Kornimate/medical-research-clean huggingface dataset:
correlations between nutrition and urine spot checks via a urinary self-test

Conditions: Diet, Healthy

Summary: an inclusion consultation carried out by professor gamé at the chu of toulouse (rangueil site) will make it possible to provide the subject with a urinary self-test which automatically carries out and sends the measurement of 10 urinary parameters: ph, density, creatinine, magnesium, calcium, sodium, urea, uric aid, oxalate, citrate. no samples are taken and therefore stored. the data will be processed by irit in order to investigate : * the correlation of the analyses with the context of nutrition and sports activity. * the best recommendation on use (the best time) translated with www.deepl.com/translator (free version)

hypothesis we assume that frequent occasional urinary analyses carried out independently by the subject allow us to identify changes in diet. final objective: we would like to determine: * a strong correlation between the different markers and the nutritional context * the impact of physical activity on this correlation * the most relevant moment of analysis (optimising correlation) in order to define recommendations for use protocol: during the inclusion consultation, professor gamé will provide the subject's self-test, mobile application and user account. the correspondence table between the user account and the data identifying the subject will only be accessible and kept by professor gamé and his team. during this consultation, will be exposed : * the context and objectives of the study * the use of the self-test and its recommendations thus, no samples will be taken and therefore retained. the cartridges are single-use cartridges and will therefore be thrown away by the subject. the reader will be returned to the partner who developed it (innopsys) at the end of the protocol. the subject will have recommendations on the frequency of use which will not be binding and will not have any impact on his participation in the trial. these recommendations will be composed of 2 phases: phase 1: frequency of use: 3x/day for 1 month. phase 2: frequency of free use. this phase will make it possible to observe the level of acceptability of the technology. the subject will provide information on his diet by sending a photo of his meals via the mobile application provided. this will then be analysed by algorithms (or operators if the accuracy of the algorithms is insufficient) to extract the type and quantity of food ingested. throughout the protocol, the subject will be able to send summary data of his or her sporting activities via the web application linked to the project. these data will be : * the number of steps taken * average heart rate * the duration of the effort * the theoretical energy expended the subject may request a consultation with professor gamé during the study in order to have a medical opinion on these results.

Eligibility criteria:
inclusion criteria: - exclusion criteria: chronic disease
a phase i double blind study of metformin acting on endogenous neural progenitor cells in children with multiple sclerosis

Conditions: Multiple Sclerosis (MS)

Summary: a randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. all subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.


Eligibility criteria:
inclusion criteria: * patients with a history of ms with anterior visual pathway involvement and longer than 6 months after presentation with on or an acute demyelinating event/relapse * age 10 year to 25 years and 11 months * latency delay \> 115 milliseconds on baseline full-field transient pattern reversal vep in at least one eye (electrophysiological evidence of demyelination) or \> 10 milliseconds difference between eyes * retinal nerve fiber layer (rnfl) thickness on baseline oct ≥60 µm * stable immunomodulatory therapy - no switch or planned switch in \> 6 months and no change in doses in 30 days prior to screening * no significant renal or liver abnormalities * expanded disability status scale (edss) 0-6.0 (inclusive) * has either english as his or her native language or english comprehension needed to complete the neuropsychological testing * meet criteria for adequate organ function requirements as described below: adequate renal function defined as: creatinine clearance or radioisotope glomerular filtration rate (gfr) \> 70 ml/min/1.73 m2 or serum creatinine based on age/gender as follows: range serum creatinine level (µmol/l): age 5 to \<12 years (male)=25-50, age 5 to \<12 years (female)=25-50; age 12 to \<15 years (male)=37-67, age 12 to \<15 years (female)=37-67; age 15 to \<19 years (male)=51-89, age 15 to \<19 years (female)=40-69; age ≥19 years (male)=58-110; age ≥19 years (male)=46-92 adequate liver function defined as: total bilirubin \< 1.5 x upper limit of normal (uln) for age sgot (ast) or sgpt (alt) \< 1.5 x upper limit of normal (uln) for age exclusion criteria: * a history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders) * severe refractive error (± 6 diopters) * unstable and/or insulin-dependent (type 1) diabetes, metabolic acidosis and/or lactic acidosis * history of unexplained hypoglycemia (\<2.8 mmol/l) * already on metformin * concomitant use of any other putative remyelinating therapy as determined by the principal/qualified investigator * treatment for an acute attack with corticosteroids within 30 days prior to screening / relapse within 30 days prior to screening * concomitant use of insulin * concomitant use of any drugs that are listed to have drug-drug interactions with metformin (i.e. calcium channel blockers, diuretics, etc.) as determined by principal/qualified investigator * lactate levels \> 1.5x upper limit of normal * pregnancy

