Kornimate/medical-research-clean huggingface dataset:
autologous transplantation of cultivated limbal stem cells on amniotic membrane in limbal stem cell deficiency (lsd) patients

Conditions: Limbal Stem Cell Deficiency

Summary: the purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.

ocular surface is composed of corneal and conjunctival epithelial cells. normal cornea is essential for normal vision. defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. restoring ocular health in these eyes has traditionally been frustrating. ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). the donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. the tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. the surgery is undertaken under either local or general anesthesia.

Eligibility criteria:
inclusion criteria: * patient with unilateral limbal stem cell insufficiency and totally corneal vascularization * presence of goblet cells on the cornea * minimum tear was about 5 mm * minimum duration of deficiency was 3 years * vision was light perception exclusion criteria: * systemic disease affecting both eyes such as stevens-johnson syndrome

Keywords: limbal stem cell deficiency
efficacy of a new thickened extensively hydrolyzed formula

Conditions: Protein Allergy; Cow's Milk Protein Hypersensitivity

Summary: cow milk allergy (cma) occurs in 2 to 5 % of all infants. reflux, regurgitation and vomiting are well recognised symptoms of cma. the recommended treatment of cma is an extensive hydrolysate. the north american society of pediatric gastroenterology hepatology and nutrition (naspghan) \& the european society of pediatric gastroenterology hepatology and nutrition (espghan) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of cma. one of the preferred proposed options is to thicken an extensive hydrolysate . this study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of cma and presenting with frequent regurgitation.


Eligibility criteria:
inclusion criteria: * term born infants * having a vandenplas' score of regurgitation of at least 2 * with suspected diagnosis of cma because of clinical history/symptoms (based on a cow's milk protein hypersensitivity (cmph) score of 10 or more) and/or positive immunoglobulin e (ige) testing, radioallergosorbent test (rast) or skin prick test exclusion criteria: * exclusively breast fed infants * fed with an extensively hydrolysed formula or amino acid formula
tissue repair device (vergenixtm str) in patients with epicondylitis (tennis elbow)

Conditions: Non Ruptured Tendon Injuries; Tendinopathy

Summary: the vergenixtm str device is intended for the repair of non ruptured tendon injuries (tendinopathy).

the vergenixtm str device is an advanced soft tissue repair device, made of lyophilized type i rhcollagen and calcium chloride that will be mixed with autologous prp prior to injection for the repair of non ruptured tendon injuries (tendinopathy). three (3) ml of the mixed solution will be injected into the common extensor tendon.

Eligibility criteria:
inclusion criteria: 1. man or woman aged 18 - 80 years old. 2. clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension. 3. documented ultrasonography diagnosis of common extensor tendinosis and possible tear based on abnormal echotexture (tendon thickening, anechoic areas, areas of hypoechogencicity, loss of fibrillar pattern). 4. chronic symptoms (equal or greater than 3 months). 5. prtee questionnaire score of at least 50 out of 100. 6. for child-bearing potential females, documentation of birth control. 7. signing informed consent form. - exclusion criteria: 1. acute symptom onset (less than 3 months). 2. history of acute elbow trauma. 3. history of rheumatoid arthritis. 4. history of inflammatory disease 5. history of fibromyalgia 6. the patient has active malignant disease of any kind. a patient who has had a malignant disease in the past, was treated and is currently disease-free for at least 5 years, may be considered for study entry. 7. the patient is treated with anti-coagulant medication 8. the patient previously underwent a surgery for lateral epicondylitis. 9. the patient previously received local injections, including steroids within the last 30 days 10. signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion). 11. wounds around the elbow 12. likely problems, in the judgment of the investigator, with maintaining follow-up. 13. clinically significant abnormalities in hematology and blood chemistry lab tests at screening that in the opinion of the investigator might interfere with the patient's safety or participation in the study. 14. known as positive hiv, hepatitis b, or hepatitis c. 15. known history of a significant medical disorder, which in the investigator's judgment contraindicates the patient's participation. 16. known hypersensitivity and/or allergy to collagen. 17. drug or alcohol abuse (by history). 18. pregnancy of child-bearing potential females. 19. participation in another study within 30 days prior to screening visit. -

Keywords: safety and performance
evaluate the pharmacokinetics of quetiapine fumarate in chinese schizophrenic patients

Conditions: Schizophrenia

Summary: the primary objective of the study is to evaluate the pharmacokinetics of xr quetiapine fumarate(300mg,600mg,and 800mg once-daily) in chinese schizophrenic patients .


