility, acceptability, and patient compliance for this type of approach while preserving clinical efficacy on anxiety and depression.

Eligibility criteria:
inclusion criteria: * patient suffering from parkinson's disease, * patient aged over 18 and under 80, * patient with a hoehn and yahr stage of 1 to 3, * patient affiliated or beneficiary of the social security system, * patient having signed a free, informed and written consent exclusion criteria: * patient with severe motor fluctuations (i.e. scoring 4 to at least one of the following items of part iv of the movement disorder society unified parkinson disease rating scale: 4.1 and 4.2 for dyskinesias; 4.3, 4.4 and 4.5 for motor fluctuations), * patient with acute depression not stabilized by treatment or dating from less than 6 months, * patient with non-stabilized psycho-behavioral disorders (hallucinations, psychoses, impulse control disorders) dating from less than 6 months, * patient with major cognitive impairment (montreal cognitive assessment ≤24), * patient who has already participated in a structured mindfulness meditation program * patient placed under judicial safeguard, guardianship or curator ship, * pregnant or breastfeeding women.

Keywords: mindfulness adapted mbsr program feasibility efficacy
the findings of magnetic resonance imaging in subtypes of tics-related disorders

Conditions: Tourette Syndrome in Children

Summary: the findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders


Eligibility criteria:
inclusion criteria: * age less than 18 years old * diagnosed as tourette syndrome or chronic tic disorders exclusion criteria: * history of neuropsychiatric disorders * already receive treatment for tourette syndrome/chronic tics disorder * have some device not allowed for mri scan

Keywords: mri pediatric neurology
social functioning in schizophrenia

Conditions: Schizophrenia

Summary: there are two research purposes of this study. one is to explore which psychosocial issue or biological issue would affect the social function among people with schizophrenia. the other one is to explore which social function would affect the job tenure among people with schizophrenia. there are 60 participants diagnosed with schizophrenia and divided into two groups, employment and unemployment. we will use several social function tests to collect social function, panss to evaluate their psychotic symptoms. and then we will compare and analysis the data through statistic software. finally, we will have he answer about how social skills affect the social function and which social skill would affect the job tenure among people with schizophrenia.


Eligibility criteria:
inclusion criteria: * schizophrenia exclusion criteria: * substance abuse
ultrasound examination and guided injection into the acromio-clavicular joint

Conditions: Osteoarthritis of Acromioclavicular Joint

Summary: is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound?


Eligibility criteria:
inclusion criteria: * adults over 18 years with ac joint degenerative changes
prospective pilot study of multimodal radiological evaluation feasibility during chemoradiotherapy of rectal adenocarcinomas

Conditions: Rectal Adenocarcinoma

Summary: the objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

the objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas. it is based on a structured clinical and radiological pathway for patients, using diffusion mri and f misonidazole pet. validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.

Eligibility criteria:
inclusion criteria: * locally advanced (≥t3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge. exclusion criteria: * synchonous metastatis * previous malignant tumour * previous radiotherapy/ chemotherapy * performance status who\>2 * contraindication to 5 fu

Keywords: chemotherapy rectal adenocarcinoma proctectomy fmiso tep mri
lung bacteriobiota and influenza mortality

Conditions: Influenza; Critical Illness

Summary: influenza is a potentially lethal disease still responsible for thousands excess deaths both in europe and the united states. despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. lung microbiota has been shown to be involved in the immunity against influenza and is correlated with lung inflammation in numerous chronic respiratory diseases. we therefore aim to analyse the correlation between lung bacteriobiota and influenza icu mortality

influenza is a viral disease which is still responsible for thousands of excess deaths par year both in europe and in the us. despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. as lung microbiota is correlated with lung inflammation in numerous chronic respiratory diseases, we hypothesize that lung microbiota would be correlated with influenza outcomes. in a pilot study, we found that lung bacteriobiota but not mycobiota is associated with influenza icu mortality. we therefore aim to confirm this correlation between lung bacteriobiota and influenza mortality.