Keywords: remyelination youth white matter neural precursor cells clinical trial metformin
edoxaban management in diagnostic and therapeutic procedures

Conditions: Atrial Fibrillation; Venous Thromboembolism

Summary: patients receiving novel oral anticoagulation (noacs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. short half-lives and rapid onset of action allow for short periods of noac interruption without heparin bridging. there is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (nvaf) or venous thromboembolism (vte) will be collected in this registry.

patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. the study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (ecrf). patients will be followed for 30 days after the procedure.

Eligibility criteria:
inclusion criteria: * patients taking edoxaban for a therapeutic indication for edoxaban according to smpc including nvaf, dvt or pe * patients with a planned or unplanned diagnostic or therapeutic procedure * written informed consent * availability of patients for follow-up by telephone by the site * no concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) exclusion criteria: * none

Keywords: diagnostic procedures interventional procedures planned or unplanned edoxaban-treated population
nocturnal nasal continuous positive airway pressure in aspiration pneumonia

Conditions: Aspiration Pneumonia

Summary: numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (gerd). previous studies have been demonstrated that continuous positive airway pressure (cpap) is an acceptable means of managing chronic aspiration, atelectasis, and gerd. the purpose of this study is to determine whether nocturnal nasal cpap is beneficial in patients with aspiration pneumonia and that it would contribute to the rapid clinical stability of aspiration pneumonia.


Eligibility criteria:
inclusion criteria: * age ≥ 65 years * diagnosis of pneumonia: the presence of new pulmonary infiltration in dependent areas on chest radiographs at the time of hospitalization with at least one of the following 1. new or increased cough 2. abnormal temperature (\ 37.8℃) 3. abnormal serum leukocyte count (leukocytosis, left shift, or leukopenia) * aspiration tendency or risk factors for frequent or large volume aspiration with at least one of the following 1. altered mental status 2. gastrointestinal disorder 3. dysphagia or swallowing difficulties 4. esophageal motility disorders 5. tracheostomy state 6. enteral tube feeding * informed consent exclusion criteria: * severe hypercapnia (paco2 \> 70mmhg) * respiratory arrest requiring tracheal intubation * cardiac arrest, acute coronary syndrome or life threatening arrhythmias * failure of more than two organs * recent trauma or burns of the neck and face * non- cooperation * pregnancy * withdrawal of consent * refusal of treatment

Keywords: aspiration pneumonia continuous positive airway pressure, cpap
screening for glaucoma in namil area, south korea

Conditions: Glaucoma; Intraocular Pressure; Optic Nerve Head; Visual Field

Summary: the purpose of this study is to study the prevalence of glaucoma in korea, the investigators selected namil area in geumsan city, located in central korea. the residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.

screening includes following examinations; questionaire and consent form, visual acuity test, auto-refraction, iol master measurement, pachymetry, fdt perimetry, fundus photography, slit lamp examination, goldmann applanation tonometry, gonioscopy, and binocular optic disc evaluation. for the cases showing any abnormality in fdt perimetry, optic disc morphology, or intraocular pressure, humphrey automated visual field test is to be performed as an extended examination. finally, optic nerve head evaluation by oct or gdx analyzer is to be used as a confirmation test, as well as additional humphrey visual field test.

Eligibility criteria:
inclusion criteria: * all residents aged over 40 in namil area exclusion criteria: * individuals registered but not actually living in this area

Keywords: prevalence study glaucoma
rtms for the treatment of neuropathic pain in diabetic patients

Conditions: Neuropathic Pain; Diabetic Neuropathies

Summary: tis study aims to assess whether multiple sessions of sham-controlled hf-rtms applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients. this study will also investigate the effect of those rtms sessions on functional connectivity of the m1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fmri, mrs and paired-pulse stimulation respectively in those patients. subjects will be randomized into two groups to receive real or sham rtms protocol. a washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli. one daily rtms session for 5 days of hf-rtms, will be delivered through an h-coil applied to the primary motor area of the leg. each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 hz at 100% of resting motor threshold (rmt), with an intertrain interval of 30s