Eligibility criteria:
inclusion criteria: * men and women aged 18 through 60 years inclusive * schizophrenia diagnosis * body mass index (bmi) 20-27 kg/m2 (inclusive) * provision of written informed consent before initiation of any study exclusion criteria: * aids \& hepatitis b * history of seizure disorder * history of episodic,idiopathic orthostatic hypotension

Keywords: quetiapine fumarate(seroquel) extended-release(xr) china pk study pharmacokinetics parameters
the effect of chronic remote ischaemic preconditioning on blood pressure in older adults

Conditions: Hypertension; Vascular Diseases

Summary: the purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults

hypertension and stroke remain leading causes of mortality across the world (1). hypertension affects more than 1 in 4 adults and is the 3rd biggest risk factor for premature death and disability in the uk (2). cerebrovascular disease is ranked 4th in the list of leading causes of death in the uk (3). at present, the treatment of these conditions largely involves chronic pharmacotherapy. in parallel, it is increasingly appreciated that polypharmacy poses a significant challenge to our older adult population. guthrie et al showed that the number of people prescribed \>5 medications in an area of the uk doubled between 1995 and 2010 (from 11.4% to 20.8%) (4). age is significantly associated with polypharmacy, with an odds ratio of 118.3 when those aged 20-29 are compared to those \>80. what's more, it has been estimated that adverse drug reactions account for 6.5% of hospital admissions (5), with age correlating significantly with admissions for this reason. therefore, discovering a non-pharmacological intervention for hypertension and cerebrovascular disease could greatly benefit the population, particularly the elderly, both in terms of treating the diseases themselves and reducing the harmful effects of polypharmacy. remote ischaemic preconditioning (ripc) is the induction of non-lethal ischaemia in one organ or tissue, with the aim of conditioning a distant organ or tissue against ischaemic events. it is achieved via inflation of a blood pressure cuff to supra-systolic pressures for a short period of time. a recent meta-analysis showed that chronic ric, but not acute ric, significantly lowered diastolic and mean arterial blood pressure (6). the studies included in this review were small and performed in a younger population, hence larger studies are needed to clarify the effect of ric in the field of hypertension and, importantly, the elderly.

Eligibility criteria:
inclusion criteria: * participant is aged \>65y and \<85y. * participant is willing and able to give informed consent for participation in the study. * participant is physically able to perform ripc. exclusion criteria: * a bmi \ 35 kg/m2 * active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (bp \> 160/100), active angina, heart failure (class iii/iv), arrhythmia, right to left cardiac shunt, recent cardiac event, copd, pulmonary hypertension or recent (6 mo) stroke. * if history of hypertension, no recent alteration to antihypertensive medication (3 months). * a history of, or current neurological or musculoskeletal conditions (e.g. epilepsy) * having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Keywords: remote ischaemic preconditioning non-pharmacological remote ischaemic conditioning randomised controlled trial
dose optimization in 3d pulsed dose rate brachytherapy for patients with locally advanced cervical cancer

Conditions: Cervical Adenocarcinoma; Stage IB Cervical Cancer; Stage II Cervical Cancer; Stage III Cervical Cancer

Summary: this prospective phase ii trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 gy over 90% of its volume) and the intermediate target volume (60 gy to 90 % of its volume) in 3d pulsed dose rate brachytherapy in treating patients with locally advanced cervical cancer.