Eligibility criteria:
inclusion criteria: * patient above 18 year-old admitted to intensive care unit * influenza diagnosis by pcr or rapid diagnostic test exclusion criteria: * guardianship or curatorship * prisoners * no health insurance * no legal representative

Keywords: influenza microbiota intensive care unit
measurement of in vivo mitochondrial capacity in infants

Conditions: Healthy Infants

Summary: the overarching aim of this project is to determine the test re-test reliability of 31p-magnetic resonance spectroscopy measurements in infants. primary endpoints include two separate measures of in vivo mitochondrial capacity (atpmax) over a 1-10 day period to assess feasibility and reliability.


Eligibility criteria:
inclusion criteria: * healthy, full-term infant * aged 14-28 days at visit 1 * willingness of parents to be notified of incidental findings from study procedures exclusion criteria: * born preterm * implanted metal or electronic objects that render mri unsafe * unable to complete 2 clinic visits 1-10 days apart at pennington biomedical research center

Keywords: neonates mitochondria mri
carboplatin plus vinorelbine in treating patients with stage iiib or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i/ii trial to study the effectiveness of combining carboplatin and vinorelbine in treating patients who have stage iiib or stage iv non-small cell lung cancer.

objectives: i. determine the feasibility of chemotherapy with carboplatin and vinorelbine in patients with stage iiib or iv non-small cell lung cancer. ii. determine the maximum tolerated dose and dose limiting toxicities of this regimen in these patients. iii. determine the response rate and survival of these patients after this treatment. outline: this is a dose escalation study of vinorelbine. patients receive carboplatin iv over 30 minutes followed by vinorelbine iv over 6-10 minutes on days 1 and 8. treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. patients are followed at 1 month. projected accrual: a total of 12-36 patients will be accrued for this study over 6-12 months.

Eligibility criteria:
disease characteristics: histologically or cytologically proven stage iiib or iv non-small cell lung cancer patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 8 weeks hematopoietic: wbc at least 3000/mm3 absolute neutrophil count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times normal sgot no greater than 3 times normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance at least 50 ml/min other: no significant active infection no other severe medical illness no prior significant symptomatic peripheral neuropathy (grade 2 or worse) no concurrent neuropathy not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 3 weeks since prior chemotherapy and recovered no more than 1 prior chemotherapy regimen no prior vinorelbine endocrine therapy: not specified radiotherapy: recovered from any prior radiotherapy no prior radiotherapy to more than 10% of bone marrow surgery: at least 2 weeks since prior major surgery and recovered other: at least 30 days since prior experimental therapy

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
non-pulmonary contributors of exercise intolerance in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with cf.

exercise intolerance is a critical problem for people with cystic fibrosis (cf) able to predict hospitalization independent of lung function. recent studies have suggested that certain supplements may help improving exercise intolerance.

Eligibility criteria:
inclusion criteria: cf * diagnosis of cf * men and women (\> 18 yrs. old) * fev1 percent predicted \> 40% * patients with or without cf related diabetes * resting oxygen saturation (room air) \>90% * traditional cf-antioxidant medications * ability to perform reliable/reproducible pfts * clinically stable for 4 weeks (no exacerbations or need for antibiotic antioxidant within 4 weeks of testing or major change in medical status) * pancreatic sufficient and pancreatic insufficient patients exclusion criteria: cf * children 17 years old and younger * fev1\<40% predicted * resting o2 saturation \<90% * clinical diagnosis of heart disease * clinical diagnosis of pah * febrile illness within 4 weeks of a study visit * antioxidant for pulmonary exacerbation within 4 weeks of a study visit * currently smoking, pregnant or nursing * vasoactive medications (i.e. nitrates, beta-blockers, viagra etc.) * patients with b. cepacia

Keywords: resveratrol nicotinamide riboside exercise intolerance