Kornimate/medical-research-clean huggingface dataset:
the snec dsaek endoglide clinical trial

Conditions: Bullous Keratopathy

Summary: the purpose of this study is to determine the clinical safety and efficacy of the endoglide as a donor insertion device in dsaek surgery. the investigators hypotheses is that the endoglide will cause less endothelial damage compared to the investigators previous technique of glide insertion but will have the same low complication rate as the previous device. hence the investigators aim to evaluate the surgical efficacy of the endoglide to enable consistent double coiling of the donor lenticule in dsaek surgery with minimal endothelial touch. evaluate ease of insertion of the endoglide through a 4 to 4.5mm scleral tunnel wound. evaluate ability of the endoglide to consistently effect complete wound sealing, so as to stabilize anterior chamber with an ac maintainer in position. evaluate ease of donor pull-through from the endoglide chamber into the ac and to evaluate spontaneous uncoiling of the donor in the ac. evaluate clinical efficacy and safety outcomes in endoglide assisted dsaek surgery in study patients with corneal decompensation requiring dsaek surgery, in terms of postoperative visual acuity, primary graft failure rate, donor dislocation rate, endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured by corneal thickness parameters with the visante as-oct. the investigators will perfprm a prospective phase ii clinical trial using the endoglide for donor insertion in 100 corneal patients referred to the snec corneal clinics of the study investigators with moderate degrees of corneal decompensation from a variety of disorders which require dsaek corneal transplantation surgery, with or without concurrent cataract surgery, to restore visual acuity.


Eligibility criteria:
inclusion criteria: 1. patients presenting with corneal decompensation or bullous keratopathy requiring corneal transplantation for visual restoration and pain relief 2. clinical diagnoses including post-surgical forms of corneal decompensation (all forms of pseudophakic and aphakic bullous keratopathy including tass and irreversible descemets detachment), post-laser corneal decompensation, fuchs' and other forms of endothelial dystrophy, traumatic corneal decompensation, post-inflammatory corneal decompensation, etc. 3. mild to moderate forms of corneal decompensation 4. patients who agree to study participation following full informed consent 5. patients who agree to adhere to the standard snec clinical dsaek protocol in terms of pre and postoperative investigations and follow-up visits up to 12 months exclusion criteria: 1. severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for dsaek surgery as apposed to penetrating keratoplasty 2. patients with complex anterior segment complications precluding a successful dsaek procedure 3. patients unkeen to participate in the clinical trial

Keywords: endoglide endothelial keratoplasty donor insertion dsaek corneal transplant patients with bullous keratopathy
multicenter safety trial assessing an innovative tumor molecular and cellular print medical device in glioma

Conditions: Glioma : Oligodendroglioma or Astrocytoma

Summary: the purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device protool.

current limitations in the management of high grade brain tumors partly reside in the lack of access to pathological tissue. conventional biopsy devices can cause severe side effects, thus limiting the amount of tissue that can be collected for molecular characterization. the brain-tissue-imprint devices evaluated in this trial offers a unique opportunity to perform multiple non-lesion sampling in both tumor tissue and peritumoral areas. the approach relies on the use of tailored silicon chips integrated in surgical devices enabling tissue sampling through a brief "silicon to tissue contact", thus limiting potential side effects, and opening a way to extensive molecular investigation of brain tumors and their microenvironment.

Eligibility criteria:
inclusion criteria: * more or equal than 18 years old * patient affiliated to social security or similarly regime * informed consent form signed * glial tumor suspicion * stereotaxic biopsy indication * karnofsky score \> 70% * hematological assessment : * neutrophils \> 1500/mm3 * platelet \> 150 000 * blood creatinin normal * alkaline phosphatases and transaminases no more than two times normal * bilirubin \< 1.5 times normal exclusion criteria: * pregnant women and lactating mothers * ward of court or under guardianship * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalized without their consent * person under legal protection * person participating in another clinical study * intratumoral hemorrhage mri detected * treatment anticoagulant or antisludge treatments * active infections and non controled or medical affection or psychiatric intercurrent non treated * evolutive cerebral oedema without corticoid response * non controled epilepsy without antiepileptics response * susceptibility to medical device materials allergy
loop diuretics in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease

