Kornimate/medical-research-clean huggingface dataset:
the impact of modified wheat bran on carbohydrate fermentation in the colon in healthy and obese subjects

Conditions: Healthy; Obese

Summary: during this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.


Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years old * bmi between 18 and 25 kg/m² or higher than 30 kg/m² * regular diet * not dieting exclusion criteria: * use of antibiotics in the month preceding the study * diabetes type 1 or 2 * abdominal surgery (except from appendectomy) * use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication * use of pre- or probiotic supplements in the month preceding the study * chronic gastrointestinal diseases, such as inflammatory bowel disease (crohn's disease, ulcerative colitis), irritable bowel disease... * pregnancy or lactation * blood donation in the last 3 months * abnormal hb-level (standard range between 14 and 18 g/dl for men and between 12 and 16 g/dl for women) * participation in clinical studies involving radiation exposure in the past year
a fih trial of the streamline™ surgical system

Conditions: Intraocular Pressure; Open Angle Glaucoma

Summary: the purpose of this study is to evaluate the safety and intraocular pressure lowering effectiveness of the streamline™ surgical system.

this is a prospective, nonrandomized, open-label study evaluating the safety and iop-lowering effectiveness of cpi visco-surgical system (streamline™ surgical system) in patients with open-angle glaucoma undergoing cataract surgery.

Eligibility criteria:
inclusion criteria: subjects must meet all the following criteria in order to be eligible for participation in this study: 1. subjects qualifying for cataract surgery 2. subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated iop of 21-36 mmhg. exclusion criteria: * subjects are ineligible for participation in this study if s/he meets any of the following criteria: 1. patients who could not be washed-out of iop-lowering medications. .

Keywords: intraocular pressure glaucoma glaucoma surgery ab interno
precise gene signature for predicting outcomes in pdac

Conditions: Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC); Precise Prognostic and Predictive Signature

Summary: the current tnm staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (pdac). tumor mutation and copy number variation (cnv) markers may have a higher predictive value. in this study, whole exosome sequencing was performed for patients with stage i-ii pdac undergoing r0 resection. the investigators aimed to identify genes with discrepant statuses of mutations or cnvs between patients with and without relapse within 1 year after r0 resection, and then to construct a support vector machine (svm)-based prognostic classifier (the svm signature) for pdac using machine learning; the investigators then aimed to further validate the svm signature in an independent cohort.


Eligibility criteria:
inclusion criteria: * availability of hematoxylin and eosin slides with invasive tumor components * availability of clinicopathologic characteristics and follow-up data * no previous history of cancer exclusion criteria: * no formalin-fixed, paraffin-embedded (ffpe) tumor sample of primary tumor * receipt of any neoadjuvant and/or adjuvant cancer-directed therapy * survival time \<3 months after resection
efficacy of phenytoin phonophoresis on pressure ulcer healing

Conditions: Pressure Ulcer

Summary: efficacy of phenytoin phonophoresis on pressure ulcer healing

the purpose of the study is to evaluate the therapeutic effect of phenytoin phonophoresis on the healing of pressure ulcers. subjects: forty patients suffering from pressure ulcers will be randomly divided into two equal groups each one has 20 patients, they will be selected from al kaser al aini. in this study, the patients will be randomly assigned into two equal groups (20 patients for each group) and will receive the treatment program three sessions per week for 6 weeks as a total period of treatment. phenytoin phonophoresis group (study group): this group includes 20 patients with pressure ulcers who will receive topical phenytoin with ultrasound in addition to their conventional treatment. phenytoin phonophoresis group (control group): this group will include 20 patients with pressure ulcers who will receive phenytoin with a placebo ultrasound. equipment and tools: measurement equipment: saline injection method. therapeutic equipment: ultrasonic device, topical phenytoin, and hydrogel sheet.

Eligibility criteria:
inclusion criteria: ages range from 40 to 60 years, both genders, patients with pressure ulcers, and patients who will sign their informed consent. exclusion criteria: patients with a history of hypersensitivity to phenytoin, pneumonia, immune deficiency, infection, advanced diabetic patients, radiotherapy in the ulcer area, osteomyelitis in the ulcer area, venous ulcers, burn wounds, leprosy trophic ulcers, traumatic wounds, pregnant subjects, terminally ill subjects, and the use of antineoplastic agents or systemic glucocorticosteroids.

Keywords: phenytoin phonophoresis pressure ulcer
trial of adaptive 18f-fdg-pet biological intensity-modulated radiotherapy (bg-imrt) in patients with head and neck tumor

Conditions: Head and Neck Tumor

Summary: this study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are fdg-avid after two weeks of radiotherapy.


Eligibility criteria:
inclusion criteria: * head and neck tumor * aged \> 18 years
study of 5-fluorouracil (5-fu) in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.

5-fluorouracil (5-fu) has been the most widely used agent in the treatment of early stage and advanced colorectal cancer. traditionally, 5-fu dosing is based on body surface area (bsa). however, bsa-dosing has been associated with a wide range of pharmacokinetic (pk) variability, resulting in marked differences in drug exposure and toxicities in an individual. there is a significant association between the risk of 5-fu-related toxicities and the extent of 5- fu systemic exposure, which can be measured using a well-established pharmacokinetic (pk) assay.

