Kornimate/medical-research-clean huggingface dataset:
a phase1 study to explore the safety of eos789 in patients with chronic kidney disease and hyperphosphatemia on hemodialysis

Conditions: Hyperphosphatemia

Summary: this study is a randomized study designed as a 2x2 cross-over in two periods (period 1 and period 2) to assess the safety, pharmacokinetics (pk), pharmacodynamics (pd), and efficacy of eos789 in patients with chronic kidney disease (ckd) and hyperphosphatemia receiving hemodialysis. period 1 is double-blind and period 2 is open-label. period 1 and period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. eos789 and its combination with sevelamer carbonate are tested in period 1 and period 2 respectively.


Eligibility criteria:
inclusion criteria: - patients with ckd and hyperphosphatemia must meet the following criteria for study entry: * age ≥18 years * on thrice-weekly hemodialysis for at least 3 months prior to screening * not having changed dialysis prescription within 4 weeks prior to screening for dialyzer, calcium concentration in dialysate, or dry weight more than 1 kg * receiving stable doses of treatments affecting serum phosphorus for at least 4 weeks prior to screening and willing to discontinue these treatments exclusion criteria: - patients with ckd and hyperphosphatemia who meet any of the following criteria will be excluded from study entry: * uncontrolled diabetes and/or hypertension in the opinion of the investigators * uncontrolled chronic constipation and/or diarrhea in the opinion of the investigators * hospitalization for cardiac disease in previous 3 months * evidence of acute or chronic hepatitis or known liver cirrhosis * aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \>2.5 x upper limit of normal (uln)
four versus six cycles of pemetrexed/platinum for mpm

Conditions: Malignant Pleural Mesothelioma

Summary: the prognosis of mesothelioma is generally poor. the median survival of patients with unresectable malignant mesothelioma ranges approximately between 6-12 months. survival is poor because there is no curative treatment. treatment options include surgery, chemotherapy and radiotherapy. recently multimodality treatment regimens have been reported to prolong survival. other new therapeutic approaches include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and photodynamic therapy, but the results have not yet been completely validated. even with the introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean survival of 12 months. the current standard of care for unresectable malignant pleural mesothelioma is pemetrexed/cisplatin. this regimen was compared to cisplatin alone in a study including 448 patients from 19 countries which was the largest trial to date among patients suffering from malignant mesothelioma. results showed statistically significant increase in overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for cisplatin alone. in addition, there was an improvement in lung function (forced vital capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm. until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in malignant mesothelioma and there are no approved predictive markers for response. pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable toxicity and so we need to rationalize its use in our egyptian patients. therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for response.


Eligibility criteria:
inclusion criteria: 1. histologic or cytologic diagnosis of malignant pleural mesothelioma 2. no prior chemotherapy. 3. ecog less than or equal to 2 . 4. measurable disease according to the requirements of swog criteria. 5. age ≥ 18 years . 6. estimated life expectancy of at least 12 weeks . 7. adequate bone marrow reserve (white blood cells \[wbc\] ≥ 3.5 × 109 /l, neutrophils ≥ 1.5 × 109 /l, platelets ≥ 100 × 109 /l, and hemoglobin ≥ 9.0 gm/dl). exclusion criteria: 1. presence of central nervous system metastases. 2. inadequate liver function (bilirubin \> 1.5 times upper normal limit \[unl\] and alanine transaminase \[alt\] or aspartate transaminase \[ast\] \> 3.0 unl or up to 5.0 unl in the presence of hepatic metastases). 3. inadequate renal function (creatinine \> 1.25 times unl, creatinine clearance \< 50ml/min). 4. serious concomitant systemic disorder incompatible with the study. 5. second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, t1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence). 6. pregnancy

Keywords: mpm
to develop a walking exercise program for non-ambulatory stroke survivors

Conditions: Stroke; Walking, Difficulty; Cardiovascular Injury

Summary: the goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. the main question it aims to answer is: • will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise? participants will walk on a treadmill with a partial body-weight support system and the gait training device. researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (sbp), and a1c levels in the blood.

stroke is a leading cause of death and permanent disability. about 795,000 strokes occur in the us each year and more than seven million americans are living with effects of stroke. cardiovascular diseases are commonly presented and are primary causes of death in stroke survivors. numerous studies have proven the benefits of walking or other forms of aerobic exercise for cardiovascular and pulmonary function in people after stroke. this proposed randomized controlled efficacy trial will primarily examine whether the investigators' gait training can improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise. the investigators have recently developed a novel gait training device and a training program. the experimental group in the proposed project will undergo an 8-week gait training program using a treadmill with body-weight support and the investigators' novel gait training device. the control group will receive an 8-week sitting leg cycling exercise program with similar exercise intensity, frequency, and duration. the proposed project will examine differences between the two groups using a set of comprehensive outcome assessments of cardiovascular, pulmonary, and sensorimotor functions.