in ckd, impairment of renal function causes fluid and sodium retention and consequently expansion of extracellular volume, which corresponds to about 5% of body weight in absence of peripheral edema. in particular, sodium retention increases exponentially as glomerular filtration rate declines and is of primary importance in the pathogenesis of hypertension. therefore, reduction of salt intake in renal patients allows a better blood pressure control. despite the evidence collected on the beneficial effects of salt restriction in ckd, compliance with dietary prescription is generally poor in patients followed up in the real world of clinical practice. in the presence of poor adherence to salt restriction, diuretics agents become the cornerstone of treatment of hypertension secondary to ckd. disappointingly, nephrologists are reluctant to "adequately" use loop diuretics in their hypertensive ckd patients, probably because of the fear of side effects and of the amazing absence in medical literature of studies of middle-long term on diuretic efficacy. therefore, the primary aim of this study is to evaluate efficacy and safety of loop diuretics on blood pressure control in patients affected by ckd.

Eligibility criteria:
inclusion criteria: * chronic renal insufficiency in stage ckd 3 and 4 (gfr 60-15 ml/min/m2) estimated by cockcroft-gault formula corrected for body surface * systolic blood pressure \>140 mmhg in treatment with at least 1 class of antihypertensive drugs * patients not in treatment from at least one month with loop diuretics exclusion criteria: * loop diuretics treatment * variation of serum creatinine \>30% in the last 3 months * steroid therapy and/or cytotoxic agents * edema syndromes (nephrotic syndrome, cirrhosis, heart failure nyha class 3 or 4) * neoplasia

Keywords: loop diuretics chronic kidney disease hypertension blood pressure control left ventricular mass
spa therapy in knee osteoarthritis: study on cost/effectiveness - cost/utility and possible mechanisms of action

Conditions: Osteoarthritis, Knee

Summary: the aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible mechanisms of action of spa therapy in patients with primary knee osteoarthritis (oa).

oa is the most common rheumatic disease and the most important from the social-economic point of view because of its frequency, causing functional impairment and disability in older people, important health resource utilization and costs (drugs, physical therapies, spa therapy, surgical prothesis, early retirement). thermal therapy is one of the most commonly used non-pharmacological approaches for oa, but it is still being discussed and its role in modern medicine is still not clear. the action mechanisms of mud packs and thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment. furthermore, there are no data about cost analysis of spa therapy in oa. the aim of this study is to analyze for the first time the cost/effectiveness- cost/utility for spa therapy in comparison to conventional treatments in knee oa (one-year-follow-up)and to assess changes of some biomarkers or mediators of cartilage damage in order to identify new possible mechanisms of action of spa therapy in rheumatic diseases.

Eligibility criteria:
inclusion criteria: * patients suffering from oa of the knee according to american college of rheumatology (acr) criteria and to standard radiography of the knee exclusion criteria: * patients enrolled in other research protocols * patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months * patients affected by neoplastic diseases or in the last five years, with cardiovascular disease of recent onset, suffering from inflammatory diseases in the acute phase, serious impairment of hematopoietic, renal and hepatic systems, other inflammatory rheumatic or autoimmune disorders, or unable to complete the questionnaires and the daily diary for the collection of socio-economic data

Keywords: cost-effectiveness analysis cost-utility analysis osteoarthritis spa therapy randomized clinical trial mechanisms of action
investigation of sexual function in crohn's disease patients with perianal fistulas

Conditions: Crohn's Disease; Peri-anal Fistulas; Sexual Dysfunction

Summary: objective: the aim of this study is to investigate whether crohn's disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify crohn's disease patients that would benefit from sexual health interventions. hypothesis: crohn's patients with active perianal fistulas will have decreased sexual drive, performance, and satisfaction than those with crohn's disease in remission.

subject selection: inclusion criteria patients in a stable sexual relationship between the ages of 19 and 70 of both sexes with crohn's disease, as diagnosed based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months will be included in this study. patients included in this study will have been sexually active in the last 4 weeks. exclusion criteria all patients with known depression will be excluded from the study to prevent confounding the findings. patients that qualify for the study will be recruited, and be divided into inactive crohn's disease group with no peri-anal fistulas as a control group and an active crohn's disease with peri-anal fistula as the study group. inactive crohn's disease patients will be defined as patients with harvey-bradshaw scores below 5. fistula patients will be defined as patients with single or multiple draining fistulas, including perianal fistulas and enterocutaneous fistulas, for at least three months (17).