Eligibility criteria:
inclusion criteria: * males or females at least 18 years of age. * histologically confirmed metastatic colorectal cancer eligible for treatment with 5-fu. * no prior therapy for metastatic disease. if adjuvant 5-fu or folfox was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease. * adequate organ function. * eastern cooperative oncology group (ecog) status less than or equal to 2. * life expectancy \> 3 months. exclusion criteria: * untreated brain metastasis. treated brain metastases are allowed as long as symptoms have resolved off of steroids. * at least 4 weeks from any prior surgery or 2 weeks from radiation treatments. * known dihydropyrimidine dehydrogenase (dpd) deficiency.

Keywords: 5-fluorouracil (5-fu) pharmacokinetic assay
community paramedicine at home

Conditions: Cardiovascular Disease; Diabetes Mellitus; Accidental Falls; Social Isolation; Food Insecurity

Summary: community paramedicine @home (cp@home) is a novel community paramedicine health assessment program for high users of emergency medical services (ems). individuals who have been identified as active callers to ems, individuals who have called ems for lift-assists, and direct paramedic referrals are referred into the community paramedicine home visit program. the program will focus on in-home chronic disease management, community health service connections, and ems usage education. aside from chronic disease management, aspects of the program include health-related quality of life, social isolation and other social determinants of health. participants in the program will have up to 3 one-on-one home visits from a community paramedic to ultimately reduce repeat ems calls and improve their overall health.


Eligibility criteria:
inclusion criteria: * 3 or more ems calls in the last 6 months from intervention start date and active caller in the last 30 days or * any call for a lift assist to ems in the past 30 days or * paramedic referral into program (identified by paramedic through usual practice) exclusion criteria: * individuals living in long term care facilities * individuals currently involved in a home visit or social navigator program

Keywords: community paramedicine paramedic emergency medical services high frequency callers lift assists
real-life management of patients eligible for car-t cell therapy

Conditions: Hemopathy

Summary: adoptive immunotherapy using car-t cells is now one of the advanced therapy medicines routinely used for relapsed or refractory lymphoid hemopathies. in 2023, in france, 5 types of car-t cells have marketing authorization for 6 different indications. however, these marketing authorizations are based on clinical trials involving a limited number of selected patients. real-life data are essential for assessing the post-authorization use of these innovative treatments. the french national descar-t registry, promoted by lysarc and in which toulouse university hospital plays an active role, is an international reference for this real-life evaluation. it does not, however, allow precise evaluation of patient-centered indicators and care pathways. with the increasing number of indications and candidate patients, toulouse university hospital, the only healthcare facility authorized in the western occitanie region to administer car-t cells, is faced with growing hospital needs and longer treatment times. in 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the onco-occitanie ouest regional cancer network. the selection of patients for car-t cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), car-t cell care pathways also need to be evaluated in terms of their "quality of life" dimension. the impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the car-t cell treatment pathway. the creation of a registry of patients eligible for car-t cells at toulouse university hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million.

ambispective observational cohort: this observational study is monocentric. for each patient, data will be collected during 5 years.

Eligibility criteria:
inclusion criteria: * patient eligible for car-t treatment for hemopathy at toulouse university hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028 * patient able to understand the purpose and constraints of the research project * patient has read the study information leaflet and does not object to the research. exclusion criteria: * patient under guardianship, curatorship or safeguard of justice * patient objects to the collection of data concerning him/her

Keywords: car-t cells real life care pathways quality of life
precision exercise therapeutics (pet-pilot)

Conditions: Overweight; Healthy

Summary: the aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.

this pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size. 25 participants will be recruited to undergo three sets of experiments. an experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. the exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. a set consists of test-retest of the same experiment. the objectives of this pilot study are 1. to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities 2. to estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout 3. to assess the fidelity of the test- and exercise protocols

Eligibility criteria:
inclusion criteria: * bmi\>25 * age\> 40 years * inactivity, defined as \< 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \< 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak) exclusion criteria: * • hba1c\>53 mmol/mol * uncontrolled hypertension * uncontrolled hyperlipidemia, * known hyperthyroid disease * endocrine disorders causing obesity * known autoimmune disease * unstable cardiovascular disease * glucose lowering medications except for low dose metformin (=\<1000 mg/day) * current treatment with anti-inflammatory medication, unless pain killers without prescription * no participation in other research intervention studies * pregnancy/considering pregnancy within the study period * conditions countering exercise
rice trial: rifaximin in chronic hepatic encephalopathy - a randomized, controlled trial