Eligibility criteria:
inclusion criteria: * must be 18 to 80 years old * male or female * independent ambulation before stroke * able to understand and follow verbal commands in english * have physicians' approval for exercise * be in a stable medical condition * must be after the first stroke * unable to walk independently * in the chronic stage (at least 6 months after stroke onset) exclusion criteria: * musculoskeletal or other disorders that prevent the participant from participating in the exercise * blood pressure higher than 200/110 mm hg * diagnosis of severe depression * functionally restricted passive movement in the major joints of lower limbs * unable to speak or understand english * unable to travel to the research laboratory * currently participate in other walking training using treadmill with or without a body-weight support system * body weight greater than 400 lbs

Keywords: stroke unable to walk
a study versus e2020 10mg followed by an open-label extension phase to explore the safety of e2020 sr 23 mg in japanese subjects with severe alzheimer's type dementia

Conditions: Alzheimer's Type Dementia

Summary: the purpose of this study is to compare 23 mg donepezil sustained release (sr) to the currently marketed formulation of 10 mg donepezil immediate release (ir) in patients with severe alzheimer's disease.


Eligibility criteria:
inclusion criteria * diagnostic evidence of probable alzheimer's disease (ad) consistent with the diagnostic and statistical manual for mental disorders-version iv (dsm-iv) * hachinski ischemic score * functional assessment staging (fast) scale greater than or equal to 6 at screening. * mini-mental state examination (mmse) score of 1 to 12 at screening * subjects who are on a stable aricept- dose of 10 mg immediate release (ir), taken as a single, daily dose for 3 months prior to the screening visit * evidence consistent with alzheimer's disease (ad) on any cranial image on magnetic resonance imaging (mri) or computed tomography (ct) scan or etc. obtained within 24 months prior to the screening visit. subjects who have any observations of dementia other than alzheimer's type after the last image diagnosis should be reconfirmed. * age 50 years * written informed consent is to have been obtained from the subject (if possible) or from the subject's legal guardian or other representative exclusion criteria * subjects with dementia other than alzheimer's type * subjects with significant neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, a history of head injury with loss of consciousness, or a history of brain surgery followed by persistent deficits * subjects with allergy to donepezil hydrochloride or piperidine derivatives * subjects with a cause of alzheimer's disease (ad) which is supported by any laboratory tests such as vitamin b12, folate levels, triiodothyronine, free triiodothyronine, thyroxine, thyroid stimulating hormone (tsh) or serologic test for syphilis

Keywords: alzheimer disease dementia delirium amnestic cognitive disorders donepezil brain diseases central nervous system diseases nervous system diseases tauopathies neurodegenerative diseases mental disorders cholinesterase inhibitors enzy
contribution of narrow band imaging (nbi) for the characterization of scalloped polyps (nbi polypes coliques)

Conditions: Polyps of Colon

Summary: this prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in nbi (narrow band imaging) in patients with screening colonoscopy. the nbi is a so-called "virtual" electronic staining technique available on conventional olympus endoscopes without additional intervention. the colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in nbi for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie nice classification for adenomatous polyps and wasp classification for festooned polyps).


Eligibility criteria:
pre-inclusion criteria: * major patient with a colonoscopy scheduled in one of the participating hospitals (chd vendée and chu nantes). * patient who agreed to participate in the study and gave his express consent * patient affiliated with a social security system or beneficiary of a scheme inclusion criteria: * patient with 1 or more polyps less than 20 mm observed during colonoscopy exclusion criteria: * patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms * patient with chronic inflammatory bowel disease (ibd): crohn's disease or unclassified colitis * patient with familial adenomatous polyposis * pregnant or lactating woman * minor patient * major patient under tutorship, curatorship, or deprived of liberty * patient unable to understand protocol and / or give express consent * patient not affiliated with a social security system or beneficiary of such a scheme * patient hospitalized or treated without their consent
metformin use in chronic kidney disease: the ckd-met study

Conditions: Type 2 Diabetes; Chronic Kidney Disease

Summary: metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit. yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (ckd) patients. the aim of the study is to describe the use and side-effects of metformin in ckd patients in routine practice.


Eligibility criteria:
inclusion criteria: * 18 years old or more * type 2 diabetes * seen by a nephrologist (consultation or hospitalization) between march 2014 and march 2020 in the department of nephrology, lyon sud university hospital, france exclusion criteria: * on-going treatment by dialysis * kidney transplantation * type 1 diabetes * missing data (metformin treatment)

Keywords: metformin type 2 diabetes chronic kidney disease antidiabetic medications lactic acidosis
exercise training in dialysis patients with restless legs syndrome (rls)

Conditions: Restless Legs Syndrome; End Stage Renal Disease; Hemodialysis; Muscle Cachexia; Sleep Disorders

Summary: uremic etiology restless legs syndrome (rls) has been associated with poorer quality of life (qol) compared to rls-free counterparts mainly due to sleep deprivation factors. exercise training in hemodialysis (hd) patients with rls has been proven to be a safe approach in temporally ameliorating rls symptoms similarly to the use of pharmacological treatment with dopamine agonists. however it not known whether the exercise anabolic stimulus and the dopamine agonist treatment could act synergistically for the improvement of physical functioning and muscle performance as well as in the amelioration of augmentation symptoms in hemodialysis patients with rls.