Eligibility criteria:
inclusion criteria: * patients in a stable sexual relationship between 19-70 years old with crohn's disease * crohn's disease diagnosis is based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months * patients will have been sexually active in the last 4 weeks. exclusion criteria: * all patients with known depression will be excluded from the study to prevent confounding the findings.
ondansetron vs ondansetron plus dexamethasone for relieving intrathecal morphine side effects after c-section

Conditions: Pruritus; Cesarean Section

Summary: background: common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. serotonin (5-ht3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. it was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus. objectives: the purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (ponv). methods: a prospective randomized double blind study that will be conducted between june 2016 and june 2017. patients will be randomly allocated into two groups. the first group will receive 4 mg intravenous (iv) ondansetron while the other group will receive 4 mg iv ondansetron plus 8 mg dexamethasone.

a prospective randomized double blind study will be conducted between june 2016 and june 2017. the sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. after obtaining informed consent, all eligible patients will receive spinal anesthesia. the first group will receive 4 mg intravenous (iv) ondansetron with 2 ml saline while the other group will receive 4 mg iv ondansetron plus 8 mg (2 ml) dexamethasone.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology physical status 1 and 2 * scheduled for elective c-section surgery under spinal anesthesia exclusion criteria: * patients with cardiac and psychological problems * patients who take sedatives or narcotics * patient who have allergy to study drugs
the incidence, risk factors, and effects of constipation in critical patients

Conditions: Constipation

Summary: this study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and c-reactive protein levels, and body temperature.

constipation is one of the most encountered nursing problems in intensive care unit patients. constipation is an important issue, especially in intensive care patients, requiring careful discussion since it has negative effects as well as high incidence and excessive risk factors. furthermore, untreated constipation in these patients delays enteral feeding prolonging the time of weaning from the mechanical ventilator, which consequently increases the duration of stay in the intensive care unit. additionally, it involves complications such as distention, nausea-vomiting, an increase in bacterial infection rate, high morbidity, and mortality. therefore, the definitions, risks, and effects of constipation, especially early and late constipation, in critically ill patients should be determined for evidence-based interventions. however, studies on the subject are limited.

Eligibility criteria:
inclusion criteria: * \>18 years * not abdominal surgery * not stoma * not constipation during admission * not intraperitoneal infection * not had a recent colonoscopy -\> 5 hospitalization days exclusion criteria: * having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension) * order for regular laxatives or enemas * not meet inclusion criteria during follow-up

Keywords: critical care constipation intensive care nursing
annual study for fluarix registration

Conditions: Influenza

Summary: a pre-requisite to the yearly licensing process of the influenza vaccine (fluarixtm/ influsplit ssw®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).

since 1998 it is common practice within the european community, to grant new licensees for influenza vaccines including the actual strain composition, by realizing the eu "mutual recognition procedure" the procedure foresees the clinical testing of the vaccine before approval according to the particulars in the eu-document cpmp/bwp/214/96: "note for guidance on harmonization of requirements for influenza vaccines" of the "committee for proprietary medical products (cpmp) as sub-organization of the "european agency for the evaluation of medicinal products". assessment of the immunogenicity and reactogenicity of the in its strain composition actualized, influenza split vaccine2004/2005 (influenza split vaccine 2005/2006) versus the criteria of the cpmp.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study. * all subjects, enrolled in this study, must not been immunized against influenza within the season 2003/2004. * written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * acute disease at the time of enrolment. (acute disease is defined as the presence of a moderate or severe illness with or without fever). all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature \<37.5°c (99.5°f). * acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. * pregnancy (exclusion by safe contraception; pregnancy test at day 0. * known allergic reactions, probably caused by one or more vaccine ingredients. * drug and/or alcohol abusers
adjunctive curcumin for symptomatic adolescents with bipolar disorder: brain and body considerations