Eligibility criteria:
inclusion criteria: * written informed consent to participate in this study is obtained * the subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2 * the patient has laboratory-confirmed diabetes * patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings * a score of \> /= 4 on the the 'douleur neuropathique en 4 questions' (dn4) questionnaire (30), conforming the diagnosis of neuropathic pain. * the patient has a painful diabetic neuropathy for at least 6 months * the patient has a numeric pain rating scale (nprs) score \>/= 4. * the patient is resistant to standard therapies for neuropathic pain exclusion criteria: * the patient has an implanted cardiac device, such as a pacemaker or a defibrillator * the patient has an implanted neurostimulator * the patient has cochlear implants/ear implants, magnetic dental im-plants * the patient has a drug infusion pump * the patient has cerebral artery aneurysm clips * the patient has a history of epilepsy * the patient has a history of migraine or severe headaches * the patient has significant psychiatric disorders * for female patients: the subject is pregnant or lactating * other formal contra-indication for rtms or mri
staar visian toric icl post-approval study

Conditions: Myopic Astigmatism

Summary: the objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the visian® toric implantable collamer® lens (icl).

this study will be conducted at 6-8 clinical sites in the us, by surgeons qualified by experience and training to implant visian toric icls.

Eligibility criteria:
inclusion criteria: * moderate to high myopia with astigmatism correctable with available ticl powers. * stable refractive history within 0.50 d each cylinder and spherical equivalent (se) for 1 year prior to implantation. * able and willing to return for scheduled follow-up examinations after surgery. * able to read, understand and provide written informed consent on the institutional review board (irb)-approved informed consent form (icf) and provide authorization as appropriate for local privacy regulations. * other protocol-specified inclusion criteria may apply. exclusion criteria: * insulin-dependent diabetes or diabetic retinopathy. * history of previous ocular surgery. * cataract of any grade. * monocular. * pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study. * other protocol-specified exclusion criteria may apply.

Keywords: nearsightedness phakic iol toric icl ticl tmicl visian astigmatism
effect of perioperative roxadustat in elective lumbar interbody fusion surgery.

Conditions: Perioperative Anemia

Summary: the goal of this clinical trial is to assess whether roxadustat can reduce perioperative blood transfusions in patients with anemia undergoing elective lumbar interbody fusion surgery. it will also evaluate the safety of roxadustat in this context. the main questions it aims to answer are: * does roxadustat reduce the need for perioperative red blood cell transfusions? * is roxadustat safe for use in patients during the perioperative period? researchers will compare roxadustat to standard clinical care without roxadustat to determine its effectiveness and safety. participants will: * take roxadustat orally three times a week for three weeks (two weeks before surgery and one week post-surgery). * undergo regular blood tests and follow-up monitoring during the hospital stay and up to 6 months after surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years, no upper age limit, sex unrestricted. * scheduled for elective lumbar interbody fusion surgery. * diagnosed with anemia (hemoglobin levels: male \<130g/l, female \<120g/l). * willing to participate and able to voluntarily sign an informed consent form. exclusion criteria: * patients admitted on an emergency basis. * patients with moderate to severe anemia (hemoglobin levels \<90g/l). * patients already enrolled in another clinical study. * patients unable to comply with the study protocol due to cognitive or language barriers. * pregnant or breastfeeding women. * patients who have already received erythropoiesis-stimulating agents, iron supplements, or other treatments to increase hemoglobin levels. * patients with severe infections. * patients with a history of acute coronary syndrome, heart failure, or cerebrovascular events within the last 3 months. * any other medical condition that may pose a safety risk, confound efficacy or safety evaluations, or interfere with study participation.

Keywords: anemia roxadustat transfusion surgery
prevalence of psychiatric disorders in the refugee population of turkey

Conditions: Psychiatric Disorder

Summary: the investigators are planning to diagnose psychiatric disorders in willing participants from the refugee population in turkey.


