Kornimate/medical-research-clean huggingface dataset:
tolerability and safety and health outcomes in relapsing multiple sclerosis (ms) patients

Conditions: Relapsing Multiple Sclerosis

Summary: this study will assess tolerability and safety and health outcomes in relapsing ms patients taking fty720.


Eligibility criteria:
inclusion criteria: * 18-65 years of age, must have relapsing ms exclusion criteria: * patients with a type of ms that is not relapsing * patients with history of chronic immune disease * patients with a history of certain cancers * diabetic patients with certain eye disorders * patients who are on certain immunosuppressive medications or heart medications * patients with certain heart conditions * patients with certain lung conditions other protocol-defined inclusion/exclusion criteria may apply.

Keywords: relapsing multiple sclerosis ms safety tolerability health outcomes
management of fragments during ureteroscopy

Conditions: Urinary Stones

Summary: the purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.


Eligibility criteria:
inclusion criteria: * patient with ureteral stones suitable for endoscopic treatment exclusion criteria: * presence of ipsilateral kidney stones * known ureteral stricture * previous placement of ureteral stent * use of drugs with known activity on smooth ureteral muscle * unwillingness or impossibility to return for follow-up
prevalence and associated factors of sarcopenia among elderly patients in osteoporosis clinic

Conditions: Sarcopenia; Osteoporosis

Summary: this was a cross-sectional study. patients who attended the osteoporosis clinic of kowloon hospital from june to december 2022 were recruited. grip strength and appendicular skeletal muscle mass index were measured with a jamar dynamometer and a bioimpedance analyser. since most patients in our clinic are of chinese ethnicity, the diagnostic criteria in the consensus update on sarcopenia diagnosis and treatment by the asian working group for sarcopenia in 2019 was utilised. the diagnosis of sarcopenia was established by the presence of both low grip strength (male: \< 28 kg, female \< 18 kg) and low appendicular skeletal mass (male: \< 7.0 kg/m2, female: \< 5.7 kg/m2)


Eligibility criteria:
inclusion criteria: * patients aged 60 years old or above * diagnosed with osteoporosis by: fragility fracture or t-score ≤-2.5 sds at any site on dxa scan and; * able to read and write chinese exclusion criteria: * unable to maintain standing posture for bioimpedance analysis * modified functional ambulation classification (mfac) ≤ iv * incompetent in giving consent * unable to follow instructions * implanted with metal in any of four limbs * implanted with pacemaker, implantable cardioverter defibrillator or any other types of electrical device

Keywords: osteosarcopenia sarcopenia osteoporosis geriatric medicine
weekly gemcitabine, epirubicin, and docetaxel in locally advanced or inflammatory breast cancer

Conditions: Breast Cancer

Summary: treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. the aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

upon determination of eligibility, all patients will be receive: gemcitabine + epirubicin + docetaxel

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * adenocarcinoma of the breast confirmed by biopsy * female patients \>18 years of age * normal cardiac function * ability to perform activities of daily living with minimal assistance * chemotherapy naïve or have received prior chemotherapy \> 5 years ago * adequate bone marrow, liver and kidney function * be informed of the investigational nature of this study * sign an informed consent form * sentinel lymph node and/or axillary dissection prior to enrollment exclusion criteria: you cannot participate in this study if any of the following apply to you: * life expectancy of \< than 6 months * history of significant heart disease * prior chemotherapy or hormonal therapy * concurrent trastuzumab therapy * history of significant psychiatric disorders * history of active uncontrolled infection please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
bowel preparation by face-to-face re-education on the day of colonoscopy for outpatient: a rct

Conditions: Bowel Preparation

Summary: the study compares the efficacy of bowel preparation between the face-to-face re-education(ffre group) and normal education (no-ffre group) in patients.

despite advances in bowel preparation methods,bowel preparation is inadequate in up to one-third of all colonoscopies in reported series.inadequate bowel cleansing results in negative consequences for the examination, including incomplete visualisation of the colon, missed lesions, procedural difficulties, prolonged procedure time and reduced time interval until follow-up, and an estimated 12-22% increase in overall colonoscopy cost. the adequacy of a bowel preparation is closely linked to patient compliance with both dietary and purge instructions.one study performed in asia showed that non-compliance with bowel preparation instructions, lower education level, and a long wait for the colonoscopy appointment were independent risk factors for poor bowel preparation. another study performed in china showed that telephone re-education（tre) about the details of bowel preparation on the day before colonoscopy significantly improved the quality of bowel preparation and pdr. so,it is reasonable to hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation. the study compares the efficacy of bowel preparation between the face-to-face re-education (ffre group) and telephone re-education (tre group) in patients.