Conditions: Bipolar Disorder

Summary: this study will enroll 30 adolescents with bipolar disorder (bd) who are suffering from symptoms of depression despite already taking a traditional mood-stabilizing medication. curcumin will be added to their current medications for 8 weeks. during these 8 weeks, their mood symptoms will be assessed regularly. height, weight, and blood pressure will also be measured repeatedly. blood tests will be completed before treatment, after 4 weeks of treatment, and at the end of the study. blood tests will allow us to determine whether changes in inflammation and oxidative stress explain curcumin's effect on mood. finally, we will use sophisticated technology to measure blood vessel functioning. we have three main predictions: 1. curcumin will improve mood symptoms without causing physical problems; 2. curcumin will reduce inflammation and oxidative stress, and these reductions will be linked to improvements in mood; 3. curcumin will improve blood vessel functioning, and these improvements will be linked to improved inflammation and oxidative stress.


Eligibility criteria:
inclusion criteria: * english speaking * all races and ethnicities * bipolar disorder i or ii * currently treated with lithium, divalproex, lamotrigine, and/or second generation antipsychotic * doses stable for greater than or equal to 4 weeks * current cgi bp score of moderate or greater * current cdrs-r severity of greater than or equal to 35 exclusion criteria: * if female, pregnant or sexually active without reliable contraception * significant suicidal ideations (as determined by clinical interview or cdrs-r \> 3) and/or any suicidal intent, even if fleeting or non-recurrent, in the preceding 2 weeks * substance dependence within the past 2 months * daily antidepressant, glucocorticoid, nonsteroidal anti-inflammatory, anti-platelet, anti-coagulant, antacid, or oral hypoglycemic medication or insulin; high-dose antioxidant vitamin supplements or other natural health products that may function as an antidepressant within 30 days of baseline * iq\<80 or autistic disorder * full threshold mania and/or ymrs \> 20 and/or psychosis * hypersensitivity to curcumin/turmeric, gelatin * dietary consumption of curcumin/turmeric \> 3 times/week * clinically significant or unstable medical disorder; known gallstones and/or bile duct obstruction, stomach ulcers, excessive stomach acid/heartburn/gastroesophageal reflux disease (gerd); or clinically significant baseline laboratory abnormalities; or alt and /or ast above the upper limit of normal on repeat examination at baseline * severe depression (cdrs-r \> 98) and/or severely ill (cgi bp \>5)
inflammatory regulation effect of nac on covid-19 treatment

Conditions: COVID-19

Summary: study times to evaluate the efficacy of n-acetylcysteine therapy in the management of adult admitted patients with covid-19.


Eligibility criteria:
inclusion criteria: * adult above 18 years of age * admitted to the hospital with confirmed covid-19 by rt-pcr test * on oxygen supplement exclusion criteria: * active use of nac * known nac allergy * in the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment * all patients enrolled in any other investigational drug studies in covid-19.

Keywords: nac
safety and tolerability of cidofovir gel applied on cervix squamous lesions

Conditions: Uterine Cervical Neoplasms; Cervix Intraepithelial Neoplasia

Summary: human papilloma virus (hpv) infections induce cervical intraepithelial neoplasia (cin) of cervix. to reduce incidence of invasive tumor associated with high grade cin lesions, the standard treatment is the conisation of cervix (surgical act). a local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation. this clinical study is aimed at : 1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade cin lesions; 2. evaluating the pharmacokinetic (pk) profile of cidofovir after local application.


Eligibility criteria:
inclusion criteria: * women aged between 18 and 50 years old * volunteers * informed consent signed * cervical lesion classified cin 2 or 3, on a biopsy made during the 6 preceding weeks * no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring) exclusion criteria: * pregnancy or breast feeding * subtotal hysterectomy * current or ancient renal impairment * current immune disorder * current use of drugs interfering with renal function * current treatment for any cancer * current use of treatment interfering with immunity * current use of anti-viral treatment * current or recent participation to another experimental study during the last 3 months before the screening visit * current vaginal application of drugs or cosmetics * local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

Keywords: cervix intraepithelial neoplasia grades 2 and 3