* the causes of treatment failure and death in cervical cancer are still often linked to a local cancer progression * the importance of local control for healing, than the cervix situation in the center of pelvis between bladder and rectum which are sensitive organs to irradiation justify the use of utero-vaginal brachytherapy * this open label, multicenter, phase ii study evaluates the benefit of increasing in dose to the target volume at high risk and the intermediate target volume in 3d pulsed dose rate brachytherapy in treating patients with locally advanced cervical cancer. * local control and tolerance are evaluated

Eligibility criteria:
inclusion criteria: * primitive cervical cancer * adenocarcinoma histologically advanced * ib2, ii and iii stage * curative treatment * indication of utero-vaginal brachytherapy with external radiotherapy * non-metastatic tumor and life expectancy \> 6 months * patient informed and follow possible * performance status ≤ 2 * unplanned surgery * age ≥ 18 years old * ability to provide written informed consent before the start of any study specific procedures exclusion criteria: * primitive endometrial cancer * other diseases * carcinoma in situ and stages ≤ b * distant metastases * history of pelvic irradiation or a first pelvic cancer * contraindication to mri * history of subtotal or total hysterectomy * pregnant or breast feeding females * inability to support low dose rate continuous brachytherapy or pulsed flow * person in emergencies * person unable to give personally consent * patient participating in another clinical research except in case of local recurrence or observational research

Keywords: pulsed dose-rate brachytherapy 3d dosimetry prospective studies radiotherapy dosage uterine cervical neoplasms/radiotherapy brachytherapy/methods
to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder (MDD)

Summary: this is a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (mdd). enrollment into the study will be from eligible participants who have completed participation in protocol 31-08-255 \[nct01111539\], 31-08-256 \[nct01111552\], or 31-08-263 \[nct01111565\] ("rollover" participants).


Eligibility criteria:
inclusion criteria: * participants who participated in protocol 31-08-255, 31-08-256, or 31-08-263. exclusion criteria: * participants with a current need for involuntary commitment or who have been hospitalized ≤ 28 days of the baseline visit for the current major depressive episode. * participants with a diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar i or ii disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder. * participants with a diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. * participants experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode. * participants who have met diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for substance abuse in the past 6 months (prior to the baseline visit) and/or dependence up to and including the past 12 months (prior to the baseline visit), including alcohol and benzodiazepines, but excluding caffeine and nicotine. participants with two positive drug results for cocaine should be excluded from the study. * participants with hypothyroidism or hyperthyroidism. * participants with a significant risk of committing suicide based on history, investigator's judgment, and/or evaluation based on the columbia-suicide severity rating scale (c-ssrs). * participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders. * participants with insulin-dependent diabetes mellitus (iddm). * participants with epilepsy or significant history of seizure disorders, except for a single childhood febrile seizure, post-traumatic, etc.

Keywords: major depressive disorder mdd depression
analgesic self-medication for acute pain by patients awaiting a consultation with a general practitioner

Conditions: Acute Pain

Summary: what are the terms of use of analgesics for acute pain on an outpatient basis before a consultation with a general practitioner? descriptive epidemiological study of patients in general practice in rhône-alpes


Eligibility criteria:
inclusion criteria: * adult patient * without cognitive impairment * having acute pain for less than 3 months * consultant to the practices participating to the study. exclusion criteria: * patients who do not understand french * patients protected by law

Keywords: acute pain analgesics self medication
the effect of omega-3 supplementation on muscle functioning, inflammation and muscle signaling

Conditions: Aging

Summary: elderly are supplemented with either omega-3 (3 x 1.1g per day) or placebo (corn oil) during 14 weeks. the last 12 weeks, supplementation is combined with resistance exercise training (3x per week) focusing on upper leg strength. in the present project, the investigators study whether differences in muscle strength and/or muscle mass between conditions can be explained by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in muscle molecular signaling.

elderly are supplemented with either omega-3 (3 x 1.1g per day) or placebo (corn oil) during 14 weeks. the last 12 weeks, supplementation is combined with resistance exercise training (3x per week) focusing on upper leg strength. in the present project, the investigators study whether differences in muscle strength and/or muscle mass between conditions can be explained by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in muscle molecular signaling.