Eligibility criteria:
inclusion criteria: * outpatients aged 18-80 years undergoing colonoscopy who had provided written informed consent exclusion criteria: * history of colorectal surgery * severe colonic stricture or obstructing tumour * dysphagia * compromised swallowing reflex or mental status * significant gastroparesis or gastric outlet obstruction or ileus * known or suspected bowel obstruction or perforation * severe chronic renal failure (creatinine clearance\<30 ml/min) * severe congestive heart failure (new york heart association class iii or iv) * uncontrolled hypertension (systolic blood pressure\>170 mm hg, diastolic blood pressure\>100 mm hg) * toxic colitis or megacolon * dehydration * disturbance of electrolytes * pregnancy or lactation * unable to give informed consent * haemodynamically unstable

Keywords: bowel preparation polyethylene glycol face-to-face re-education telephone re-education boston bowel preparation scale
impact of the "kid'em app" digital guidance tool for setting rehabilitation goals by the rehabilitation professional for children with chronic conditions impacting physical health (read'app't)

Conditions: Children with Chronic Illnesses Affecting Physical Health

Summary: on an individual level, the first expected benefit for the child using the "kid'em app" would be an improvement in the quality of his or her rehabilitation goals, which would be more specific, measurable, activity-related, realistic and time-defined (smart). a second expected benefit for the child, thanks to the work carried out in rehabilitation sessions on objectives adapted to his or her needs and day-to-day life, encouraging commitment and motivation, would be to improve the effectiveness of the care offered to him or her, thereby enhancing autonomy and physical health. for parents, taking part in goal-setting, by contributing their knowledge of their child and his or her daily life, would increase their involvement in their child's care and improve their satisfaction with the care offered. by setting smart functional goals and facilitating communication between therapist, child and family, we expect to see a more child- and family-centred approach to care. on a collective level, the "kid'em app" proposal would, as recommended by the who, improve professional rehabilitation practices and facilitate convergence towards good clinical practices for professionals (physiotherapists, occupational therapists, prms, etc.), thereby increasing the efficiency of the child rehabilitation care system. if its value is demonstrated, the kid'em app could be adapted for children with other chronic illnesses requiring non-motor rehabilitation follow-up. the digitization of this goal-setting tool means that this low-cost practice could be widely disseminated.


Eligibility criteria:
inclusion criteria: * children with chronic illnesses affecting their physical health (e.g. cerebral palsy, neuromuscular disease, brachial plexus paralysis, etc.). * children receiving rehabilitation care to promote autonomy and physical health. * child with at least one rehabilitation session/week with the same professional for a period of 3 months * children aged 5 to 17 wishing to participate in the study * parental consent for study participation and signature of consent form exclusion criteria: * children without chronic illnesses that do not affect their physical health * children unable to express their views and priorities * children unable to collaborate with the rehabilitation professional when using the kid'em app * children already familiar with the "kid'em app" product * children whose parents are minors or unable to give informed consent

Keywords: chronic disease children
randomized controlled trial of higher-volume feedings in preterm neonates

Conditions: Infant Premature

Summary: the primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day

the proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (pma)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). this is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.

Eligibility criteria:
inclusion criteria: * inborn or outborn infants born at a gestational age of 32 weeks or less; birthweight 1001-2500; feeding volume of at least 120 ml/kg/day; enrolled prior to 28 days of age and prior to exceeding 32 weeks exclusion criteria: * hemodynamically significant patent ductus arteriosis; history of necrotizing enterocolitis bell stage ii or greater; known gastrointestinal or neurologic malformations; prior or planned enrollment into the nichd milk trial; terminal illness or decision to withhold or limit support

Keywords: nutritional support
living conditions and breast cancer

Conditions: Breast Neoplasms

Summary: the main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score spice (2 groups: precarious and insecure) and stage at diagnosis (2 groups: cas: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).

our secondary objectives include: * to study the link between cancer stage at diagnosis and diverse parameters describing living conditions * to construct a new score for social fragility based on new data collected in this study, and to compare this score with the epices score * to study patient quality of life at study baseline

Eligibility criteria:
inclusion criteria (for cases): * patient has been correctly informed about the study, and agrees to participate * the patient must be insured or beneficiary of a health insurance plan * incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage iii-iv, surgical cases inclusion criteria (for controls): * patient has been correctly informed about the study, and agrees to participate * the patient must be insured or beneficiary of a health insurance plan * incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage i-ii, surgical cases exclusion criteria (for cases and controls): * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient is pregnant, parturient, or breastfeeding * the patient is opposed to study participation * women not able to answer a questionnaire due to language barriers or due to vascular or degenerative cerebral dysfunction * it is impossible to correctly inform the patient

Keywords: breast cancer living conditions social fragility
study to evaluate the efficacy and tolerability of apevinat bc compared to vitamin complex

Conditions: Lack of Appetite; Anorexia

Summary: the purpose of this study is to evaluate the efficacy and tolerability of apevinat bc compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of b and c vitamins.

apevinat bc presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin b complex and c, in balanced amounts. this combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. for the anorexic patients that are common b and c hypovitaminosis, the use of apevinat bc will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with b and c vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic. the current study will compare the efficacy and tolerability of apevinat bc to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and b and c hypovitaminosis.