Eligibility criteria:
inclusion criteria: * having official refugee status in turkey, willing to participate in the study exclusion criteria: * having any disability that prevents answering interviewers' questions
an explorative study of afatinib in the treatment of advanced cancer carrying an egfr, a her2 or a her3 mutation

Conditions: Cancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation

Summary: objective(s):to investigate the efficacy and safety of afatinib in egfr, her 2 and her3 mutated cancers, regardless of cancer type, excluding egfr mutated non-small cell lung cancer. methodology:open label, genomic driven trial (basket trial) no. of patients total entered:optimal simon two stage design for the three genetic driven cohorts: 10 patients will be enrolled per cancer type in the first stage and an additional 19 in the second stage (maximum total 87 patients) indication : cancers harbouring an egfr mutation(excluding non-squamous non- small cell lung cancer, a registered indication), a her2 mutation or a her3 mutation test product(s) : afatinib at progression paclitaxel will be added for those patients that have no contra-indications dose: starting dose of afatinib at 40 mg/day. dose increase to 50 mg in the absence of adverse events. stepwise dose reduction to 30,20, 10 mg/day according to drug-related adverse events. at progression, addition of paclitaxel 80 mg/m2 weekly 3w/4 to afatinib 40 mg/day . mode of admin. : oral for afatinib intravenous for paclitaxel duration of treatment: continuous treatment until progression or unacceptable adverse events or withdrawal of consent. at disease progression, add paclitaxel until progression or unacceptable adverse event or withdrawal of consent if no contra-indications. criteria for efficacy: primary endpoint: • response rate (cr+ pr) via recist v1.1 secondary endpoints: * disease control rate (cr+pr+sd) * progression free survival * overall survival * to correlate tumor response with findings on tumor biopsies * to investigate resistance mechanisms * response rate (cr+ pr) determined by recist and progression free survival on the combination therapy of afatinib and paclitaxel criteria for safety: incidence and intensity of adverse events according ctcae v4.0


Eligibility criteria:
inclusion criteria: * women and men with locally advanced or metastatic cancers harboring either an activating egfr mutation or a her2 mutation or a her3 mutation * failure of at least one line of standard systemic therapy * no eligibility for other open genomic driven phase i, ii or iii trial available for these tumor genotypes * ecog performance status ≤2 * patient with a life expectancy \>3 months * patients able to provide written informed consent prior to enrollment into the clinical trial. * adequate organ function exclusion criteria: * non squamous non-small cell lung cancer harbouring an egfr mutation (registered indication) * chemotherapy, biological therapy or investigational agents within four weeks prior to the start of study treatment * known hypersensitivity to afatinib or the excipients of any of the trial drugs * prior treatment with afatinib
a study of a novel iron-based phosphate binder ap301 in patients with hyperphosphatemia in the u.s. and china

Conditions: Hyperphosphatemia; Chronic Kidney Disease, Receiving Dialysis; ESRD (End-Stage Renal Disease); Dialysis

Summary: the goal of this clinical trial is to learn if ap301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. the main questions it aims to answer are: * does ap301 lower blood phosphate levels? * does ap301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * what discomfort or medical problem do the patients have when taking ap301? * does ap301 improve quality of life in chinese patients? the researchers will compare ap301 to an ineffective comparator (a look-alike substance that contains low dose ap301) to see if ap301 works to treat elevated blood phosphate. in the study, the patients will experience the following stages in a chronicle order: * stop all using blood phosphate-lowering drugs, * take ap301 or the comparator three times a day for 8 weeks, * take ap301 three times a day for 24 weeks, and * take ap301 or the comparator three times a day for 3 weeks. in the first 32 weeks, the dose of ap301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. if the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.


Eligibility criteria:
key inclusion criteria: * provision of signed and dated icf * adult when signing the icf * patients on dialysis for ≥ 3 months before signing the icf and throughout the study * for hd patients, spkt/v ≥ 1.2; for pd patients, total kt/v ≥ 1.7/week * patients who receive phosphate binders over 4 weeks and their serum phosphate level is: 1. screening: 1.13 mmol/l (3.5 mg/dl) ≤ serum phosphate \< 2.58 mmol/l (8.0 mg/dl) 2. after washout: 1.94 mmol/l (6.0 mg/dl) ≤ serum phosphate \< 3.23 mmol/l (10.0 mg/dl) key exclusion criteria: * history or plan of kidney transplantation * history or plan of parathyroid intervention 6 months before signing the icf * serum calcium \ 2.75 mmol/l (11 mg/dl) at screening * serum intact parathyroid hormone \> 127 pmol/l (1200 pg/ml) at screening * presence of clinically significant gastrointestinal (gi) disorder * history of gastrectomy or duodenectomy, or gi surgery within 3 months before signing the icf * known allergic to any ingredient of ap301, or known history of severe allergies leading to emergency medical care * female who are breastfeeding

Keywords: hyperphosphatemia ap301 dialysis eskd