Conditions: Hepatic Encephalopathy

Summary: the purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: 1. cirrhosis of any cause 2. history of previous admission for acute he within 12 months of screening and conn grade 0-1 he at time of enrollment 3. an institutional review board (irb/ec) approved informed consent is signed and dated prior to any study-related activities being initiated. 4. subject is a male or a non-pregnant and non-lactating female. women of non-childbearing potential or who are practicing adequate birth control are eligible. the investigator is responsible for determining whether the subject has adequate birth control for study participation. 5. subject is ≥18 years of age. 6. subject is capable and willing to comply with all study procedures. 7. if the subject has a history of a portal-systemic shunt, shunt placement or revision must be \>6 months from screening for tips or a surgical shunt. exclusion criteria: 1. subject has a significant medical or psychiatric condition which, in the opinion of the investigator, precludes participation in the study. 2. subject has a history of allergy or intolerance to lactulose. 3. subject has a history of allergy or intolerance to rifampin or rifaximin. 4. subject has participated in an investigational drug or device study within the 30 days prior to study screening. 5. subject is pregnant or is lactating. 6. subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the investigator. 7. subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond he that, in the opinion of the investigator, could impact their performance on neuropsychological assessments and psychometric tests. 8. subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits. 9. subject's current, required medications are on prohibited concurrent medication listing. 10. hemoglobin \< 8.0 at time of screening 11. severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 meq/l, serum calcium greater than 11 mg/dl) at time of screening 12. ongoing gastrointestinal bleeding at time of screening 13. chronic renal insufficiency with a serum creatinine \> 3.0 at time of screening 14. history of tuberculosis infection

Keywords: encephalopathy, hepatic portosystemic encephalopathy encephalopathy, hepatocerebral encephalopathy, portal-systemic encephalopathy, portosystemic hepatic coma hepatic stupor hepatocerebral encephalopathy portal-systemic encephalopathy
study evaluating htc-867 in healthy young and elderly subjects

Conditions: Healthy Subjects

Summary: the purpose of this study is to assess the safety and tolerability of ascending single oral doses of htc-867 in healthy young and elderly subjects. this study will also evaluate the way the drug enters and leaves the blood and tissues over time and how the drug acts on and in the body in a fasted and fed state.


Eligibility criteria:
inclusion: 1. men or women of nonchildbearing potential (woncbp) aged 18 to 50 years or 65 or greater inclusive at screening. woncbp may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone \[fsh\] ≥38 miu/ml) and must have a negative pregnancy test result within 48 hours before administration of study drug. women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration. 2. healthy as determined by the investigator on the basis of screening evaluations. 3. the elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness if it is well controlled and does not interfere with the primary objective of the study. subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead electrocardiograms (ecgs), or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions, so long as those deviations do not meet the stated specific criteria for exclusion exclusion: 1. presence or history of any disorder that may prevent the successful completion of the study. 2. history of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia. 3. history of vertigo.

Keywords: schizophrenia
minoxidil 5% / botanical hair regimen in men with thinning hair and male pattern hair loss/androgenic alopecia

Conditions: Male Pattern of Hair Loss, Androgenic Alopecia

Summary: the purpose of this study is to characterize the effect of minoxidil 5% foam and botanical hair solution regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (norwood iii \& iv).


Eligibility criteria:
key inclusion criteria: 1. male patients age 18 to 60 years at the time of enrollment. 2. men who have self-perceived thinning hair. 3. men who have presentation of male pattern hair loss/androgenic alopecia (norwood iii \& iv). key exclusion criteria: 1. history of allergic reactions or severe intolerance to minoxidil and botanical hair solution product ingredients. 2. plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study. 3 subjects taking or planning to take topical or systemic prescription or otc medications for treating hair loss and/or hair volume. 4. any significant history of concurrent medical disease, which in the judgment of the investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.
cpap to reduce arterial stiffness in non sleepy, moderate to severe obstructive sleep apnea (stiffsleep)

Conditions: Obstructive Sleep Apnea; Vascular Stiffness; Sleep Disorder Daytime Somnolence

Summary: this study intends to determine whether continuous positive airway pressure (cpap) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea .

obstructive sleep apnea (osa) is associated with increased cardiovascular morbidity and mortality. arterial stiffness, evaluated by pulse wave velocity, is related to atherosclerosis and cardiovascular risk. it has been reported that arterial stiffness is higher in patients with osa than in healthy control groups, and it is assumed that it decreases after treatment with cpap. in patients with osa without daytime hypersomnolence it is not clear if cpap has some benefits on cardiovascular events and hypertension. this study aims to evaluate the effect of cpap therapy in an interventional cohort of patients with moderate to severe osa, in which each patient will be is own control, for ethical reasons; the effect of cpap therapy on the subcohorts of sleepy and of nonsleepy patients will be compared. the effect of a three months trial of cpap will be assessed.

Eligibility criteria:
inclusion criteria: * moderate to severe obstructive sleep apnea, defined as apnea/hypopnea index superior to 15 exclusion criteria: * epworth sleep scale superior to 16 * other sleep diseases * moderate or severe lung disease * cardiac disease other than hypertension * cerebrovascular diseases * other vascular diseases * other chronic diseases except metabolic syndrome

Keywords: obstructive sleep apnea arterial stiffness cpap excessive daytime sleepiness pulse wave velocity