Eligibility criteria:
inclusion criteria: * patients who presents lack of appetite; * wash out 20 days after ingestion before similar drug; * responsible for the least able to understand and maintain their adherence to protocol; * patients of all ethnic groups of both sexes, aged 7-14 years; * responsible for the minor must consent to participate in the same study, through the signing of consentiment term; * responsible for the minor should be able to understand the proper use of medication; exclusion criteria: * patients with parasitic infections; * patients with angle closure glaucoma or open; * patients with a predisposition to urinary retention; * patients with peptic ulcer or stenotic pylorus-duodenal obstruction; * debilitated patients or in acute asthma attack; * patients who have poor appetite caused by any serious illness; * patients who are taking any medications that depress the central nervous system; * patients who take medication monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazine, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotrophin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, primidone, salicylates; * patients with known hypersensitivity to any components of the formula; * patients who are participating in another clinical trial; * inability to compliance with the protocol; * any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.

Keywords: phase iii apevinat bc lack of appetite
a real-world evidence (rwe) long-term follow-up study to assess outcomes of alcon monofocal intraocular lenses

Conditions: Aphakia

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to describe the long-term safety and performance of acrysof single-piece and acrysof multi-piece monofocal intraocular lenses (iols).

the study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Eligibility criteria:
key inclusion criteria: * subject is implanted with one of the study iol models between 3 and 5 years previously. * subject follow-up is expected to be possible during the duration of the study. * subject or legally authorized representative must be able to understand and sign the irb/ec approved informed consent form. minor subjects will complete an assent form. * documented medical history and required pre-operative baseline information is available for retrospective data collection. key exclusion criteria: * subject is participating in a separate investigational drug or device study. * pregnancy at the time of enrollment.

Keywords: intraocular lens cataract
epithelial dysmetabolism and renal fibrosis in anca vasculitis

Conditions: ANCA Associated Vasculitis; Extramembranous Glomerulopathy; Nephrotic Syndrome, Minimal Change; Interstitial Nephritis; IgA Nephropathy; Segmental Hyalinosis; Diabetic Nephropathies

Summary: the project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.

patients with anca vasculitis with rapidly progressive glomerulonephritis with "crescent" will be compared to six other groups made up of patients with another nephropathy 1/extramembranous glomerulonephritis and 2/ nephropathy with minimal glomerular lesion (lgm) characterized by the absence of significant tubulointerstitial fibrosis lesions and slow evolution towards end-stage chronic renal failure ). other groups of patients will 3/have interstitial nephropathy, 4/iga mesangial glomerulopathy , 5/diabetic nephropathy, or 6/collapsing focal segmental hyalinosis.

Eligibility criteria:
inclusion criteria: * patients with an indication for initial diagnostic pbr on native kidney * 18 ans ≥ age ≤ 90 ans * affiliation to french health insurance * patient having given consent for the anca vasculitis group: • diagnosis of anca vasculitis retained on renal biopsy with anca anti-proteinase 3 (pr3) or anca anti-myeloperoxidase (mpo) for the control groups: • diagnosis retained after the renal biopsy * interstitial nephritis * or glomerular nephropathy such as minimal change nephropathy * or segmental hyalinosis in itscollapsing form * or extramembranous glomerulopathy, * or glomerulopathy with mesangial iga deposits * or diabetic nephropathy. exclusion criteria: * kidney transplant patient * patient on dialysis (hemodialysis or peritoneal dialysis) * patient under legal protection, guardianship or curatorship * pregnancy or breastfeeding * enrollement in an interventional study except studies relating to anca vasculitis and nephropathy with mesangial iga deposits.

Keywords: nephropathy cohort
health-related quality of life after massive burn injury

Conditions: Patients With Massive Burn Injury

Summary: massive burns are serious life-threatening conditions. recent advances in their management now allow the survival of a growing number of patients. the burn care paradigm is transformed: the evaluation of survival at the end of acute care is no longer sufficient for a good evaluation of practices; the attention now focuses on long-term health-related quality of life (hr-qol).the recently validated french translation of the burn specific health scale brief version makes this evaluation now feasible in french burn centers. the objectives of this study are to evaluate the hr-qol of massive burn survivors, to compare it to another chronic condition (necrotizing fasciitis) and to determine the main predictive factor of health-related quality of life. this study is retrospectively conducted in 18 patients who survived a massive burn injury involving more than 80% of the total body surface area, or more than 70% of the total body surface area if the injury occured during childhood and who were treated between 1997 and 2017 in our lyon burn center. short form-36 medical outcomes survey (sf-36), and brief version of burn speciﬁc health scale (bshs-b) are used for the present evaluation.

the hypotheses are as follows: * the hr-qol of massive burns shows a significative alteration compared to general population * this alteration is comparable with another chronic disease * the main predictors of impaired quality of life related to physical health status are hand injury, age at time of burn and time since burn * the main predictive factors of change in quality of life related to mental health status are age of onset and facial involvement.

Eligibility criteria:
inclusion criteria: 1. patients over 14 years of age 2. patients with a childhood burn reaching more than 70% of the total body surface or adult patients with burns of more than 80% of total body surface area 3. patients who were treated at the burn center between january 1997 and january 2017 4. patients who survived after initial hospitalization for burn management exclusion criteria: 1. patients with superficial burning, without sequelae or with extensive sequelae at less than 70% of total body surface area in children and less than 80% of total body surface area in adults 2. patients who expressed opposition to their participation in the study