this is a randomized, placebo-controlled study to evaluate the acute and long term (6 months) effect of exercise training in combination with dopamine agonists in quality of life, muscle function, sleep quality and metabolism in patients with restless legs syndrome (rls) receiving dialysis therapy. objectives - aims: 1. to investigate whether a single bout of intradialytic exercise session could have an effect in motor restlessness often seen during hemodialysis session in patients with rls 2. to investigate whether a 24 weeks therapy with dopamine agonist or placebo will have an effect in sleep quality, functional capacity and metabolic profile of the hemodialysis patients with rls 3. to examine whether dopamine agonists or placebo and aerobic intradialytic exercise act synergistically for the improvement of physical functioning and muscle performance as well as it could reduce the signs of augmentation in hemodialysis patients with rls

Eligibility criteria:
inclusion criteria: * clinically stable hemodialysis patients with positive diagnosis in irlss questionnaire for the rls will be eligible to participate. entry criteria included being on chronic hemodialysis for six months, able to perform an exercise training, with dialysis delivery (kt/v) \> 1.1. exclusion criteria: * patients were excluded from the study if they were diagnosed with neuropathies or reasons for being in a catabolic state (including malignancies, hiv and opportunistic infections, active inflammation), within 3 months prior to the start of the study. in addition patients treated with drugs recommended for the treatment of rls as well as patients with parkinson's disease or untreated depression will be also excluded.

Keywords: rls muscle dialysis exercise dopamine agonist sleep
effect of different feeding modes in intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: this was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with intracerebral hemorrhage.the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage. the main questions it aims to answer are: compared to nasogastric tube feeding, can the intermittent oro-esophageal tube feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of patients with intracerebral hemorrhage compared to nasogastric tube feeding, is the intermittent oro-esophageal tube feeding safer. participants will be divided into two groups randomly, with different nutritional support respectively.

safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. nasogastric tube feeding has been the mainstay in china but has a significant risk of adverse events. intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace nasogastric tube feeding. this study reports the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy. however, in the field of intracerebral hemorrhage combined with tracheostomy, research on intermittent oro-esophageal tube feeding is still relatively limited. therefore, this study was carried out to explore the clinical effect of intermittent oro-esophageal tube feeding vs. nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for intracerebral hemorrhage. * with placement of a tracheotomy tube. * requiring enteral nutrition support. * age over 18 years. * able to cooperate with treatment and questionnaire investigation. exclusion criteria: * combined with tumors in the head, neck, esophagus, or gastrointestinal tract * an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus * with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys * with severe hemorrhagic disease or bleeding tendency; * with contraindications for enteral nutrition * with dysphagia caused by non-stroke-related reasons in the past
stem cells tratment for the local feminine stress urinary incontinence treatment (hulpuro)

Conditions: Urinary Incontinence

Summary: evaluate the feasability and security of the autologous asc for the femenine stress urinary incontinence

evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

Eligibility criteria:
inclusion criteria: 1. -signed informed consen 2. -good general state of health according to the findings of ythe clinical history and the physical examination 3. -postmenopausal or over 18 years old women taking highly effective contraceptives following the ich (m3) ema guide 4. -women having rejected de rehabilitation treatment or in which the treatment had failed 5. -genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution exclusion criteria: 1. -pregnant or lactating women 2. -active urine infection 3. -presenting an infravesical obstruction 4. -alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion 5. -presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years 6. -cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study 7. -any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study 8. -subjects with congenital or aquired inmunodeficiencies, b and/or c hepatitis, tuberculose or treponema diagnosed at the moment of inclusion 9. -anesthesic allergy 10. -major surgery or severe trauma in the previous 6 months 11. -administration of any drug under experimentation in the present or 3 months before recruitement

Keywords: feminine stress urinary incontinence autologous expanded stem cells
aerobic exercise as add-on treatment for inpatients with depression

Conditions: Depression

Summary: the aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (hpa-axis), brain-derived neurotrophic factor (bdnf) and heartrate variability (hrv). amendment 1 (nov. 2016): additional evaluation of tnf-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples.

patients are randomly assigned to the intervention group (ig) or control group (cg). the ig will train three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. the exercise will take place under supervision. cg will absolve a basic stretching and mobilisation program 3 times per week, also under supervision for 6 consecutive weeks. at the end of every week physical fitness is evaluated by the queens step test. no other activities with moderate or high intensity are allowed throughout the intervention time. all patients will participate in the multimodal treatment program of the depression ward, which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy and ergotherapy.

Eligibility criteria:
inclusion criteria: * inpatient treatment on the depression ward * international classification of diseases (icd)-10: f32, f33 or f31 * hdrs-17\>16 points * written informed consent exclusion criteria: * any physical condition that prohibits endurance exercise * 3 or more cardiovascular risk factors (hypertonia, family history, smoking, hypertriglyceridemia, diabetes) * pathological ecg * bmi \> 35 kg/m2 * pregnancy * acute suicidal ideation * comorbid substance dependence (except nicotine) * major comorbid psychiatric disorder * regular high intensity exercise prior to treatment