Eligibility criteria:
inclusion criteria: * aged \>= 65 years exclusion criteria: * bmi \ 35 * regular nsaid intake in the last 3 months * omega-3 supplementation in the last year * regular resistance exercise in the last year * cancer, liver and renal disease, unstable cardiovascular disease, musculoskeletal disease * cognitive limitations that might interfere with the (adherence to) the intervention or with the testing of outcome parameters * unstable body weight * smoking

Keywords: muscle metabolism inflammation muscle molecular signaling muscle functioning
prospective cohort study of outcome after minimally invasive posterior cervical spine surgery

Conditions: Spinal Curvature

Summary: in case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (acdf), tubular retractor assisted micro-foraminotomy (mtpf) and posterior percutaneous cervical foraminotomy and discectomy (p-pecd). p-pecd is a modern technique and there was no rct with mtpf, although p-pecd showed not inferior result to acdf. nowadays mtpf and p-pecd are minimally invasive surgical techniques, but there was no comparative study. the primary object of the study is to compare radiological outcome (segment angle) after mtpf or p-pecd.

p-pecds are performed in seoul national university hospital mtpfs are performed in kyoung-pook national university hospital and acdf are performed in seoul national university bundang hospital.

Eligibility criteria:
inclusion criteria: * cervical radicular pain * no cervical myelopathy exclusion criteria: * motor weakness less than mmt gr iii * cervical myelopathy * opll and myelopathy * previous cervical spine surgery * combined fracture or spinal tumor

Keywords: cervical vertebra surgery tubular retractor endoscope
comparing the quality of topical autologous serum in different etiologies of dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: human autologous serum is commonly used in the treatment of dry eye disease. however, different patients may have different effect with autologous serum treatment. we would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye.

dry eye is an important issue in the filed of ophthalmology and has great influence on the quality of life in many patients. traditional treatment was mainly focused on artificial tear supplement. inflammatory factors are identified in the recent days and are thought to play an important role in the etiology of dry eye. anti-inflammatory agent like topical immunosuppressant has become another choice in the treatment of dry eye. conventional artificial tear has similar biochemical features and osmolarity with natural tear but lacks the anti-inflammatory cytokines. therefore, autologous serum has been applied as a substitute of natural tear because it has more anti-inflammatory cytokines. clinical trials have shown that autologous serum drops improve ocular irritation symptoms, and conjunctival and corneal dye staining in dry eye. however, in the manufacture of autologous serum, it is hard to standardize every step and control quality. what's more, the patient may have different etiology of dry eye, including primary sjogren's syndrome, secondary sjogren's syndrome, other autoimmune disease, or ocular graft versus host disease. the etiology of dry eye may have different response to autologous serum. however, we don't know if the autologous serum from different patients' have different components and the different components of cytokines may have different treatment efficacy. this is what we want to know in this study. since human autologous serum is needed for cytokine analysis, we proposed this project to collect human serum from volunteers。

Eligibility criteria:
inclusion criteria * healthy volunteer control without ophthalmic history * patients with primary sjogren's syndrome: according to the classification of american european consensus group of rheumatologist and ophthalmologists, * patient with secondary sjogren's syndrome: sjogren's syndrome associated with systemic lupus erythematosus, systemic sclerosis (scleroderma), rheumatoid arthritis, mixed connective tissue disease, inflammatory muscle disease, autoimmune liver disease, and autoimmune thyroid disease * ocular graft versus host disease * volunteers with dry eye symptoms but not diagnosed with primary sjogren's syndrome, secondary sjogren's syndrome and ocular graft versus host disease exclusion criteria * patients who decline to receive the venipuncture for blood sampling. * patients younger than 20 years old or older than 80 years old.

Keywords: dry eye
effect of combination therapy with two drugs (colesevelam and ezetimibe) in patients with high cholesterol

Conditions: Hypercholesterolemia

Summary: assess the efficacy of welchol® plus zetia® in treating patients with high cholesterol


Eligibility criteria:
inclusion criteria: * 18-80 years of age, inclusive; * a history of primary hypercholesterolemia exclusion criteria: * any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data; * hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease

Keywords: safety efficacy welchol® zocor® zetia®